ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that results from multiple ATTAC clinical studies of dendritic cell vaccines have been published online by American Association for Cancer Research (AACR) in an article titled, “Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.”

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma (GBM), with leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells.

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: 9/24

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

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!

Gaithersburg, MD, September 1, 2020 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe ARDS, including that caused by COVID-19. Based upon the company’s research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

OxiWear's own founder is a user herself of its oxygen monitor for patients with severe pulmonary hypertension.

Image: Shavini Fernando is founder and CEO of OxiWear. LESLIE E. KOSSOFF/GEORGETOWN UNIVERSITY

Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, joins BioTalk to discuss her career, the economic development environment in Baltimore, and how to create a greater sense of partnership between perceived competing regions.

Listen now via Apple https://apple.co/2DikZfg, Google https://bit.ly/2Exq5oD , Spotify https://spoti.fi/31GmIUV, TuneIn https://bit.ly/32FjGQ5, and YouTube Audio https://bit.ly/31IwGFl.

Michele L. Whelley, President & CEO, is an economic development professional who is well-known throughout the region’s business community, Whelley brings new energy and focus to marketing the region, ensuring that EAGB will continue to strengthen its marketing platform as a critical component of fostering and supporting a vibrant and growing economy throughout the Greater Baltimore region.  
 

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

Imagine being able to use science to choose the right music for an advertising campaign or being able to order food and groceries on a military base from a veteran-owned small business.

Hampton Roads startups are bringing these ideas and more to this year’s 757 Accelerate program. In the midst of a global pandemic, the region’s startup accelerator is moving its entire program online and implementing a new abridged program for three more area startups.

Image: From left, Secret Chord Laboratories founders Scott Miles, David Rosen and Robert Abelow will be participating in the third 757 Accelerate startup program. Due to the coronavirus pandemic, the program will be switching to operating virtually this year. (Courtesy photo)

ROCKVILLE, Md., Aug. 25, 2020 /PRNewswire/ -- 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 announced the clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR). The IND is active, and REGENXBIO plans to begin dosing patients in a Phase II trial, ALTITUDE, in the second half of 2020.

GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Arcellx today announced the award of an EvansMDS Discovery Research Grant to Johns Hopkins University to support development of an Arcellx ARC-sparX therapy in the treatment of high-risk myelodysplastic syndromes (MDS). The collaborative effort, led by Amy E. DeZern, M.D., at the Johns Hopkins University School of Medicine, aims to advance development of ACLX-002, an immune cell therapy candidate directed at the therapeutic target CD123. The collaboration includes research to be conducted by Craig Jordan, Ph.D., of the University of Colorado School of Medicine, and materials and expertise to be contributed by Arcellx.

Coronavirus made 2020 the year of the pivot.

But the D.C.-area ventures having real, direct impact on the Covid-19 crisis have done more than tweak their business models; they’re innovating, persevering and committing to getting us through the pandemic in one piece.

They’re laying groundwork and executing on plans to tackle the disease. They’re developing resources and launching initiatives to serve our communities, as we grapple with dangerous and disruptive ripple effects born from the public health emergency. They’re conducting research, donating dollars and delivering on their promises, all with one goal: to push through this period and make life easier in the interim, and thereafter.

Image: Coronavirus has challenged the region's businesses to step up. fpm - https://www.bizjournals.com

(Reuters) - Catalent Inc said on Monday its Maryland facility would make the drug substance used in the COVID-19 vaccine being developed by AstraZeneca Plc and the University of Oxford, starting “late in the third quarter” this year.

The New Jersey-based company said the drug substance will be made at its commercial gene therapy manufacturing facility in Harmans.

Catalent would supply the so-called viral vector, which is a genetically modified harmless virus designed to trick the human body into producing certain parts of the coronavirus. These proteins, in turn, prompt the immune system to develop an arsenal for any real COVID-19 infections.

A huge portion of a campus in Research Triangle Park has been sold in a deal that tops $590 million.

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector. 

Image: Peter Meath - https://medcitynews.com

Qiagen has announced plans to launch a new digital test for COVID-19 antibodies that can run multiple samples at once on a small portable device and deliver results in about 10 minutes. 

With a small digital hub and interchangeable testing stick system, the eHub was developed for use against the novel coronavirus in collaboration with Australian diagnostic developer Ellume. The device can process up to eight samples simultaneously, or up to 32 tests per hour, to detect the presence of IgA, IgM or IgG antibodies in plasma or serum.

CAMBRIDGE, Md. and LONDON, Aug. 26, 2020 (GLOBE NEWSWIRE) -- OS Therapies, and late-stage clinical research biotechnology company focused on Osteosarcoma and other solid tumors today announced the co-exclusive licensing of BlinkBio’s novel Si-Linker and Cassette Payload technologies, and exclusive licensing of the BlinkBio technology to target Folate Receptor Alpha (FRα) for tumors and other targeted diseases.

GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Marvin L. White as a Class II director to serve on the board effective October 1, 2020, with an initial term expiring at the 2023 annual meeting of stockholders. Mr. White was also appointed as a member of both the Scientific Review Committee and Strategic Operations Committee of the board.

Humans are not the only species facing a potential threat from SARS-CoV-2, according to the results of a study by an international scientific team headed by researchers at the University of California, Davis (UC Davis). Using genomic analysis to compare the amino acids of a key part of the ACE2 protein that is used by SARS-CoV-2 to gain entry into human cells, with those of the ACE2 protein in more than 400 other animals, the team found it feasible that many different species, including some, like the Western lowland gorilla, which are highly endangered, could potentially be infected by the virus.

Image: Western lowland gorilla (Trisha Shears/FreeImages)

The United States aims to invest $765 million over the next 5 years in a dozen scientific centers dedicated to the study of artificial intelligence (AI) and quantum information science (QIS), such as quantum computing, the White House announced today. Numerous private tech companies such as IBM, Google, and Intel will also contribute to the twin pushes, which call for a total of more than $1 billion in research investment.

The US National Institutes of Health (NIH) is one of the largest early stage life sciences investors, and funds over $1B in awards each year through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programmes, according to NIH representatives who spoke at the “Key Role of NIH in the Product Development Pipeline” panel session at the Biotechnology Innovation Organization (BIO) Digital International Convention on 9 June.

SOMERSET, N.J. – Aug 24, 2020 — Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.

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

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

CONSIDERATIONS:

• Technical Feasibility and IP
• Commercialization and Marketing Strategy
• Leadership Team and Collaborations
• Funding to Date and Financial Projections

CRITERIA:

• Demonstrated Proof of Concept/MVP
• Have received funding (dilutive/nondilutive)
• Understand regulatory and reimbursement hurdles
• A clear path to market and scalable

PREVIOUS WINNERS:

Sonavex

LifeSprout

Galen Robotics

Floreo

Applications due: 9/15

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

3rd Annual BioHealth Capital Region Investor Forum

Ocr 20 - 21st, 2020

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.

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!

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!

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.

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.

“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.

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.

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.

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. 

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.

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.