Despite Vertex Pharmaceuticals Inc.’s mostly positive phase III study results of a non-opioid for treating moderate to severe acute pain, the data for a key secondary endpoint show VX-548 is not as effective as Vicodin (hydrocodone, Abbvie Inc.). Neither of two randomized, double-blind, placebo-controlled, pivotal studies, one after abdominoplasty surgery and one after bunionectomy surgery, met the key secondary endpoint of VX-548 being superior to hydrocodone bitartrate/acetaminophen in patients’ pain levels. However, the selective NaV1.8 inhibitor resulted in statistically significant improvement in pain compared to placebo and a clinically meaningful reduction in pain from baseline in both studies. That was good enough to prompt Vertex to say it plans to submit an NDA to the U.S. FDA by the middle of 2024.

Aiming to focus on BMS tie-up for Abecma, 2seventy offloads R&D assets to Regeneron

2seventy bio Inc. shares (NASDAQ:TSVT) rose 11%, or 49 cents, to trade midday at $3.89 on word that the Cambridge, Mass.-based firm is selling its R&D pipeline to Regeneron Pharmaceuticals Inc., which will launch Regeneron Cell Medicines to move the work forward. Along with an up-front sum of $5 million, 2seventy stands to collect a milestone payment for the first major market approval plus royalties on revenues generated by the transferred assets. 2seventy intends to focus all efforts on the partnership with Bristol Myers Squibb Co. for Abecma (idecabtagene vicleucel), a B-cell maturation antigen-directed, genetically modified autologous CAR T cell immunotherapy for relapsed or refractory multiple myeloma. Abecma was approved by the U.S. FDA in March 2021. Shares of Regeneron (NASDAQ:REGN) were trading at $947.29, down $8.51.

Cour’s nanoparticles down-regulate autoimmunity with $105M series A

A company focused on regulating immune response through nanoparticle technology, Cour Pharmaceuticals, has raised $105 million in a series A round to move its lead autoimmune disease products into phase IIa trials. Proceeds will advance Cour’s candidates into proof-of-concept studies in myasthenia gravis and type 1 diabetes. The Chicago-based company also has existing phase II partnered programs with Takeda Pharmaceutical Co. Ltd. in celiac disease and with Ironwood Pharmaceuticals Inc. in primary biliary cholangitis. Cour’s antigen-specific immune tolerance platform reprograms the immune system to target the root cause of immune-mediated diseases.

Australia takes first steps toward meaningful reforms to health technology process

The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment (HTA) process that has remained unchanged for 30 years. The need for reforms were triggered in January 2022 by a parliamentary report, The New Frontier: Delivering better health for all Australians, which recommended significant changes to Australia’s health care system to ensure Australians have faster access to new drugs and devices. The report featured 31 recommendations that include streamlining the HTA process, particularly for cell and gene therapies, and establishing a separate center for precision medicine and rare diseases within the Department of Health.

Comparative genomics offers path to being tough as nails – or squirrels

Humans love to think of our species as unique. But on a genetic level, such uniqueness is surprisingly hard to find. And while that may be a blow to the ego, it also means that an evolutionary lens is one way to search for insights into human diseases. Animals are “adapted to use the same genes that you and I have, but in very different ways,” Ashley Zehnder told BioWorld. Zehnder is co-founder and CEO of Fauna Bio Inc., which uses comparative genomics to identify gene networks that underlie disease resistance in different animal species. Fauna’s ultimate goal is to identify drug targets in conserved genes.

Newco news: Vision Care’s iPS retinal cells primed for global market

Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies: Vision Care Group is the parent company, VCCT is the cell therapy subsidiary, and VCGT is the gene therapy subsidiary.

Combined candidiasis fungicidal appears superior to miconazole alone in phase II

The topical combination therapy miconazole plus domiphen bromide (MCZ-DB) resolved signs and symptoms of acute vulvovaginal candidiasis and eradicated the yeast Candida albicans from vaginal swabs to a greater extent than miconazole (MCZ) alone in a phase II study, according to Hyloris Pharmaceuticals SA and Purna Female Healthcare. As a miconazole potentiator and repurposed molecule, the DB portion of the drug is designed to make the plasma membrane and the vacuolar membrane of Candida spp more permeable, helping MCZ to exert its antifungal effect and potentially preventing further fungal growth.

Pearsanta acquires MDNA for $25M

Pearsanta Inc., a subsidiary of Aditxt Inc., formed in Feb. 2023, acquired MDNA Life Sciences Inc. for $25 million in stock, marking Aditxt’s second deal announced in a month. The company moved into the women’s health market with the $100 million planned acquisition of Evofem Biosciences Inc., maker of the contraceptive gel Phexxi, which it reported on Dec. 12. The deals show boldness on the part of Aditxt’s management team as the company just announced it regained compliance with Nasdaq’s continued listing rule for minimum stockholder’s equity on Jan. 2.

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