NEW YORK – Allarity Therapeutics said this week that it is experiencing slower than anticipated patient enrollment to its clinical trials evaluating Ixempra (ixabepilone) and stenoparib for DRP biomarker-selected patients with breast and ovarian cancers, respectively. To increase enrollment in the Ixempra Phase II breast cancer trial in time to report out data by late 2023, Allarity said it has amended the protocol to lower the Ixempra-DRP companion diagnostic cutoff score from 67 percent to 33 percent. Allarity has also adjusted its dosing strategy for the stenoparib trial and expanded CRO partnerships to address the lagging enrollment.
The US Food and Drug Administration this week granted orphan drug designation to Transcenta's anti-Claudin 18.2 monoclonal antibody, osemitamab, for the treatment of patients with pancreatic cancer. Transcenta is studying osemitamab in patients with gastric, gastroesophageal, and pancreatic cancers that express Claudin 18.2. Osemitamab was also granted orphan drug designation in 2021 for patients with gastric cancer and gastroesophageal junction cancer.
Iovance Biotherapeutics said last week that it has finished submitting all parts of its rolling biologics license application to the US Food and Drug Administration for its autologous tumor-infiltrating lymphocyte therapy lifileucel for previously treated advanced melanoma patients. Iovance also said it reached an agreement with the FDA on the design of a new registrational Phase III trial, TILVANCE-301, seeking approval for lifileucel combined with Merck's Keytruda (pembrolizumab) as frontline treatment for advanced melanoma. The FDA has 60 days to determine the BLA's acceptability for review.
Immutep said this week that it would expand the number of patients enrolled in the Phase I INSIGHT-003 trial evaluating the combination of LAG-3-targeted protein, eftilagimod alpha, with standard-of-care anti-PD-1 therapy and chemotherapy in first-line non-small cell lung cancer. The trial has reached its initial enrollment target of 20 patients and will now expand its enrollment to 50 patients. Researchers are exploring the combination in patients with low-PD-L1 expression, or a PD-L1 tumor proportion score of less than 50 percent.
Thermo Fisher Scientific said this week that its partner Arsenal Biosciences has advanced its autologous integrated circuit T-cell therapy into clinical manufacturing for platinum-resistant ovarian cancer. Thermo Fisher partnered with ArsenalBio in 2020 to provide support for cell therapy manufacturing.
MetroHealth of Cleveland, Ohio, said this week that it has launched its good manufacturing practices (GMP) vector and cellular facility for production and processing of cellular immunotherapies including CAR T-cell and tumor-infiltrating lymphocyte cancer therapies. It will be the first safety-net hospital in the US to offer in-house production of viral vectors and cellular therapies, providing those treatments to underserved communities in the Cleveland area.
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.