NEW YORK – MorphoSys this week said the US Food and Drug Administration has granted fast-track designation to its EZH1/2 inhibitor tulmimetostat as a potential treatment for patients with previously treated, advanced, recurrent, or metastatic endometrial cancer with ARID1A mutations. The agency granted fast-track designation to this program based on tulmimetostat's activity in preclinical studies and preliminary data from a Phase I/II trial investigating the agent in patients with ARID1A-mutated endometrial and ovarian clear cell cancer, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, and BAP1-mutated mesothelioma and castration-resistant prostate cancer. The FDA reviews fast-track designated products at an expedited clip because the agency has determined that these therapies could potentially address an unmet need in a serious condition.
Boston University Chobanian & Avedisian School of Medicine this week announced that Julia TCW, an assistant professor of pharmacology and bioinformatics, received a five-year $3.9 million grant from the National Institutes of Health's National Institute on Aging to study Alzheimer's disease interventions targeted at the microglia. While microglia can protect against developing Alzheimer's, certain genetic and environmental factors alternatively can cause the immune cells to escalate disease through inflammation and neurotoxicity. Her research will investigate pharmacological and cell therapeutic interventions targeted at the microglia in an effort to protect against disease progression.
Ideaya Biosciences this week began the expansion of its Phase I study of PARG inhibitor IDE161 in cancers with homologous recombination deficiency (HRD). The expansion will focus on estrogen receptor (ER)-positive, HER2-negative breast cancer and ovarian cancer patients with tumors that harbor HRD. The Phase I study will continue to evaluate dosage of IDE161 monotherapy to determine the Phase II recommended dose.
Bethesda, Maryland-based Gain Therapeutics this week announced it has been granted permission to start a Phase I trial in Australia of GT-02287, a disease-modifying drug candidate designed to slow or halt progression of Parkinson's disease associated with GBA1 gene mutations. This is the first therapy in the biotechnology firm's pipeline to enter clinical development. Gain Therapeutics said it will soon begin dosing healthy volunteers for the study, in which it will assess safety and pharmacokinetics of the drug.
Quest Diagnostics said this week that it is collaborating with healthcare-focused relief and development organization Americares to provide no-cost diagnostic services and expanded telehealth to free and charitable clinics across the US with the goal of reducing health disparities in underserved communities. The partners will provide no-cost diagnostic services to 10 clinics for one year to help patients manage chronic disease. Additionally, clinics in Baltimore, Chicago, Houston, and Richmond, Virginia, will receive grants through the Quest Diagnostics Foundation for telehealth services.
The Mayo Clinic and GE HealthCare this week announced a collaboration focused on medical imaging and targeted radiopharmaceuticals. The partners aim to broaden access to theranostic agents through more efficiently producing the radioisotopes used in these therapies. The collaboration will span clinical research, product development, and multimodal data across multiple cancer types and other conditions.
German molecular diagnostics firm Oncgnostics said last week that it has received a multi-million-dollar investment from Hong Kong-based Grande Bio-tech to make Oncgnostics' cervical cancer diagnostic test, GynTect, available in Southeast Asia. Oncgnostics, based in Jena, has been distributing the test in China since 2022 through a partnership with Shanghai-based GeneoDx and received approval for the test, sold in China under the name GongAnLi, from the National Medical Products Administration that same year. The tests detects cancer-related DNA methylation changes from cervical swabs.
Congenica said this week that it has formed a partnership with myTomorrows, an online platform for matching patients to clinical trials, to present cancer trial and pre-approval treatment options to clinicians through Congenica's precision oncology portal. The companies expect the service to go live in the 2024 first quarter.
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 Medicine Online.