NEW YORK – CRISPR-based drug developer HuidaGene Therapeutics this week said it has received rare pediatric disease designation from the US Food and Drug Administration for HG004, a one-time treatment candidate for inherited retinal diseases caused by mutations in the RPE65 gene, which can result in blindness. In preclinical mouse studies, HG004 has shown promise for recovering retinal function, the company said. The FDA in March also granted the Shanghai-based biotech firm orphan drug designation for HG004.
Duality Biologics said this week that it has expanded an existing collaboration with BioNTech to include the development of the antibody-drug conjugate DB-1305 in HER2-expressing solid tumors. The deal gives BioNTech the rights to develop, manufacture, and commercialize DB-1305 globally, excluding Hong Kong, Macau, and mainland China. In April 2023, the two firms announced a licensing agreement focused on two other antibody-drug conjugates, DB-1303 and DB-1311. With the expanded agreement, DualityBio will receive upfront payments, and be eligible for development, regulatory and commercial milestone payments, and single-digit to low-double-digit tiered royalty payments on DB-1305.
Anixa Biosciences said this week that the Cleveland Clinic has begun enrolling triple-negative breast cancer patients into an arm of its Phase I trial evaluating Anixa's breast cancer vaccine combined with Merck's checkpoint inhibitor Keytruda (pembrolizumab). Through the already ongoing Phase Ia trial, Anixa and the Cleveland Clinic are evaluating Anixa's vaccine in patients who have had TNBC within the last three years and have completely responded to curative treatment but are deemed to be at high risk of recurrence. The new treatment arm is designed to help Anixa determine whether Keytruda can improve patients' immune responses to the vaccine.
MiRxes said this week that its flagship GastroClear PCR-based in vitro diagnostic test for the early detection of gastric cancer has been granted breakthrough device designation by the US Food and Drug Administration. MiRxes developed GastroClear in Singapore through a seven-year public-private partnership involving researchers and physicians at A*STAR's Bioprocessing Technology Institute, the Diagnostics Development Hub, the Singapore Gastric Cancer Consortium, the National University of Singapore, the National University Hospital, and Tan Tock Seng Hospital. The test was approved by the Singapore Health Science Authority in 2019, and MiRxes recently conducted a large prospective clinical trial involving more than 9,000 patients to support the test's registration with China's National Medical Product Administration. The company said it is evaluating partnerships to launch the test in the US.
Last month the company said it completed a Series D financing round totaling $50 million primarily to support the commercialization of GastroClear in the Asia-Pacific region.
Telix Pharmaceuticals said this week that it has treated the first prostate cancer patient in its China-based Phase III trial of Illuccix (Ga-68 PSMA-11). The firm already netted US Food and Drug Administration approval for Illuccix as a method of diagnosing prostate cancer and identifying patients eligible for treatment with prostate-specific membrane antigen (PSMA)-directed therapeutic radionuclides. Now, Telix is conducting the registration-directed study in China in the hopes of securing similar regulatory approval for Illuccix there. Telix is collaborating with Grand Pharmaceutical Group Limited to conduct the study in up to 110 prostate cancer patients.
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 Medicine Online.