MANASSAS, VA. (PRWEB) OCTOBER 26, 2022

Diversity and inclusion in clinical trials are critical to achieving accurate and reliable results.(1) Participation in clinical trials is voluntary, and individuals of different ages, genders, races, ethnicities, genetic backgrounds, geographic locations, and environments will respond differently to the same treatments. An effective way to achieve diversity in clinical trials is through decentralization with standardized procedures across multiple sites.(2) To facilitate the efficient execution of multi-center clinical trials globally, Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, and his team have developed the modular Jeeva™ eClinical Cloud.

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company advancing a phage bank, the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced the appointment of Edward Fang, M.D. as Chief Medical Officer. Dr. Fang’s responsibilities include overseeing clinical development for APT's phage bank treatment candidates through commercialization.

Tweet this “I am excited to welcome Dr. Fang, who brings broad expertise in therapeutic approaches to bacterial infectious disease and clinical trial execution to APT,” stated Greg Merril, CEO and Co-Founder of Adaptive Phage Therapeutics. “With Dr. Fang’s addition to APT’s leadership, I am confident that APT will achieve its short-term objective of rapidly progressing ongoing clinical trials, and longer-term objectives of leveraging expanding phage banks to deliver the first antimicrobials that adapt to the emergence of resistance. This approach does not decrease in coverage over time and will not require, or benefit from, market-suppressing stewardship.”

ROCKVILLE, MARYLAND, BioHealth Innovation Inc. (BHI) is pleased to welcome Monique Bennett, Ph.D., as the new Senior Life Sciences Business Strategist. In this role, Dr. Bennett will work one-on-one with entrepreneurs and will lead BHI’s team of strategists that provide a variety of client services including non-dilutive funding assistance and go-to-market strategies.  

FREDERICK, MD (October 24, 2022) – The Maryland Tech Council (MTC), the largest technology and life sciences trade association in the state, has named the Honorable Kelly M. Schulz, a former cybersecurity small business partner, state legislator, and two-time state cabinet secretary, as its new CEO.

As Secretary of the Maryland Department of Commerce from 2019 to 2021, Schulz oversaw the state’s primary economic development agency, responsible for attracting new businesses, promoting innovation, and accelerating job growth. Under her leadership, the department served as the largest resource to provide financial assistance to struggling Maryland companies adversely impacted by COVID-19. She previously served as Secretary of the Maryland Department of Labor from 2015 to 2018. During her tenure, Maryland’s apprenticeship program grew to its highest level since 2008, with more than 10,000 apprentices statewide and received national recognition as one of America’s top programs.

Oct 19 (Reuters) - JPMorgan Chase & Co (JPM.N) is launching a platform that aims to connect startup founders with venture capital investors to simplify the fundraising process, the bank told Reuters.

The new platform, Capital Connect, focuses on serving the financing needs of startups from their early stages, marking the ambition of the biggest U.S. bank by assets to further expand into the private market and build a founder-friendly brand in Silicon Valley.

20 weeks' journey of US Market Entry Program is finally completed. The program is to provide soft landing for medical start-ups from Korea. 5 start-up cohorts, after competitive selection, have been fostered by BioHealth Innovation (BHI) and KOSME (Korea SMEs and Startups Agency).

The synergy between strong Korean Government support and local expertise delivered significant impact to us. Congratulations to 5 cohort start-ups for successfully achieved the mission !

Medtronic (NYSE:MDT) revealed its plans for an incubation and acceleration platform for innovation in the neurovascular space.

In a presentation yesterday at DeviceTalks West in Santa Clara, California, the company unveiled its plan to bring innovations to market to address strokes. Daniel Volz, president of Medtronic Neurovascular, and Derek Crittenden, Medtronic’s new technology & strategy program manager, presented the news.

Image: Dan Volz (right) and Derek Crittenden (left) present the Medtronic Co-Lab program at DeviceTalks West in Santa Clara, California. - https://www.massdevice.com

The entrepreneurial spirit burns bright at Johns Hopkins University, with alumni launching startups in sectors ranging from life sciences to the metaverse.

Enter A-Level Capital, a group of budding undergraduate investors on a mission to help Hopkins-born startups succeed. Founded by Carey Business School alum Elizabeth Galbut and Whiting School of Engineering alum Demi Obayomi, the student-run venture capital firm targets early-stage companies created or run by Hopkins alumni.

Image: https://hub.jhu.edu/

Johns Hopkins University is one of several partners behind the launch of The Light of Baltimore Incubator at Baker Donelson, a partnership with Bloomberg Philanthropies and Goldman Sachs 10,000 Small Businesses, to provide office space, mentorship, and legal and marketing support for 26 HopkinsLocal businesses and other regional small businesses.

Image: https://hub.jhu.edu

Enrollment has begun in an early-stage clinical trial evaluating bacteriophage therapy in adults with cystic fibrosis (CF) who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs. The trial is evaluating whether the bacteriophage, or “phage,” therapy is safe and able to reduce the amount of bacteria in the lungs of volunteers. The trial is being conducted by the Antibacterial Resistance Leadership Group (ARLG), funded by the National Institute of Allergy and Infectious Diseases. Investigators aim to enroll up to 72 adults at 16 CF centers across the United States.

AMPEL Biosolutions (AMPEL), located in Charlottesville, Virginia is a leading personalized precision medicine company developing tools that can help autoimmune and inflammatory disease patients improve their quality of life. AMPEL is one of the exciting companies that have emerged from the Charlottesville (CVille) biohub clustered around the University of Virginia (UVA).

Image: https://biobuzz.io

An Annapolis company that hopes to create a non-drug treatment for migraine and mood disorders has raised $4 million of a $7 million series A round.

The funding round will help Mi-Helper conduct clinical studies to get U.S. Food and Drug Administration clearance for its eponymous device. Mi-Helper has already gone through clinical studies at the Mayo Clinic, Michigan State University and Atrium Health and CEO Steve Schaefer plans for the device to hit the market in 2024. The company is planning to conduct a large at-home study to see if patients will be able to use the device at home instead of at a doctor’s office.

Image: CEO Steve Schaefer hopes Mi-Helper can provide a drug free treatment for migraines. Courtesy of Steve Schaefer

A throng of entrepreneurs, academics, developers and prominent life sciences players milled about two construction vehicles parked on a vacant, grass-covered lot at West Fayette Street and Martin Luther King Jr. Boulevard in West Baltimore Friday afternoon.

The crowd came to celebrate the start of construction on 4MLK, a project that has been in the works for nearly a decade and will eventually provide the local life sciences sector with badly needed wet lab space.

COLUMBIA, Md. (October 18, 2022)—TEDCO, Maryland’s economic engine for technology companies, announced today its Seed Funds invested $200,000 in CoolTech, LLC, a Maryland-based medical device start-up. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and includes gap financing.

“CoolTech is leveraging its patented platform to develop novel therapies such as transnasal evaporative cooling for temperature management and thermodynamic neuromodulation for migraine and other pain disorders.  Without using drugs or chemicals, we drive results, with lower cost and virtually no side effects,” said CoolTech CEO, Steven Schaefer. “Thanks to TEDCO, we are tackling some of the most debilitating clinical conditions in the world.”

Without much fanfare, Congress recently passed legislation reauthorizing the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs and President Biden quickly signed it into law. The reauthorization of this critical program builds off of important pieces of recent economic legislation like the Inflation Reduction Act, the Bipartisan Infrastructure Law, and the American Rescue Plan. While many Americans, including small business owners and entrepreneurs, may not be aware of either of these U.S. Small Business Administration (SBA) efforts, their reauthorization is a big deal for innovation.

Image: 1982: President Ronald Reagan, surrounded by Rep. John LaFalce, D-N.Y., and Sen. Warren Rudman, R-N.H., after signing the Small Business Innovation Development Act into law in the Rose Garden. - BETTMANN ARCHIVE

FOSTER CITY, Calif. & ROCKVILLE, Md.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) and MacroGenics (NASDAQ: MGNX) today announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART® platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics. MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome (CRS), a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing.

Neuroene Therapeutics Co-Founder and CEO Sherine Chan, Ph.D., joins Rich Bendis on BioTalk to discuss winning the 7th Annual BioHealth Capital Region Crab Trap, their drug discovery platform and being located at JLABS @ Washington, DC.

Listen now via Google bit.ly/3D5tm9O, apple.co/3eGzXy7, or Spotify spoti.fi/3D6lgOx.

Baltimore's Vita Therapeutics announced the completion of a $31 million series B funding round on Wednesday, propelling the cell therapy company toward a clinical trial and the development of new treatments for rare diseases.

Image: Vita Therapeutics, led by CEO Douglas Falk, recently completed a $31 million series B funding round. - Douglas Falk

“The 2022 venture capital market” is nearly a misnomer, as each quarter that passes seems to bring with it a new normal for startup investment. The pace of quarterly change in how venture investors are disbursing capital is making full-year numbers almost misleading.

The change inside of 2022, in other words, may at times mask just how much things have been evolving more recently; January and February feel like years ago in startup time, not merely a few quarters back.

Image: https://techcrunch.com/

We are so thankful for our Entrepreneurs-in-Residence (EIRs), who provide free business development guidance and counsel to assist #SmallBiz awardees with progress toward #commercialization objectives and ensuring success in the market. Each EIR brings unique expertise and experience from the field. Learn more and connect with an EIR today: https://bit.ly/3Ov55gH #Entrepreneur

Venture-capital firms are jumping into the stock market, buying up battered shares in publicly traded tech companies at a time when they are investing less in the startups that have long been their focus.

Some major venture firms including Accel and Lightspeed Venture Partners have purchased more stocks of companies they first backed as startups this year, defying the industry norm of selling those shares soon after public listings.

Image: One of Amplitude’s largest shareholders when the data-analytics firm went public was Sequoia Capital. PHOTO: ANDREW KELLY/ASSOCIATED PRESS

Oct 10 (Reuters) - California-based diagnostics company Bio-Rad Laboratories (BIO.N) is in talks to merge with Qiagen NV (QIA.DE), the Wall Street Journal reported on Monday, citing people familiar with the matter.

Talks between the two companies have been going on for a while but an agreement is unlikely for another few weeks, the report said.

U.S-listed shares of Qiagen rose 8% while Bio-Rad fell nearly 10% after the report.

Biotech and life sciences companies can benefit from partnering with the federal government in many ways, from funding to increased access to resources and manufacturing. But lesser-known than its counterparts at the National Institute of Health and National Cancer Institute is the Biomedical Advanced Research and Development Authority, or BARDA.

Image: https://biobuzz.io/

What does the Zulu word “ubuntu” have to do with a successful science and tech fund at Maryland’s TEDCO? To start, it’s been a guiding force for that fund’s leader.

The Maryland Technology Development Corporation (TEDCO) has an important mission in Maryland: “enhance economic empowerment by fostering an inclusive and entrepreneurial innovation ecosystem. Identify, invest in, and help grow technology companies in Maryland.”

Image: https://www.tedcomd.com/about-tedco/staff/arti-santhanam-phd

Oct 12, 2022

• Homologous boosting with the prototype Novavax COVID-19 vaccine induced robust antibody titers for Omicron BA.1, BA.2, and BA.5
• Study 307 (Lot Consistency) achieved its primary endpoint, showing that three vaccine lots induced a comparable immune response thereby demonstrating the consistency of the manufacturing process
• A durable immunogenicity response was observed following primary vaccination as well as boosting which matched the levels previously associated with protection

GAITHERSBURG, Md., Oct. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today presented data from the Phase 3 PREVENT-19 trial and Study 307 (Lot Consistency) at the World Vaccine Congress Europe 2022. PREVENT-19 data in both adults aged 18 and older and adolescents aged 12 through 17 showed the prototype Novavax COVID-19 vaccine (NVX-CoV2373) achieved its pre-specified immunologic endpoint. Study 307 (Lot Consistency) met its primary endpoint, showing that three lots of the Novavax COVID-19 vaccine tested as a heterologous booster induced consistent immune responses in previously vaccinated adults aged 18 to 49.

WASHINGTON--(BUSINESS WIRE)--The Biotechnology Innovation Organization (BIO) – the world’s largest science and public advocacy organization, representing 1,000 members — announced today that Rachel King, co-founder and former CEO of GlycoMimetics, Inc., has agreed to serve as interim President and CEO. King’s appointment follows Dr. Michelle McMurry-Heath stepping down as President and CEO to serve as an Advisor to the Executive Committee of the BIO Board of Directors. The organization is searching for a full-time successor.

Neuroene and Polaris Genomics benefit from increased prizes

Did you miss the 7th Annual BioHealth Capital Region Crab Trap Competition? Below we are
sharing a review of the event, participants, judges, and video replays.

Thank you to all the Sponsors and Partners of the event and region this year.

(Winner) Neuroene Therapeutics (watch presentation)
(Montgomery County Winner) , Polaris Genomics (watch presentation)
(Finalist) Kubanda Cryotherapy (watch presentation)
(Finalist) Perfusion Medical (watch presentation)
(Finalist) VPIX Medical (watch presentation)

Click here to read more.

Doubling the University of Maryland BioPark’s lab space, the two-phase 4MLK development project will represent more than $320 million in total capital investment

BALTIMORE, Maryland, September 22, 2022 — University of Maryland, Baltimore (UMB) and Wexford Science & Technology, LLC, announced today that 4MLK, the newest development project in the University of Maryland BioPark, is slated to move forward, with groundbreaking this fall (2022) and delivering in summer 2024. The 8-story, 250,000-square-foot building, Phase I of a two-phase project representing a $320 million total capital investment, will provide critical wet laboratory space in downtown Baltimore for researchers and companies, flexible lab and office/support space for start-ups, and Class A office space, along with areas for convening and a conference center.

GAITHERSBURG, Md--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company advancing the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced that the Defense Health Agency (DHA) has awarded an additional $5 million to support clinical development of APT’s adaptive bacteriophage (“phage”) therapy in treatment of diabetic foot osteomyelitis (DFO). APT is evaluating safety and efficacy of its precision phage-based therapy in the ongoing Phase 1/2 DANCE™ (DFO Adaptive Novel Care Evaluation) clinical trial.

Image: https://www.businesswire.com

The collaboration will explore EBV and HTLV-1 antigen-specific immune responses in immunological diseases

GAITHERSBURG, Md., Oct. 06, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced a collaboration with the National Institute of Neurological Disorders and Stroke (NINDS), a division of the U.S. National Institutes of Health (NIH). The collaboration will focus on enriching and expanding virus-specific T cell populations and determining their activity against infected human cell lines. The goal of this collaboration is to develop adoptive cell therapies that may benefit patients afflicted with immunological disorders related to these viral infections. Initially, we will focus our efforts on studying Epstein-Barr virus (EBV) and Human T-cell Leukemia Virus, type 1 (HTLV-1).

WASHINGTON – Administrator Isabella Casillas Guzman, head of the U.S. Small Business Administration and voice for America’s 33 million small businesses in President Biden’s Cabinet, released the following statement today after the House voted to reauthorize funding for the Small Business Innovation Research (SBIR) program:

It’s no secret that a recession could hit the United States before the year ends. No one knows for sure yet, and many economists believe that the current record high inflation and capital markets distress are symptoms of what could be a substantial economic downturn,

Possible effects have already hit the biotech and life sciences. To discuss how the Biohealth Capital Region would fare out in a potential recession, and whether it can actually avoid one, the I-270 Innovation Labs brought together an outstanding group of regional experts from across key sectors connected to both industries.

Image: https://biobuzz.io

Today, the U.S. Economic Development Administration awarded 51 “Build to Scale” grants – totaling $47 million – to organizations that support technology entrepreneurs, catalyze innovation and fuel economic growth. [Read full press release here]

EDA’s “Build to Scale” program provides annual grants that aim to accelerate technology entrepreneurship by increasing inclusive access to support and startup capital. The 2022 awardees will leverage an additional $48 million in matching funds from a variety of private and public sector sources. These EDA investments support advanced manufacturing, bioscience, clean energy and blue economy clusters in regions throughout the United States.

Image: https://content.govdelivery.com/

The Richmond area is planning a major pharmaceutical manufacturing initiative to build drugs here, restore the nation’s stockpile of essential medicines and to make them more affordably.

The sprawling enterprise has major players, including Virginia Commonwealth University, the cities of Richmond and Petersburg and drug manufacturers Civica, Phlow and AMPAC Fine Chemicals.

Now it has a new pivotal piece: the money.

The initiative, named the Alliance for Building Better Medicine, has received $53 million from the federal government’s Build Back Better Regional Challenge. Those funds come in addition to $14 million in local donations and $45 million from the state.

The money will help build labs in downtown Richmond and Chesterfield County and manufacturing facilities in Petersburg. Not only will the alliance bring jobs to the area, it will boost national security, said Sen. Mark Warner, D-Va., who came to Richmond on Tuesday to celebrate the budding development.

Click here to read more.

BELTSVILLE, Md., Oct. 04, 2022 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the initiation of a Phase 1b/2 clinical trial to evaluate NC410 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with immune checkpoint refractory or immune checkpoint naïve solid tumors. In addition, NextCure announced it has entered into a supply agreement for KEYTRUDA with Merck (known as MSD outside the United States and Canada).

NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells. Under the terms of the agreement, NextCure will sponsor the study and Merck will supply KEYTRUDA. The Phase 1b/2 trial will evaluate NC410 in combination with KEYTRUDA in patients with immune checkpoint refractory colorectal, esophageal, endometrial and head and neck cancers or immune checkpoint naïve patients with colorectal and ovarian cancers. The company expects to report initial Phase 1b data in mid-2023 followed by the initiation of the Phase 2 component of the study.