On July 11, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that its Chief Science Officer Peter Ellmark will hold a presentation on the company’s CD40 program at the 3rd Annual Tumor Myeloid-Directed Therapies Summit, taking place July 18-20, 2023, in Boston, as well co-hosting the Industry Leaders’ Fireside Chat: "Reviewing the Current Landscape & Future Potential of the Myeloid" (Press release, Alligator Bioscience, JUL 11, 2023, View Source [SID1234633158]).
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The presentation, entitled "Targeting CD40 on Myeloid Cells to Reverse the Suppressive Tumor Microenvironment & Enhance T Cell Priming", highlights the latest very promising interim results from the ongoing OPTIMIZE-1 Phase 2 study assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINIOX, in previously untreated (1st line) patients with metastatic pancreatic ductal adenocarcinoma.
Preclinical data on mitazalimab as well as clinical efficacy and pharmacodynamic biomarker data from the OPTIMIZE-1 interim readout will also feature in the presentation, along with preclinical in vivo and in vitro data on ATOR-4066, a 3rd generation bispecific antibody targeting CD40 and CEACAM5. ATOR-4066 was developed by Alligator’s proprietary Neo-X-Prime platform that generates bispecific conditional antibody agonists able to ignificantly boost dendritic cells and T-cell activation by efficiently connecting them to CEACAM5-expressing tumor debris.
In summary, the latest OPTIMIZE-1 interim results include the continued follow-up on the futility analysis cohort (23 patients), which showed a deepening of tumor responses and an increase in the Objective Response Rate (ORR) to 57% from 52%. The interim ORR of 44% in the full OPTIMIZE-1 cohort (57 patients) confirms the benefit of mitazalimab added to mFOLFIRINOX. The median Duration of Response (DoR) of 8.7 months compares favorably with the 5.9[1] months reported with FOLFIRINOX in a similar patient population.
This year, mitazalimab has been granted orphan drug designation (ODD) in the U.S. by the Food and Drug Administration. Orphan designation is granted to medicines that treat rare diseases and qualifies the sponsor to regulatory and financial benefits, including marketing exclusivity once the product has been approved.