AstraZeneca, Merck score China OK for Lynparza; Regeneron spotlights mid-stage data for rare disease drug
→ As they continue to scoop up wins for their PARP juggernaut Lynparza, AstraZeneca — along with their partners at Merck — have scored approval in China as a first-line maintenance treatment for a form of ovarian cancer. Regulators based their decision on results from the SOLO-1 trial, in which the drug lowered the risk of disease progression or death by 70% when compared to placebo. It marks a major addition to the list of 65 countries in which Lynparza is approved to treat platinum-sensitive relapsed ovarian cancer, the companies said.
→ Regeneron released positive early data from a small, Phase II trial on a rare blood disorder. Six patients were given Regeneron’s anti-C5 antibody pozelimab for paroxysmal nocturnal hemoglobinuria, or PNS, a chronic and life-threatening condition where red blood cells routinely rupture and spill their contents into the blood, causing fatigue, shortness of breath and blood clots. The patients given a weekly 800 mg subcutaneous injection of the antibody saw their levels of lactate dehydrogenase — an enzyme that falls into the blood when red blood cells break — return to normal.
→ GlaxoSmithKline’s HIV-focused subsidiary ViiV has completed its pitch to the FDA for what it hopes to be the latest addition to an arsenal of antiretroviral agents. The drug, fostemsavir, is a prodrug of temsavir and works by binding directly to the surface of the virus. In a Phase III trial involving heavily pre-treated patients with multidrug resistance, fostemsavir performed better than placebo as measured by a decline in HIV-1 RNA.
→ For its next foray into AI-powered drug discovery, AstraZeneca has turned to Gatehouse Bio — a portfolio company in its Boston Bio Hub incubator harnessing small RNA signatures to find molecular pathways associated with disease. The startup will apply its platform to identify new targets for respiratory and cardiovascular diseases.
→ Back in May, microbiome upstart Vedanta Biosciences got an extra $18.5 million in the bank as part of a $45.5 million Series C round financing. Today, the biotech secured more cash through a research grant from CARB-X of $5.8 million — the second it’s received from the non-profit. In addition, the company is eligible for $3.5 million in further funding upon completion of specific milestones. The new infusion will help push VE707 — Vedanta’s preclinical human microbiome-derived discovery program designed to prevent infection and colonization of multi-drug resistant infections by restoring a healthy microbiota.