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.

Is there a recession on the horizon?

Some economists say yes — and predict it’s going to be bad — while others say the United States will avoid one altogether. Still others forecast that one will linger for a while, but be relatively shallow.

But even if the country can’t dodge what many fear will follow record levels of inflation, a panel of experts in the life sciences field said on Tuesday they’re optimistic that the Frederick County biohealth sector may be spared from the worst effects of an economic downturn.

Image: Staff photo by Angela Roberts

Partnership combines miRecule’s unique RNA therapeutic discovery and conjugation platforms with Sanofi’s NANOBODY® technology to create a groundbreaking treatment for FSHD miRecule will receive an upfront payment with potential future milestone payments of nearly $400 million, in addition to tiered royalties Collaboration marks the first licensing transaction leveraging miRecule’s proprietary DREAmiR™ discovery platform, validating foundational science, and bolstering commitment to further expansion of the company’s RNA therapeutic pipeline October 04, 2022 07:00 AM Eastern Daylight Time GAITHERSBURG, Md.--(BUSINESS WIRE)--miRecule, Inc., an innovator of next-generation RNA therapeutics, today announced a strategic collaboration and exclusive license agreement with Sanofi to develop and commercialize a best-in-class antibody-RNA conjugate (ARC) for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The collaboration marks miRecule’s first licensing transaction leveraging its proprietary DREAmiR platform.

October 04, 2022 08:29 AM Eastern Daylight Time

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.

Johns Hopkins University is teaming with two D.C.-area institutions, Howard University and the National Institutes of Health, to create a new accelerator to help companies and research scientists focused on treating neurological conditions.

The nonprofit biotechnology accelerator, NeuroTech Harbor, is funded by an NIH investment of $5 million a year over five years, which could go up to $20 million annually. The NeuroTech Harbor plans to launch 45 new neurological companies over the next five years.

Image: NeuroTech Harbor Executive Director Sri Sarma views the project as a catalyst to turn Baltimore into a the Silicon Valley of neurological technology. COURTESY OF SRI SARMA

The BioHealth Capital Region has made a name for itself in the last few years, currently holding tight to its #4 ranking on the Genetic & Engineering News (GEN) Top 10 Biopharma Clusters list. As more life science companies flock to the region, though, a new challenge arises – how do we create a strong pipeline of local talent to support their needs? This pipeline not only includes the high concentration of experienced talent the BHCR is known for but entry-level employees and people without four-year degrees who can be trained on-the-job.

Did you miss the 8^th Annual BioHealth Capital Region Forum? Below we are sharing many of the panels, fireside chats, and keynotes from this event hosted on September 20^th, 2022, from USP in Rockville, Maryland.

The year’s theme was “Imagine the Future Together,” with discussions on Healthcare Innovation, Change, Diversity, Equity, and Inclusion.

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

Quantum World Congress is where global trailblazers, game-changers, innovators, and visionaries come together to accelerate a quantum-ready future

Quantum World Congress is the first-of-its-kind global conference, exposition, and networking event that brings a quantum-ready future into focus. Cross-sector, multi-disciplinary leaders and participants from around the world will gather for three days—November 29-December 1—in Washington, D.C. at the Ronald Reagan Building and International Trade Center to explore this groundbreaking field. This event welcomes quantum technology visionaries, policymakers, researchers, business and investment leaders, educators, and students to discuss and showcase major developments in quantum solutions, research, education, workforce, thought leadership, policy, business, and investment. Technology builders and buyers will also discuss national and global progress as well as challenges and opportunities in the development of quantum computing, sensing, communications, and materials.

We are pleased to share an exciting new funding opportunity from the NIH Blueprint Innovation Hubs that you or your colleagues may be interested in.

NeuroTech Harbor and CIMIT’s CINTA program, through the NIH Blueprint MedTech Incubator hubs program, are currently seeking proposals from academic and industry applicants who have emerging technologies that aim to improve the diagnosis and/or treatment of disorders of the nervous system. Awards up to $500K per year (up to 4 years) to the most promising and innovative neurotechnologies to help support their development journey toward commercialization.

#KeiretsuBacked Sisu Global named in the list of the 100 Most Influential Medtech Companies! They were awarded in the latest issue of Medical Design & Outsourcing, read here: https://bit.ly/3LRI0EI

NEWARK, Del., Sept. 29, 2022 /PRNewswire/ -- The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announces a Biomanufacturing Readiness Levels (BRLs) framework to lay the groundwork for a universal assessment of technology maturity and readiness level for commercial biomanufacturing technology adoption.

The BRL framework, described in the Biotechnology and Bioengineering journal, will benefit technology innovators, developers, and adopters with the ability to assess the maturity level of technology implementation during the clinical trials and commercial scale manufacturing processes that will allow them to overcome technology adoption hurdles from inception to commercialization. Modeled after the successful Manufacturing Readiness Levels developed by the Department of Defense, BRLs provide a tailored approach to the technology adoption journey that is specific to the biopharmaceutical industry.

GAITHERSBURG, Maryland and VANCOUVER, British Columbia – September 29, 2022 – miRecule, Inc., an innovator of next-generation RNA therapeutics, and SOLVE FSHD, a venture-philanthropy organization catalyzing the pace of innovation to accelerate a cure for facioscapulohumeral muscular dystrophy (FSHD), today announced that SOLVE FSHD has invested US$1 million in miRecule to support the discovery of the company’s anticipated best-in-class antibody-RNA conjugate (ARC) designed to be a disease-modifying treatment for the underserved FSHD patient population.

Click here to read/download the PDF

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:

"Today's Congressional vote demonstrates overwhelming bipartisan support for the Small Business Innovation Research program which is vital to our nation's capacity to innovate and improve the lives of all Americans.  When President Biden signs this bill, America's innovators, scientists and entrepreneurs will have another three years of certainty as they continue to create opportunities which lead to jobs and equity in our nation's innovation economy.  If past performance of the SBIR program is any guide, new generations of entrepreneurs will be breaking barriers in science, medicine, and technology, while ensuring that the United States maintains its position as an innovation leader at the forefront of science and technology in a rapidly evolving global market.  A new three-year reauthorization for SBIR is a significant win for our nation's small businesses and the American jobs it supports."

Some economists say yes — and predict it's going to be bad — while others say the United States will avoid one altogether. Still others forecast that one will linger for a while, but be relatively shallow.

But even if the country can't dodge what many fear will follow record levels of inflation, a panel of experts in the life sciences field said on Tuesday they're optimistic that the Frederick County biohealth sector may be spared from the worst effects of an economic downturn.

Newswise — The National Institutes of Health, through its Blueprint MedTech program, has established two incubator hubs and launched a funding solicitation in support of commercially viable, clinically focused neurotechnology solutions to diagnose and treat disorders of the nervous system. Blueprint MedTech relies on the collaborative framework of the NIH Blueprint for Neuroscience Research, which includes the NIH Office of the Director and 12 NIH institutes and centers that support research on the nervous system.

Vertex Pharmaceuticals will continue to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support gene-edited cell therapy exa-cel, formerly known as CTX001™ for hemoglobinopathies

ROCKVILLE, Md., Sept. 28, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with Vertex Pharmaceuticals Incorporated, a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

Twenty-four week interim analysis on approximately 160 subjects planned for Q1 2023 September 28, 2022 07:30 ET | Source: Altimmune, Inc

GAITHERSBURG, Md., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of first dosing of all subjects in its Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH).

MOMENTUM is a multicenter, randomized, placebo-controlled trial that is ongoing at approximately 30 sites in the United States, with Dr. Louis J. Aronne, Founder and Director of the Center for Weight Management at Weill-Cornell Medical Center, and a leading authority in obesity and obesity clinical trials, serving as the Principal Investigator. Approximately 320 subjects with obesity or overweight and without diabetes are being randomized 1:1:1:1 to either 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. The primary endpoint of the trial is the relative (percent) change in body weight at 48-weeks compared to baseline, with additional readouts including metabolic and lipid profiles, cardiovascular measures and glucose homeostasis.

The Company's Fifth Acquisition Deepens Ophthalmology Credentials and Enhances Global Reach

ROCKVILLE, Md., Sept. 28, 2022 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Clinical Edge. Clinical Edge trains and certifies visual function examiners at investigator sites conducting Phase I to IV ophthalmic clinical trials.

The combination of Optym, Emmes' ophthalmology certification unit, and Clinical Edge will make the organization a leader in ophthalmic certification and training services.

Emmes officially rolled out the new name – OptymEdge – and branding ahead of the American Academy of Ophthalmology annual meeting, which takes place in Chicago from September 30 to October 3.

GAITHERSBURG, Md., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of exclusive worldwide rights to TEMBEXA® (brincidofovir), the first oral antiviral approved by the U.S. Food and Drug Administration (FDA) for all age groups for the treatment of smallpox, from Chimerix. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

The completion of the acquisition follows the satisfaction or waiver by the parties, as applicable, of all closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended, and receipt of consent from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for a sub-contract agreement between Chimerix and Emergent.

Today, President Joe Biden announced his intent to appoint Dr. Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health (ARPA-H), a new agency established to drive biomedical innovation that supports the health of all Americans.  On the 60th anniversary of President John F. Kennedy’s Moonshot speech, Dr. Wegrzyn will join President Biden today at the John F. Kennedy Presidential Library in Boston as he discusses his bold vision for another American Moonshot: ending cancer as we know it.

ROCKVILLE, MARYLAND, September 26, 2022 – When it was announced that the winner of the 7^th Annual BioHealth Capital Region Crab Trap would be the recipients of a larger than ever prize pool, organizers didn't expect that two companies would benefit thanks to unique circumstances. The main winner, Neuroene Therapeutics, a biotech company focused on discovering, developing, and commercializing novel therapeutics for difficult-to-treat neurological disorders, was selected from five finalists as the company with the most commercial potential at the 7^th Annual Crab Trap Competition.

Gaithersburg-based Neuroene Therapeutics and its approach to treating a rare form of epilepsy were crowned the winner of the seventh annual Crab Trap Competition, which highlights the commercialization potential of biohealth technologies throughout the BioHealth Capital Region.

The company was largely recognized for its lead asset, NT102, a Vitamin K analog demonstrating broad seizure protection in preclinical animal models. In particular, the asset showed protection against seizures in Dravet syndrome, a rare genetic disease marked by severe encephalopathy and epilepsy that doesn’t respond well to current medications.

BaneBio is proud to be a sponsor of this invite-only VIP panel event I-270 Innovation Labs.

Startups. Capital. Entrepreneurship. These weren’t always terms in Amy White’s daily lexicon.

A trained scientist, White dedicated 15 years to teaching microbiology, focusing on the world that happens within the laboratory.

“I really never thought beyond the pipette, right,” she recalled at a recent biotech event, Game Changer Week, that was organized in Roanoke.

Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient's age.