Roche's Sabry retires; Duchenne drug test fails

BioPharma Dive is trialing a new format that consolidates brief industry updates. Below is a summary of recent news from companies including Merck & Co., Cartography Biosciences, Roche, Novartis, Novo Nordisk, and Nippon Shinyaku.

Merck & Co.'s Keytruda has shown promising results in extending the lives of patients with a challenging type of breast cancer when used as a neoadjuvant (preoperative) and adjuvant therapy. The Keynote-522 study contrasted regimens involving Keytruda and chemotherapy against neoadjuvant chemotherapy alone in early-stage, high-risk triple-negative breast cancer. The results, which have already led to U.S. approval in July 2021, were statistically significant and clinically meaningful according to Merck.

Cartography Biosciences has formed a research partnership with Gilead Sciences, securing $20 million in funding. The collaboration aims to identify cancer drug targets, specifically for breast and lung cancers. Cartography utilizes computational and genomics platforms to pinpoint novel tumor-selective antigens, having raised $57 million in Series A funding two years prior.

Roche's head of pharma partnering, James Sabry, is set to retire after a fourteen-year tenure. He will be succeeded by Boris Zatra, who will assume the role of head of group business development on July 1. This new position amalgamates several dealmaking responsibilities. Zatra will report directly to Roche CEO Thomas Schinecker and become part of an expanded executive committee.

Preliminary findings from a confirmatory clinical trial of Nippon Shinyaku's drug Viltepso for Duchenne muscular dystrophy did not yield significant benefits over a placebo. The study involved 77 ambulatory boys with Duchenne, assessing the time required for participants to stand from a lying position over 48 weeks. Both the Viltepso and placebo groups showed increased velocity from baseline with no meaningful difference, casting doubt on the efficacy of Viltepso, which received accelerated FDA approval in 2020. Nippon Shinyaku is conducting further analyses and collaborating with regulators.

Novartis has announced positive Phase 3 trial results for two kidney disease medications. Atrasentan, acquired through the acquisition of Chinook Therapeutics, significantly reduced protein levels in urine compared to a placebo in patients with IgA nephropathy, a rare kidney condition. Another drug, Fabhalta, already approved and marketed by Novartis, also lowered proteinuria in patients with C3 glomerulopathy, an even rarer kidney disease. Proteinuria reduction is often a surrogate marker for kidney disease benefits. Novartis intends to seek regulatory approvals for both drugs for their respective conditions.

Novo Nordisk faced a setback as an FDA advisory panel voted 7-4 against recommending approval of its weekly insulin injection, insulin icodec, for Type 1 diabetes. Despite the potential for a more convenient alternative to daily injections, concerns were raised about a higher incidence of hypoglycemia in trial participants using insulin icodec compared to a comparator treatment. While the FDA typically follows its advisers' recommendations, it is not mandatory. In contrast, European regulators have recently approved insulin icodec for sale.