BioHealth Innovation Weekly for February 06, 2024

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February 06, 2024

BioHealth Innovation, Inc. (BHI) Welcomes Yaminah Leggett-Wells, Senior Director, Alliance Management at Amgen as Newest Member of the Board of Directors

ROCKVILLE, MARYLAND, February 5, 2024 – BioHealth Innovation, Inc. (BHI), a leading public-private nonprofit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, proudly announces the appointment of Yaminah Leggett-Wells to its esteemed Board of Directors.

Yaminah Leggett-Wells serves as the Senior Director of Alliance Management at Amgen, overseeing global partnerships spanning all stages of drug development. With over 20 years of experience in the pharmaceutical industry, her expertise includes strategic leadership, clinical operations, business development, and project and alliance management.

Yaminah Leggett-Wells’ appointment to the BHI Board of Directors is a significant addition who brings valuable skills and experience to our organization,” remarked Richard Bendis, President and CEO of BHI. “Her extensive pharmaceutical industry background and commitment to our region make her an outstanding asset to our Board and our mission in the BioHealth Capital Region.”

Yaminah joined Amgen in 2023 following Amgen’s acquisition of Horizon Therapeutics. Prior to this, she played instrumental roles in the development of medicines for asthma and neuromyelitis optica spectrum disorder at AstraZeneca and Viela Bio, demonstrating her in-depth knowledge of drug development and regulatory affairs.

Maxim Biomedical, Inc. Secures Second NIH RADx Tech High Performance Award for Continued Development of At-Home FiarFly™ Reader and COVID-19 & Flu A/B Rapid Test

ROCKVILLE, Md., Feb. 1, 2024 /PRNewswire/ -- MaximBio, a leading innovator in next-generation healthcare diagnostic technologies, is pleased to announce that it has been granted a second follow-on award from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx^®) Tech program for the continued development of its revolutionary FiarFly™ reader and COVID-19 & Flu A/B multiplex test. This additional Phase 2 award, totaling approximately $4.4 million, will be used to accelerate the development of the FiarFly™ reader and COVID-19 & Flu A/B multiplex test and quickly prepare for clinical trials targeting this influenza season.

WBJ: AstraZeneca doubles down on Montgomery County with $300M investment

By Sara Gilgore – Staff Reporter, Washington Business Journal - AstraZeneca PLC (NYSE: AZN) is leaving no doubt about its commitment to Montgomery County, pouring $300 million into a new U.S. manufacturing hub it’s establishing in Rockville just a couple months after taking over another building nearby.

The British pharmaceutical giant said Tuesday the facility at 9950 Medical Center Drive will start out as a space to make T-cell therapies for clinical trials in cancer, and could support other disease areas and commercial work going forward. The company also said it expects to create more than 150 new jobs at the site.

GEN: Novo Holdings Buys Catalent for $16.5B; Sells Three Sites to Novo Nordisk for $11B

By Alex Philippidis -February 5, 2024 - Novo Holdings, the asset manager of the foundation that controls Novo Nordisk, has agreed to acquire contract development and manufacturing organization (CDMO) Catalent for $16.5 billion—with the buyer standing to recoup two-thirds of that expense by selling three of Catalent’s fill-finish sites to Novo Nordisk for $11 billion upfront so it can meet booming demand for its blockbuster obesity drugs Wegovy^® and diabetes drug Ozempic^®, the companies said today.

The three sites—consisting of facilities in Bloomington, IN; Brussels, Belgium; and Anagni, Italy—employ more than 3,000 people combined, about one sixth of Catalent’s total global workforce of more than 18,000 people, including 3,000 scientists and technicians.

Baltimore's LifeSprout Enters into Licensing Agreement with Boyang Trading to Develop and Commercialize Next-Generation Lumina™ Dermal Filler in Greater China

BALTIMORE, Jan. 31, 2024 /PRNewswire/ -- LifeSprout, a privately held regenerative medicine company founded with technology licensed from Johns Hopkins University, today announced it has entered into a definitive agreement with Boyang Trading Co., Ltd. to exclusively develop and commercialize the Lumina™ dermal filler in mainland China, Hong Kong, Macau, and Taiwan.

Lumina is the first product from LifeSprout's proprietary Regenerative Matrix platform. The technology comprises biomimetic, biocompatible, biodegradable materials engineered to look and feel like native soft tissue.

Revolo Biotherapeutics Receives Orphan Drug Designation from the U.S. FDA for its First-in-Class Peptide as a Potential Treatment for Eosinophilic Esophagitis

GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.

MaxCyte and Wugen Sign Strategic Platform License to Expedite Scale-Up of Clinical and Commercial Manufacturing of Wugen’s Investigational Allogeneic, Off-the-Shelf Cell Therapies for Cancers

ROCKVILLE, Md. and ST. LOUIS, Jan. 30, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte will receive annual license fees and program-related revenue.

FDA Grants Orphan Drug Designation (ODD) Status to NeoImmuneTech’s NT-I7 for Advanced Pancreatic Cancer Treatment

ROCKVILLE, Md., Jan. 30, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.^[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.^[1]^,[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a "silent killer" because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.²

BioBuzz: Virginia Bio-Connect – The Success of Virginia’s First Statewide Collaborative Life Sciences Initiative

By Jelena Ivanjac | January 30, 2024 - The end of 2023 marked the completion of Virginia’s first statewide life sciences initiative, Virginia Bio-Connect, which started in April 2021. This comprehensive industry cluster strengthening project, supported by Virginia Growth and Opportunity Foundation funding and led by the Virginia Biotechnology Association, engaged thousands of life sciences professionals and hundreds of organizations and companies within the sector with the overarching goal of fostering a more connected life sciences ecosystem, providing support for early-stage companies, and driving workforce development throughout the state.

Bio: House passes bill restoring full R&D expensing

On January 31, the House passed legislation to restore the immediate expensing of R&D expenses. The Biotechnology Innovation Organization (BIO) has long advocated for this change.

Until 2022, research and development expenses were 100% tax deductible each year. However, the Tax Cuts and Jobs Act of 2017 required companies to amortize domestic expenditures over five years, and international expenditures over 15 years.

The $78 billion Tax Relief for American Families and Workers Act, passed yesterday, would reverse the change and reinstate R&D expensing. R&D expenses would be 100% deductible through 2025.

BioHealth Innovation Insights from the 2024 J.P. Morgan Healthcare Conference

BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here's a summary of their observations and thoughts.

GEN: Top 10 Biopharma Takeover Targets of 2024

By Alex Philippidis - February 1, 2024 - Viewed simply by numbers of merger and acquisition (M&A) deals, 2023 was a down year: 1,078 biotech companies found buyers last year, down from 1,088 in 2022, while the number of pharma companies carrying out buyouts fell more significantly, from 778 two years ago to 679.

These numbers come from LSEG, the global financial markets infrastructure and data provider that owns the London Stock Exchange. LSEG’s data also reveals marked increases in the dollar values assigned to the biotech companies and pharma companies that are being acquired. The total value of biotech M&A in 2023 stood at $122.2 billion, up 45% from $84.2 billion a year earlier. The total value of pharma M&A jumped 38% year over year, from $98.5 billion in 2022 to $135.5 billion in 2023.

Deadline Approaching: Apply to Be Part of the Maryland Delegation at BIO 2024

The Maryland Department of Commerce invites companies to seize the opportunity to join the Maryland delegation at the BIO International Convention in San Diego, CA, this June 3-6, 2024. This event offers unparalleled networking, learning, and visibility for companies in the biotech sector.

Benefit from a complimentary Premier Access pass, which includes access to key partnering sessions, exhibitor booths, educational content, and exclusive networking receptions. Your company will also gain promotional exposure as part of the delegation.

To be eligible, companies must be registered and in good standing in Maryland. Selected companies are expected to actively participate in pre-conference and event activities, and share insights post-event.

Applications are due by February 21, 2024. Click here to apply now. For queries, contact life.sciences@maryland.gov. This is a valuable opportunity to showcase your company on a global stage. Apply now to join the Maryland delegation at BIO 2024.

Infinity Bio Launches Next-Generation Antibody Profiling Platform Utilizing MIPSA Technology

BALTIMORE--(BUSINESS WIRE)--Infinity Bio, Inc. announces its new antibody profiling platform, leveraging Molecular Indexing of Proteins by Self-Assembly (MIPSA) technology. This platform offers unparalleled depth in immune system analysis, advancing immunology, virology, autoimmunity, and allergy research, providing new disease insights, and discovering new biomarkers and treatments. The MIPSA technology exploits recent advances in high throughput DNA sequencing and DNA synthesis, to create and analyze the most complete panels of immune targets available.

The immune system crafts antibodies from approximately one quadrillion options, enabling it to identify and neutralize any infectious threat. However, flaws in the immune system can result in excessive inflammation, autoimmunity, or allergies. Infinity Bio’s scientists have developed a novel technique, MIPSA, to examine the extensive array of antibodies present in blood or other fluid, providing comprehensive understanding of individual immune responses.