Cyteir Therapeutics Announces Prioritization of CYT-0851 Development and Extended Cash Runway
19 Janeiro 2023 - 6:30PM
Business Wire
- Encouraging early clinical results observed
in treating ovarian cancer with CYT-0851 combination therapy
- Strategic prioritization of clinical
development of CYT-0851 combination therapy for ovarian cancer,
together with deferral of other development activities, is expected
to extend cash runway into 2026
Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT) today
announced the strategic prioritization of clinical development of
CYT-0851, an investigational monocarboxylate transporter inhibitor,
as a potential combination therapy for the treatment of ovarian
cancer. The prioritization follows encouraging preliminary clinical
activity in a small number of patients observed in the Phase 1 dose
escalation cohort with CYT-0851 in combination with capecitabine in
advanced ovarian cancer. Cyteir plans to expand its evaluation of
CYT-0851 in combination with capecitabine to treat advanced ovarian
cancer and enroll additional patients in the first half of 2023 to
further support these early signals. If successful, the combination
of CYT-0851 with capecitabine has the potential to be an all-oral
treatment for ovarian cancer. In conjunction with focusing clinical
activities on ovarian cancer, Cyteir is reducing headcount by
approximately 70% and deferring research and development in other
areas, which is expected to extend Cyteir’s cash runway into
2026.
CYT-0851 Development to Prioritize Combination
Therapy
- Phase 1 dose escalation cohorts with CYT-0851 in combination
with capecitabine for the treatment of advanced ovarian cancer have
shown encouraging preliminary clinical activity. To date, thirteen
patients have been treated with CYT-0851 (from 100-400mg daily) and
capecitabine, including five patients with advanced ovarian cancer.
Responses and disease stabilization observed in these ovarian
cancer patients in the 300mg and 400mg CYT-0851 dose levels are
encouraging, and have led to Cyteir’s decision to focus on further
development of this capecitabine combination in advanced ovarian
cancer. Overall, CYT-0851 continues to be generally well tolerated
with no new safety concerns.
- In the first quarter of 2023, Cyteir expects to determine a
maximum tolerated dose (“MTD”) for CYT-0851 in combination with
capecitabine and focus its efforts on enrolling and treating
additional patients with advanced ovarian cancer at the MTD. If the
data from these additional patients further support Cyteir’s focus
on ovarian cancer, Cyteir intends to pursue development and
potential registration of CYT-0851 in combination with capecitabine
as an all-oral treatment for platinum resistant ovarian
cancer.
- In addition, Cyteir is evaluating CYT-0851 in Phase 1 dose
escalation cohorts in combination with gemcitabine. To date, ten
patients have been treated with CYT-0851 (from 100-200mg daily) and
gemcitabine. Cyteir will continue the ongoing dose escalation
cohorts with CYT-0851 and gemcitabine in solid tumor patients to
identify an MTD, which could provide an additional opportunity to
develop CYT-0851 as a combination therapy to treat patients with
platinum resistant ovarian cancer.
- Enrollment in the Phase 2 monotherapy cohorts with CYT-0851
will be suspended due to insufficient monotherapy activity observed
to date. Cyteir plans to disclose the Phase 1 combination data for
CYT-0851 in mid-2023.
“We are encouraged by these early signals and believe that an
initial focus on the combination of CYT-0851 and capecitabine
represents the greatest likelihood of success and an opportunity to
serve patients with advanced ovarian cancer that have a high unmet
medical need. This combination, if successful, has the potential to
be an all-oral treatment regimen for patients with platinum
resistant ovarian cancer,” said Markus Renschler, MD, Cyteir’s
President and CEO. “This strategic prioritization and the difficult
decision to reduce our workforce is expected to extend our cash
runway into 2026 and, if supported by the data and regulatory
feedback, allows us to advance CYT-0851 into a potentially
registrational trial as early as the second half of 2024. I
personally would like to thank all of our dedicated employees and
express my gratitude for their hard work in advancing our pipeline,
and I wish them the best in the future.”
In the United States, it is estimated that a total of
approximately 13,000 patients are available for drug treatment per
year who are platinum resistant and have progressed after two lines
of prior therapy, or have progressed after at least three prior
lines of therapy.
Deferral of R&D Activities Beyond Clinical Development of
CYT-0851 to Extend Cash Runway
In conjunction with focusing development activities on CYT-0851,
Cyteir announced that it will be suspending all preclinical
research. Specific actions include:
- Ceasing drug discovery projects focused on identifying
inhibitors of DNA damage repair; and
- Reducing company headcount to approximately 15 full-time
employees.
Based on current estimates, including assumptions for
continuation of clinical development of CYT-0851 towards
registration as a combination therapy, Cyteir expects that these
actions will extend its cash runway into 2026. As of December 31,
2022, on an unaudited basis, Cyteir had approximately $147 million
in cash and cash equivalents. Cyteir estimates that it will incur
aggregate charges of approximately $2.5 million to $3 million, all
of which are anticipated to result in future cash expenditures,
primarily for one-time employee severance and benefit costs, the
majority of which are expected to be incurred in the first quarter
of 2023.
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. 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. Follow Cyteir on social media: LinkedIn
and Twitter and at www.cyteir.com.
About Capecitabine and Gemcitabine
Capecitabine is a nucleoside metabolic inhibitor that is
approved in the U.S. for the treatment of patients with adjuvant
colon cancer, metastatic colorectal cancer, and metastatic breast
cancer. It is an orally administered systemic prodrug of
5’-deoxy-5-fluorouridine (5’-DFUR) which is converted to
5-fluorouracil. Gemcitabine is approved in the U.S. in combination
with carboplatin for the treatment of ovarian cancer, in
combination with paclitaxel for the treatment of breast cancer, in
combination with cisplatin for treatment of non-small cell lunch
cancer, and as a single agent for the treatment of pancreatic
cancer. Gemcitabine kills cells undergoing DNA synthesis and blocks
the progression of cells through the G1/S-phase boundary.
Forward-Looking Statements
This press release contains forward-looking statements. 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. These
forward-looking statements include: the benefits and potential
impact of our portfolio prioritization; expected timing to receive
clinical data from current ongoing clinical studies and to
determine an MTD; expected cost savings from these changes; and our
expected extended cash runway.
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 the reduction in
headcount may be larger than currently anticipated; that Cyteir may
incur additional costs not currently anticipated; that the rate of
enrollment in Cyteir’s current clinical studies may not proceed as
anticipated; that Cyteir’s clinical trials may fail to demonstrate
adequately the safety and efficacy of any of its drug candidates;
that early clinical results in a small number of patients may not
be predictive of future results; that preclinical testing of
Cyteir’s compounds may not be predictive of the results or success
of clinical trials; that the preclinical and clinical development
of Cyteir’s compounds may be delayed or otherwise take longer
and/or cost more than planned; 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, except as may be required
by applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230119005876/en/
Lisa Hayes Vice President, Investor Relations and Corporate
Communications 908-868-8926 Lisa.Hayes@cyteir.com
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