Alligator Bioscience

• Study conducted by Moores Cancer Center at University of California San Diego to evaluate safety and efficacy of mitazalimab injected intratumorally at the time of surgical irreversible electroporation (IRE)
• Preclinical data suggest combination of IRE with CD40 agonism can generate systemic anti-tumor effects
• Mitazalimab demonstrated significant survival benefit in combination with mFOLFIRINOX over standard of care in OPTIMIZE-1 Phase 2 study in first-line metastatic pancreatic cancer

Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces the initiation of an investigator initiated Phase 1 clinical study (NCT06205849) evaluating the safety and efficacy of the company's lead asset mitazalimab (CD40 mAb agonist) injected intratumorally at the time of surgical irreversible electroporation (IRE) in patients with locally advanced pancreatic cancer (LAPC).

The NCI-funded Phase 1a/1b single-center study will enroll up to 18 patients, who will receive a single intratumoral injection of mitazalimab immediately after the surgical IRE, a form of non-thermal ablation that is currently in clinical use for selected patients with LAPC. The study is being conducted by researchers at Moores Cancer Center at UC San Diego. Alligator will supply mitazalimab for the study.

"The preclinical data generated in our lab shows that the combination of IRE with an antibody that stimulates the CD40 receptor improves the response to IRE and inhibits metastatic tumor growth," said Rebekah White, MD, principal investigator of Phase 1 of the study and associate professor of Surgery at UC San Diego School of Medicine. "While IRE is widely used in patients with LAPC, most will ultimately develop distant metastases. We believe that local delivery of mitazalimab at the time of IRE in patients with LAPC will be safe, augment the immune effects of IRE and decrease the risk of recurrence."

"Intratumoral delivery of immunotherapy is gaining increased importance, and in the setting of localized disease provides an opportunity to efficiently activate the immune cells in the tumor microenvironment. In this investigator-initiated study, we are looking forward to evaluating the combination of mitazalimab administered directly into the tumor alongside IRE," said Sumeet Ambarkhane, CMO of Alligator Bioscience. "The strong clinical data generated by mitazalimab over the last 12 months have received a great amount of interest from the scientific and medical communities. We are very pleased that an accomplished center of clinical excellence, such as Moores Cancer Center, is conducting this study, which could broaden the clinical applicability of mitazalimab in pancreatic cancer patients."

In January 2024, Alligator announced positive top-line results from the OPTIMIZE-1 Phase 2 study evaluating mitazalimab in combination with mFOLFIRINOX in 1st line metastatic pancreatic cancer. The study met its primary endpoint and also demonstrated a median Overall Survival (mOS) of 14.3 months, compared to 11.1 months for standard of care, along with an unprecedented Duration of Response of 12.5 months, compared to 5.9 months with FOLFIRINOX alone.[1]

[1] Conroy et al., N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923