NEW YORK – The US Food and Drug Administration this week granted fast track designation to Carrick Therapeutics' oral CDK7 inhibitor samuraciclib for both hormone receptor-positive, HER2-negative breast cancer and triple negative breast cancer, or TNBC. Specifically, the agency granted fast track status to samuraciclib plus the endocrine therapy fulvestrant for advanced HR-positive, HER2-negative breast cancer patients whose cancers are resistant to CDK4/6 inhibitors, and the agency granted fast track status to samuraciclib plus chemotherapy for locally advanced or metastatic TNBC patients. Carrick expects to present results from the ongoing Phase IIa study evaluating samuraciclib for HR-positive, HER2-negative breast cancer at an upcoming medical conference.
Sutro Biopharma said this week that the US Food and Drug Administration has granted fast track designation to STRO-002, the firm's folate receptor alpha (FolRα)-targeting antibody-drug conjugate, for patients with previously treated, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Sutro is currently evaluating STRO-002 in a Phase I trial, dubbed STRO-001-GM1, for this ovarian cancer patient population. Although Sutro's investigators are enrolling patients to the trial regardless of FolRα expression status, all patients are required to provide a tissue sample for FolRα expression analysis prior to treatment.
Senhwa Biosciences said this week that the US Food and Drug Administration has granted fast track designation to the firm's CK2 inhibitor, silmitasertib, for patients with recurrent SHH-driven medulloblastoma. The agent is currently being evaluated in an ongoing Phase I/II trial — conducted through Senhwa's partner, the Pediatric Brain Tumor Consortium — of children and adults with recurrent SHH-driven medulloblastoma. Last year, the agent also received rare pediatric disease designation from the FDA.
Telix Pharmaceuticals said this week that it has expanded its ProstACT program with two additional studies evaluating its molecularly targeted radiation therapy, TLX591, for prostate cancer patients. One of the two new studies, dubbed ProstACT SELECT, is a multicenter Phase I study comparing 68Ga-PSMA (gallium) and 177Lu-PSMA (lutetium) with the goal of better selecting prostate patients for treatment with TLX591. The second study, ProstACT TARGET, is a Phase II trial designed to evaluate TLX591 combined with radiation therapy in patients with oligometastatic prostate-specific membrane antigen (PSMA)-expressing cancer. Both studies will enroll roughly 50 patients, respectively, across multiple sites. Telix will conduct the ProstACT TARGET study in collaboration with GenesisCare.
Separately this week, Telix said that it has launched a Phase II study evaluating the feasibility of using the firm's TLX250-CDx PET/CT to detect CA9 expression in triple-negative breast cancer, which Telix says will serve as the basis for potential future therapeutic strategies. The study, dubbed OPALESCENCE, will join other Telix studies focused on CA9 as a therapeutic target.
Coeptis Therapeutics said this week that it has exercised its option to acquire two technology assets from VyGen-Bio focused on treating CD38-positive cancers. Under the terms of the agreement, Coeptis and VyGen-Bio, a subsidiary of Vycellix, will codevelop CD38-GEAR-NK, a cell therapy product designed to keep CD38-positive natural killer cells from being targeted by anti-CD38 monoclonal antibodies, as well as an in vitro diagnostic tool to identify patients who may be eligible for anti-CD38 monoclonal antibody treatment. The announcement that Coeptis has exercised its options to acquire the assets follows an initial announcement about the codevelopment plans made in May.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.