Alkermes plc, of Dublin, said it has completed the acquisition of Boston-based Rodin Therapeutics Inc., for $100 million up front and up to $850 million in clinical, regulatory and commercial milestones, Rodin has been working to develop first-in-class, orally available, brain-permeable therapeutics for synaptopathies by designing molecules that target specific HDAC complexes. The approach is designed to reactivate neuronal gene expression, strengthen existing synapses and promote the creation of new synapses. Synaptic dysfunction is a pathological feature observed in many neurodegenerative and neuropsychiatric diseases.
Avita Medical Ltd., of Melbourne, Australia, and the Gates Center for Regenerative Medicine at the University of Colorado Anschutz Medical Campus will collaborate on preclinical proof of concept and development of a spray-on treatment of genetically modified cells for patients with epidermolysis bullosa (EB), with potential applicability to other genetic skin disorders. Avita supplies the platform and the Gates Center provides the reprogramming and gene editing technology. EB is a group of rare and incurable skin disorders caused by mutations in genes encoding structural proteins, resulting in skin fragility and blistering, leading to chronic wounds and, in some subtypes, an increased risk of squamous cell carcinoma or death. No financial terms were announced.
New data from Nashville’s Cumberland Pharmaceuticals Inc. show 78% of 1,063 patients with gram-positive infections had a positive clinical response when treated with injectable Vibativ (telavancin). Overall positive clinical response rates by infection type were comparable at 74% in patients with bacteremia or endocarditis, 79% in patients with bone and joint infections, 80% in patients with complicated skin and skin structure infections and 67% in patients with lower respiratory tract infections. The real-world data were published in Drugs – Real World Outcomes.
Enochian Biosciences Inc., of Los Angeles, agreed in principle to acquire an exclusive license for a hepatitis B virus (HBV) infections treatment being developed by G-Tech Bio LLC. No financial terms were announced. Enochian is a preclinical-stage biotechnology company using exclusive licenses for genetically modified cellular and immune-therapy technologies to treat HIV and HBV by re-engineering cells and then injecting or reinfusing the re-engineered cells back into the patient.
Saint-Prex, Switzerland-based Ferring Pharmaceuticals and Blackstone Life Sciences will jointly invest more than $570 million in nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy in late-stage development for patients with high-grade, Bacillus Calmette-Guérin unresponsive, non-muscle invasive bladder cancer. Fergene, a new gene therapy company and a Ferring subsidiary, was created to commercialize nadofaragene firadenovec in the U.S. and to advance its global clinical development. Blackstone will invest $400 million and Ferring will invest up to $170 million in Fergene.
In a stock and cash transaction expected to close by year-end, Generex Biotechnology Corp., of Miramar, Fla., will acquire a 51% interest in Altucell Inc., of New York. The deal is expected to close by the end of the year. Altucell’s patent portfolio includes global patents for its cell encapsulation platform and patents for the chemistry, manufacturing and ultra-purification of capsules.
Geneuro SA, of Geneva, said researchers at Karolinska Institutet and the Academic Specialist Center of Stockholm have agreed to collaborate with the company on a new single-center study of its monoclonal antibody, temelimab, designed to neutralize a pathogenic envelope protein for the potential treatment of multiple sclerosis. The one-year trial will enroll patients whose disability progresses without relapses and will document the safety and tolerability of temelimab following higher doses, as well as efficacy based on the latest biomarkers associated with disease progression.
Ico Therapeutics Inc., of Vancouver, British Columbia, said Boston-based Alexion Pharmaceuticals Inc. purchased the assets of Immune Pharmaceuticals Inc., of Fort Lee, N.J., including the obligations related to the sublicense of Ico-008 that Ico had with Immune. Alexion will pay $6 million in accordance with the bankruptcy proceedings of Immune. The obligations assumed include milestone payments of up to $32 million and royalties on sales of bertilimumab, also known as iCo-008, an antibody targeting eotaxin-1. Upon closing, Alexion gains the rights to develop and commercialize Ico-008 for non-ophthalmic indications worldwide, while Ico will continue to retain worldwide ophthalmic use indications and is in the planning stages for an additional phase II trial.
Liminal Biosciences Inc., of Laval, Quebec, said it closed on the previously announced divestment of its Isle of Man-based bioseparations business, operated through its subsidiary, Prometic Bioseparations Ltd., to global investment firm KKR & Co.
Predictive Oncology Inc., of Minneapolis, regained compliance with Nasdaq's minimum bid price requirement. Company shares (NASDAQ:POAI) fell about 1% to close at $3.28 on Monday.
PTC Therapeutics Inc., of South Plainfield, N.J., said FDA acceptance with priority review of the Genentech Inc. NDA for the survival motor neuron-2 splicing modifier risdiplam (RG-7916) to treat spinal muscular atrophy triggered a $15 million milestone payment by Genentech’s parent, Roche Holding AG, of Basel, Switzerland. Risdiplam was produced from PTC’s splicing platform. Earlier this month, the companies reported success without disclosing details in part two of the pivotal Sunfish study.
Sorrento Therapeutics Inc., of San Diego, said it received and has rejected an unsolicited, nonbinding term sheet proposal submitted by two biopharmaceutical companies to acquire all issued and outstanding shares of the company for between $3 and $5 per share in cash. Discussion with other potential partners around licensing and collaboration "represent potential short- and long-term value creation significantly exceeding the current all cash proposal," the company said. Company shares (NASDAQ:SRNE) rose 94.3% to $3.11 on Monday
Venatorx Pharmaceuticals Inc., of Malvern, Pa. said the Boston University-based nonprofit Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding the company up to $4.1 million in nondilutive funding to support development of its non-beta-lactam penicillin binding protein inhibitor program, which targets multidrug-resistant gonorrhea. The company said it could receive up to an additional $8.9 million from CARB-X if certain project milestones are met.
Willow Biosciences Inc., a Calgary, Alberta-based company focused on the production of cannabinoids for the treatment of pain, anxiety, obesity and brain disorders, has received conditional approval from the Toronto Stock Exchange to list its common shares on the market.