527th Edition, October 5, 2022

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October 5, 2022

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miRecule Enters into Strategic Collaboration with Sanofi to Accelerate Discovery and Development of a Best-in-Class Antibody-RNA Conjugate to Treat Facioscapulohumeral Muscular Dystrophy (FSHD) | Business Wire

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.

SOLVE FSHD Invests US $1 Million in miRecule to Accelerate Development of Best-in-Class Antibody-RNA Conjugate to Treat Facioscapulohumeral Muscular Dystrophy

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.

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BioHealth Executive-In-Residence Montgomery County, MD

BioHealth Innovation, Inc. (BHI) has partnered with Montgomery County, Maryland to support entrepreneurs seeking to commercialize life sciences, digital health, and medical device technologies. The new BHI-County agreement will fund one or more Executives in Residence, dedicated to cultivating the local life sciences ecosystem within Montgomery County.The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist (generally in their first 5-7 years after receiving their PhD) who wants to engage with the biohealth industry in new ways.

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8th Annual BioHealth Capital Region Forum Recap

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.

SISU Global Names One of MedTech's 100 Largest Players

#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

Emmes Acquires Clinical Edge

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.

Emergent BioSolutions Completes Acquisition of Exclusive Worldwide Rights to TEMBEXA® (brincidofovir), the First FDA-Approved Smallpox Oral Antiviral for All Ages

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.

Gaithersburg’s Adaptive Phage Therapeutics Awarded Additional $5 Million from U.S. Defense Health Agency to Support Diabetic Foot Osteomyelitis Clinical Trial

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.

MaxCyte Signs Strategic Platform License with Vertex Pharmaceuticals to Advance CRISPR/Cas9-based Gene-editing Program

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.

Altimmune Announces First Dosing of All Subjects in Phase 2 MOMENTUM Trial of Pemvidutide in Subjects with Obesity or Overweight

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.

How Do We Bolster the BioHealth Capital Region Workforce? · BioBuzz

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.

Registration is Now Open for Quantum World Congress

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.

Johns Hopkins University partners with NIH, Howard University for accelerator – Washington Business Journal

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

NIIMBL Releases the First Industry-wide Biomanufacturing Readiness Level Framework for Biologics

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.

Do you have groundbreaking technology that can diagnosis or treat disorders of nervous system?

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.

Administrator Guzman Applauds Passage of Small Business Innovation Research (SBIR) Program Reauthorization, Committing to Scientific and Technology Innovation

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."

Additional Information on New NIH MedTech Program: Incubator hubs will provide subawards to technology innovation teams and aim to accelerate medical devices to treat, diagnose nervous system disorders – The LaunchPort

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.

President Biden Announces Intent to Appoint Dr. Renee Wegrzyn as Inaugural Director of Advanced Research Projects Agency for Health (ARPA-H) – The White House

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.

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