Cyteir Therapeutics Announces First Patient Dosed in Phase 1 Combination Trial With CYT-0851

Rhea-AI Summary

Cyteir Therapeutics (NASDAQ: CYT) announced the first patient has been dosed in a Phase 1 trial for its investigational drug CYT-0851. This trial evaluates CYT-0851 in combination with three chemotherapy regimens for hematologic malignancies and solid tumors. The drug aims to inhibit double-strand DNA repair, potentially expanding treatment options across various cancers. Initial safety data is anticipated by year-end, with further development expected if successful.

Positive

• First patient dosed in Phase 1 trial for CYT-0851, marking a significant development milestone.
• CYT-0851 shows promising monotherapy activity and safety, supporting its combination use.
• Potential to expand treatment options across multiple tumor types.

Negative

• Company has not successfully completed any clinical trials to date.
• Expectations of continued financial losses and need for substantial additional funding.
• Risks associated with regulatory approval of drug candidates.

LEXINGTON, Mass.--(BUSINESS WIRE)-- Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, today announced that the first patient has been dosed in a Phase 1 trial evaluating CYT-0851 in combination with three standard-of-care chemotherapy regimens in both hematologic malignancies and solid tumors.

“Dosing the first patient in the phase 1 combination trial with CYT-0851 is an important milestone in the development of CYT-0851. As most cancer treatments are delivered in combination, CYT-0851’s monotherapy clinical activity and favorable safety profile seen to date allow us to assess the safety in combination with commonly used chemotherapy regimens in this clinical trial,” said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. “We are excited to advance CYT-0851 into combination therapy as it has the potential to expand access to a wide range of tumor types and patients in earlier lines of treatment beyond the potential of monotherapy with CYT-0851.”

CYT-0851 Phase 1 Combination Trial

CYT-0851, is a potent and selective, oral investigational drug that was designed to inhibit RAD51-mediated homologous recombination and the repair of double-strand DNA breaks. The Phase 1 combination trial with CYT-0851 is with three standard-of-care regimens: rituximab plus bendamustine, gemcitabine, and capecitabine, in both hematologic malignancies and solid tumors (NCT Number NCT03997968). Initial safety data from these combinations is expected by year end.

Once the Phase 1 dose-finding portion for combinations is complete, CYT-0851 may move into Phase 2 dose confirmation and signal seeking combination cohorts. Potential tumor types that could be targeted with the proposed combinations include breast cancer, pancreatic cancer, colorectal cancer, ovarian cancer, soft-tissue sarcoma, diffuse large B-cell lymphoma and follicular lymphoma.

About Cyteir Therapeutics, Inc.

Cyteir is a clinical-stage oncology company that is focused on the discovery and development of next-generation synthetically lethal therapies to treat cancer. The company is using its expertise in DNA damage response biology to advance a pipeline of novel drug candidates that selectively target key cancer vulnerabilities. Cyteir’s wholly owned lead compound, CYT-0851, is a potent and selective, oral investigational drug that was designed to inhibit RAD51-mediated homologous recombination and the repair of double-strand DNA breaks.

Forward-Looking Statements

This press release contains “forward-looking statements” regarding Cyteir’s expected clinical developments. Forward-looking statements include statements identified by words such as “could,” “may,” “might,” “will,” “likely,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “expects,” “continues,” “projects” and similar references to future periods. Forward-looking statements are based on our current expectations and assumptions regarding capital market conditions, our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include: our limited operating history and that we have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability; that we have incurred significant losses since inception and expect to incur losses for the foreseeable future and may never achieve or maintain profitability; our need substantial additional funding; that we have never successfully completed any clinical trials, and we may be unable to do so for any drug candidates we develop; that our clinical trials may fail to demonstrate adequately the safety and efficacy of any of our drug candidates, which would delay or prevent further clinical development of those candidates, or prevent marketing approval from FDA or similar regulatory authorities; our intention to develop CYT-0851, and potentially future drug candidates, for use in combination with other therapies, which exposes us to additional risks; if we are unable to successfully develop and commercialize companion diagnostic tests for our drug candidates, or experience significant delays in doing so, we may not realize the full commercial potential of our drug candidates; synthetic lethality represents an emerging class of precision medicine targets, and negative perceptions of the efficacy, safety or tolerability of this class of targets, including any that we develop, could adversely affect our ability to conduct our business, advance our drug candidates or obtain regulatory approvals; if we are unable to adequately protect and enforce our intellectual property or obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize technology and products similar or identical to ours, and our ability to successfully develop and commercialize our technology and products may be impaired, the continuing outbreak of COVID-19 in the United States and other countries may adversely affect our business and the market price of our common stock; and other factors set forth under the heading “Risk Factors” in Cyteir’s final prospectus dated June 17, 2021 related to our initial public offering, which is available on the U.S. Securities and Exchange Commission (SEC) website at www.sec.gov. Additional information will be made available by our quarterly reports on Form 10-Q and other filings that we make from time to time with the SEC. Any forward-looking statement made in this press release speaks only as of the date on which it is made. The company does not undertake any obligation to update any such statement or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the SEC. You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220112005369/en/

INVESTORS:

Lisa Hayes

Vice President, Investor Relations and Corporate Communications

908-868-8926

Lisa.Hayes@cyteir.com

MEDIA:

Michele Parisi

925-429-1850

mparisi@forwardhealthinc.com

Source: Cyteir Therapeutics

FAQ

What is the purpose of the Phase 1 trial for CYT-0851?

The Phase 1 trial aims to evaluate the safety and efficacy of CYT-0851 in combination with standard chemotherapy regimens for treating various cancers.

What chemotherapy regimens are used in the CYT-0851 trial?

The trial combines CYT-0851 with rituximab plus bendamustine, gemcitabine, and capecitabine.

When will initial safety data from the CYT-0851 trial be available?

Initial safety data from the trial is expected by the end of this year.

What types of cancer could CYT-0851 potentially target?

CYT-0851 may target breast, pancreatic, colorectal, ovarian cancers, among others.

What are the risks associated with the development of CYT-0851?

Risks include the possibility of failing to demonstrate adequate safety and efficacy, which could delay or prevent further clinical development.