Pancreatic Cancer Program
- Pancreatic cancer Phase 2 trial of
onvansertib + SoC in the second-line setting demonstrated greater
efficacy vs. historical controls with ORR of 19% (vs. 7.7%) and
mPFS of 5.0 months (vs. 3.1 months) -
- Pancreatic cancer biomarker discovery trial
in refractory patients demonstrated tumor biomarker response
to onvansertib treatment as a single-agent -
- Based on positive data from both pancreatic
trials and supportive preclinical data, a first-line pancreatic
investigator-initiated trial is planned to evaluate the efficacy of
onvansertib + SoC -
Small Cell Lung Cancer Program
- Preliminary data from small cell lung cancer
Phase 2 trial in refractory patients with extensive stage disease
demonstrate single-agent activity from onvansertib monotherapy
-
- Company will hold a conference call today at
5:00 p.m. ET/2:00 p.m. PT
-
SAN
DIEGO, Sept. 26, 2023 /PRNewswire/ -- Cardiff
Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology
company leveraging PLK1 inhibition to develop novel therapies
across a range of cancers, today announced positive clinical
data with onvansertib monotherapy and combination therapy in our
ongoing trials in metastatic pancreatic ductal adenocarcinoma
(mPDAC) and small cell lung cancer (SCLC), as well as plans for a
mPDAC first-line investigator-initiated trial (IIT) of the
combination of onvansertib plus standard-of-care (SoC).
"We are excited that the data released from these trials, in two
challenging cancers with low survival rates, expands the
opportunity for onvansertib beyond our lead program in RAS-mutated
mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of
Cardiff Oncology. "In pancreatic cancer, the strength of the data
provides a clear rationale for a first-line trial using onvansertib
in combination with standard of care, which we believe provides the
greatest opportunity for a positive impact on patients. In small
cell lung cancer, we are encouraged to observe single-agent
activity with onvansertib monotherapy in this difficult-to-treat
extensive stage refractory setting."
mPDAC Phase 2 CRDF-001 trial: 19% ORR and 5.0-month
mPFS
Data from the ongoing Phase 2 open-label trial of onvansertib
combined with nanoliposomal irinotecan, leucovorin, and 5-FU in
patients with second-line mPDAC demonstrated an objective response
rate (ORR) of 19% (4 of 21 evaluable patients; 1 confirmed PR, 3
waiting for confirmatory scan) and median progression-free survival
(mPFS) of 5.0 months as of the data cutoff of September 13, 2023. Historical control trials in
similar patient populations have shown an ORR of 7.7% and mPFS of
3.1 months with SoC.
mPDAC biomarker discovery trial: decrease in
clinically-validated tumor biomarkers from onvansertib
monotherapy
The investigator-initiated biomarker discovery trial is
exploring the impact of onvansertib 10-day monotherapy on tumors in
mPDAC patients, and is currently enrolling at the Oregon Health
& Science University (OHSU) Knight Cancer Institute. Two
patients have been enrolled to date. One patient demonstrated an
86% decrease in Ki67, a well-established biomarker of tumor
proliferation, and a 28% decrease in CA 19-9, a clinically-used
biomarker to monitor treatment response.
"Serum carbohydrate antigen 19-9 is the most extensively studied
and validated serum biomarker in PDAC, which provides a clinically
meaningful surrogate for response to treatment. We are encouraged
by the ability of onvansertib to provide an approximately 30%
reduction in this biomarker with only 10 days of monotherapy in a
refractory setting," said Fairooz Kabbinavar, MD, Chief Medical
Officer of Cardiff Oncology. "We will continue to explore
onvansertib in the first-line mPDAC investigator-initiated trial at
the OHSU Knight Cancer Institute."
Update in Clinical Development Plan for mPDAC
The next trial in mPDAC will be a new Phase 2
investigator-initiated trial at OHSU Knight Cancer Institute in
mPDAC in the first-line setting. There are two cohorts in this
trial. In cohort 1, patients will receive the combination of
onvansertib with SoC (Gemzar + Abraxane). In cohort 2, patients
will receive 10 days of onvansertib monotherapy followed by
onvansertib + SoC to identify biomarkers that predict response to
onvansertib.
SCLC Phase 2 Investigator-Initiated Trial
The ongoing Phase 2 trial of onvansertib monotherapy in patients
with relapsed extensive stage SCLC who have received up to two
prior therapies is currently enrolling patients at
the University of Pittsburgh Medical Center. An
examination of the safety data from the first six patients by the
institutional review board confirmed the trial can continue to
enroll as planned. Preliminary efficacy data in evaluable patients
will be discussed on the company conference call.
Conference Call and Webcast
Cardiff Oncology will host a corresponding conference call and
live webcast at 5:00 p.m.
ET/2:00 p.m. PT on
September 26, 2023. Individuals
interested in listening to the live conference call may do so by
using the webcast link in the "Investors" section of the company's
website at www.cardiffoncology.com. A webcast replay will be
available in the investor relations section on the company's
website for 30 days following the completion of the call.
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 RAS-mutated metastatic
colorectal cancer (mCRC) and metastatic pancreatic ductal
adenocarcinoma (mPDAC), as well as in investigator-initiated trials
in small cell lung cancer (SCLC) and triple negative breast cancer
(TNBC). 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.