BHI Weekly Newsletter Archives

This invitation-only event is free for executive level biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of speakers to this virtual event!

*Please note that attendees’ name might be recorded if participating in the chat function during the event.

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Don’t miss your change to be named the BioHealth Startup with the Most Commectial Potential at the BHCR Forum, win $10,000 and more!

Applications due: 9/15

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

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Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.   

Register one team or multiple teams this month to compete for the Cup in September!

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3rd Annual BioHealth Capital Region Investor Forum

Ocr 20 – 21st, 2020

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ANNAPOLIS, MD—Governor Larry Hogan today commended the nearly 40 Maryland life sciences companies that are working on developing and manufacturing COVID-19 vaccines and therapeutics, improving diagnostic tests, and providing clinical research and technological support to ensure safe and effective health care delivery.

The University System of Maryland and Johns Hopkins University have also dedicated millions of dollars toward research, testing, and clinical trials. The University of Maryland School of Medicine recently began phase 3 trials of a COVID-19 vaccine.

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“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features 5 Questions with Judy Costello who is Managing Director of Economic Development for BioHealth Innovation, Inc. (BHI).

Judy Costello is Managing Director of Economic Development for BioHealth Innovation, Inc. (BHI). Prior to joining BHI, she served as Director of the Maryland Department of Commerce’s Office of BioHealth and Life Sciences and as Deputy Director of the department’s BioMaryland Center. In these positions, she has worked to grow the region’s biohealth cluster by supporting industry recruitment and retention, commercialization, workforce, non-dilutive and dilutive fundraising, international soft landing, partnership, and promotion activities. She previously served as Executive Director of the Business Alliance for Innovation and Entrepreneurship.

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The biotechnology company Novavax will soon begin the second phase of human testing for its COVID-19 vaccine.

The so-called phase 2b clinical trial will include a group of 2,665 healthy adults in South Africa, as well as a group of 240 adults with HIV who are considered medically stable but whose immune responses may differ from individuals without HIV, according to a statement released by Novavax on Aug. 17. HIV advocacy groups have pushed for people with HIV to be included in clinical trials for COVID-19 vaccines, as companies like Moderna and Pfizer initially said they would exclude volunteers with the infection, Science Magazine reported.

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GAITHERSBURG, MD, AUGUST 18, 2020 — MaxCyte, Inc., a global cell-based therapies and life sciences company, today announces the expansion of subsidiary CARMA Cell Therapies’ ongoing Phase I intraperitoneal delivery and dose-escalation trial of MCY-M11, its lead anti-mesothelin CAR-PBMC cell therapy candidate. The expansion will involve a new parallel cohort of patients and the initiation of two additional clinical sites.

The new parallel Phase I cohort will evaluate intraperitoneal delivery of MCY-M11 at escalating doses in additional patients with relapsed/refractory ovarian cancer and malignant peritoneal mesothelioma, with the addition of a preconditioning regimen of cyclophosphamide prior to MCY-M11 infusion. This parallel Phase I cohort with preconditioning will progress independently from the ongoing evaluation of MCY-M11 in the existing no-preconditioning Phase I cohort. The MCY-M11 Phase I trial will also allow for multiple treatment cycles where indicated for both future preconditioning and no-preconditioning patients.

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The OrganoPlate® Graft is the first in vitro cell culture platform that allows vascularization of 3D tissues like spheroids, organoids, and tumors in vitro.

In this webinar, you will learn:

Limitations of current models How to build 3D vascularized tissues How to form vascular beds in vitro How to add 3D microtissues in the OrganoPlate Graft How to set up available assays How to get started in your lab

Image: https://go.mimetas.com

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced Mayo Clinic has committed $1.75M as a lead investor in a $7 million convertible note financing round.

Mayo Clinic is collaborating with APT to conduct a clinical trial using PhageBankTM investigational therapy to address the significant unmet need for alternative treatments for chronic infections following joint replacement (referred to as “periprosthetic joint infections,” or “PJIs”). Proceeds from the convertible note are designated to initiate the trial.

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The University System of Maryland has partnered with Labster to provide its virtual laboratory simulations across all USM institutions. The university is working to integrate virtual science labs into its course offerings as the COVID-19 pandemic has limited students’ and instructors’ access to classrooms.

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Maryland’s 8th Congressional District has the highest proportion of science and engineering jobs in its workforce out of any district in the United States, according to a new report from the Information Technology Industry Council.

About 4.6% of the jobs in the district — which encompasses parts of Montgomery, Frederick and Carroll County — are in science and engineering, but the report found that the median U.S. district has less than 1% of such jobs.

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Maryland’s Department of Health announced Thursday it will partner with 13 hospitals around the state to launch an antibody study on unused blood samples. It’s part of a new program to incorporate antibody testing into the state’s continued strategy to fight COVID-19.

The News4 I-Team first asked about that strategy in May, when Virginia began posting its antibody testing details online, with positive and negative results listed by local health district. In mid-July, Maryland provided the I-Team with data showing more than 81,000 Marylanders had been antibody tested through private vendors.

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The coronavirus pandemic has impacted cities across the country with varying force. New York City has been hardest hit, and it’s no secret that the Big Apple is going to be one of the places that will have the most challenging time bouncing back from the coronavirus pandemic, no matter when things subside. But which cities will have the best coronavirus recovery? And which other cities will struggle? Moody’s Analytics has issued a report that examines the potential to recover from coronavirus among the top 100 metro areas in the US—and while some of the results are to be expected, some are more surprising.

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(Rockville, MD – August 20, 2020) – Scheer Partners is proud to announce that 704 Quince Orchard Road, Gaithersburg, Maryland is 100% leased.

In 2018 Scheer Partners’ affiliate, South Duvall, part of a joint venture with a publicly traded REIT, acquired 704 Quince Orchard Road. 704 Quince Orchard Road presented an opportunity to convert an underperforming office building in the Gaithersburg Life Sciences Cluster. Scheer Partners, Inc. provided brokerage, construction management, and property management services for the 80,000 square foot project and made the entire building “lab-ready.” Scheer Partners’ Adnan Sheikh spearheaded construction management of the project in partnership with their Property Management Division, led by Ayesha Murray, which continues to ensure the building operates at peak performance.

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The cells that allow people to smell are a key entryway for the coronavirus, making nose coverings crucial, suggests new research from the Johns Hopkins University.

The nose already had been emerging as a main door for the virus and related respiratory disease. But this research specifically points to the olfactory cells because they have a very large number of receptors on their surface called ACE2 that have been shown to be vulnerable to coronaviruses.

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The National Institute of Allergy and Infectious Diseases (NIAID) recently reissued the funding opportunity announcement (FOA) for the New Innovators Award (PAR-20-259). The first application due date is November 2, 2020.

The NIAID New Innovator Award supports a postdoctoral or newly independent Early Stage Investigator of exceptional creativity who proposes novel, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID. Applications proposing unexpected convergence of disciplines, new scientific directions, or the use of novel methodologies are encouraged.

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Sweden expects to have as many as 18m doses of coronavirus vaccine by next year, enough to inoculate the entire Swedish population, according to the country’s vaccine coordinator. “If these vaccines work and are safe, it’s possible that we will have vaccinated everyone who wants it next year, or at the start of 2022,” Richard Bergström told the Dagens Nyheter newspaper.

Image: Sweden’s vaccine coordinator Richard Bergström. Photo: Stina Stjernkvist/TT

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GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The Phase 2 clinical trial expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial’s population. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

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Women Building Bio is where the vision is transformed into reality. Women advancing the industry with all stakeholders, men and women, front and center joining forces.

Come join us for this half day interactive virtual conference on September 16, 2020.

Click here to register.

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

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This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati, AstraZeneca, Deloitte, and Montgomery County Economic Development Corp.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

Click here to register!

#BHCRForum20

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Baltimore, MD. (Aug. 10, 2020) — The University System of Maryland (USM) Momentum Fund has invested $250K in miRecule, an emerging biotech company with a cutting-edge discovery platform to create RNA therapeutics alongside theFSHD Society as a co-investor. This investment is complemented by recent funding raised over the past year, which includes lead investor Alexandria Venture Investments as well as Pathway Bioventures, Alumni Ventures Group, and angel investors. In total, miRecule’s seed round raised more than $3.5M in private seed funding. In addition to its private investments miRecule has also been awarded a non-dilutive $2M Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute.

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GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the shelf life of NARCAN® (naloxone HCl) Nasal Spray from 24 months to 36 months. Narcan Nasal Spray was the first intranasal form of naloxone approved by FDA and Health Canada for the emergency treatment of known or suspected opioid overdose.

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PASADENA, Calif., Aug. 13, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, is at the vanguard of the vital life science ecosystem that is advancing solutions for COVID-19 through a multifaceted, highly impactful strategy that includes a mission-critical focus on making rapid COVID-19 testing available to all Americans. Widespread screening and diagnostic testing, in addition to safe and effective vaccines and therapies, are desperately needed to resolve the global COVID-19 pandemic.

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Our annual cluster ranking profiles the top U.S. life sciences hubs and tracks the progress of the up-andcoming life sciencesmarkets that are fast becoming options of choice for life sciences companies and investors alike. Finally, the outlook introduces prominent industry trends that will provide new engines of growth.

In this report

In addition to highlighting the current state of life sciences real estate clusters across the U.S., this report will provide answers to three critical questions that both life sciences companies and lab developers must consider in order to remain at the crest of industry trends.

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Venlo, The Netherlands, August 13, 2020 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it will continue to execute its successful growth strategy aiming to create significant value for shareholders and other stakeholders after the voluntary public takeover offer by Thermo Fisher Scientific, Inc. (NYSE: TMO) did not achieve the minimum 66.67% acceptance threshold from QIAGEN shareholders.

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GERMANTOWN, Md., Aug. 17, 2020 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the first patient has been dosed with Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse™ platform designed to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597). HPV-associated cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

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SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency’s review to be complete in April 2021.

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Maryland has become a key part of the strategy for Kite, a Gilead company, and its mission to find a cure for cancer. As the California-based company focuses more and more on cutting-edge cell therapy research and manufacturing, Kite is expanding its toehold in the BioSpace Hotbed region known as BioCapital.

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ROCKVILLE, Md., Aug. 12, 2020 /PRNewswire/ — Emmes today announced that it provided the data and statistical analysis support for the Phase 1 clinical trial of the investigational COVID-19 vaccine mRNA-1273. Three Emmes employees were co-authors on the Preliminary Report about the clinical trial, “An mRNA Vaccine against SARS-CoV-2,” published in the New England Journal of Medicine on July 14.

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COLUMBIA, Md. (August 13, 2020)— TEDCO, Maryland’s economic engine for technology companies, announced its recent round of investments in six (6) start-up companies and funding to fifteen (15) university projects through the Maryland Innovation Initiative (MII).

Established in 2012, the MII program was created as a partnership between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park. The program’s mission is to accelerate promising technologies with significant commercial potential to market while leveraging each partner University’s strengths.

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We sourced the community, built a roster of Greater Washington’s hottest enterprises and innovators, and narrowed that list to the ecosystem’s 50 elite.

Then Thursday afternoon, we celebrated those fast-growing, move-making players: DC Inno’s 2020 Inno on Fire winners. All had banner years — for expansions, launches, fundraises and pivots — and all in a time of profound, unprecedented change.

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The 2020 Technology Showcase is going virtual! Reserve the afternoon of September 9th on your calendar for the 2020 Technology Showcase. The 4th annual event will highlight technologies being developed at the NCI and the Frederick National Laboratory for Cancer Research (FNL) to encourage technology licensing and collaborations, startup company formation and the translation of NCI discoveries into solutions to benefit patients. 

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Emergent BioSolutions CEO Bob Kramer joined Jim Cramer on “Mad Money” to discuss the biopharmaceutical company’s role in the quest to bring a Covid-19 vaccine to market.

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Alexandria Real Estate Equities, Inc. (NYSE:ARE), an S&P 500® urban office REIT, is the first and longest-tenured owner, operator, and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, including Greater Boston, San Francisco, New York City, San Diego, Seattle, Maryland, and Research Triangle. Alexandria has a longstanding and proven track record of developing Class A properties clustered in life science, technology, and agtech campuses that provide our innovative tenants with highly dynamic and collaborative environments that enhance their ability to successfully recruit and retain world-class talent and inspire productivity, efficiency, creativity, and success. For more information, please visit www.are.com.

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Originally Aired: August 12, 2020 Time: 3:00 pm ET

Gene therapy has undergone a renaissance in recent years, with several drugs offering beneficial, even life-saving treatments, now approved by the FDA and EMA. A big reason for this turnaround is the emergence of adeno-associated virus (AAV) as a generally safe and efficient vector for therapeutic gene delivery.

Earlier this summer, reports emerged of two fatalities in young boys in a clinical trial for a rare muscle disorder using AAV. This sad news has turned the spotlight on viral dosage, vector manufacturing and immune responses as factors we need to better understand to ensure the safety of gene therapy treatments in the future.

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The incubation period of a disease is the time between infection and the emergence of symptoms. Although it varies from person to person, understanding the average incubation period of an infectious disease is critical to controlling it.

Authorities use the incubation period to determine the length of quarantine, for instance, as well as to understand how the disease is transmitted and to identify the source of the outbreak.

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It takes no time for Francis Collins, the director of the National Institutes of Health, to recall the moment when he knew he wanted to be a scientist. “Tenth-grade chemistry class,” he says over the phone from his home office in Chevy Chase, Md., where he has been working since most of the NIH campus in Bethesda, Md., shut down in March. Much of the science he had learned before then was “descriptive” and uninteresting, he explains—but for this class, students used experiments to figure things out. “It became clear to me that science is like a detective story,” says Dr. Collins, 70. “If you’re good at it, you’ll discover…

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Montgomery County is closing all testing sites Friday until further notice after issues were raised by the state with some testing kits.

Anyone who was tested at a county-sponsored clinic in the past two weeks should be retested at another community-based clinic, the county said on its website.

Maryland’s department of health raised questions about protocols used with some test kits by AdvaGenix, which uses self-administered kits to collect saliva. These kits account for about 7% of all tests conducted in the county, adding up to hundreds every day.

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

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BioHealth Innovation (BHI) was created in 2012 by Rich Bendis and key industry leaders to accelerate the commercialization of high potential scientist entrepreneurs and companies within the BioHealth Capital Region (BHCR), which consists of Maryland, Virginia and Washington, D.C.

Prior to BHI’s launch, the region’s development efforts were heavily focused on academic and government research assets. BHI’s mission is to give the life science industry a greater voice within the region and to be more market and entrepreneur-driven. During the last 8.5 years, BHI has grown substantially and spearheaded the effort to create a strong regional brand that is now known as the BHCR.

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Reporting to Vice President and Chief Innovation Officer, the senior licensing associate independently manages a docket of technologies and has advanced level skills in technology marketing and licensing. The individual assumes primary responsibility for directly facilitating the technology transfer, development and commercialization of assigned technologies and faculty/departmental clients, assisting faculty and staff with the establishment of new commercialization agreements and business development relationships, supporting the establishment of R&D collaborations with industry partners to advance early stage discoveries, and managing relationships with key stakeholders internal and external the organization to proactively enable technology transfer. The Senior Licensing Associate will provide high quality services including invention receipt and capture, patentability assessment, market outreach (in-depth marketing support strategic and tactical), business development (structuring, drafting and negotiating commercialization agreements) and shall deliver the highest quality of customer service. This position will also manage other functions for the office as assigned in addition to technology licensing.

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The BioHealth Capital Region and BioForward Wisconsin come together as Lisa Johnson joins Rich Bendis on BioTalk to discuss her career, the industry, and growing biohealth in the Midwest. 

Listen now via Google https://bit.ly/2DtF6Y1, Apple, https://apple.co/3fJU0q3, Spotify https://spoti.fi/3fFpb5H, TuneIn https://bit.ly/3iqNAh9, and YouTube Audio https://bit.ly/2PERPcH

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GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1.

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GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced Mayo Clinic has committed $1.75M as a lead investor in a $7 million convertible note financing round.

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Download an A to Z business guide that offers federal, state and local resources to help your Montgomery County business succeed. The newly expanded, 14-page MCEDC Business Resource Guide. Find funding, training, talent, support for women and diverse businesses and more—a handy guide to use and share.

Click here to download.

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GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) (the “Company”) announced today that it intends to offer $400 million aggregate principal amount of senior unsecured notes with an expected maturity date of August 2028 (the “Notes”). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by all of the Company’s direct and indirect subsidiaries that guarantee debt under its credit facilities. The Company intends to use the net proceeds of the offering to repay the $353 million outstanding under its $600 million revolving credit facility with the remainder to be used for general corporate purposes.

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The study found the candidate elicits “robust antibody responses” and is well-tolerated, the company said Tuesday.

Image: Novavax is advancing a Covid-19 vaccine candidate through clinical trials. COURTESY NOVAVAX

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ROCKVILLE, Md., Aug. 6, 2020 /PRNewswire/ — Emmes today announced that three corporate vice presidents have been promoted. Dr. Traci Clemons has been named chief research officer, Marian Ewell is now chief scientific innovation officer, and Jennifer Hester is the company’s chief human resources officer. These are all newly created positions for the company.

Image: Dr. Traci Clemons

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GAITHERSBURG, Md., July 23, 2020 /PRNewswire/ — Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company will fast-track the manufacture and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN) under US FDA ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

Image: SHYCOCAN Devices

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This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

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With so much attention on COVID-19 treatment and vaccine developments, life science laboratories are getting more notice.

Alexandria Real Estate Equities (NYSE:ARE) is a real estate investment trust (REIT) based in Pasadena, California. It’s the largest landlord in the US for laboratories and related offices.

Its top companies by rent revenues include Amgen (NASDAQ:AMGN), Bristol-Myers Squibb (NYSE:BMY), Celgene, Eli Lilly (NYSE:LLY), Merck (NYSE:MRK)—which we own in Profitable Investing—Moderna (NASDAQ:MRNA), Novartis (NYSE:NVS), Pfizer (NYSE:PFE) and Sanofi (NASDAQ:SNY).

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The University of Maryland School of Medicine and about 30 other U.S. centers have begun recruiting thousands of volunteers living in COVID-19 hot spots to join the nation’s most advanced trial for a vaccine against the disease.

The vaccine was developed by the Massachusetts biotech company Moderna along with the National Institutes of Health. It is among several vaccines to reach a Phase 3 trial globally but was the first one announced under Operation Warp Speed, the federal program to quickly identify, produce and distribute 300 million doses of a COVID-19 vaccine.

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PHILADELPHIA, Aug. 5, 2020 /PRNewswire/ — GSK today launched a national campaign to help increase low rates of vaccination among older adults. The campaign, Brought to You By Vaccines, will educate adults ages 50 and older about the value of vaccines and the urgent need to talk to their healthcare provider or pharmacist about the recommended vaccines they need or may have recently missed.

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The U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded Johns Hopkins researchers $35 million for clinical trials to test a convalescent blood plasma outpatient treatment to fight COVID-19.

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ROCKVILLE, Md.–(BUSINESS WIRE)– 20/20 GeneSystems, Inc. is proud to announce that in partnership with Linkou Chang Gung Memorial Hospital, the largest hospital in Taiwan, it has won the 2020 Taipei Biotech “Technology Transfer Cooperation Award” Gold Medal Award, the Oscar in the biotechnology industry, for its OneTest an artificial intelligence (AI) powered blood test that can assist in the early detection of many common cancers.

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The two co-founders behind TruGenomix have a vision for helping veterans and others who might be prone to post-traumatic stress disorder (PTSD). A new partnership with Sanford Health will help them work toward this vision.

Charles Cathlin serves as chief executive officer, and Tshaka Cunningham, Ph.D., is chief scientific officer of their small, veteran-owned precision behavioral health company based in Maryland.

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REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today reported positive one year data from patients in Cohorts 4 and 5 of the Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD). The Company plans to initiate a pivotal program for subretinal delivery of RGX-314 in patients with wet AMD by the end of 2020. In addition, REGENXBIO today announced that a Phase II trial of RGX-314 for the treatment of wet AMD delivered to the suprachoroidal space (AAVIATE) is active and expected to enroll patients in the third quarter of 2020.

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The Covid-19 Pandemic vividly demonstrates the need for rethinking ways to manufacture biological materials and create sustainable medical product supply lines for the United States. New program funding, new regulatory schemes and new community engagement are all solutions as we witness the renaissance of life science manufacturing in the US from Delaware to Alabama to California. Join a discussion of best bio and pharma manufacturing practices, public policies and programs to help the US respond to the Covid-19 Pandemic and create a more resilient manufacturing infrastructure.

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The Frederick Innovative Technology Center business incubator and accelerator, or FITCI, as it is better known, has been a linchpin for the Frederick, Maryland life science ecosystem for more than 15 years. BioHealth Capital Region signature companies like RoosterBio, Inc., BioFactura, Theradaptive, KempBio (now Kemp Proteins), and Bridgepath Scientific all made their start at FITCI.

Image: https://biobuzz.io

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The year 2020 began with great promise and opportunity for the Aug. 6 guest of the weekly web-based program, Virtual Face to Face with Dr. Bruce Jarrell. After tearful goodbyes here at the University of Maryland, Baltimore (UMB), the University System of Maryland (USM) embraced former president Jay A. Perman, MD, as its new chancellor on Jan. 6.

Image: https://www.umaryland.edu

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The Johns Hopkins University on Thursday reversed plans to bring undergraduate students back for in-person classes, housing, or activities, urging them to stay away from Baltimore for the fall semester. Employees, the campus said, should expect to work from home through the end of the year.

Image: COURTESY OF JOHNS HOPKINS U.

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Today the Cystic Fibrosis Foundation announced a collaboration with Longwood Fund, a biotech-focused venture capital firm, to accelerate innovative therapies for cystic fibrosis. Together, Longwood and the CF Foundation are dedicating resources to advance projects with transformative potential and incentivize early stage companies to prioritize CF drug discovery and development. The Foundation has committed $20 million to the collaboration as part of its Path to a Cure.

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Each year, the FNIH recognizes outstanding achievements by a promising young scientist in biomedical research by bestowing the Lurie Prize in Biomedical Sciences, a $100,000 award. The prize is made possible by a generous gift from philanthropist Ann Lurie.

The awardee is selected by a jury of six distinguished biomedical researchers including:

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Telemedicine is having its moment. Over the last few months, millions of people have relied on video or telephone calls to talk to their doctors. But as the pandemic moves across the United States, and eventually recedes in some places, how long will the moment last?

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Pfizer’s disclosure last week that it may reverse plans to in-shore manufacturing facilities and science jobs to the United States is just the tip of the iceberg of the problems we’ll face if President Trump implements his executive order to implement foreign reference pricing to determine drug prices under Medicare.

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Researchers at the Ragon Institute of MGH, MIT and Harvard, and the University of Washington (UW) School of Medicine, have identified five immune response markers that, collectively, were able to distinguish between those COVID-19 patients who convalesced from the infection, and those who didn’t survive the disease. The researchers used a systems serology technique to generate a detailed profile of SARS-Co-2-specific humoral—antibody generating—responses in hospitalized patients, which they validated in a second patient cohort. The findings indicated that individuals who survived COVID-19 infection and those who died exhibited antibody responses that were primarily directed against different SARS-CoV-2 proteins.

Image: NIH

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Johns Hopkins University became the latest school to announce that it will be conducting classes for the upcoming fall semester virtually, one of the many institutions of higher education to forgo in-person learning as the coronavirus pandemic rages.

This follows the spring 2020 semester that was moved online during the onset of the virus.

Image: https://thehill.com

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GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID‑19 vaccine with and without Matrix‑M™ adjuvant in healthy adults 18-59 years of age. NVX‑CoV2373, the Company’s recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org.

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Jennifer Butler, Executive Vice President and General Manager, Innate Pharma US Inc. joins Rich Bendis on BioTalk to discuss her career, bringing Innate from France to the US, and goals.

Listen now on Apple https://apple.co/3i30Bxs, Google https://bit.ly/2PkUw2U, Spotify https://spoti.fi/31gDh8n, TuneIn https://bit.ly/3fqn7i3, and YouTube Audio https://bit.ly/3kgU9ou.

Jennifer Butler was appointed Executive Vice President and General Manager of Innate Pharma US Inc. in March 2019.

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Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the publication of a Nature paper entitled, “Association of COVID-19 inflammation with activation of the C5a-C5aR1 axis,” authored by Innate researchers in partnership with scientists from Hôpitaux Universitaires de Marseille AP-HM (La Timone and North Hospitals), Laveran Hospital, Aix Marseille University, the Centre d’Immunologie de Marseille-Luminy (Inserm, CNRS, AMU) and Marseille Immunopole/AP-HM immunoprofiling laboratory at La Timone Hospital.

This Marseille-based exploratory research taskforce, named EXPLORE COVID-19, analyzed immune cells in COVID-19 patients at different stages of the disease. The goal of the study was to gain translational insights to better understand the immune response in COVID-19 patients and identify potential targets to fight the viral infection.

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This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

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FREDERICK, Md., July 29, 2020 /PRNewswire-PRWeb/ — BioFactura, Inc. today announced a $1 million Small Business Innovation Research (SBIR) Phase II contract awarded by the Joint Science & Technology Office—Chemical and Biological Defense (JSTO-CBD) of the Department of Defense (DoD). The goal of this project is to develop, optimize, and scale-up a highly efficient mammalian cell culture-based bioprocess suitable to meet surge requirement needs for rapid manufacture of a monoclonal antibody (mAb) therapeutic against the Marburg virus (MARV) biothreat.

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Johns Hopkins cancer diagnostics spinoff Thrive Earlier Detection Corp. has raised $257 million in new funding a little over a year after it closed another huge round.

Thrive launched in May 2019 with $110 million in funding for its cancer-detecting blood test developed by researchers at Johns Hopkins. That Series A round was remarkable for its size. It was the largest ever raised in support of a Hopkins-licensed technology, and among the largest raised by any firm co-based in the Baltimore area.

Image: https://www-bizjournals-com

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Charlottesville, Va., July 28, 2020 – HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received Fast Track and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for HST5040, a once-daily oral small molecule drug being developed to treat methylmalonic acidemia (MMA) and propionic acidemia (PA).

In June, HemoShear received clearance from the FDA for its Investigational New Drug application to conduct a phase 2 clinical study of HST5040 in patients with MMA and PA. MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids.

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BALTIMORE (WJZ) — Johns Hopkins researchers have received over $30 million in funding from the U.S. Department of Defense for two nationwide clinical trials to test the effectiveness of a convalescent blood plasma outpatient treatment.

The treatment is a transfusion of a blood product from COVID-19 survivors that contains antibodies that may help the patient’s immune system fight the virus, researchers say.

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ROCKVILLE, Md., July 28, 2020 — American Gene Technologies (AGT), an internationally recognized leading gene and cell therapy company in Rockville, Maryland, today announced it has leased a spacious, modern facility in the Maryland life sciences corridor, across from National Cancer Institute and Johns Hopkins Shady Grove Campus.

Image: https://www.americangene.com

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Six months into the COVID-19 pandemic, the question of why tests that detect the presence of the SARS-CoV-2 virus are not faster, better, and cheaper in this country still remains. Despite an incredibly complicated answer, the National Institutes of Health (NIH) has announced that they are going to help some companies work to develop their technologies, with the hope of getting over this roadblock. The program will give $248.7 million to seven biomedical diagnostic companies. The money is intended to support a range of new lab-based and point-of-care tests that, they hope, could significantly increase the number, type, and availability of tests by millions per week as early as September 2020.

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COLUMBIA, Md., July 28, 2020 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced today the appointments of Michael Hauser as the Managing Director of Investments and Terry Rauh as the Vice President, Chief Administrative Officer.

“Michael and Terry bring many years of leadership experience to fill these critical roles at TEDCO,” said Troy LeMaile-Stovall, TEDCO’s incoming CEO and executive director. “Leveraging their extensive knowledge of the Maryland business and innovation ecosystem, we’re looking forward to the impact they will make in fostering TEDCO’s mission.”

Image: Michael Hauser, TEDCO

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Biotechnology led the healthcare industry in investment activity from private equity and venture capital during the first half of 2020, drawing nearly $12.60 billion in funding, up from $7.28 billion for the year-ago period.

The biotechnology sector either announced or concluded 342 deals globally as of June 30, comprising mergers and acquisitions and private placements, where the main investor was either a venture capitalist, a hedge fund manager or a private equity company, according to an analysis by S&P Global Market Intelligence.

Image: https://www.spglobal.com

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BALTIMORE (WJZ) — Johns Hopkins Hospital ranked no. 3 among the nation’s best hospitals, according to U.S. News & World Report.

The Best Hospitals List was released Tuesday with The Mayo Clinic earning the no. 1 overall ranking this year, followed by Cleveland Clinic at no. 2 out of 4,500 hospitals.

U.S. News & World Report also ranked 12 specialties at Hopkins among the top 10 in the country. Ear, Nose, and Throat, Neurology and Neurosurgery, Psychiatry, and Rheumatology ranked no. 1.

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“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features Jamie Lacey-Moreira, Principal and Founder, PressComm PR, LLC.

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Rita Colwell is perhaps best known for her research on the pathogenic bacterium Vibrio cholerae. But the designation of pioneer is a label befitting Colwell for far-reaching contributions to many other areas, including her decades-long fight against sexism in a male-dominated field.

Colwell’s unique perspective on sexism in science is now able to be explored in her book, A Lab of One’s Own: One Woman’s Personal Journey Through Sexism in Science, which will be released on August 4th.

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Regina E. Dugan is chief executive of Wellcome Leap, a nonprofit that seeks breakthroughs in human health. From 2009 to 2012, she served as director of the Defense Advanced Research Projects Agency.

The global pandemic is a hinge in history. Hundreds of thousands of lives lost globally; trillions in economic damage. It is as if the 1918 flu and the 1929 crash happened in the same year. It is the kind of event that alters the course of history so much that we measure time by it: before the pandemic — and after. It is a Sputnik moment.

Image: Astronaut Buzz Aldrin walks on the surface of the moon on July 20, 1969. (Neil Armstrong/NASA via AP)

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Future pandemics—and suffering of the kind inflicted by COVID-19—could be avoided if we troubled ourselves to see where dangerous pathogens lie in wait. We could, two unrelated studies suggest, save ourselves untold woe and conserve our fortunes if we were to look into matters geographic, zoologic, and genomic. More specifically, we need to keep our eyes wide open when we venture into the planet’s last wild places. There, we may run into wild animals that are infected with pathogens harboring wild genetic traits—which is to say, genetic traits that evolved naturally, beyond our gaze, and that waited patiently, perhaps decades, for a chance to strike.

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Now Accepting Rolling Grant Applications

The Illumina Accelerator Sequencing Grant Competition encourages entrepreneurs to build startups using next-generation sequencing. Awarded grant winners have the opportunity to spend one week at Illumina Accelerator in the San Francisco Bay Area to run proof-of-concept sequencing experiments. It’s a great way to learn more about each other and to help advance your genomics-driven startup.

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BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., joins BioTalk to discuss his background with the University of Maryland, the BioHealth Capital Region, and the creation of his company in Frederick.

Listen now via Google https://bit.ly/3hz2jpU, Apple https://apple.co/3eYLiUs, Spotify https://spoti.fi/3f3cqBU, TuneIn https://bit.ly/302voUG, and YouTube (Audio Only) https://bit.ly/3f3cQZ0

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GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

“Emergent is driven by our desire to advance solutions that will make an impact on this pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Sharing a passion for science, we are encouraged by AstraZeneca’s investigational COVID-19 vaccine and look forward to supporting its continued progress.”

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GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

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GAITHERSBURG, Md., July 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the Company has entered into an agreement with Vigene Biosciences (“Vigene”) to manufacture AdCOVIDTM, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization (CDMO), specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, Altimmune plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

“Vigene is a fantastic partner to advance AdCOVID into Phase 1 clinical testing and beyond,” said Dr. Vipin K. Garg, President and CEO of Altimmune. Dr. Garg continued, “We believe Vigene’s deep experience in viral vector production and their collaborative, client focused approach will help facilitate Altimmune’s timeline for clinical development of AdCOVID.”

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TEDCO, Maryland’s state-backed agency that supports early-stage tech companies, has named Troy LeMaile-Stovall as its next CEO.

Lemaile-Stovall, who is currently COO of the University of the District of Columbia (UDC) and leads a management consulting firm, will start in the role on Sept. 7. He was introduced at a virtual press conference on Wednesday, where he spoke about leadership in a time that includes a pandemic, economic downturn and a nationwide push for racial justice. While we’re still in the midst of what could be long-term shifts taking place, he said he was “excited about how we move from economic development to economic empowerment for all of the citizens of Maryland.”

Image: Troy Lemaile-Stovall will begin as CEO of TEDCO in September. (Courtesy photo)

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ROCKVILLE, Md. and BEIJING, July 21, 2020 /PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

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Manassas, VA – On June 17, 2020, Serpin Pharma was notified by the U.S. Food and Drug Administration (FDA) that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients. The Principal Investigator is Serpin Pharma’s collaborator,

Dr. Michael Yun Shim, John L. Guerrant Assoc. Professor of Medicine and Medical Imaging, Div. of Pulmonary & Critical Care of the University of Virginia. Dr. Larry Altstiel, acting Chief Medical Officer for Serpin Pharma, said, “SP16 is a potent new antiinflammatory drug rather than a non-specific, toxic immunosuppressive drug. SP16 reduces the production of inflammatory cytokines (e.g., IL-1β, TNF-α, IL-6) while sparing normal and protective immune function. It is effective in several animal models of acute inflammation, in particular, following a severe lung infection. Therefore, SP16, by its ability to inhibit excess cytokine production, may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection.”

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This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

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Emergent BioSolutions (NYSE:EBS) has signed an agreement with AstraZeneca (NYSE:AZN) to provide contract development and manufacturing (CDMO) services for large-scale drug substance manufacturing for AZN’s COVID-19 vaccine candidate, AZD1222.

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Driven entrepreneurs and savvy startup leaders participated in the recent “Fueling an Innovation Ecosystem for Startups to Thrive” webinar that featured prominent connectors and innovators from the BioHealth Capital Region (BHCR). The virtual event was sponsored by WorkForce Genetics and covered a wide range of topics including the pandemic, critical regional resources for startups, advice for approaching investors and a list of the biggest mistakes made by entrepreneurs when seeking funding.

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Excited to announce that TruGenomix just won Start Up of the Year Pitch Event. Great pitch Charles Cathlin !!!!! #SDVOB #ptsd #TruGenomix #veteranshelpingveterans

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SIOUX FALLS, S.D., July 23, 2020 /PRNewswire/ — Sanford Health, the largest provider of rural healthcare in the country, today announced an $800,000 investment in TruGenomix, a veteran-owned precision behavioral health company.

As part of the strategic partnership, Sanford Health will support TruGenomix by providing its state-of-the-art lab and research capabilities to validate a first-to-market patented blood test for post-traumatic stress disorder (PTSD). The genomic test enables earlier identification and improves outcomes for high-risk populations, including veterans, active-duty service members, frontline health care workers, and first responders.

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ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

The proof-of-concept, randomized, multicenter, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days. Key secondary endpoints include intensive care unit (ICU) length of stay, hospital length of stay, and oxygen saturation at the end of the study. Top-line data are expected in the fourth quarter of 2020.

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Virologist Andrew Pekosz has a team of 15 people working around the clock in his lab at the Johns Hopkins Bloomberg School of Public Health supporting work on a potential treatment for COVID-19. Pekosz’s lab is testing the blood of coronavirus survivors for plasma antibodies that researchers think might help treat critically ill coronavirus patients.

Image: Nekeshia Maloney, JHTV’s director of contracts

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BALTIMORE, July 23, 2020 /PRNewswire/ — Vita Therapeutics, Inc. announced today that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD).

VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. The company plans to continue to progress this treatment towards clinical trials and plans to bring it forward for other congenital muscular dystrophy diseases as well. This therapy was exclusively licensed from technology originally invented at Johns Hopkins University and the Kennedy Krieger Institute in the labs of Dr. Kathryn Wagner and Dr. Gabsang Lee.

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WASHINGTON – (July 22, 2020) – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces eight winners chosen in its special COVID-19 edition of the “Make Your Medical Device Pitch for Kids!” competition. Focused on innovations in COVID-19-related pediatric medical devices that will improve children’s health care, 16 finalists competed on Monday, July 20 in a virtual pitch event for a share of $250,000 in total grant awards.

Image: Judges award grants for pediatric medical devices that address COVID-19-related needs – https://www.openpr.com

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Pascal Soriot isn’t letting the all-consuming R&D and manufacturing work on a Covid-19 vaccine slow down his hunt for AstraZeneca’s next blockbuster cancer drugs.

The latest deal with Daiichi Sankyo consists of $1 billion in upfront cash payment spread over 2 years: $350 million upon completion, and $325 million each at the 12-month and 24-month mark. Regulatory milestones add up to another $1 billion while sales-related fees tot up to $4 billion.

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When it comes to Maryland companies, the pandemic isn’t slowing down venture capital funding.

Data from the latest MoneyTree report by PricewaterhouseCoopers/CB Insights shows that Maryland companies collectively received $358 million in venture capital funding for the second quarter of 2020, marking a big uptick in dollars over the prior quarter even amid a global pandemic and economic downturn.

Image: Looking up in Harbor East. (photo by Wikimedia Commons user Bohemian Baltimore, obtained under a Creative Commons license.)

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“Today, we feel forgotten. Everyone believes we still won. The class of 2024 didn’t win. After calls and emails, we’re met with another unyielding reality: we can’t come to campus.”

These are the words of an open letter circulating among international students of the class of 2024 asking for Hopkins to advocate for them.

Last week, the Trump administration abruptly dropped its plans to ban international students taking online-only courses from residing in the U.S. Given that instruction at Hopkins will go fully online following Thanksgiving break, international students at Hopkins would not have been able to return to campus for any portion of the semester had the rule stayed in place.

Image: CC BY-NC-SA 2.0 Most incoming international students will not be able to enter the United States this fall.

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Since May, the University System of Maryland has said that remote learning and in-person classes will return in the fall. It recently explained why it is sticking with that model.

“Opting for a hybrid model — combining in-person and remote learning — is, by no stretch, an easy out. It doesn’t save us money, it doesn’t save us time, it doesn’t save us planning. It’s a high-cost, high-effort undertaking,” Chancellor Jay A. Perman said in a statement.

However, it is choosing the model because he said there are students who need the campus environment.

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Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

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Vaccitech is a spinout company from the University of Oxford’s Jenner Institute, one of the oldest and most renowned vaccine research centers in the world.

You probably haven’t heard of them, but they are now working alongside AstraZeneca on a COVID-19 vaccine the World Health Organization believes is leading the race in creating an inoculation against SARS-CoV-02.

Data posted this month from just over 1,000 patients in a phase 1/2 trial showed it to be broadly effective in creating an immune response, though many questions remain and a series of bigger, late-stage tests is necessary to find those answers out.

Image: Bill Enright, Vaccitech CEO (Vaccitech)

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Deloitte has launched the Life Sciences Catalyst in Cambridge, a collaborative platform enabling organisations in the biotech, medtech, pharmaceutical and technology sectors, as well as prospective investors, to come together to tackle the biggest challenges facing their industries.

The Life Sciences Catalyst will facilitate connections between people, businesses and investors to support companies with their growth, regardless of their evolutionary stage.

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To limit the spread of Covid-19, the U.S. Centers for Disease Control and Prevention recommends that individuals practice social distancing. When local conditions allow for retail stores to open, they confront a variety of guidelines that vary by state. For example North Carolina places specific limits on the number of customers allowed per square foot, while Oregon generally advises that the number of customers in the store should be limited so that customers can remain six feet apart. Whether or not customers are required by law to wear masks in stores depends on the state. How retailers implement these guidelines also varies among types of retailers and even within store categories. Grocery stores, for example, have adopted a wide variety of specific methods to ensure that customers remain apart.

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