Mestag Therapeutics Ltd. has sealed a potential $1.9 billion agreement with Merck & Co. Inc., in which it will apply its expertise in activated fibroblasts to identify novel targets for inflammatory diseases. The pharma company has the option to license one or more targets, up to a prespecified number, and will take on all subsequent discovery, development and commercialization work.
Research into the regulation of gene expression experienced a significant breakthrough with the discovery of microRNA, small RNA molecules that do not code for proteins but control their translation. This finding has earned its authors Victor Ambros and Gary Ruvkun the 2024 Nobel Prize in Physiology or Medicine.
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) on Sept. 26 will take up a controversy that’s hardly new: whether approval of immune checkpoint inhibitor drugs should be restricted in accordance with PD-L1 expression.
Metastatic solid tumors may be curable now. Among the most profound results presented over the weekend at the European Society for Medical Oncology (ESMO) 2024 Congress were the 10-year data from the Checkmate-067 and Keynote-006 trials, the phase III trials that tested Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line agents in advanced or metastatic melanoma.
Cellular immunotherapy is the Lamine Yamal of cancer therapy. It is easy to forget how young the field is – and that as stunning as it is to watch in action already, it is still reaching its full potential. One aspect of doing so is working in a broader range of tumor types. The field made a giant step toward that goal with last week’s approval of Tecelra (afamitresgene autoleucel, Adaptimmune Therapeutics plc), the first CAR T cell to be approved for treatment of a solid tumor.
The dealmaking continues at Boehringer Ingelheim GmbH as it plans to buy Nerio Therapeutics Inc. for $1.3 billion. The German company is bolstering its cancer programs with the Nerio acquisition, which will be added to multibillion-dollar deals cut earlier this year for cancer immunotherapies and nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) treatments.
Catalym GmbH has closed a $150 million series D to take its first in class immune potentiator visugromab into phase IIb development in a number of solid tumors. The round follows on the heels of data from a phase I/IIa trial which showed visugromab in combination with the PD-1 inhibitor antibody Opdivo (nivolumab, Bristol Myers Squibb) increased T-cell infiltration and generated durable antitumor responses in patients who had exhausted all other treatment options.
The adverse effects of PD-1 blockers on the CNS observed in cancer patients could occur through their effects on an enzyme that activates microglia. Pharmacological inhibition of the enzyme in mice reduced microglial activation and cognitive deficit without altering the antitumor capacity of the immunotherapy.
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