- Advance to first-line RAS-mutated
mCRC follows the strong signal from new clinical and preclinical
data, and agreement with FDA -
- First-line mCRC represents
substantial increase in patient impact and market opportunity over
second-line -
- Pfizer Ignite will be responsible for
the clinical execution of new first-line mCRC trial with
interim topline data expected in mid-2024 -
- Cash position on June 30, 2023 was $89.4
million; sufficient to fund operations into 2025 and through
interim topline results from mCRC trial -
- Company will hold a conference call
today at 5:00 p.m. ET/2:00 p.m.
PT -
SAN
DIEGO, Aug. 7, 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 plans to advance the company's lead program to the
first-line setting of metastatic colorectal cancer (mCRC) and
conduct its new CRDF-004 trial with study execution support from
Pfizer Ignite, a new end-to-end service for biotech companies.
"Our advance to the first-line mCRC setting is the result of a
comprehensive data-driven review coupled with the agreement and
support of the FDA. Ultimately, this decision moves Cardiff
Oncology into a stronger position to realize the promise of
onvansertib for the benefit of patients and all of our
stakeholders," said Mark Erlander,
Ph.D., Chief Executive Officer of Cardiff Oncology. "We are
delighted to expand our relationship with Pfizer and conduct this
new first-line trial beginning this fall through Pfizer Ignite,
leveraging its clinical execution capabilities and expertise."
The company estimates that there are 48,000 new patients in the
U.S. annually in the first-line RAS-mutated mCRC setting for whom
there are no ongoing clinical trials and no new treatments approved
in the past 20 years.
Dr. Erlander continued: "Key to today's decision has been our
discovery of a novel mechanism of action by which onvansertib
inhibits angiogenesis by turning off a 'survival switch' for
tumorigenesis. This has helped us understand onvansertib's
interaction with bevacizumab, and the compelling clinical results
we observed in our Phase 1b/2
second-line KRAS-mutated mCRC trial."
The clinical activities of the company's new CRDF-004 trial in
first-line RAS-mutated mCRC will be conducted with support from
Pfizer Ignite. This expands the relationship established in
November 2021 when Pfizer made an
equity investment in Cardiff Oncology and nominated Adam Schayowitz, Ph.D., Vice President &
Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and
Melanoma, Pfizer Global Product Development as a Scientific
Advisory Board member.
Pfizer Ignite is a new end-to-end service for biotech companies
with high potential science that leverages Pfizer Inc.'s
significant R&D capabilities, scale and expertise to accelerate
the development of breakthrough therapies.
Cardiff Oncology will maintain full economic ownership and
control of onvansertib.
"We believe onvansertib, by inhibiting PLK1, has the potential
to play a meaningful role in the treatment of several types of
cancer, including the lead program in RAS-mutated mCRC," said Dr.
Schayowitz. "We believe that by combining Pfizer's clinical
development capabilities and expertise, with onvansertib's
promising novel clinical findings, we have an opportunity to
accelerate the advancement of this program for the benefit of the
many patients in the RAS-mutated mCRC setting."
Cardiff Oncology's new lead program in first-line RAS-mutated
mCRC will consist of two trials that will be conducted
sequentially. The first trial will be CRDF-004, a Phase 2
randomized trial generating preliminary safety and efficacy data
and evaluating two different doses of onvansertib to confirm an
optimal dose. Onvansertib will be added to standard-of-care
consisting of FOLFIRI plus bevacizumab, or FOLFOX plus bevacizumab.
A total of 90 patients will be randomized in a 1:1:1 ratio to
either 20mg of onvansertib plus standard-of-care, 30mg of
onvansertib plus standard-of-care, or standard-of-care alone.
Interim topline results from this trial are expected in
mid-2024.
Contingent upon the results of CRDF-004, Cardiff Oncology will
initiate a Phase 3, randomized trial with registrational intent.
The FDA has agreed that a seamless trial with objective response
rate (ORR) at an interim point is an acceptable endpoint to pursue
accelerated approval, with progression-free survival (PFS) and
trend in overall survival being the endpoints for full
approval.
"The stand-out results from our Phase 1b/2 second-line mCRC trial of onvansertib were
observed in a well-defined subset of patients, namely those who had
not previously been treated with bevacizumab in the first-line
setting," said Fairooz Kabbinavar, MD, Chief Medical Officer of
Cardiff Oncology. "Bev naïve patients in our Phase 1b/2 trial who received FOLFIRI, bevacizumab and
onvansertib had a remarkable 73% ORR and 15-month mPFS, comparing
favorably against historical controls that report an ORR of
approximately 25% with a 7 to 8-month mPFS. Such high levels of
efficacy have not been previously observed in 2nd line
mCRC. The clinical and preclinical data we are reporting today
confirm our initial finding, and based on highly encouraging
interactions with the FDA and Pfizer, we are moving into first-line
RAS-mutated mCRC where we believe enrollment should occur more
quickly given the significantly larger number of first-line
patients versus second-line."
Consistent with the strategic decision to focus on first-line
RAS-mutated mCRC, Cardiff Oncology will discontinue enrollment in
its ONSEMBLE second-line trial to focus resources on its new lead
first-line program. This decision is driven by the fact that both
trials essentially test the same clinical hypothesis, the
importance of deploying the Company's capital efficiently, and the
FDA's suggestion that Cardiff Oncology consider focusing on the
first-line RAS-mutated mCRC setting.
All other Cardiff Oncology programs remain unaffected by this
decision.
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
August 7, 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 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/cardiff-oncology-announces-new-lead-program-in-first-line-metastatic-colorectal-cancer-and-expanded-pfizer-relationship-301894991.html
SOURCE Cardiff Oncology, Inc.