Neon Therapeutics, Inc. (Nasdaq: NTGN) today announced the acceptance of its Clinical Trial Authorization (CTA) from the Dutch Health Authority (DHA) for its personal neoantigen-targeted T cell therapy candidate, NEO-PTC-01. Neon’s initial Phase 1 clinical trial of NEO-PTC-01 will be in patients with metastatic melanoma who are not responsive to checkpoint inhibitors.  NEO-PTC-01 is a personal neoantigen-targeted T cell therapy candidate derived from patients’ peripheral blood mononuclear cells (PBMCs) and consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor.

The Phase 1 dose-finding clinical trial in metastatic melanoma will be conducted in collaboration with the Netherlands Cancer Institute and is expected to begin in the third quarter of 2020, subject to the ability to commence that trial in the Netherlands in light of the current COVID-19 outbreak. Neon is also planning for a second indication for NEO-PTC-01 in metastatic ovarian cancer, as well as for the potential to both expand to other solid tumor types and pursue clinical development in the United States.

“We are excited to be able to initiate this first-in-human study of NEO-PTC-01 as it brings us closer to demonstrating NEO-PTC-01’s potential to prime, activate and expand neoantigen-targeting T cells in solid tumors. Importantly, moving forward with this important trial advances our goal to shift the paradigm in the treatment of cancer patients towards an era of truly personal immuno-oncology therapies,” said Hugh O’Dowd, Chief Executive Officer of Neon.

“We believe that NEO-PTC-01 has several key advantages that overcome the challenges of other cell therapy approaches. In preclinical studies, including research using patient tumor samples, we have demonstrated the ability to produce multiple neoantigen-specific CD8+ and CD4+ T cell populations, including both memory and de novo T cell responses. We have further shown that these T cell populations kill tumor cells by targeting tumor neoantigens,” said Richard Gaynor, M.D., President of Research and Development at Neon. “We believe that our approach to leveraging these neoantigen targets will provide the tumor specificity required to develop safe, effective and durable T cell therapies for the treatment of solid tumors. We look forward to demonstrating these potential benefits in our Phase 1 study in checkpoint inhibitor, non-responsive metastatic melanoma, which will commence later this year.”

About Neon Therapeutics

Neon is a biotechnology company developing novel neoantigen-targeted T cell therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both personal and precision neoantigen-targeted T cell therapy candidates. Neon’s most advanced program is NEO-PTC-01, its personalized neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor.

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Forward-Looking Statements

This press release contains “forward-looking statements” of Neon Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our completed and ongoing research into oncology targets; the timing of clinical trials; the abilities of our RECON bioinformatics platform; our ability to obtain and maintain regulatory approval of our product candidates; the design and potential efficacy of therapeutic approaches; financial plans and projections; and our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to the initiation, timing and conduct of studies, clinical trials and other research and development requirements for our product candidates; the risk that any of our research activities will result in a clinical application; the risk that any one or more of our product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future studies or trials; the risk that our collaborations will not continue or will not be successful; risks related to our ability to protect and maintain our intellectual property position; risks related to our capital requirements and use of capital and unexpected expenditures; and risks related to the ability of our licensors to protect and maintain their intellectual property position. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Neon’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Neon’s definitive proxy statement, as filed with the Securities and Exchange Commission on April 2, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Neon’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Neon undertakes no duty to update this information unless required by law.

Investor Contact:Will O’Connor, Stern Investor 212-362-1200

Media Contact:Stephanie Simon, Ten Bridge 617-581-9333

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