by Jakub Jarolím, Business Intelligence Department
Dear customer, we are sorry but your browser doesn't support all necessary features for good site view. Please switch to one of the modern browsers (Chrome, Safari, Firefox).
Sotio Biotech
29/11/2022
October 2022 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Markets made a big comeback in October with NBI adding 9 %
Markets made a big comeback in October, including Nasdaq Biotech Index adding 9 % during the month. The upcoming FED meeting will be crucial for market expectations going forward.
The central bank is expected to announced interest rate hikes and their size in the near future.
Antibody-Drug Conjugates
Trodelvy will be examined in February for label expansion under Priority Review
Gilead Sciences is looking ahead to a February 2023 PDUFA date on its sBLA for Trodelvy sacituzumab govitecan-hziy to treat unresectable locally advanced or metastatic HR-positive HER2-negative breast cancer.
Interleukin-15 and Interleukin-2
Sanofi will discontinue ongoing Phase 2 trials evaluating IL-2 compound from Synthorx
After seeing BMS and Nektar Therapeutics give up on their candidate, Sanofi has reported “lower than projected” efficacy data on its prospect and rethought its plans for its IL-2 molecule. Sanofi entered the IL-2 space through its $2.5 billion takeover of Synthorx.
The deal gave Sanofi control of SAR444245, then known as THOR-707. Sanofi has initiated a clutch of midphase clinical trials to assess SAR444245 in various combinations and indications. The early signs from the trials were bad enough to prompt Sanofi to change course.
Cell Therapies
Allogene’s ALLO-501A advances into potentially pivotal trial
Five years after the first autologous CAR T cell therapy was approved, an off-the-shelf allogeneic CAR T program, ALLO-501A, is moving into a Phase 2 that Allogene Therapeutics expects to support regulatory approval in the US.
Other Innovative Treatment Areas
GSK makes checkpoint progress as PD-1, TIM3 programs advance
With GSK’s Jemperli meeting the primary endpoint in a Phase 2 non-inferiority study against Keytruda, the pharma has gotten a needed win for a PD-1 inhibitor that could be an essential piece in its strategy to expand its checkpoint inhibitor portfolio.
GSK said Jemperli dostarlimab plus chemotherapy met the primary ORR endpoint in the Phase 2 PERLA study, though no data were reported. The head-to-head trial evaluated chemotherapy plus Jemperli or Keytruda to treat first-line NSCLC.
Share on social networks