The Lancet Oncology Publishes Alligator Bioscience's Phase 2 Mitazalimab Pancreatic Cancer Data

Lund, Sweden – Alligator Bioscience, listed on Nasdaq Stockholm under the ticker ATORX, has announced the publication of promising Phase 2 data for its leading drug candidate, mitazalimab, in combination with mFOLFIRINOX, in first-line metastatic pancreatic cancer. These findings have been published in The Lancet Oncology, a prestigious clinical oncology journal.

The Phase 2 study, known as OPTIMIZE-1, reported an Objective Response Rate (ORR) of 40.4% in 57 evaluable patients, thus meeting its primary endpoint. The study involved a novel combination of mitazalimab, a CD40 monoclonal antibody agonist, with mFOLFIRINOX, a chemotherapy regimen, and showcased a unique dosing schedule. The results indicated a remarkable Duration of Response (DoR) with a median of 12.5 months and an Overall Survival (OS) with a median of 14.3 months. These outcomes are significantly better compared to historical data for FOLFIRINOX alone and other standard treatments or investigational therapies.

The study's findings, which were also shared at the American Society of Clinical Oncology (ASCO) annual meeting on June 1, will be updated with longer follow-up data expected by the end of June 2024.

The Lancet Oncology's publication highlights the critical need for effective treatments in metastatic pancreatic ductal adenocarcinoma (mPDAC), a condition associated with very poor prognoses and a five-year survival rate of less than 5%. The OPTIMIZE-1 trial demonstrated a confirmed ORR of 40.4% in 57 evaluable patients, with an unconfirmed ORR of 50.9%. Additionally, the median DoR was 12.5 months, median OS was 14.3 months, and median Progression-Free Survival (PFS) was 7.7 months. These results compare favorably to those previously reported for FOLFIRINOX and the recently approved NALIRIFOX regimen.

Prof. Jean-Luc van Laethem, the Principal Investigator of the OPTIMIZE-1 trial and Head of the Digestive Oncology Department at Erasme Hospital (ULB) in Brussels, emphasized the study's significant findings. He noted the superior outcomes of mitazalimab in combination with mFOLFIRINOX, particularly the increased ORR and PFS compared to FOLFIRINOX alone. Prof. van Laethem also mentioned that the biomarker associations and long-lasting responses observed are promising indicators of the treatment's potential to improve survival rates.

The OPTIMIZE-1 trial was an open-label, single-arm, multicenter Phase 1b/2 study, focusing on the safety and efficacy of mitazalimab combined with mFOLFIRINOX. The favorable outcomes observed in this study are expected to improve as many patients were still alive at the time of the analysis in November 2023.

The CEO of Alligator Bioscience, Søren Bregenholt, remarked on the importance of the publication in The Lancet Oncology, noting it validates the promising results of the OPTIMIZE-1 study. He also mentioned that more comprehensive data, including 18-month survival follow-up, are anticipated by the end of June 2024, which will offer deeper insights into mitazalimab's potential.

The publication titled "Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study" was provisionally published on June 1, 2024. Alongside this, two posters presenting the OPTIMIZE-1 data were showcased at the 2024 ASCO Annual Meeting.

Pancreatic cancer, the 12th most common cancer by patient numbers, has an extremely poor prognosis. It is projected to become the second leading cause of cancer death in the western world by 2030. Current systemic therapies offer marginal benefits, highlighting the need for new effective treatment options like mitazalimab combined with mFOLFIRINOX.

Overall, the OPTIMIZE-1 trial results provide a strong rationale for further development of mitazalimab and mFOLFIRINOX in treating metastatic pancreatic cancer, potentially offering new hope for patients with this challenging condition.

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