NEW YORK – The US Food and Drug Administration this week granted orphan drug designation to Omega Therapeutics' OTX-2002 as a treatment for relapsed or refractory hepatocellular carcinoma patients. The drug, an epigenomic controller, is designed to downregulate MYC expression. Omega recently dosed the first patient in its Phase I/II MYCHELANGELO I trial evaluating OTX-2002 as monotherapy and combined with standard of care for both hepatocellular carcinoma and other solid tumors associated with the MYC oncogene. Though Omega is not enrolling patients to the clinical trial on the basis of MYC expression, the firm will evaluate the impact of MYC expression on treatment response in the trial.
Rain Therapeutics this week announced plans to amend the protocol for its Phase II basket trial evaluating milademetan for advanced MDM2-amplified solid tumors. As a result of an interim analysis, the firm said it would adjust the MDM2 copy number threshold to copy number greater than or equal to eight. Previously, the copy number threshold was greater than or equal to 12. Among the first 10 patients treated on the Phase II MANTRA-2 trial, the MDM2-p53 inhibitor led to unconfirmed partial responses in two patients and what Rain considered promising tumor regression in two patients.
Oncoshot, a Singapore-based company specializing in oncology clinical trial matching, said this week that it is collaborating with Singapore's Icon Cancer Centre and Roche to facilitate more comprehensive genomic profiling data to increase access to clinical trial options for cancer patients. Oncoshot said that through this collaboration the partners will be able to easily identify cancer patients who are a match for existing clinical trials being run within their networks. Furthermore, real-time population matching will enable companies and clinical research organizations on the Oncoshot clinical trial platform to engage Icon as a preferred clinical trial center, increasing patient access to clinical trial options for their cancer. For its part, Roche will provide comprehensive genomic profiling data from tests that analyze over 300 genes known to drive cancer growth, Oncoshot said.
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.