NEW YORK – The US Food and Drug Administration this week granted breakthrough therapy designation to Moderna and Mercks' personalized cancer vaccine mRNA-4157/V940 combined with Merck's checkpoint inhibitor Keytruda (pembrolizumab) as adjuvant therapy for patients with high-risk melanoma following surgical resection. The FDA's breakthrough therapy designation allows for the expedited development and review of certain drugs based on promising preliminary clinical evidence. The FDA based its designation on the results of the KEYNOTE-942 clinical trial.
Gilead Sciences subsidiary Kite said this week that it has completed the previously announced acquisition of cell therapy firm Tmunity Therapeutics. With the acquisition, Gilead gains access to Tmunity's rapid CAR T-cell therapy manufacturing process and armored cell therapy platform, which it is developing to enhance CAR T-cell therapies' anti-tumor activity.
Kinnate Biopharma said this week that it began a Phase I trial of its pan-RAF inhibitor exarafenib in China and Taiwan in patients with advanced solid tumors bearing BRAF class I, II, and III alterations and those with NRAS-mutant melanoma. The company also announced that it acquired Kinnjiu Biopharma, and plans to use Kinnjiu's structure to support clinical development of its kinase inhibitors in China, Hong Kong, Macau, and Taiwan.
Oncocyte said this week that it has completed the previously announced sale of 70 percent of its ownership stake in its subsidiary Razor Genomics and identified the buyer as Dragon Scientific. Financial terms of the deal were not disclosed. Oncocyte retains a 30 percent equity stake in Razor but said it is no longer responsible for an estimated $8 million in annual operating expense and $13 million in future milestone and development payments. The deal involved the transfer of all the assets and liabilities related to the DetermaRx lung cancer prognostic test to Dragon.
Swiss startup 4D Lifetec said last week that it is preparing to launch its early cancer detection tests in the US market, and it is strengthening its scientific and commercial presence in the US ahead of that launch through a newly opened branch office on the MIT campus in Cambridge, Massachusetts. The company launched sales last year in Europe of its blood-based 4D Lifetest Lung Dx assay for detection of early-stage lung cancer, and it has secured CE-IVD marking for 4D Lifetest assays for breast, prostate, and colon cancers.
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.