NEW YORK – Cofactor Genomics said this week that Stanford University has joined its PREDAPT (Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies) clinical trial evaluating use of the company's OncoPrism immunotherapy predictive diagnostic assay across 11 cancers. There are more than 20 health systems participating in the PREDAPT trial, which is evaluating OncoPrism's ability to predict response to immunotherapy in triple-negative breast, cervical, colorectal, esophageal, gastric, head and neck, kidney, liver, lung, and urothelial cancers.
China's National Medical Products Administration this week approved AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) as a treatment for unresectable or metastatic breast cancer patients with low HER2-expressing tumors. Patients are considered HER2 low and eligible for the antibody-drug conjugate if they have an immunohistochemistry score of 1+ or an IHC 2+ score with a negative in situ hybridization result. The NMPA, like the US Food and Drug Administration did last year, approved this indication based on the results of the DESTINY-Breast04 trial, in which Enhertu-treated patients had a 50 percent lower risk of disease progression or death compared to patients on their physicians' choice of chemotherapy. Enhertu is already approved in China for HER2-positive metastatic breast cancer.
South Korean biotechnology company Bridge Biotherapeutics this week said it has joined the Prognostic Lung Fibrosis Consortium (PROLIFIC), a nonprofit consortium of drugmakers and research institutions committed to developing personalized treatments for pulmonary fibrosis. The other organizations in PROLIFIC, which was founded in 2020 by the Pulmonary Fibrosis Foundation and Bristol Myers Squibb, are Chiesi, Galapagos, Galecto, Genentech, Gilead, Lassen Therapeutics, Lung Therapeutics, NeRRe Therapeutics, Novartis, OptiKira, Pliant Therapeutics, Three Lakes Foundation, and Tvardi Therapeutics.
The collaborators have so far identified a dozen biomarkers of epithelial damage, fibrosis, inflammation, and thrombosis based on published data. In the near term, they want to develop these biomarkers into validated tests for diagnosing pulmonary fibrosis, predicting response to treatments, and enabling comparisons of drug efficacy across clinical trials. "As a member of PROLIFIC, we will be able to tap into a diverse range of expertise, technology, and data that will enable us to accelerate detection of pulmonary fibrosis and speed the entire industry's development of new treatments," Sujin Jung, VP of clinical development and operations at Bridge Biotherapeutics, said in a statement.
BPGBio announced this week that it has entered into a strategic partnership with private investment group Grupo Terralpe to commercialize its PstateDx prostate cancer test in Mexico. The mass spectrometry-based test is intended to help physicians differentiate between benign prostatic hyperplasia and aggressive prostate cancer. Financial terms of the arrangement were not disclosed. The company said in a statement that it is exploring commercial opportunities in other geographical regions.
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.