BioHealth Innovation Weekly for May 9, 2023

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May 9, 2023

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TEDCO Announces Investment into Rise Therapeutics

Biotech company receives follow-on funding to accelerate ongoing clinical development efforts

COLUMBIA, Md. (May 8, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $200,000 into Rise Therapeutics, a Maryland-based biotechnology company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provides access to gap financing.

"We are thrilled to receive this follow-on investment from TEDCO," said Gary Fanger, Ph.D, president and CEO of Rise Therapeutics. "This funding will allow us to accelerate our ongoing clinical development efforts and move closer to bringing our synthetic biology-based immunotherapy drugs to market; we are grateful to TEDCO for their support."

US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
US launch is planned before the 2023/24 RSV season

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.

Tony Wood, Chief Scientific Officer, GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

MaxCyte Signs Strategic Platform License with Walking Fish Therapeutics to Support the Development of its Innovative B Cell Platform

Walking Fish to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to engineer novel B-cell based medicines for the treatment of serious diseases

ROCKVILLE, Md., May 04, 2023 (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 to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Walking Fish Therapeutics, Inc. a biotechnology company that is rapidly advancing B cell-based therapeutics.

Under the terms of the agreement, Walking Fish obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees, clinical milestone payments and sales-based payments.

Gain Therapeutics Awarded CHF 2.5 million Innosuisse Grant to Advance Lead Program in GBA1 Parkinson’s Disease

BETHESDA, Md., May 03, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today announced that Innosuisse, the Swiss Innovation Agency, supports GT Gain Therapeutics SA with the amount of CHF 2.5 million (~$2.8 million) to develop GT-02287, Gain’s lead program for GBA1 Parkinson’s disease.

The Company’s Swiss Accelerator innovation project supported by Innosuisse entitled “Harnessing Structurally Targeted Allosteric Regulators to treat Parkinson’s Disease” includes clinical pharmacology and preclinical studies with the Company’s drug candidate GT-02287, which will be conducted as the lead program progresses through Phase 1 and Phase 2 clinical studies in GBA1 Parkinson’s disease.

Discover the Future of Pediatric Healthcare: Register Now for the 2023 Children’s National Innovation Day & Showcase

Registration is Open for the 2023 Children’s National Innovation Day & Showcase

Date: May 31, 2023 Time: 10:00 am - 7:00 pm Location: Children’s National Research and Innovation Campus (CNRIC), Washington, DC Registration Link: Click here to register

The organizers of the 2023 Children’s National Innovation Day & Showcase are thrilled to announce that registration is now open for this premier event highlighting innovation in pediatric healthcare. The event will take place on May 31, 2023, at the Children’s National Research and Innovation Campus (CNRIC) in Washington, DC.

USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, & Crab Trap Competition on September 19, 20 & 21

BioHealth Innovation, Inc. (BHI) is proud to announce that US Pharmacopeia (USP) will be hosting the 9th Annual BioHealth Capital Region Forum for the second year in a row on September 19th and 20th, 2023. In addition to this flagship event, USP will also host the 8th Annual BioHealth Capital Region Crab Trap Competition on September 20th and the 6th Annual BioHealth Capital Region Investment Conference on September 21st.

"We are looking forward to once again hosting the BioHealth Capital Region Forum. As an integral part of this dynamic region, USP is deeply committed to fostering innovation and collaboration across the BioHealth space. USP eagerly anticipates bringing together leading minds and stakeholders to advance our shared vision for the future." said Anthony Lakavage, J.D., SVP of Global External Affairs at USP.

BioTalk: Ensuring Quality and Compliance with Gaurav Walia - Mastering the Art of CSV in Life Sciences

Join us on an informative episode of BioTalk with Rich Bendis as we delve into the fascinating realm of computer systems validation (CSV) and its significant impact on quality assurance in the life sciences industry. Our guest, Mr. Gaurav Walia, Senior Global Director of Business Development at PQE Group and Principal SME of Computer Systems Validation, Computer Software Assurance, and Data Integrity and Sr. Associate Partner, brings extensive expertise in CSV and compliance consulting services.

Discover the essential role of CSV in ensuring the integrity, reliability, and compliance of computerized systems used in pharmaceutical and medical device manufacturing. Mr. Walia, a recognized authority in the field, will provide insights into CSV's challenges and best practices, emphasizing the critical importance of regulatory adherence and data integrity.

Listen now via your favorite podcast platform

Apple - https://apple.co/40NNJRL
Google - https://bit.ly/3HoBrrY
Spotify - https://spoti.fi/3AB7EbJ
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TuneIn - https://bit.ly/3Nj8KAH
YouTube (Audio) - https://bit.ly/3narsja