SHANGHAI, China, April. 29, 2020 -- Genor Biopharma Co. Inc, a pre-commercial stage biopharmaceutical company focused on developing and commercializing immune-oncology therapeutics, today presented preliminary clinical data of two studies on its investigational PD-1 inhibitor Geptanolimab (GB226) at the 111st American Association for Cancer Research (AACR) Annual Meeting. Dr. SHI Yuankai orally presented the data on PTCL at the clinical trials plenary session on April. 28 (EDT). “Genor is the first biopharmaceutical company gloabally to present clinical data on PD-1 for PTCL with more than 100 patients enrolled, while relapsed/refractory patients represent significant unmet medical needs globally. So far, neither US nor Chinese FDA has approved any PD-1 in this setting.” Commented Dr. GUO Feng, CEO of Genor, “We remain committed in addressing unmet medical needs in China and globally, with our differentiated clinical development strategies for our candidate drugs.”
The two clinical trials presented at AACR are designed to evaluate the efficacy and safety of Geptanolimab monotherapy in relapsed/refractory peripheral T-cell Lymphoma (PTCL) and in relapsed/refractory alveola soft partsarcoma (ASPS), separately.
Gxplore-002 is a Phase 2 registration study designed to evaluate Geptanolimab monotherapy in relapsed/refractory peripheral T-cell Lymphoma (PTCL). This single-arm study enrolled 102 patients.
The primary endpoint of the study is Objective response rate (ORR), the secondary endpoints include Duration of response (DOR), Overall survival (OS), Progression free survival (PFS), Disease control rate (DCR), Time to response (TTR).
Geptanolimab showed promising clinical activity in treatment of R/R PTCL: ORR was 36.3%, and DCR was 55.9%. The median DOR was 6.83 months. The clinical benefits have been achieved in all sub-patient populations, for example, ORRs were 58.3% and 33.3% in patients with ALK-negative anaplastic large cell lymphoma (ALK negative ALCL), and those who relapsed after receiving chidamide as front-line therapy, respectively. Treatment response was assessed according to Lugano 2014 criteria by the independent review committee.
Dr. SHI Yuankai presented data of GB226 on ASPS - Poster
Gxplore-005 is a multicenter, open-label, single-arm, phase 2 trial examining Geptanolimab in relapsed/refractory alveola soft part sarcoma (ASPS). Preliminary clinical data indicated an ORR of 37.8%, and a DCR of 86.5%.
Among patients who received anlotinib as earlier lines of therapy, an ORR of 33% was achieved. The safety data is in line with adverse events profile of PD-1 class in this setting.
About Geptanolimab (GB226)
Geptanolimab (GB226) is a pre-commercial stage programmed cell death-1 (PD-1) antibody developed by Genor Biopharma. Genor Biopharma has been evaluating Geptanolimab in multiple solid/non-solid tumor indications, both as a monotherapy and in combinations.
About Genor Biopharma
Genor Biopharma Co. Ltd (“Genor”) is a biopharmaceutical powerhouse focusing on developing and commercializing oncology and autoimmune drugs. Genor has successfully developed drug candidates targeting pathways with blockbuster potentials, encompassing top three oncology targets and five out of the ten bestselling drugs globally. Genor has leveraged primarily in-house capabilities in establishing a pipeline of 15 targeted drug candidates with tremendous commercialization potentials in China that cover both proven and novel biological pathways.
This press release contains forward-looking statements which reflect Genor Biopharma's current expectations regarding future events, including its expectations for the clinical development of Geptanolimab. Forward-looking statements involve risks and uncertainties. Genor Biopharma undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.