CAMBRIDGE, Mass. & OXFORD, England--(BUSINESS WIRE)-- 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, today 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.

About T-SIGn^®

Akamis Bio’s Tumor-Specific Immuno-Gene (T-SIGn^®) therapeutics are chimeric group B adenoviral vector-based, tumor gene therapies which are capable of homing specifically to primary and metastatic solid tumors following intravenous delivery. Once at the tumor site, T-SIGn^® therapeutics can drive intratumoral expression of multiple immunologically active biomolecules and therapeutic proteins encoded by the vector to remodel the tumor microenvironment and trigger robust antitumor immune responses. T-SIGn^® therapeutics have potential for use in the treatment of solid tumors as monotherapy, as well as in combination with other immuno-oncology agents (e.g., checkpoint inhibitors, antibody drug conjugates, bispecific T-cell engagers, and cell therapies) to enable and/or enhance the efficacy of those modalities in the solid tumor setting. Akamis Bio has an extensive and growing body of clinical experience with T-SIGn^® therapeutics with more than 200 patients treated across both the monotherapy setting, as well as in combination with checkpoint inhibitors. Across clinical studies, T-SIGn^® therapeutics have demonstrated a consistent safety and tolerability profile, as well as promising preliminary evidence of clinical activity.

About Cohort C of the REVOLUTION Platform Study

Cohort C of the REVOLUTION platform study is a Phase 1 study evaluating the safety, tolerability and preliminary efficacy of NG-350A in combination with ipilimumab (YERVOY^®) and gemcitabine/paclitaxel in patients with previously untreated metastatic pancreatic adenocarcinoma. This study is being conducted in collaboration with the Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI). Learn more at https://clinicaltrials.gov/ct2/show/NCT04787991.

About the Cancer Research Institute

The Cancer Research Institute (CRI), established in 1953, is a highly rated U.S. nonprofit organization dedicated exclusively to saving more lives by fueling the discovery and development of powerful immunotherapies for all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $500 million in support of research conducted by immunologists and tumor immunologists at the world’s leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to cancerresearch.org.

About the Parker Institute for Cancer Immunotherapy

The Parker Institute for Cancer Immunotherapy (PICI) is radically changing the way cancer research is done. Founded in 2016 through a $250 million gift from Silicon Valley entrepreneur and philanthropist Sean Parker, the San Francisco-based nonprofit is an unprecedented collaboration between the country’s leading immunotherapy researchers and cancer centers, including Dana-Farber Cancer Institute, Stanford Medicine, Gladstone Institutes, the University of California, Los Angeles, the University of California, San Francisco and the University of Pennsylvania. The institute also supports top researchers at other institutions, including City of Hope, Fred Hutchinson Cancer Center, Icahn School of Medicine at Mount Sinai, Institute for Systems Biology, Memorial Sloan Kettering Cancer Center, The University of Texas MD Anderson Cancer Center and Washington University School of Medicine in St. Louis. By forging alliances with academic, industry and nonprofit partners, PICI makes big bets on bold research to fulfill its mission: to accelerate the development of breakthrough immune therapies to turn all cancers into curable diseases. Learn more at parkerici.org.

About Akamis Bio

Akamis Bio is a clinical-stage oncology company whose mission is to leverage its groundbreaking Tumor-Specific Immuno-Gene Therapy (T-SIGn^®) platform to positively impact the lives of people living with cancer. To achieve that mission, the company is developing a portfolio of solid tumor-targeted T-SIGn^® therapeutics which aim to enable a patient’s own immune system to recognize, attack, and clear their cancer. Akamis Bio has a growing pipeline of T-SIGn^® therapeutics anchored by its two clinical stage programs, NG-350A (an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody) and NG-641 (a stromal-targeted tumor gene therapy leveraging a viral vector encoding a FAP-CD3 bispecific antibody, CXCL-9, CXCL-10, and interferon alpha). NG-350A and NG-641 are both being investigated in ongoing Phase 1 clinical studies in patients with metastatic or advanced epithelial tumors. In addition to internal pipeline development efforts, Akamis Bio has a number of T-SIGn^® platform-focused collaborations with leaders in the immuno-oncology field including BMS, Merck, the Parker Institute for Cancer Immunotherapy, and the Cancer Research Institute. To learn more, please visit www.akamisbio.com.

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