Cibotercept

Plus, news about Inflammasome Therapeutics, Johnson & Johnson and Verastem: Autoimmune disease startup nabs $30M: Hinge Bio de-stealthed with a Series A on Wednesday, led by hedge fund titan Steve Cohen’s firm Point72. The round will help get Hinge’s lead program, HB2198, into a Phase 1 trial for lupus. HB2198 is designed to target both CD19 and CD20 and “reset” the immune system by depleting B cells. — Max Gelman Keros halts all dosing in Phase 2 trial: The company said it ​​voluntarily stopped giving patients cibotercept (KER-012) to all patients in the trial after seeing additional heart-related side effects. Keros previously halted two of three dosing arms last month in the pulmonary arterial hypertension study. Keros stock $KROS fell 20% premarket. — Max Gelman Eye disease biotech toplines five-patient dataset: Inflammasome said its treatment for geographic atrophy reduced lesion growth by an average of 66% after three months. Patients received an injection into the eye of the program, called a K8 implant. Researchers intend to give patients a second injection after three months and will expand the trial to 30 patients. — Max Gelman Johnson & Johnson files bladder cancer drug device in the US : The pharma is seeking approval of TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The product uses a silicone tube to deliver gemcitabine directly to the bladder. One of its pivotal trials yielded a complete response rate of 83.5%, but the other was stopped early after an interim look showed TAR-200 was no better than chemo. — Elizabeth Cairns Verastem licenses GenFleet’s oral KRAS inhibitor for $5M upfront : VS-7375 is a selective KRAS G12D (ON/OFF) inhibitor in Phase 1 trials in China in advanced KRAS G12D-mutant solid tumors. Verastem will get rights outside China , Hong Kong, Macau and Taiwan, and plans to start a US Phase 1/2a trial in mid-2025. The US biotech will provide $1.5 million of research support over the first three years, and milestone and option payments could total $620 million, according to a filing , with royalties on top. — Elizabeth Cairns

Keros Therapeutics said Thursday morning it has voluntarily halted two of three dosing arms of its experimental drug in a Phase 2 trial due to a safety concern. The Boston-area biotech said there was an “unanticipated observation of pericardial effusion adverse events” in the so-called TROPOS study , which is testing cibotercept (KER-012) with background therapy in patients with pulmonary arterial hypertension, or PAH. The rare, progressive disease is marked by high blood pressure in the lungs. Fluid builds up in the area around the heart during pericardial effusion. Kero’s stock price $KROS immediately went into free fall upon the pre-market news, sliding about 70% before the opening bell. “We are working diligently to gain a better understanding of these unanticipated findings,” Keros CEO Jasbir Seehra said in a statement. “Above all, patient safety is our top priority when conducting any clinical trial.” Seehra said the biotech will work with trial investigators, the FDA and other regulatory authorities. The trial is being conducted in 55 sites worldwide in countries like the US, Australia, Germany and South Korea, according to the clinical trial database. Cibotercept is still on track for a topline data readout in the second quarter of 2025, Keros said Thursday morning. The trial is fully enrolled and dosing continues in the 1.5 mg/kg treatment arm, Keros said, after it conducted a risk and benefit assessment. That Phase 2 readout could “inform its safety differentiation vs approved Winrevair ,” Jefferies analyst Kelly Shi wrote in a Dec. 3 note, referring to Merck’s recently greenlit PAH drug. She wrote that cibotercept could become a multibillion-dollar drug. Last week, Takeda paid $200 million upfront for the license to a different Keros drug , an experimental anemia medicine known as elritercept, and promised more than $1 billion in biobucks. The upfront payment would help fund cibotercept and other pipeline drugs, Keros said last week.