This week's Lab Notes has items on an antibiotic company's licensing deal, a partnership to find new uses for existing drugs, additional Food and Drug Administration designations for an experimental cell therapy, and more.
Here's the roundup:
Venatorx Pharmaceuticals
The privately owned Malvern pharmaceutical company entered into a licensing agreement with Menarini Group, an Italian biopharmaceutical group, for the exclusive rights to commercialize cefepime-taniborbactam in 96 countries.
Cefepime-taniborbactam is an investigational combination antibiotic being developed by Venatorx to treat adults with complicated urinary tract infections.
Menarini will hold rights to the therapy in Europe, Latin America, Middle East, Turkey and North Africa and the Commonwealth of Independent States, provided approval is secured from the relevant health authorities.
Under the terms of the deal, Venatorx will receive an undisclosed upfront fee and additional payments tied to research and development, regulatory, and sales-based milestones. Venatorx is also eligible for potential royalty payments based on a percentage of future product sales.
Specific financial terms of the agreement are being kept confidential.
"Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets,” said Christopher J. Burns, CEO of Venatorx, citing the company's global commercial infrastructure and experience in commercializing infectious disease products.
Elcin Barker Ergun, CEO of the Menarini Group, said the addition of cefepime-taniborbactam will expand Menarini's existing portfolio of antimicrobial anti-infectives.
In November, Venatorx entered into an exclusive license agreement with Melinta Therapeutics of Parsipanny, New Jersey, to commercialize cefepime-taniborbactam in the United States. That partnership followed Venatorx’s submission last summer of a new drug application for the combination antibiotic.
Every Cure
The Philadelphia-based nonprofit organization working to "unlock the full potential" of existing medicines to treat every disease possible has formed a collaboration with California medical technology company Atropos Health.
Atropos Health is the developer of Geneva OS, a proprietary operating system for rapidly transforming clinical medical data into real world insights.
The partnership will allow Every Cure to leverage Geneva OS and data from the Atropos Evidence Network to confirm and enhance findings from Every Cure's AI-driven data platform that emulates the effect of therapies.
“The collaboration with Atropos Health adds a critical input to our AI platform for identifying new treatment opportunities from existing medicines,” said Dr. David Fajgenbaum, co-founder and president of Every Cure.
Fajgenbaum is an associate professor of medicine in translational medicine and human genetics at the University of Pennsylvania's Perelman School of Medicine.
By using Atropos’ real-world evidence, Fajgenbaum said, the organization can discover new treatment opportunities, confirm bioinformatic-based predictions, and generate the evidence needed to drive therapies rapidly into clinical use.
“Finding new uses for existing drugs is the fastest way to relieve the suffering of patients struggling with diseases with no existing treatments,” added Dr. Grant Mitchell, CEO and co-founder of Every Cure.
Founded in 2022, Every Cure is developing what it calls a comprehensive, open-source data engine to generate predictive efficacy scores for 3,000 drugs against 20,000 diseases.
Cabaletta Bio
The Philadelphia biotechnology company said the FDA has granted second and third Fast Track program designations for its experimental cell therapy CABA-201.
The Fast Track program is designed to expedite the development of treatments for serous health conditions with unmet needs.
The new designations cover the therapy's potential use as a treatment for patients with dermatomyositis, a rare inflammatory disease marked by muscle weakness and a distinctive skin rash, and for the treatment of patients with systemic sclerosis, also a rare disease that causes skin tightening and joint pain.
Cabaletta (NASDAQ: CABA) previously received the designation for the experimental cell therapy's use as a treatment for lupus.
Quick Hits
Shares of Aclaris Therapeutics (NASDAQ: ACRS) dropped by more than 20% this week after the Wayne biopharmaceutical company announced what it called "not statistically superior" top-line results from mid-stage testing of ATI-1777, its experimental treatment for mild to severe atopic dermatitis. … New Hope-based Orchestra BioMed Holdings (NASDAQ: OBIO) said the first patient was randomized in its late-stage trial evaluating the effectiveness and safety of its atrioventricular interval modulation therapy, also known as BackBeat CNT, for the treatment of pacemaker-indicated patients with uncontrolled high blood pressure despite the use of antihypertensive medications. Orchestra is developing the technology in a partnership with Medtronic, which will have exclusive global rights to commercialize the product if approved. … Neuraptive Therapeutics of Wayne said it demonstrated proof-of-concept for NTX-001, its experimental treatment for peripheral nerve injuries.
