Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
Upcoming catalysts from Annexon Biosciences Inc. put some joy into shares as the firm talked up its prospects during the recent J.P. Morgan Healthcare Conference, where attendees heard Jan. 8 about the news ahead with C1q protein complex inhibitor ANX-005 in Huntington’s disease (HD) as well as progress in Guillain-Barre syndrome (GBS), and more. The stock (NASDAQ:ANNX) enjoyed a 43% stock boost in the days after JPM, rising from $4.79 on Jan 8 to $6.84 on Jan. 13.
Bio-Thera Solutions Ltd. has obtained NMPA approval for BAT-1806 to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis and cytokine release syndrome. BAT-1806 is the world’s first tocilizumab biosimilar approved for marketing, according to Guangzhou, China-based Bio-Thera.
Alpine Immune Science Inc.’s update in its earnings report Nov. 14 on its ALPN-303 program added more intrigue to the notion of targeting B cell cytokines B cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) together in lupus, as other players are trying the dual approach as well, including China’s Remegen Co. Ltd. and Vera Therapeutics Inc.<
Since the advent of COVID-19 mRNA vaccines, the space has steadily grown hotter, a situation on which Anima Biotech Inc. has capitalized by way of a potential $580 million-plus deal with Abbvie Inc. to deploy mRNA biology modulators for three targets across oncology and Immunology.
Trex Bio Inc., which kicked off 2022 with a big pharma partnership, is back at it again, starting the new year with a potential $1.1 billion agreement with original backer Eli Lilly and Co. targeting immune-mediated diseases. Under the terms, Trexbio gets $55 million up front, with Lilly picking up an exclusive worldwide license for candidates from three programs.
After comparing the response to the two types of vaccines for the respiratory syncytial virus (RSV) based on its fusion protein (F), prefusion (pre-F) versus postfusion (post-F) vaccines, scientists at the National Institutes of Health (NIH) and Astrazeneca plc have demonstrated that targeting the pre-F protein led to better protection. No more bets on RSV immunization based on the post-F protein of the virus. Laboratories can now bet all on red for the pre-F technology.
In one of the first large preclinical deals of 2023, Evoq Therapeutics Inc. is licensing for up to $685.5 million its Nanodisc technology to Gilead Sciences Inc. to develop new rheumatoid arthritis and lupus treatments. The potential payout includes up-front fees, an option exercise and milestone payments across both programs. Evoq also could receive tiered royalties on any sales that result.
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
With $20 million raised in a series B round led by Brandon Capital and Tenmile, Aravax Pty Ltd. is poised to begin phase II trials of its immunotherapy, PVX-108, for peanut allergy. “Our product is unlike other approaches that are in later stages of development, and those products generally use natural extracts from peanuts to treat peanut allergy,” Aravax CEO Pascal Hickey told BioWorld.