SAN
DIEGO, March 28, 2023 /PRNewswire/
-- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage
biotechnology company leveraging PLK1 inhibition, a well-validated
oncology drug target, to develop novel therapies across a range of
cancers, today announced that the first patient was dosed
this month with its investigational drug onvansertib in its Phase 2
ONSEMBLE trial (NCT05593328). The trial is designed to demonstrate
a clinically meaningful difference in response and onvansertib's
contribution to standard of care (SoC) FOLFIRI/bevacizumab for the
second line treatment of patients with KRAS/NRAS-mutated metastatic
colorectal cancer (mCRC).
"We are excited to be underway with our ONSEMBLE trial that
builds on the promising efficacy and tolerability results
demonstrated in our phase 1b/2 trial
in mCRC," said Fairooz Kabbinavar, MD, Chief Medical Officer of
Cardiff Oncology. "mCRC is a difficult-to-treat cancer and patients
in the second line setting need novel therapeutic options to
improve clinical outcomes. Based on our open-label phase
1b/2 trial, we believe the
combination of onvansertib with FOLFIRI/bevacizumab could
positively impact patients' responses to treatment and the
durability of the responses. Nearly half of our planned 40 sites in
the US are open to enroll patients and we've seen great enthusiasm
from participating investigators."
The Phase 2 ONSEMBLE trial includes patients with mCRC who have
a documented KRAS or NRAS mutation and have previously received one
prior chemotherapy regimen with or without bevacizumab in the first
line metastatic setting. Patients are being randomized to
onvansertib plus FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab
(standard of care). The primary endpoint is objective
response rate determined by the Response Evaluation Criteria in
Solid Tumors via an independent central review. The secondary
endpoints include progression-free survival, overall survival,
duration of response and safety. The trial is being led by
Heinz-Josef Lenz, MD, USC Norris Comprehensive Cancer Center, who has
experience with the Company's mCRC clinical program, having served
as the principal investigator for the Phase 1b/2 trial.
The Company recently introduced the members of its Scientific
Advisory Board, which will continue to provide insight and guidance
related to the ONSEMBLE trial and its strategy to advance
onvansertib through later-stage clinical development.
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company
leveraging PLK1 inhibition, a well-validated oncology drug target,
to develop novel therapies across a range of cancers. The Company's
lead asset is onvansertib, a PLK1 inhibitor being evaluated in
combination with standard-of-care (SoC) therapeutics in clinical
programs targeting indications such as KRAS/NRAS-mutated metastatic
colorectal cancer (mCRC) and metastatic pancreatic ductal
adenocarcinoma (mPDAC), as well as in investigator-initiated trials
in triple negative breast cancer (TNBC) and small cell lung cancer
(SCLC). These programs and the Company's broader development
strategy are designed to target tumor vulnerabilities in order to
overcome treatment resistance and deliver superior clinical benefit
compared to the SoC alone. For more information, please visit
https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified using words such as
"anticipate," "believe," "forecast," "estimated" and "intend" or
other similar terms or expressions that concern Cardiff Oncology's
expectations, strategy, plans or intentions. These forward-looking
statements are based on Cardiff Oncology's current expectations and
actual results could differ materially. There are several factors
that could cause actual events to differ materially from those
indicated by such forward-looking statements. These factors
include, but are not limited to, clinical trials involve a lengthy
and expensive process with an uncertain outcome, and results of
earlier studies and trials may not be predictive of future trial
results; our clinical trials may be suspended or discontinued due
to unexpected side effects or other safety risks that could
preclude approval of our product candidate; risks related to
business interruptions, including the outbreak of COVID-19
coronavirus, which could seriously harm our financial condition and
increase our costs and expenses; uncertainties of government or
third party payer reimbursement; dependence on key personnel;
limited experience in marketing and sales; substantial competition;
uncertainties of patent protection and litigation; dependence upon
third parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations.
There are no guarantees that our product candidate will be utilized
or prove to be commercially successful. Additionally, there are no
guarantees that future clinical trials will be completed or
successful or that any precision medicine therapeutics will receive
regulatory approval for any indication or prove to be commercially
successful. Investors should read the risk factors set forth in
Cardiff Oncology's Form 10-K for the year ended December 31, 2022, and other periodic reports
filed with the Securities and Exchange Commission. While the list
of factors presented here is considered representative, no such
list should be considered to be a complete statement of all
potential risks and uncertainties. Unlisted factors may present
significant additional obstacles to the realization of
forward-looking statements. Forward-looking statements included
herein are made as of the date hereof, and Cardiff Oncology does
not undertake any obligation to update publicly such statements to
reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Richa Kumari
Taft Communications
551 344-5592
richa@taftcommunications.com
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SOURCE Cardiff Oncology, Inc.
