IL-38 mRNA profiling in more than 60 cancer types has revealed a particularly high frequency (60-80%) of IL-38 expression in certain subtypes of solid tumors with high unmet clinical need

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

IND filing scheduled for 2H 2022

EXTON, Pa.–(BUSINESS WIRE)– Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that uses its human memory B-cell platform to discover and develop first-in-class antibody therapeutics, today announced ongoing development updates 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 evidence from the literature^1.2, suggests that IL-38 attenuates the natural anti-tumor immune response. In animal tests, blocking IL-38 activity using the Immunome antibody produced an anti-tumor effect.

To help guide the clinical development of IMM-ONC-01, Immunome conducted an extensive evaluation of the mRNA expression profile of IL-38 using a proprietary commercial database of more than 60 cancer subtypes established by Tempus Labs. The analysis identified a high frequency of IL-38 mRNA expression in several cancers, including gastroesophageal squamous cell carcinoma (>80%), head and neck squamous cell carcinoma (> 60%) and squamous cell and basal cell carcinoma of the skin (>70%). The Company plans to share the study results at an upcoming oncobiology conference.

“We hope that IMM-ONC-01 could provide a new treatment option for people with cancers with high unmet need and could also be synergistic when combined with PD-1 inhibitors,” said Purnanand Sarma, PhD, President and CEO of Immunome. “The results of this important evaluation will allow us to better identify the patient populations most likely to respond to treatment with IMM-ONC-01 and to 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 patients who are waiting.

To support the next steps in the development of IMM-ONC-01, Immunome is collaborating with the Fox Chase Cancer Center to directly measure the 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 refine its clinical development plan.

“We look forward to working closely with the Immunome team to investigate the role of IL-38 in head and neck cancer, supporting the focus on this cancer of our specialized research program. excellence in NIH-funded research,” said Erica Golemis, PhD, professor. and WW 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 effectively advance a potential new treatment, but also expand our understanding of the processes which lead to the expression of IL-38. cancers.

IL-38 is increasingly considered a key cytokine in inflammation and cancer research.^1.2 Preclinical research has confirmed that blocking IL-38 function with an antibody could restore the 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 the role of IL-38 in cancer and other diseases suggests that Immunome’s platform has the potential to identify other highly relevant yet unknown targets in oncology and inflammatory diseases.

About IMM-ONC-01

IMM-ONC-01 is a first-in-class therapeutic antibody targeting IL-38, an innate immune checkpoint that is part of the IL-1 family of cytokines. When expressed, IL-38 reduces immune cell infiltration into the tumor microenvironment. Immunome’s preclinical research has confirmed that using IMM-ONC-01 to block IL-38 expression enhances anti-tumor immunity and could serve as an effective treatment for cancers that have high expression. elevated IL-38 levels, including gastroesophageal squamous cell carcinoma, head and neck squamous cell carcinoma, and skin squamous cell 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 uses its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics designed to change the way diseases are treated. The company’s initial focus is to develop therapies to treat oncology and infectious diseases, including COVID-19. Immunome’s proprietary discovery engine identifies new therapeutic antibodies and their targets by leveraging highly educated components of the immune system, memory B cells, from patients whose bodies have learned to fight their disease. For more information, please visit www.immunome.com or follow Immunome on Twitter and LinkedIn.

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements” intended to qualify for the “safe harbor” of liability established by the Private Securities Litigation Reform Act of 1995, as amended, including without limitation limited to, express or implied statements regarding Immunome. beliefs and expectations regarding the advancement of its IMM-ONC-01 program, the expected timeline for filing an IND related to IMM-ONC-01, and the potential of Immunome’s platform to identify relevant targets in oncology and disease inflammatory. Forward-looking statements can be identified by the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “plan”, “project”, “suggest”, “may ‘, ‘will’, ‘could’, ‘should’, ‘seek’, ‘potential’ and similar expressions. Forward-looking statements are based on Immunome’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties associated with: the impact of the COVID-19 pandemic on business, operations, strategy, objectives and Immunome’s planned milestones; that research and development data is subject to differing interpretations and assessments, including during the peer review/publication process, in the broader scientific community and by regulatory authorities; whether the data will be published in a scientific journal and, if so, when and with what modifications; Immunome’s ability to execute its strategy, including with respect to its R&D efforts, IND submissions and other regulatory filings, the timing of such filings, and the timing and nature of governmental authorities’ comments thereon , the initiation and completion of any clinical studies, confirmatory testing and other milestones as planned; the efficacy of Immunome’s product candidates, including the possibility that other preclinical data and any clinical trial data may be inconsistent with the data used to advance the product candidates and that other variants of concern may emerge ; Immunome’s ability to fund transactions; Immunome’s dependence on suppliers; the competitive landscape; and additional risks and uncertainties discussed in greater detail under the heading “Risk Factors” in Immunome’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) on March 25, 2021, and elsewhere in 10-Q Filings and Other SEC Filings and Reports. The forward-looking statements contained in this announcement are made as of this date, and Immunome undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. , except as may be required under applicable law. straight. In this press release, we may discuss our current and potential future product candidates that have not yet undergone clinical trials or been approved for marketing by the United States Food and Drug Administration or a other governmental authority, including expectations regarding their therapeutic potential and benefits. No representation is made as to the safety or effectiveness of any of these current or potential future product candidates for the use for which these product candidates are being investigated.

REFERENCES

1. Diaz-Barreiro, A., Huard, A., & Palmer, G. (2022). Multiple roles of IL-38 in inflammation and cancer. Cytokine, 151155808. https://doi.org/10.1016/j.cyto.2022.155808
2. de Graaf, DM, Teufel, LU, Joosten, LAB and Dinarello, CA (2022). Interleukin-38 in health and disease. Cytokine 152155824. https://doi.org/10.1016/j.cyto.2022.155824.

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