Evolveimmune Therapeutics Inc. has secured its fourth big pharma investor and its first pharma development partnership in a deal with Abbvie Inc. The multitarget development deal with Abbvie includes $65 million now, combined between an up-front payment and an equity investment. Evolveimmune is also eligible for up to $1.4 million in aggregate option fees and milestone payments, as well as tiered royalties on sales of products that are optioned by Abbvie.
FDA adcom grapples with uncertainties in type 1 diabetes
Given the paucity of clinical studies of chronic kidney disease in type 1 diabetes (T1D), U.S. FDA reviewers and members of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee were scratching their heads this morning over whether better glycemic control is enough to offset the diabetic ketoacidosis risks seen with Lexicon Pharmaceuticals Inc.’s sotagliflozin. Another question the agency and panel are grappling with is whether the findings from a cardiovascular outcomes trial looking at the drug in patients with type 2 diabetes are relevant to the T1D population. In opening the meeting, the FDA’s Patrick Archdeacon noted the importance of optimizing glycemic control and the need to do more to address the lack of effective treatments in T1D. He added that the agency needs to find the appropriate balance between providing access to new treatments and the evidence it requires to show effectiveness.
Ono skips option on itolizumab, Equillium sinks
Shares of Equillium Inc. (NASDAQ:EQ) were trading at 90 cents, down 48 cents, or 34%, after the firm said Ono Pharmaceutical Co. Ltd. is letting expire the option to acquire rights to itolizumab. The decision was not related to data from any clinical program, Equillium pointed out, and there have been no safety concerns with the compound. Ahead are top-line data from the phase III Equator study in acute graft-vs.-host disease, which could come as soon as the first quarter of 2025, as well as top-line findings from a phase II trial in ulcerative colitis, due at that time. Itolizumab is a monoclonal antibody that targets the CD6-ALCAM signaling pathway, which plays a central role in the modulation of effector T cells.
BioWorld Cancer Index continues to decline amid broader market gains
The BioWorld Cancer Index (BCI) took a hit in September, ending the month down 11.52%, a notable slide from its 3.94% decline at the end of July and 9.63% drop by the end of August. The BCI’s performance starkly contrasts with the Nasdaq Biotechnology Index, which jumped 9.09%, and the Dow Jones Industrial Average’s 12.31% gain over the same nine-month period.
Astrazeneca’s China president under investigation in China
Astrazeneca plc’s China president, Leon Wang, is under investigation in mainland China, the company said in an Oct. 30 statement. Although details are scant, Astrazeneca said Wang is “cooperating with an ongoing investigation by Chinese authorities,” and the company’s China operations will continue under the leadership of the current general manager of Astrazeneca China. According to local Chinese media reports, the investigation comes months after police detained several Astrazeneca employees who were questioned about bringing an unapproved cancer drug into the country.
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