NEW YORK – Day One Biopharmaceuticals said this week that the US Food and Drug Administration has granted rare pediatric disease designation to its pan-RAF kinase inhibitor, Day101, as a treatment for pediatric patients with low-grade gliomas harboring activating RAF alterations. Day One is currently evaluating the agent in the Phase II FIREFLY-1 trial as a treatment for pediatric or young adult patients with recurrent or progressive, low-grade gliomas harboring known BRAF alterations. The rare pediatric disease designation makes Day One eligible for priority review for any subsequent marketing application should Day101 receive approval. The agent has received similar rare-disease treatment designations in the US and Europe.
Fresh off its July 23 initial public offering, Sophia Genetics said this week that it has completed a previously announced $20 million private placement of 1,111,111 shares to an affiliate of GE Healthcare, with which the firm signed a letter of intent to codevelop new artificial intelligence-driven analytics and workflow technologies. With these technologies, Sophia hopes to improve its ability to match cancer patients to treatments based on their genetic and tumor profiles. IPO underwriters JP Morgan, Morgan Stanley, Cowen, and Credit Suisse hold the option to purchase as many as 1,950,000 additional shares at $18 each.
Genetron Health said this week that it has entered the priority review and approval process under the National Medical Products Administration (NMPA) of China for its companion diagnostic kit for avapritinib (CStone Pharmaceutical's Ayvakit). According to the company, the test is the first companion diagnostic developed in China to go through the NMPA's accelerated review channel, which expedites the evaluation of qualified medical devices that are deemed urgent and necessary. Genetron's real-time PCR test detects PDGFRA D842V gene mutations in gastrointestinal stromal tumor (GIST) patients eligible to receive avapritinib. A clinical study showed that the test's ability to detect these mutations is on par with Sanger sequencing, with concordance rates of over 99 percent.
Global Cancer Technology this week said it has obtained an exclusive license to Baylor Scott & White Research Institute's (BSWRI) biomarker technology that it will use within its glioblastoma research efforts. GCT will use the biomarker technology, which the partners did not further describe, within its preclinical and clinical studies to advance glioblastoma treatments. The technology can improve diagnosis and guide treatment options for patients, according to GCT. The company added that it will begin clinical trials of PI3K inhibitors using BSWRI's biomarker technology later this year.
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.