- CYT-0851 demonstrated activity in combination
with capecitabine in heavily pretreated platinum-refractory or
-resistant ovarian cancer patients with a generally well tolerated
safety profile
- Overall disease control rate was 91% in the
capecitabine combination with a median progression-free survival of
170 days
Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT) today
presented ongoing results from a dose expansion cohort in its Phase
1 combination study of CYT-0851 with capecitabine in patients with
platinum-refractory or -resistant ovarian cancer in a late-breaker
poster titled “Phase 1 Dose Expansion Results of CYT-0851, a
Monocarboxylate Transporter (MCT) Inhibitor, in Combination with
Capecitabine in Platinum-Resistant Ovarian Cancer” (Poster: LB_A13)
at the 2023 AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics meeting in Boston,
Massachusetts.
“The results from the expansion cohort support the initial
findings in our Phase 1 dose escalation study of CYT-0851 in
combination with capecitabine in ovarian cancer,” said Markus
Renschler, MD, President and Chief Executive Officer of Cyteir,
“confirming a high level of tumor control with an all-oral
outpatient regimen that was generally well tolerated.”
Phase 1 Study Objectives
The primary objective of the expansion cohort of the ongoing
Phase 1 combination study is to determine in advanced
platinum-resistant ovarian cancer patients the safety and
tolerability of the CYT-0851 plus capecitabine combination. Other
secondary objectives included the determination of pharmacokinetic
parameters and to characterize the preliminary anti-tumor activity.
The poster presents ongoing results for eleven evaluable patients
with platinum-refractory or -resistant ovarian cancer treated in
this expansion cohort.
Phase 1 Study Ongoing Findings
As of the September 26, 2023 data cutoff, 11 patients with
advanced ovarian cancer were treated and evaluable in the
capecitabine cohort. Patients were heavily pretreated, with a
median of six prior treatment regimens; four patients were
platinum-refractory, and seven patients were platinum-resistant.
Ten patients were treated with CYT-0851 at the recommended Phase 2
dose of 400 mg daily, and one patient was treated with CYT-0851 at
300 mg daily.
Two patients had a confirmed partial response by RECIST and one
additional patient achieved an unconfirmed partial response. Seven
patients had stable disease and one patient had progressive
disease. The disease control rate was 91% and median
progression-free survival was 170 days.
To date, CYT-0851 has exhibited a generally well tolerated
safety profile with no unanticipated toxicities observed at
clinically active doses. The median treatment compliance was 99%.
There were no treatment discontinuations or dose reductions for
treatment related adverse events. All treatment related adverse
events were mild (Grade 1-2). The most common adverse events were
fatigue (46%) and decreased appetite, diarrhea, nausea,
palmar-plantar erythrodysesthesia syndrome and vomiting (18%).
About Cyteir Therapeutics, Inc.
Cyteir is a clinical-stage oncology company that is focused on
the development of CYT-0851, an oral investigational drug that
inhibits monocarboxylate transporters. Inhibiting MCT function in
glycolytic cancer cells leads to an accumulation of intracellular
lactate that impairs glycolysis and inhibits tumor cell growth,
making MCTs an attractive target for cancer therapy. Cyteir’s
current priority in CYT-0851 development is in combination with
capecitabine and gemcitabine in a Phase 1/2 clinical study,
including patients with advanced ovarian cancer. Cyteir has engaged
Locust Walk to represent Cyteir in a potential sale of
CYT-0851.
Additional Information and Where to Find It
In connection with the proposed complete liquidation and
dissolution of the Company, Cyteir filed a preliminary proxy
statement regarding the proposed dissolution with the U.S.
Securities and Exchange Commission (the “SEC”) on October 2, 2023
and intends to file a definitive proxy statement. This Current
Report on Form 8-K does not constitute a solicitation of any vote
or approval. Cyteir may also file other documents with the SEC
regarding the proposed dissolution. This document is not a
substitute for the definitive proxy statement or any other document
that may be filed by Cyteir with the SEC.
BEFORE MAKING ANY VOTING DECISION, CYTEIR’S STOCKHOLDERS ARE
URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY AND
ANY OTHER DOCUMENTS FILED BY CYTEIR WITH THE SEC IN CONNECTION WITH
THE PROPOSED DISSOLUTION OR INCORPORATED BY REFERENCE THEREIN
BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE
PROPOSED DISSOLUTION BECAUSE THEY CONTAIN IMPORTANT INFORMATION
ABOUT THE PROPOSED DISSOLUTION.
Any vote in respect of resolutions to be proposed at a Cyteir
stockholder meeting to approve the proposed dissolution or related
matters, or other responses in relation to the proposed
dissolution, should be made only on the basis of the information
contained in Cyteir’s definitive proxy statement. Stockholders may
obtain a free copy of the definitive proxy statement and other
documents Cyteir files with the SEC (when available) through the
website maintained by the SEC at www.sec.gov. Cyteir makes
available free of charge on its investor relations website at
investors.cyteir.com copies of materials it files with, or
furnishes to, the SEC.
Participants in the Solicitation
Cyteir and certain of its directors, executive officers and
certain employees and other persons may be deemed to be
participants in the solicitation of proxies from Cyteir’s
stockholders in connection with the proposed dissolution. Security
holders may obtain information regarding the names, affiliations
and interests of Cyteir’s directors and executive officers in
Cyteir’s Proxy Statement on Schedule 14A, which was filed with the
SEC on April 27, 2023. To the extent the holdings of Cyteir’s
securities by Cyteir’s directors and executive officers have
changed since the amounts set forth in Cyteir’s Proxy Statement on
Schedule 14A, such changes have been or will be reflected on
Statements of Change in Ownership on Form 4 filed with the SEC.
Investors may obtain additional information regarding the interests
of participants in the solicitation of proxies from Cyteir’s
stockholders in connection with the proposed dissolution, which
may, in some cases, be different than those of Cyteir’s
stockholders generally, by reading the definitive proxy statement
and other materials that may be filed with the SEC in connection
with the proposed dissolution when they become available. These
documents (when available) may be obtained free of charge from the
SEC’s website at www.sec.gov and the investor relations page of the
Cyteir’s website at investors.cyteir.com.
Forward-Looking Statements
This press release contains “forward-looking statements” about
the development and potential sale of CYT-0851. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,”
“seek,” “will,” “would,” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to: that Cyteir’s
clinical trials may fail to demonstrate adequately the safety and
efficacy of CYT-0851; that preclinical testing of CYT-0851 may not
be predictive of the results or success of clinical trials; that
the clinical development of CYT-0851 may be delayed or otherwise
take longer and/or cost more than planned; that Cyteir may be
unable to initiate, enroll or complete clinical development of
CYT-0851; that the continuing global outbreak of COVID-19
(including any resurgences or variants) may result in development
or manufacturing delays, supply shortages, or shortages of
qualified healthcare personnel; that synthetic lethality, as an
emerging class of precision medicine targets, could result in
negative perceptions of the efficacy, safety or tolerability of
this class of targets, which could adversely affect our ability to
conduct our business, advance our drug candidates or obtain
regulatory approvals; the timing and outcome, if any, of a sale
process of CYT-0851; and that Cyteir’s compounds may not receive
regulatory approvals or become commercially successful products.
These and other risks and uncertainties are identified under the
heading “Risk Factors” in Cyteir’s most recent Annual Report on
Form 10-K and other filings Cyteir has made and may make with the
Securities and Exchange Commission ("SEC") in the future, available
on the SEC's website at www.sec.gov.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Cyteir does not undertake and specifically disclaims any obligation
to update any forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20231012887827/en/
Cyteir Investor Relations 857-285-4140 ir@cyteir.com
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