Gilead and Novo Nordisk expand NASH deal with new study; Pfizer out-licenses ADCs to a biotech startup
Pfizer has out-licensed a pair of antibody-drug conjugates to Cambridge, MA-based Pyxis Oncology.
Pyxis is handing over an unspecified upfront payment, milestones and a chunk of equity to Pfizer, and also gains rights to Pfizer’s ADC platform, “including various payload classes, linker technology and site-specific conjugation techniques for the future development of additional ADCs.”
Ronald Herbst, the CSO at Longwood-funded Pyxis, said:
The early generations of ADCs demonstrated significant potency, but considerable room remains for innovation to generate highly effective ADCs with an improved safety profile. PYX-201 and PYX-203 represent the next generation of ADCs that use innovative conjugation technologies.
— John Carroll
Gilead, Novo take NASH combo partnership into PhIIb
Gilead and Novo Nordisk are expanding a collaboration in a field that’s had quite the rough and tumble scene lately.
The duo is engaging in further work in their clinical NASH deal, launching a new Phase IIb study to evaluate Novo’s blockbuster semaglutide and two experimental Gilead candidates in the indication. The trial will look at semaglutide alone and in combination with the FXR agonist cilofexor and the ACC inhibitor firsocostat as part of the four-arm study.
Gilead and Novo plan to enroll about 440 patients across all four arms, looking at the impact on liver fibrosis improvement and NASH resolution. The trial will be double-blinded and placebo-controlled.
Researchers will look to build off a Phase IIa trial, which showed semaglutide alone and in combination with cilofexor and/or firsocostat was well tolerated in 108 people over 24 weeks. Additionally, post-hoc analyses of exploratory efficacy endpoints showed statistically significant improvements in hepatic steatosis and liver injury in the combo arm when compared to semaglutide alone.
Semaglutide has been approved by the FDA to treat type 2 diabetes, but not in NASH. Neither cilofexor nor firsocostat have been approved for any indication. — Max Gelman
Merck extends long-running cancer data collaboration with M2GEN
Merck has struck a deal with Tampa-based M2GEN which gives the pharma giant access to its anonymous data bank gleaned from cancer patients at 18 participating cancer clinics. Patients agree to donate their clinical and molecular data to M2GEN, which then leases it out to drug developers.
This new 5-year deal builds on a collaboration that dates back to 2006 and gave Merck some insights as it developed Keytruda. And researchers expect they can continue to use it for the next round of cancer drugs in the clinic. — John Carroll