NEW YORK – Seagen said this week that the US Food and Drug Administration accepted for priority review its supplemental new drug application for Tukysa (tucatinib) plus Genentech's Herceptin (trastuzumab) as a second-line treatment for HER2-positive colorectal cancer patients. Seagen is seeking accelerated approval of the Tukysa combination based on results from the Phase II MOUNTAINEER trial, which showed the treatment had a 38.1 percent response rate, a median progression-free survival of 8.2 months, and median overall survival of 24.1 months in HER2-positive colorectal cancer patients. The FDA will make its approval decision by Jan. 19, 2023.
Ideaya Biosciences this week closed its public offering of common stock. The company sold 8,761,905 shares at a public offering price of $10.50 per share, and the underwriters also exercised the full option to purchase additional shares at the offering price. The total proceeds from the offering were $92 million before deducting underwriting discounts, commissions, and other offering expenses. Ideaya will use the funding to advance development of its lead candidate PKC inhibitor darovasertib, along with its MAT2A inhibitor, IDE397.
Cellistic said this week that it will acquire Celyad Oncology's cell therapy manufacturing capabilities, which include its 11,000-square-foot Belgium-based good manufacturing practice (GMP) facility and employees. Under the terms of the agreement, expected to close during the fourth quarter of this year, Cellistic will pay €6 million ($5.9 million) for the cell therapy manufacturing business unit. Cellistic plans to optimize the facility to manufacture human-induced pluripotent stem cell (iPSC)-based allogeneic cell therapies.
AstraZeneca said this week that its PARP inhibitor Lynparza (olaparib) plus Genentech's Avastin (bevacizumab) was approved in China as a maintenance treatment for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer is homologous recombination deficiency (HRD)-positive. China's National Medical Products Administration approved the treatment based on results from the Phase III PAOLA-1 trial that showed Lynparza plus Avastin improved overall survival compared to Avastin alone. In PAOLA-1, HRD-positive ovarian cancer patients in the Lynparza arm lived for a median of 65.5 months versus 48.4 months on just Avastin.
The US Food and Drug Administration this week granted fast track designation to Kinnate Biopharma's pan-RAF inhibitor, KIN-2787, for the treatment of unresectable or metastatic melanoma harboring BRAF class II or class III alterations or an NRAS mutation. KIN-2787 is being studied in an ongoing Phase I trial in patients with solid tumors harboring BRAF alterations or with NRAS-mutant melanoma. The firm said the drug was designed to target class I, II, and III BRAF mutations, which sets it apart from competitors that target only class I BRAF mutations.
Exact Sciences said this week that it has awarded $525,000 in grants to eight health centers that focus on improving colorectal cancer screening rates in vulnerable populations. Under the program, called Funding Opportunities for CRC Screening Uptake Strategies (FOCUS), awardees will implement intervention strategies to increase colorectal cancer screening rates. The recipients are the Access Community Health Center in Madison, Wisconsin; AtlantiCare Health Services in Atlantic City, New Jersey; Community HealthCare Network in New York; Angeles Community Health Center in Los Angeles; Mariposa Community Health Center in Santa Cruz County, Arizona; Mount Sinai Internal Medicine Associates in New York; Mountain Park Health Center in Phoenix, Arizona; and San Joaquin Health Center in Stockton, California.
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.