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.
Dialing down the immune response remains at the heart of myriad drug development efforts in autoimmune disease. Targeting cytokines, such as tumor necrosis factor alpha or interleukin-12 (IL-12) and IL-23, IL-6, or IL-17, or modulating immune cell trafficking by targeting sphingosine-1-phosphate receptor or integrins, are therapeutic mainstays. But chronic immunosuppression and all its attendant safety concerns is the price that many autoimmune disease patients pay to remain in remission.
Sotyktu (deucravacitinib), the tyrosine kinase 2 (TYK2) inhibitor for psoriasis from Bristol Myers Squibb Co., is “a good first-in-class” drug, said Nimbus Therapeutics LLC CEO Jeb Keiper, but his firm may have the best in class, ready for phase III trials. Takeda Pharmaceutical Co. Ltd. apparently believes so. The company has agreed to pay $4 billion up front and pledge as much as $2 billion more in potential milestone payments to acquire Nimbus’s wholly owned subsidiary, Nimbus Lakshmi Inc., thereby bringing aboard the TYK2 prospect called NDI-034858.
Apogee Therapeutics Inc. emerged from stealth with $169 million in financing and a pipeline of four preclinical antibody development programs that take aim at major immunological and inflammatory disorders.