Alligator Bioscience announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company's lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The second interim analysis conducted on the 23 patients included in the interim analysis, with a follow-up period of nine to 17 months, reported in January 2023.

demonstrated the following: Tumor responses deepened and the Objective Response Rate (ORR) increased to 57% (from 52%), suggesting a durable benefit for patients. Of the 13 patients achieving an objective response, seven (54%) were still ongoing in treatment for longer than 10 months with a maintained response, with the longest being 17 months. The interim analysis conducted on all 57 evaluable patients with a follow-up periodof two to 17 months demonstrated the following: 25 patients responded to treatment resulting in an interim ORR of 44%.

Median Duration of Response (DoR) was 8.7 months compared to 5.9 reported for FOLFIRINOX alone in other studies, indicating an immunostimulatory effect of mitazalimab and potential Progression Free Survival (PFS) and survival benefits. In addition, 19 patients (33%) achieved stable disease resulting in a 77% disease control rate (DCR) Furthermore, mitazalimab's manageable safety and tolerability profile in combination with mFOLFIRINOX was confirmed. These data compare favorably to the ORR of 31.6%, mPFS of 6.4 months and DoR of 5.9 months reported in similar patient populations treated with standard of care FOLFIRINOX alone.

Completion of, and patient enrolment in OPTIMIZE-1 was reported in April 2023 in May 2023, mitazalimab was granted Orphan Drug Designation by the U. S. Food and Drug Administration for the treatment of pancreatic cancer.