Natera and Neon Therapeutics Announce Clinical Trial Collaboration to Assess Treatment Response to Personal Cancer Vaccine

SAN CARLOS, Calif., & CAMBRIDGE, Mass., Oct. 18, 2018 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and Neon Therapeutics, Inc. (NASDAQ: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today announced a research collaboration using Natera's Signatera™ (RUO) circulating tumor DNA (ctDNA) assay as a biomarker to assess treatment response to NEO-PV-01 in Neon Therapeutics' NT-002 clinical trial. 

Neon Therapeutics' NT-002 clinical trial is being conducted in collaboration with Merck, also known as MSD outside of the U.S. and Canada, and is designed to evaluate the safety, tolerability, and preliminary efficacy of NEO-PV-01 in combination with KEYTRUDA^® and a chemotherapy regimen of pemetrexed and carboplatin in untreated patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Natera will utilize its Signatera (RUO) ctDNA assay on patients in this study to correlate treatment response with data from these assays.

NEO-PV-01, a personal cancer vaccine, is Neon Therapeutics' most advanced product candidate and is designed specifically for each patient based on tumor-specific DNA mutations. Natera's Signatera (RUO) assay is a unique approach to deliver a custom ctDNA assay that matches the patient's tumor profile and is intended to offer high specificity and sensitivity in measuring immunological and clinical treatment response. "This clinical trial is especially exciting for us because, for the very first time, we are combining a truly personal immunotherapy with a personalized ctDNA biomarker to better understand treatment response and resistance in patients with metastatic lung cancer," said Alexey Aleshin, M.D., M.B.A., Natera's oncology medical director.

"We are pleased to apply the Signatera technology to the patient samples that we will be receiving in connection with this clinical trial in order to measure the levels of ctDNA across multiple personal mutations," said Richard Gaynor, M.D., president of research and development at Neon Therapeutics. "We endeavor to employ novel tools in order to develop high-quality treatments for cancer patients and look forward to the information that we will receive from this collaboration."

About Signatera
Signatera (RUO) is the first ctDNA assay custom-built for treatment monitoring and minimal residual disease assessment. The Signatera (RUO) methodology differs from currently available liquid biopsy assays, which test for a panel of genes independent of an individual's tumor. Signatera (RUO) provides each patient with a customized blood test tailored to match the mutations found in that individual's tumor tissue, which maximizes sensitivity and specificity. Signatera (RUO) also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.

A recent study demonstrated the Signatera (RUO) method's ability to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small cell lung cancer (NSCLC) with 93 percent sensitivity and zero false positives.¹ Additional research presented at the 2018 American Association for Cancer Research meeting showed successful results from bladder and colorectal cancer studies, including median detection points of ctDNA that were 4.3 and 7.9 months, respectively, ahead of clinical relapse detection.^2,3

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. Follow Natera on LinkedIn and Twitter.

About Neon Therapeutics
Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of estrogen-receptor-positive breast cancer.
For more information, please visit www.neontherapeutics.com.

Natera Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Neon Therapeutics 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 include, but are not limited to, express or implied statements regarding our ability and the potential to successfully evaluate our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; the ability and willingness of our third-party collaborators to continue research and development activities relating to our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; and the potential timing and advancement of our preclinical studies and clinical trials; regulatory developments in the United States and foreign countries. 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: uncertainties related to the initiation and conduct of studies and other development requirements for our product candidates; 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 will be predictive of future results in connection with future studies or trials; and the risk that Neon's collaborations will not continue or will not be successful. 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 most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, 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.

Contacts for Natera
Investor Relations: Mike Brophy, CFO, Natera, 650-249-9090
Media: Barbara Sullivan, Sullivan & Associates, [email protected], 714-374–6174

Contacts for Neon Therapeutics
Investor Relations: Will O'Connor, Stern Investor Relations, [email protected], 212-362-1200
Media: Stephanie Simon, Ten Bridge Communications, [email protected], 617-581-9333

References

1. Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545:446–451. Doi:http://doi.org/10.1038/nature22364.
2. Birkenkamp-Demtröder K, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; AACR. Abstract 3653.
3. Andersen C, et al. Personalized circulating tumor DNA analysis to monitor colorectal cancer [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; AACR. Abstract 159.

SOURCE Natera, Inc.

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