NEW YORK – Oncotelic Therapeutics this week announced that it submitted a study protocol to the US Food and Drug Administration for a Phase I trial of its TGF-B2 inhibitor for patients with recurrent or relapsed diffuse midline glioma (DMG). About 50 percent of all childhood high-grade gliomas are DMG. The trial is the first in a series the company is planning to evaluate clinical benefit in glioma while also assessing predictive biomarkers.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) this week granted Innovation Passport designation to Blue Earth Therapeutics' investigational radiohybrid therapy 177Lu-rhPSMA-10.1 as a treatment for metastatic castrate-resistant prostate cancer (mCRPC). The Innovation Passport status is the entry point to the agency's Innovative Licensing and Access Pathway, which accelerates a therapy's time to market. Bracco subsidiary Blue Earth Therapeutics is evaluating the treatment, which is designed to target the prostate-specific membrane antigen, in a Phase I/II clinical trial.
Redx said this week that it will begin enrolling patients into combination arms in its ongoing Phase II clinical trials evaluating RXC004. In a new combination arm of the Phase II PORCUPINE trial, RXC004 will be evaluated in combination with Bristol Myers Squibb's Opdivo (nivolumab) for microsatellite stable metastatic colorectal cancer. In the new combination arm of its Phase II PORCUPINE 2 trial, meanwhile, RXC004 will be evaluated in combination with Merk's Keytruda (pembrolizumab) for biliary tract cancer patients.
4baseCare will collaborate with AstraZeneca India to help advanced cancer patients find treatment options using affordable genomics-based molecular profiling, the Mumbai-based precision oncology startup said this week.
Epigenetics firm VolitionRx this week joined the prospective study Lyonnaise Initiative for the Initiation of Lung Cancer Screening (ILYAD), which is evaluating the performance of blood biomarkers in the early detection of lung cancer. The study, being run out of the Hospices Civils de Lyon in France, will investigate the performance of Volition's Nu.Q blood test alone and in conjunction with a CT scan as a method to detect lung cancer early. Volition's test identifies and measures nucleosomes in the bloodstream that can indicate the presence of cancer.
Chinese cancer molecular profiling firm Genetron Health said this week that it has received notification from Nasdaq indicating that for the last 30 consecutive business days, the closing bid price of its American depositary shares was below the minimum of $1 per share. Genetron has until April 26, 2023, to regain compliance with the Nasdaq listing rules by having a closing bid price of at least $1 per share for at least 10 consecutive business days.
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.