Alligator Bioscience to Present Positive Phase 2 Mitazalimab Pancreatic Cancer Data at 2024 ASCO Meeting

Alligator Bioscience has revealed promising data from its OPTIMIZE-1 study, examining the efficacy of their lead drug candidate, mitazalimab, when combined with mFOLFIRINOX chemotherapy for treating chemotherapy-naïve metastatic pancreatic ductal adenocarcinoma (mPDAC). The findings show a confirmed Objective Response Rate (ORR) of 40.4% and an unconfirmed ORR of 50.9% among 57 evaluable patients, with a Disease Control Rate (DCR) of 79%. The median duration of response was 12.5 months, and the median overall survival was 14.3 months, supporting further development of mitazalimab in a Phase 3 trial. Additionally, biomarker analysis indicates a correlation between mitazalimab-induced immune activation and positive clinical outcomes.

Alligator Bioscience announced that two clinical abstracts featuring mitazalimab would be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations, scheduled between May 31 and June 4, 2024, aim to showcase the efficacy of mitazalimab as a first-line treatment for mPDAC.

Mitazalimab is a CD40 agonist that has shown substantial promise in combination with mFOLFIRINOX chemotherapy. The OPTIMIZE-1 study, designed to evaluate the safety and efficacy of this combination, has achieved its primary endpoint with favorable results. Mitazalimab-induced expansion of CD4 effector T cells one week after the first administration was identified as a significant correlate of treatment outcomes, suggesting the drug's crucial role in enhancing tumor response.

The study's results are particularly encouraging when compared to a similar patient population treated with FOLFIRINOX alone, which showed an ORR of 31.6%. The OPTIMIZE-1 data indicate a significant improvement in both response duration and overall survival, with many patients continuing treatment beyond the study period. The next planned analysis, expected in June 2024, may provide further insights into the long-term benefits of mitazalimab.

Dr. Sumeet Ambarkhane, CMO of Alligator Bioscience, emphasized the importance of these findings for patients with metastatic pancreatic cancer, a group that typically has limited treatment options. He noted that the study's outcomes support the continued development of mitazalimab in combination with mFOLFIRINOX in a Phase 3 clinical trial. The correlation of mitazalimab-induced immune activation with improved clinical outcomes also suggests that immunological markers could serve as potential biomarkers for this treatment.

The OPTIMIZE-1 study is an open-label, multi-center trial assessing mitazalimab's safety and efficacy in combination with standard chemotherapy in previously untreated patients. The study's clinicaltrials.gov identifier is NCT04888312.

The ASCO presentations include:
1. Title: "CD4 Effector T Cell Expansion to Identify Objective Responses to the CD40 Agonist Mitazalimab in Combination with Modified FOLFIRINOX (mFFX) as First-Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) in the OPTIMIZE-1 Study"
- Presenter: Dr. Peter Ellmark, PhD
- Abstract: 2569
- Track: Developmental Therapeutics-Immunotherapy
- Date/Time: June 1, 2024, 09:00 - 12:00 (GMT-5)
- Location: Hall A | On Demand

2. Title: "OPTIMIZE-1 Primary Analysis: Safety, Efficacy, and Biomarker Results of a Phase 1b/2 Study Combining CD40 Agonist Mitazalimab with mFOLFIRINOX in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)"
- Presenter: Dr. Jean-Luc Van Laethem, MD, PhD
- Abstract: 4133
- Track: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
- Date/Time: June 1, 2024, 13:30 - 16:30 (GMT-5)
- Location: Hall A | On Demand

Pancreatic cancer is a particularly aggressive disease with a poor prognosis, often diagnosed at metastatic stages. Current treatments provide limited benefit, underscoring the need for new therapeutic options. Mitazalimab's promising results in the OPTIMIZE-1 study offer hope for significant advancements in the treatment of metastatic pancreatic cancer.

Alligator Bioscience continues to develop a pipeline of tumor-directed immuno-oncology therapies, with mitazalimab as a key asset. The company is headquartered in Lund, Sweden, and its shares are listed on Nasdaq Stockholm.

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