Cibotercept

With a phase 2 trial of its pulmonary arterial hypertension drug terminated early, Keros Therapeutics said it still plans to present top-line data from all three treatment arms in the second quarter of the year.\n A month after halting dosing in two of the three treatment arms of a phase 2 trial of its pulmonary arterial hypertension drug, Keros Therapeutics has now pulled the plug on the study entirely.The Lexington, Massachusetts-based biotech had been testing 1.5-mg/kg, 3-mg/kg and 4.5-mg/kg doses of the TGF-β inhibitor, called cibotercept, in the phase 2 TROPOS study. In December, Keros voluntarily halted the two higher-dose cohorts “based on a safety review due to the unanticipated observation of pericardial effusion adverse events in the trial.”Pericardial effusion refers to an excessive buildup of fluid in the sac surrounding the heart, which is called the pericardium. The condition has a number of typical potential causes, including infection and injury.In a Wednesday morning release, Keros said it has now also stopped dosing the lowest, 1.5-mg/kg, cohort, “based on the ongoing safety review due to new observations of pericardial effusion adverse events.” “While we are disappointed in this new development, patient safety is always our top priority,” Keros CEO Jasbir Seehra, Ph.D., said in the Jan. 15 release. “We continue to work with the investigators, the FDA and other relevant regulatory authorities, and we look forward to analyzing and presenting TROPOS topline clinical data in the future.”With the trial terminated early, Keros said it still plans to present top-line data from all three treatment arms in the second quarter of the year.The company’s shares shed two-thirds of their value when the news of the first halted trials was announced in December. This morning’s update saw a further 15% stock drop in premarket trading to $10.63 from a Tuesday closing price of $12.48.

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