LUND, SWEDEN / ACCESSWIRE / July 11, 2024 / Alligator Bioscience (STO:ATORX)

• Substantial overall survival benefit and unprecedented Duration of Response reported in 18-month analysis from mitazalimab OPTIMIZE-1 Phase 2 study in 1st line pancreatic cancer

• Positive Phase 2 mitazalimab data published in The Lancet Oncology

• Johan Giléus appointed as new Chief Financial Officer

• Orion exercises development option in research collaboration and license agreement triggering milestone payment to Alligator

• Cash runway extended to Q1 2025 through financing of up to SEK 80 million

Lund, Sweden - Alligator Bioscience (Nasdaq Stockholm: ATORX)

"This quarter we have continued to push forward with the clinical and commercial development of our robust immuno-oncology pipeline. Our lead asset mitazalimab demonstrated improved median Overall Survival at the 18-month follow-up mark, building on the impressive OPTIMIZE-1 Phase 2 top-line readout in pancreatic cancer we announced at the start of the year. Our preparations for mitazalimab's Phase 3 are progressing well, along with our efforts to secure a commercial partnership. We were very pleased to see the Moores Cancer Center initiate its Phase 1 clinical study of mitazalimab injected intratumorally in patients with locally advanced pancreatic cancer. In fact, we have received a significant increase in interest from the scientific community on the potential evaluation of mitazalimab in a number of investigator-initiated trials in different tumor types. This is a highly encouraging sign of mitazalimab's growing reputation as a combination therapy in pancreatic cancer whose applicability can be broadened to other indications."
Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
Mitazalimab

• On June 26, Alligator announced positive 18-month follow-up data from the OPTIMIZE-1 Phase 2 study in pancreatic cancer, demonstrating a near doubling of the 18-month survival rate to 36.2% in patients treated with mitazalimab in combination with mFOLFIRINOX, compared to 18.6% reported with FOLFIRINOX[1] alone. The data also demonstrated an increase in the updated median Overall Survival to 14.9 months, increases in both the confirmed (42.1%) and unconfirmed (54.4%) Objective Response Rate, and an unprecedented median Duration of Response of 12.6 months. These latest OPTIMIZE-1 results compare favorably to the previously reported outcomes with first line chemotherapies FOLFIRINOX[1]and NALIRIFOX[2].

• On June 3, Alligator announced the publication of a scientific article entitled "Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study" in the world-leading clinical oncology research journal, The Lancet Oncology.

• On May 14, Alligator announced the initiation of an investigator-initiated Phase 1 clinical study evaluating the safety and efficacy of mitazalimab injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC). The study is being conducted by researchers at the Moores Cancer Center at UC San Diego (NCT06205849) and is being financed by the US National Cancer Institute.

• On April 8, " Mitazalimab, a potent CD40 agonist in combination with FOLFIRINOX demonstrates changes consistent with increased immune activation in TME[3] and peripheral blood in a preclinical pancreatic cancer tumor model " was presented by Alligator at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California.

• On June 1, " 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 " and " 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) " was presented by Alligator at the American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

• On June 29, " CD40 agonist mitazalimab combined with mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Primary analysis of the OPTIMIZE-1 phase 1b/2 study " was presented by Alligator at the European Society for Medical Oncoloy Gastrointestinal conference in Münich, Germany.