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Akamis Bio, Parker Institute for Cancer Immunotherapy and Cancer Research Institute Expand Partnership

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Akamis Bio, a clinical-stage oncology company leveraging its Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform to positively impact the lives of people living with cancer, has announced an expansion of its ongoing partnership with the Parker Institute for Cancer Immunotherapy (PICI) to include a clinical collaboration with the Cancer Research Institute (CRI) that will focus on advancing novel treatments for pancreatic cancer.

As part of the Akamis Bio, PICI, and CRI partnership, NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody, will be evaluated in combination with standard-of-care chemotherapy and the CTLA-4 inhibitor ipilimumab (YERVOY®). The NG-350A combination therapy will be part of cohort C in REVOLUTION, a platform clinical study investigating novel therapeutic combinations for the treatment of previously untreated metastatic pancreatic cancer.

NG-350A is a clinical-stage, intravenously delivered T-SIGn® therapeutic whose mechanism of action is based on CD40-mediated activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. NG-350A has the potential for use as both a monotherapy and in combination with other immuno-oncology agents.

“Pancreatic cancer is one of the most complex and difficult to treat cancers. The wide variety of cell types, molecular pathways, and immune resistance mechanisms involved in the development and progression of the disease make it nearly impossible to treat with a single agent,” said Robert Vonderheide, M.D., D.Phil., Director of the Abramson Cancer Center at Penn Medicine and lead investigator of the REVOLUTION study. “REVOLUTION was specifically designed to identify combination therapies with the potential to have a meaningful impact on disease progression. We look forward to further exploring the CD40 agonist mechanism of action for people with pancreatic cancer who are in dire need of additional treatment options.”

In 2018, Akamis Bio initiated a pre-clinical partnership with PICI, a network representing the largest concentration of immuno-oncology expertise in the world, with a focus on research to investigate the use of the company’s T-SIGn® therapeutics for the treatment of solid tumors. Akamis Bio’s relationship with PICI, which includes a financial investment by PICI in the company, has now expanded to include a clinical collaboration thanks to the generous financial and operational support of CRI for the inclusion of NG-350A in the REVOLUTION study.

“The collaboration between PICI, CRI, and Akamis Bio brings an unprecedented level of expertise to the challenge posed by solid tumors and pancreatic cancer specifically,” said John Connolly, Ph.D., Chief Scientific Officer of PICI. “This three-way collaboration exemplifies PICI’s focus on forging strategic alliances to accelerate the development of cutting-edge therapeutics for people with cancer.”

“For more than 70 years, CRI has been steadfast in our dedication to advancing the discovery and development of immunotherapies for the treatment of cancer,” said Jay Campbell, Managing Director of the Clinical Accelerator and Venture Fund at CRI. “We are pleased to support the introduction of this new cohort into the REVOLUTION study given the potential of NG-350A to positively impact the lives of individuals living with and fighting pancreatic cancer.”

“We are proud to collaborate with PICI and CRI on the REVOLUTION study,” said Howard Davis, Ph.D., Chief Executive Officer of Akamis Bio. “This study will generate important insights into the use of combination therapies for the treatment of pancreatic cancer, while providing additional NG-350A data to build upon the consistent safety and tolerability profile, as well as promising preliminary evidence of clinical activity observed to date.”

Akamis Bio is also independently evaluating NG-350A in two open-label, multicenter, Phase 1a clinical studies. These studies are evaluating the safety, tolerability, and preliminary efficacy of NG-350A as monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in people with metastatic or advanced epithelial tumors. To date, NG-350A has shown promising preliminary evidence of clinical activity including CD40-mediated stimulation of the immune system with significant and sustained increases in serum IL-12, a key marker for dendritic cell activation, as well as IFN-γ, a hallmark of effector T-cell activation. Of note, the NG-350A tumor gene therapy drove increases of IL-12 and IFN-γ which were higher and more sustained relative to results reported for other systemically dosed CD40 agonist antibodies. As the ongoing NG-350A clinical studies advance in 2023, Akamis Bio will continue to assess its safety, tolerability, and preliminary efficacy in both monotherapy and combination (with checkpoint inhibitors) settings, as well as the potential benefits of multiple cycles of NG-350A dosing. Akamis Bio anticipates the initiation of an expansion cohort study for NG-350A in early 2024 to demonstrate clinical proof-of-concept in a patient population with a single type of epithelial-derived solid tumor.