Roche AG’s Genentech unit unveiled positive phase III data from the Lidera study testing selective estrogen receptor degrader (SERD) giredestrant as an adjuvant endocrine treatment for people with ER-positive, HER2-negative, early stage breast cancer. The study met its primary endpoint at a preplanned interim analysis, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival with giredestrant vs. standard-of-care endocrine therapy. The win by Roche boosted shares of competitor Olema Pharmaceuticals Inc. (NASDAQ:OLMA), which were trading at $20.43, up $11.91, or 139%. Olema is developing the SERD palazestrant in combination with ribociclib in the same indication.

Vanda’s tradipitant has phase II success but a court setback

Top-line results from a midstage study of Vanda Pharmaceuticals Inc.’s tradipitant hit its primary endpoint by preventing the nausea and vomiting that can be caused by the GLP-1 receptor agonist Wegovy (tirzepatide, Eli Lilly and Co.) in overweight and obese adults. The positive phase II study data prompted Vanda to look at a phase III study of the neurokinin-1 receptor antagonist next year. Also, the U.S. Supreme Court decided to not review a case about the U.S. FDA’s decision to withhold tradipitant’s fast track designation because the program did not include dogs, monkeys or minipigs before allowing a clinical protocol beyond 12 weeks in humans. While Vanda had argued the additional animal studies were unjustified and unethical, a district court ruled in the FDA’s favor in 2020 on procedural and scientific grounds. The Supreme Court is leaving the lower court decision as the final ruling. Vanda’s stock (NASDAQ:VNDA) drove 21% upward at midday, with shares going for $5.35 each.

Agomab heads for phase IIb on positive Crohn’s fibrosis data

Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease. The primary endpoint of demonstrating safety and tolerability was met, with the severity and incidence of severe events similar across the two dosed arms and the placebo controlled arm of the 103-patient trial. The key secondary endpoint of selective delivery to the gastrointestinal tract with minimal systemic exposure also was met, and there were positive trends in disease activity scores and radiographic assessments of fibrotic strictures.

Harbour Biomed launches AI-based antibody development platform

Harbour Biomed is stepping up its antibody discovery process by using AI to develop innovative therapeutics. “We have done great through the traditional way of generating leads and designing molecules, but there’s a major gap as some therapeutics cannot reach the desired location or common targets,” Harbour Biomed founder, chairman and CEO Jingsong Wang told BioWorld. “We need a more efficient way to generate leads and design molecules. For Harbour, we’re looking at how to provide a unique angle and value to the industry.” To do that, the company is launching its first fully human generative AI HCAb (Heavy Chain-Only Antibody) model, powered by its Hu-matrix AI platform built on its Harbour Mice platform.

Henlius, Organon win US FDA approval of first Perjeta biosimilar

Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG). The FDA’s Nov. 13 approval covers all three of Perjeta’s indications, including in combination with trastuzumab and docetaxel to treat advanced HER2-positive breast cancer. Worldwide, Poherdy is the fourth pertuzumab biosimilar to gain regulatory clearance, following two products approved in China and one in India. China’s National Medical Products Administration accepted Henlius’ BLA of HLX-11 for review in December 2024.

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