BioHealth Innovation Weekly for April 23, 2024

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April 23, 2024

Gaithersburg's Salubris Biotherapeutics Announces $35 Million in Financing and Provides Pipeline Progress Update

Shenzhen Salubris commits additional funding to continue research and development of novel, complex biologics

First patient enrolled in RENEU-HF, the Phase 2 clinical trial of JK07 in heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF)

Clinical trial application filed for JK06, SalubrisBio’s first-in-class biparatopic ADC

April 22, 2024 07:00 AM Eastern Daylight Time
GAITHERSBURG, Md.--(BUSINESS WIRE)--Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs. SalubrisBio also provided progress updates for JK07, the first investigational antibody fusion protein for heart failure, JK08, the first investigational IL15-CTLA4 antibody fusion for solid tumors and JK06, a first-in-class biparatopic antibody-drug conjugate (ADC) targeting a known tumor antigen.

Rockville's DrFirst Acquires Myndshft Technologies to Revolutionize Medication Management by Addressing Both Pharmacy and Medical Benefits

Pioneering Move Unites Medical and Pharmacy Benefits, Enhancing Access, Affordability, and Adherence for Specialty Medications and Procedures

ROCKVILLE, Md., April 18, 2024 /PRNewswire/ -- Healthcare technology pioneer DrFirst today announced it has acquired substantially all assets of Myndshft Technologies, Inc., a leader of end-to-end real-time medical benefits and automated prior authorization (PA) software-as-a-service (SaaS). This strategic acquisition aims to improve the patient experience and expedite access to vital specialty medications, such as infusions and in-office injectables primarily covered by medical benefits. Combined with DrFirst's platform and scale, the technology will also lighten the substantial administrative load on healthcare providers and their staff.

Founded in 2018, Myndshft is the only unified platform that streamlines prior authorization and related services for both medical and pharmacy benefits. This innovative technology uses AI, machine learning, and robotic process automation (RPA) to automate and streamline complex benefits, pricing, and PA processes across various payers and therapeutic classes into one seamless, intuitive workflow. The Myndshft platform also supports labs, imaging, and other procedures covered under medical benefits, which are often prerequisites for patients prescribed specialty medications.

USP joins BARDA’s BioMaP-Consortium

Rockville, MD, April 22, 2024 – U.S. Pharmacopeia (USP) is honored to announce its selection as a member of the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), an organization that brings together biopharmaceutical industry partners across the manufacturing supply chain to support the Biomedical Advanced Research and Development Authority (BARDA).

The BioMaP-Consortium serves a critical role in ensuring that the United States can respond rapidly to public health emergencies by convening public and private industry partners to expand capacity and capabilities to produce medical countermeasures, products that help diagnose, prevent, or treat diseases related to chemical, biological, radiological, or nuclear threats.

Novavax to Supply Updated COVID-19 Vaccine to Private Healthcare Providers in the United Kingdom

April 18, 2024
For Global Investor Audience Only

Novavax’s Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) is now available to pharmacies across the United Kingdom (U.K.) for private healthcare providers to offer an updated protein-based non-mRNA option as part of the 2024 vaccination season.

Today is an important milestone for our organization. It demonstrates our commitment to deliver an updated protein-based COVID-19 vaccine as we evolve into an endemic market. It also underscores our place as a long-term partner to public health. We believe a diverse vaccine portfolio and broader access can play vital roles in protecting communities in the U.K. and elsewhere.

Novel cell therapy treatments offer promise to immune-compromised children

Multi-institute clinical trial demonstrates therapy can be safely used in pediatric regional centers

WASHINGTON, April 18, 2024 (GLOBE NEWSWIRE) -- In a first-of-its-kind clinical trial, researchers found that intravenous therapies made from virus-specific T-cells (VST) can effectively treat immunocompromised pediatric patients, far surpassing the current standard of care, according to new research published in Nature Communications.

More than 60% of patients in the phase 2 clinical trial led by investigators from Children’s National Hospital and Huntsman Cancer Institute responded to the innovative VST therapy. This new treatment uses blood from healthy donors to manufacture a highly specialized immune therapy that, when given to immune-compromised patients, prompts their immune system to fight off potentially life-threatening viruses, including cytomegalovirus, Epstein-Barr and adenovirus. Without this therapy, estimates suggest that less than 30% of patients would recover, using standard protocols.

BioPharmaDive: Biotech landlord (and BHI Board Member) Joel Marcus on research clusters and the sector’s recovery

Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.

Joel Marcus built a real estate empire on the life sciences industry’s steady growth. Over three decades, his company Alexandria Real Estate Equities has amassed tens of millions of square feet of office and laboratory space in drug development hubs like Boston, San Diego and the San Francisco Bay Area.

Those holdings have given Alexandria a front row seat to biotech’s boom over much of the past decade through to the sector’s pandemic highs and more recent downturn.

TIME: We Need to be Ready for Biotech’s ChatGPT Moment

BY ERIC SCHMIDTAPRIL 16, 2024 4:20 PM EDT
Schmidt, Commissioner, National Security Commission on Emerging Biotechnology; Co-founder with his wife Wendy, Schmidt Sciences; Former CEO & Chairman, Google

Imagine a world where everything from plastics to concrete is produced from biomass. Personalized cell and gene therapies prevent pandemics and treat previously incurable genetic diseases. Meat is lab-grown; enhanced nutrient grains are climate-resistant. This is what the future could look like in the years ahead.

The next big game-changing revolution is in biology. It will allow us to more effectively fight disease, feed the planet, generate energy, and capture carbon. Already we’re on the cusp of these opportunities. Last year saw some important milestones: the U.S. approved the production and sale of lab-grown meat for the first time; Google DeepMind’s AI predicted structures of over 2 million new materials, which can potentially be used for chips and batteries; Casgevy became the first approved commercial gene-editing treatment using CRISPR. If I were a young person today, biology would truly be one of the most fascinating things to study.

AMPEL BioSolutions Selected as Member of Prestigious Federal Health Innovation ARPA-H Network

CHARLOTTESVILLE, VA – April 22, 2024 – AMPEL BioSolutions has been selected as a member - or "spoke" - of the Customer Experience Hub of ARPANET-H, a prestigious nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H). This national effort is designed to accelerate commercialization of health breakthroughs for populations that urgently need them.

The Customer Experience Hub in Dallas joins Boston and the Nation's Capital as the three hubs across the country tasked with creating better health outcomes for all by accelerating commercialization of groundbreaking technologies that focus on health in two ways, by optimizing clinical trials for disease-altering therapies and implementing technologies that monitor & predict health outcomes. This "prevent-detect-treat" effort connects biotechnology companies with funders, universities and non-profits in order to scale health breakthroughs.