With a packed pipeline of drug candidates targeting multiple markers of cancer, Bayer AG signed on for a new project, this time going after the KRAS pathway with a global deal that could bring Kumquat Biosciences Inc. up to $1.3 billion in payments. Privately held Kumquat was launched in 2019 and has since signed three major deals, including the one with Bayer: one with Eli Lilly and Co. in 2021 worth $2.07 billion and another with Takeda Pharmaceutical Co. Ltd. in 2024 worth $1.33 billion. The KRAS G12D inhibitor received clearance of an IND in July from the U.S. FDA, and Kumquat will run the phase Ia study. Upon completion, Bayer takes over all further development and commercial activities. The $1.3 billion deal value includes up-front, clinical and commercial milestone payments, plus additional tiered royalties on net sales. Kumquat is holding on to an exclusive option to negotiate a profit-loss sharing arrangement in the U.S.

Two phase III wins for Novartis in autoimmune diseases

Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels. ITP also is an autoimmune disease. Ianalumab has a dual mechanism of action, B-cell depletion and BAFF-R inhibition.

Fosun out-licenses phase II DPP-1 to newco Expedition for $645M

Fosun Pharmaceutical Co. Ltd. subsidiary Fosun Pharma Industrial is out-licensing its phase II dipeptidyl peptidase 1 (DPP-1) inhibitor, XH-S004, to newco Expedition Therapeutics Inc. in a deal worth up to $645 million. Under the terms, Expedition gains global rights to rights to develop, manufacture and commercialize XH-S004, except in mainland China, Hong Kong and Macau. In exchange, Expedition will pay Fosun Pharma $120 million in up-front payments and development-based milestone payments and up to $525 million in sales-based milestone payments.

KDCA readies mRNA vaccines, tech for COVID-19, future outbreaks 

Korea Disease Control and Prevention Agency (KDCA) secured 5.3 million doses of COVID-19 vaccines made by Pfizer Inc./Biontech SE and Moderna Inc., officially including the mRNA-based vaccines in the country’s national immunization program on Aug. 5. Appointed as the head of the agency in July, KDCA Commissioner Lim Seung-kwan stressed the need for South Korea to strengthen health security capabilities, with the agency serving as a control tower for public health crises, including infectious disease outbreaks. In his July 14 inaugural address as the KDCA’s fourth commissioner, Lim swore to support the localization of mRNA technology and mRNA-based vaccine development as part of the KDCA’s key mid- to long-term preparations for the next big pandemic.

UK MHRA highlights potential of the vaginal microbiome in women’s health

The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions. The vaginal microbiome is a “largely overlooked area of medicine that could dramatically improve outcomes for millions of women,” according to a review of the untapped potential of this area of microbiome research, co-authored by Chrysi Sergaki, head of microbiome at MHRA and Saba Anwar, MHRA senior scientist. As one example, their analysis highlights how greater understanding of the vaginal microbiome could improve diagnosis and point to drug targets for endometriosis.

NSD2 inhibitors close chromatin and silence aggressive oncogenes

Experimental drugs that directly inhibit the NSD2 enzyme have shown potential as an effective strategy against hard-to-treat cancers, such as lung and pancreatic tumors driven by KRAS mutations. The therapeutic mechanism involves reversing a histone H3 methylation that promotes open chromatin and the expression of oncogenes.

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