Phase II data that rolled out from Merck KGaA with its Bruton's tyrosine kinase (BTK) inhibitor evobrutinib in relapsed multiple sclerosis (MS) put more eyeballs on the mechanism. It’s already well validated in oncology, but resistance has arisen there, and at least two firms – Beigene Ltd. and Nurix Therapeutics Inc. – are striving for solutions with degrader candidates.
Incyte Corp.’s bid for a once-daily vs. twice-daily version of the Janus kinase inhibitor Jakafi (ruxolitinib) was foiled, at least temporarily, by a complete response letter (CRL) from the U.S. FDA.
It is approved as a food additive. But it now appears that sucralose can dampen T-cell-mediated immune responses, suggesting it could be a means of treating T-cell-dependent autoimmune disorders. While stressing (repeatedly) that they were studying intakes well above normal, at high but achievable doses sucralose has an unexpected effect on T-cell responses and functions in autoimmune, infection and tumor models, researchers at The Francis Crick Institute, London, reported in Nature March 15, 2023.
Swiss orphan biotech AB2 Bio Ltd. has completed enrollment in a pivotal phase III trial for its recombinant interleukin-18-binding protein drug tadekinig alfa for an inherited form of the ultra-rare condition hemophagocytic lymphohistiocytosis that results from an excess of the pro-inflammatory cytokine IL-18.
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
Nektar Therapeutics Inc. President and CEO Howard Robin didn’t mince words during a call with investors after market close Feb. 23 to disclose top-line data from a phase II study testing rezpegaldesleukin (rezpeg) in systemic lupus erythematosus, which fell short of partner Eli Lilly and Co.’s criteria for advancing to phase III and raised uncertainty as to how the big pharma might proceed in other indications such as atopic dermatitis (AD).
Innocare Pharma Ltd. said it is open to new collaborations after partner Biogen Inc. decided to terminate a global deal to develop and commercialize BTK inhibitor orelabrutinib, in development for multiple sclerosis and other autoimmune diseases. Notice of the termination, disclosed in Biogen’s fourth-quarter 2022 financial report, was “based on the contract term of ‘terminate for convenience,’” Innocare told BioWorld. “We do not know their internal decision-making process.”
Aqilion AB has sold rights to its TAK1 inhibitors to Merck KGaA in an exclusive license and research collaboration agreement worth at least €960 million (US$1.03 billion) including potential milestones and royalties. The global giant will pay the Swedish biotech – which is headquartered in Helsingborg – €10 million in cash up front for the program and potential development and commercialization milestones and tiered royalties on worldwide net sales of more than €950 million.
Updated MRI results from Clene Inc.’s phase II Visionary-MS trial testing gold nanocrystal therapy CNM-Au8 bolsters the company’s premise that targeting energy metabolism could protect neuronal function in patients with multiple sclerosis and lays the groundwork for a phase III trial as soon as a strategic partner is found.
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea.
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