Cullinan Oncology Announces Clinical and Regulatory Update for CLN-081 in NSCLC EGFR Exon 20 Patients
March 28 2022 - 4:01PM
Cullinan Oncology, Inc. (Nasdaq: CGEM) (Cullinan), a
biopharmaceutical company focused on developing a diversified
pipeline of targeted therapies for cancer patients, today announced
clinical and regulatory updates on its lead program, CLN-081.
CLN-081 is being evaluated in an ongoing Phase 1/2a clinical trial
in non-small cell lung cancer (NSCLC) patients whose tumors harbor
epidermal growth factor receptor (EGFR) exon 20 insertion mutations
that have progressed on or after prior therapy.
Clinical Update:
In the ongoing Phase 1/2a study, CLN-081 was administered orally
at dose levels including 30, 45, 65, 100 and 150 mg twice daily
(BID). The most recent data now include 39 patients treated at 100
mg BID following the addition of 3 patients who were reassigned to
receive the 100 mg BID dose after enrollment at 150 mg BID was
discontinued.
Key highlights at the 100 mg BID dose level:
- Of 39 response evaluable patients, 16 achieved a confirmed
partial response for a 41% confirmed response rate.
- No patients have experienced Grade 3 or greater
treatment-related diarrhea or rash.
- Promising response durability previously observed in initial
phase 1 patient cohort (n=13) with estimated median response
duration > 15 months and median progression free survival of 12
months.
Cullinan expects to provide further data updates at medical
conferences in 2022.
Regulatory Update
The Food and Drug Administration (FDA) recently granted CLN-081
Breakthrough Therapy Designation. Consistent with the FDA’s Project
Optimus initiative regarding dose optimization, the FDA has
encouraged Cullinan to explore the potential for a food effect on
the clinical profile of the 150mg dose. In the ongoing Phase 1/2a
trial, CLN-081 was administered under fasting conditions. The FDA
has endorsed Cullinan’s plan to conduct a small food effect study
(n~20) that is designed to evaluate the potential impact of food on
exposure and other pharmacokinetic (PK) parameters at 150mg.
Cullinan expects to initiate a pivotal study in the second half of
2022 following the completion of this PK food effect study.
“Today’s update reflects the substantial progress we have made
on the CLN-081 program," said Nadim Ahmed, Chief Executive Officer
of Cullinan Oncology. “CLN-081 continues to show a differentiated
clinical profile relative to EGFR exon 20 agents, including a high
response rate, promising response durability, and favorable safety
and tolerability, which provides a potential opportunity to improve
the standard of care for patients with EGFR exon 20 mutant NSCLC.
The Breakthrough Therapy Designation status for CLN-081 underscores
its clinical profile and has facilitated productive engagement with
the FDA. As a result, we look forward to expeditiously advancing
the regulatory path for CLN-081 through rapid completion of the PK
food effect study and initiation of a pivotal study in the second
half of 2022.”
Additional information is available in a presentation
accompanying this press release on the Events section of our
website.
About CLN-081CLN-081 is an orally available,
irreversible EGFR inhibitor that selectively targets cells
expressing EGFR exon 20 insertion mutations while sparing cells
expressing wild type EGFR. Cullinan is evaluating various doses of
CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring EGFR
exon 20 mutations who have received prior therapy. CLN-081 has
received Breakthrough Therapy Designation from the FDA.
About Cullinan OncologyCullinan Oncology is a
biopharmaceutical company that is developing a diversified pipeline
of targeted therapeutic candidates across multiple modalities in
order to bring important medicines to cancer patients. The
Company’s strategy is to source innovation through both internal
discovery efforts and external collaborations, focusing on advanced
stage assets with novel technology platforms and differentiated
mechanisms. Learn more about Cullinan at
www.cullinanoncology.com.
Forward-Looking StatementsThis press release
contains forward-looking statements of Cullinan Oncology, Inc.
(Cullinan, we or our) within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, but are not limited to, express or implied statements
regarding Cullinan’s beliefs and expectations regarding our
preclinical and clinical development plans, clinical trial designs,
clinical and therapeutic potential, and strategy of CLN-081,
including but not limited to our expectations and beliefs around
its safety and efficacy and plans for future CLN-081 studies. Any
forward-looking statements in this press release are based on
management's current expectations and beliefs of future events and
are subject to known and unknown risks and uncertainties that may
cause our actual results, performance or achievements to be
materially different from any expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: uncertainty regarding the timing and
results of regulatory submissions; success of our clinical trials
and preclinical studies; risks related to our ability to protect
and maintain our intellectual property position; risks related to
manufacturing, supply, and distribution of our therapeutic
candidates; risks related to the impact of COVID-19 affecting
countries or regions in which we have operations or do business,
including potential negative impacts on our employees, customers,
supply chain and production as well as global economies and
financial markets; the risk that any one or more of our product
candidates, including those that are co-developed, will not be
successfully developed and commercialized; the risk that the
results of preclinical studies or clinical studies will not be
predictive of future results in connection with future studies; and
success of any collaboration, partnership, license or similar
agreements. These and other important risks and uncertainties
discussed in our filings with the Securities and Exchange
Commission, or SEC, including under the caption “Risk Factors” in
our most recent Annual Report on Form 10-K and subsequent filings
with the SEC, could cause actual results to differ materially from
those indicated by the forward-looking statements made in this
press release. Moreover, except as required by law, neither
Cullinan nor any other person assumes responsibility for the
accuracy and completeness of the forward-looking statements
included in this press release. Any forward-looking statement
included in this press release speaks only as of the date on which
it was made. We undertake no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise, except as required by
law.
Contacts:
Investor RelationsChad Messer+1
203.464.8900cmesser@cullinanoncology.com
MediaRose Weldon+1
215.801.7644rweldon@cullinanoncology.com
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