Cyteir Therapeutics Announces First Patient Dosed in Phase 2 with CYT-0851

Rhea-AI Summary

Cyteir Therapeutics (NASDAQ: CYT) announced the first patient dosed in a Phase 2 expansion cohort study of CYT-0851, targeting hematologic malignancies and solid tumors. This study aims to evaluate anti-tumor activity across six cancer types and confirm the safety of the drug, which is designed to inhibit RAD51-mediated DNA repair. Management expressed optimism about advancing CYT-0851 into a potential registrational trial by early next year, contingent on the study results.

Positive

• First patient dosed in Phase 2 expansion cohort study for CYT-0851.
• Study involves six cancer types, potentially broadening market opportunities.
• Management anticipates progression to a registrational intent trial early next year.

Negative

• Significant operating losses expected to continue indefinitely.
• Uncertainty in clinical trial outcomes that could affect commercialization.
• Need for substantial additional funding may pose financial risks.

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 2 expansion cohort study of CYT-0851 monotherapy that is part of the Phase 1/2 trial. CYT-0851 is being evaluated for the treatment of hematologic malignancies and solid tumors.

“We are excited to dose the first patient in the Phase 2 expansion cohort study with CYT-0851. This signal-seeking study in six different cancers will give us the data that may allow us to advance CYT-0851 into a clinical trial with potential registrational intent as soon as early next year,” said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. “I am grateful to the entire Cyteir team, our investigators and participating patients as we work together to complete these expansion cohorts.”

CYT-0851 Phase 2 Monotherapy Study
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. For the Phase 2 monotherapy expansion cohort study with CYT-0851 (NCT Number NCT03997968), we intend to enroll in six disease-specific cohorts in hematologic malignancies (relapsed and/or refractory diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma) and solid tumors (recurrent metastatic or locally advanced pancreatic cancer, progressive ovarian cancer, and metastatic soft tissue sarcoma).

The Phase 2 study is being run with a Simon two-stage design and patients will be dosed with the recommended Phase 2 dose of CYT-0851 of 400 mg once daily that was determined in the Phase 1 dose escalation study. The objectives of the expansion cohort study are to evaluate preliminary anti-tumor activity in each disease specific expansion cohort, and to confirm the safety of the chosen Phase 2 dose.

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 anticipated clinical developments including advancing CYT-0851 into a potential registrational intent trial as soon as early next year and enrollment of additional cohorts in the Company’s Phase 2 expansion study for CYT-0851. 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. 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; 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 for substantial additional funding; that we have never successfully completed any clinical trials; that our clinical trials may fail to demonstrate adequately the safety and efficacy of any of our drug candidates; our intention to develop CYT-0851, and potentially future drug candidates, for use in combination with other therapies, which exposes us to additional risks; our ability to successfully develop and commercialize companion diagnostic tests for our drug candidates; negative perceptions of the efficacy, safety or tolerability of precision medicine targets; our ability to adequately protect and enforce our intellectual property or obtain and maintain patent protection for our technology and products appropriately scoped for our commercialization plans; the continuing outbreak of COVID-19 in the United States and other countries; and other factors described in our filings with the U.S. Securities and Exchange Commission (SEC) available on the SEC’s website at www.sec.gov, including under the heading “Risk Factors” in Cyteir’s final prospectus dated June 17, 2021 related to our initial public offering. 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.

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INVESTOR:

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 CYT-0851 and what is its purpose in clinical trials?

CYT-0851 is an oral investigational drug developed by Cyteir Therapeutics, aimed at treating various cancers by inhibiting DNA repair mechanisms.

What types of cancers are being targeted in the Phase 2 study of CYT-0851?

The Phase 2 study targets hematologic malignancies such as diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma, along with solid tumors like pancreatic and ovarian cancers.

When will the results of the CYT-0851 trial be available?

While specific timelines are not disclosed, the company aims to advance to a registrational trial as early as next year, depending on trial results.

What factors could impact the success of the CYT-0851 clinical trials?

Factors include the drug's safety and efficacy demonstrated in trials, potential need for additional funding, and market perceptions regarding precision medicine.

How does CYT-0851 work to treat cancer?

CYT-0851 is designed to inhibit RAD51-mediated homologous recombination, affecting cancer cells' ability to repair double-strand DNA breaks.