Oncolys Biopharma announced that the safety endpoint of the initial safety cohort of the NRG Oncology sponsored Investigator-Initiated Phase I Clinical Trial for Telomelysin?? (OBP-301) in combination with Chemoradiation therapy in advanced esophageal or gastro-esophageal cancer has been met. The study is funded by the National Cancer Institute and is being conducted via its National Clinical Trial Network (NCTN), led by NRG Oncology.

The primary objective of this clinical trial, NRG-GI007, is to evaluate the safety of Telomelysin??, oncolytic adenoviral immunotherapy, when added to weekly carboplatin, paclitaxel and radiation therapy (chemoRT), for patients with locally advanced esophageal or Gast-esophageal (GEJ) cancer who are not candidates for surgery. Secondary objectives include toxicities, number of clinical complete responses, number of patients alive without progression and number of patients alive both at 1 and 2 years. The study is led byNRG Oncology, with Principal Investigator Dr. Geoffrey Y. Ku at Memorial Sloan Kettering Cancer Center, in New York, NY, and is open across the US in multiple NRG network centers.

To access the primary endpoint of this Phase 1 clinical trial with expansion cohort, the initial cohort of patients received three doses of 1-2 mL of OBP-301 at 1x1012 VP/mL plus chemoRT is therefore declared safe. With the safety endpoint met, enrollment to the study is now reopened to the expansion cohort to enroll 9 additional patients with this regimen. Dr. Geoffrey Y. Ku, Principal Investigator of the study, added that "The standard of care for patients with locally advanced E/GEJ cancer who do not undergo surgery is definitive chemoRT.

However, many patients develop persistent or recurrent local disease despite treatment, which can cause significant morbidity. There is therefore a high unmet medical need to improve upon the standard of care. Safety data from this study showed that the combination of OBP-301 with chemoRT is safe in this population.

This important result supports the continued development of OBP-301 + chemoRT as definitive treatment for locally advanced E/GEJ Cancer who are not candidates for surgery." The design of this Phase I clinical trial with an expansion cohort is similar to the investigator-initiated study of Telomelysin?®? (OBP-301") in combination with radiation therapy alone led by Dr. Toshiyoshi Fujiwara at Okayama University, Japan. While squamous cell cancer represents the majority of Japanese esophageal cancer, adenocarcinomas comprise the main histology of esophageal cancers in the US and Europe.

By conducting both studies, The company anticipates seeing the safety and efficacy of Telomelysin®? in both patient populations. Telomelysin??

("OBP-301) was granted Orphan-Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Esophageal Cancer, in June 2020.