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.
Investigators at the University of Bristol and Biognos AB have identified a structural feature that distinguished the deadly coronavirus strains from harmless, common cold-causing variants. The findings, which were published in the Nov. 23, 2022, issue of Science Advances, could form the basis of universal COVID antivirals, putting an end to the endless race to deal with new variants that has so far been a necessity.
A combination of radiation therapy and CD47 blockade induced an abscopal effect in animal studies even in animals that lacked T cells, researchers reported in the Nov. 21, 2022, online issue of Nature Cancer. The findings are “the first demonstration of T-cell-independent abscopal response,” co-corresponding author Edward Graves told BioWorld. “We’re not trying to say that all abscopal responses are macrophage-mediated. There are plenty that require T cells,” Graves clarified. But “there is another avenue of abscopal responses that has not been reported. ... All the abscopal literature is about stimulating an adaptive response.”
An in-depth investigation of the underlying causes of pulmonary symptoms that in some cases persist for months following recovery from the acute stage of COVID-19 has found a distinctive proinflammatory signature in the plasma and airways of affected patients.
Zenas Biopharma LLC has raised $118 million in a series B round to support a global phase III trial of its lead asset as well as other immunotherapies for autoimmune diseases in its pipeline. The study, expected to begin in 2023, will evaluate obexelimab for the treatment of patients with immunoglobulin G4-related disease in late 2022.