NEW YORK – Samsung Biologics and Bristol Myers Squibb said this week that they have expanded a strategic agreement focused on manufacturing BMS's antibody cancer drug. Under the expanded agreement, South Korea-based contract development and manufacturing organization Samsung will provide the drug substance needed to manufacture the antibody cancer drug at its facility in Songdo, South Korea.
Kinnate Biopharma said this week that it was pausing development of three of its pipeline candidates and laying off approximately 70 percent of its workforce. The firm will prioritize development of its lead candidate pan-RAF inhibitor exarafenib in combination with Pfizer's MEK inhibitor Mektovi (binimetinib), its c-MET inhibitor KIN-8741, and discovery efforts around its CDK4 selective program. The firm will pause development of its brain-penetrant MEK inhibitor KIN-7136 and explore strategic alternatives for exarafenib monotherapy and its FGFR inhibitor KIN-3248. As of June 30, Kinnate had approximately $204.3 million in cash, cash equivalents, and investments, which is expected to fund operations into the second quarter of 2026.
Biocept said this week that it has completed enrollment in the feasibility phase of its FORESEE clinical trial, in which it is evaluating its CNSide liquid biopsy assay as a tool to monitor treatment responses and help guide treatment decisions. The firm enrolled 40 patients with breast or non-small cell lung cancer with leptomeningeal metastases. Biocept expects to have results from the feasibility phase during the first half of 2024 and to begin enrolling patients to the trial's validation phase.
Nexcella this week said the US Food and Drug Administration granted orphan drug designation to its CAR T-cell therapy NXC-201 as a treatment for amyloid light chain amyloidosis. The firm is studying NXC-201 in a Phase I/IIb trial in patients with BCMA-expressing multiple myeloma and amyloidosis. The FDA grants orphan designation to drugs for rare diseases, which provides sponsors tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug after regulatory approval.
DermTech said this week that it has signed agreements with Highmark, which, alongside a favorable coverage policy, enhance access to the firm's noninvasive melanoma test. Highmark and its Blue-branded affiliates provide health insurance to approximately 7 million members in Pennsylvania, West Virginia, Delaware and New York. "We are pleased to expand our connection with one of the largest Blues plans in the US and further reduce barriers to access with our test now available as an in-network benefit," Chris Murphy, DermTech's senior director of payor access, said in a statement. The company claims total covered lives in the US of approximately 133 million.
German diagnostics firm Cerca Biotech said this week that its quality management system has achieved ISO 13485:2016 certification for the design, development, production, and distribution of in vitro diagnostics and software for molecular testing. The Berlin-based company, a subsidiary of Shuwen Biotech, offers MammaTyper, a PCR-based breast cancer subtyping test.
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.