Profiling of IL-38 mRNA in over 60 cancer types revealed notably high frequency (60-80%) of IL-38 expression in select solid tumor sub-types of high unmet clinical need

Collaboration with Fox Chase Cancer Center to directly confirm IL-38 protein expression in patients

Anticipated IND filing in 2H 2022

EXTON, PA, USA I May 23, 2022 I Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced updates to the ongoing development of its lead oncology program, IMM-ONC-01, a novel immuno-oncology agent that inhibits IL-38, an immunosuppressive cytokine.

Preclinical research conducted by Immunome, and literature evidence1,2, suggests IL-38 dampens natural anti-tumor immune response. In animal testing, blocking IL-38 activity using Immunome’s antibody produced an anti-tumor effect.

To help guide clinical development of IMM-ONC-01, Immunome conducted an extensive expression profile assessment of IL-38 mRNA using a proprietary commercial database of over 60 cancer sub-types established by Tempus Labs. The analysis identified high frequency of IL-38 mRNA expression in several cancers, notably in Gastroesophageal Squamous Carcinoma (>80%), Head and Neck Squamous Carcinoma (>60%) and Skin Squamous and Basal Cell Carcinoma (>70%). The Company plans to share results from the study at an upcoming oncobiology conference.

“We are hopeful that IMM-ONC-01 could provide a new treatment option for people with cancers with high unmet need and may also be synergistic when combined with PD-1 inhibitors,” said Purnanand Sarma, PhD, President and CEO of Immunome. “The results of this important assessment will allow us to better identify the patient populations most likely to respond to treatment with IMM-ONC-01 and streamline overall clinical development. We are on track to file an IND later in 2022 and will work as quickly as possible to advance this potentially differentiating therapy for the patients who are waiting.”

To support the next steps in the development of IMM-ONC-01, Immunome is collaborating with Fox Chase Cancer Center to directly measure IL-38 protein in patient tumors to confirm its prevalence in specific cancer types. The Company will pursue additional partnerships as necessary to use this information and further refine its clinical development plan.

“We look forward to working closely with Immunome’s team to investigate the role of IL-38 in head and neck cancer, supporting the emphasis of our NIH-funded Specialized Program in Research Excellence project on this cancer,” said Erica Golemis, PhD, professor and W.W. Smith Chair in Cancer Research at Fox Chase Cancer Center. “If the results are confirmed in patient samples for head and neck and other hard-to-treat cancers, it would not only allow Immunome to efficiently advance a potential new treatment, but also expand our understanding of the processes that drive IL-38 expressing cancers.”

IL-38 is increasingly being regarded as a key cytokine in inflammation and cancer research.1,2 Preclinical research has confirmed that blocking IL-38 function with an antibody could restore immune response and allow the body to fight tumors. IL-38 was originally identified as a novel target through Immunome’s technology platform, which can capture thousands of patient-derived memory B cells and convert them into stable hybridomas. The growing recognition of IL-38’s role in cancer and other diseases suggests that Immunome’s platform has potential to identify other highly relevant targets that are yet undiscovered in oncology and inflammatory disease.

About IMM-ONC-01

IMM-ONC-01 is a first-in-class antibody therapeutic targeting IL-38, an innate immune checkpoint that is a member of the IL-1 family of cytokines. When expressed, IL-38 reduces immune cell infiltration of the tumor microenvironment. Immunome’s preclinical research has confirmed that the use of IMM-ONC-01 to block expression of IL-38 boosts anti-tumor immunity and could serve as an effective treatment for cancers that have a high expression of IL-38, including Gastroesophageal Squamous Carcinoma, Head and Neck Squamous Carcinoma and Skin Squamous and Basal Cell Carcinoma. Immunome intends to submit an IND for IMM-ONC-01 in the second half of 2022.

About Immunome

Immunome is a biopharmaceutical company that utilizes its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics that are designed to change the way diseases are treated. The company’s initial focus is developing therapeutics to treat oncology and infectious diseases, including COVID-19. Immunome’s proprietary discovery engine identifies novel therapeutic antibodies and their targets by leveraging the highly educated components of the immune system, memory B cells, from patients whose bodies have learned to fight off their disease. For more information, please visit www.immunome.com or follow Immunome on Twitter and LinkedIn.

SOURCE: Immunome