Cullinan Oncology to Present Updated Data Highlighting the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive Non-Small Cell Lung Cancer at the 2022 ASCO Annual Meeting
April 27 2022 - 10:00AM
Cullinan Oncology, Inc. (Nasdaq: CGEM) (Cullinan), a
biopharmaceutical company focused on developing a diversified
pipeline of targeted therapies for patients with cancer, today
announced the presentation of updated clinical research
highlighting the therapeutic potential of its lead asset, CLN-081,
in patients with epidermal growth factor receptor (EGFR) exon 20
insertion mutation positive non-small cell lung cancer (NSCLC) at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting taking place in Chicago from June 3-7, 2022. CLN-081 is
being evaluated in an ongoing Phase 1/2a clinical trial in patients
with NSCLC whose tumors harbor EGFR exon 20 insertion mutations
that have progressed on or after prior therapy.
“Patients with EGFR exon 20 insertion mutations have limited
options for treatments that are safe and well-tolerated,” said
Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan
Oncology. “With a differentiated clinical profile including a high
response rate with favorable safety and tolerability, we believe
CLN-081 has the potential to be a best-in-class treatment option
for patients with persisting unmet need. We are excited to share
our updated research on CLN-081 in an oral presentation at ASCO
2022.”
The Food and Drug Administration (FDA) previously granted
CLN-081 Breakthrough Therapy Designation.
Cullinan presentations at the 2022 ASCO Annual Meeting
include:
Presentation Title: Phase (Ph) 1/2a Study of
CLN-081 in NSCLC Patients (pts) with EGFR Exon 20 Insertion
Mutations (Ins20)Author: Helena Yu, et
al.Abstract Number: 9007Session:
Oral Abstract Session/Lung Cancer—Non-Small Cell
MetastaticPresentation Date/Time: Friday, June 3,
2022, 1:00 PM-4:00 PM CDT
Poster Title: A Phase 1 Dose-Escalation Study
to Investigate the Safety, Efficacy, Pharmacokinetics, and
Pharmacodynamic Activity of CLN-619 (Anti-MICA/MICB Antibody) Alone
and in Combination with Pembrolizumab in Patients with Advanced
Solid TumorsAuthor: John D. Powderly II, et
al.Abstract Number:
TPS2688Session: Poster Session/Developmental
Therapeutics—ImmunotherapyPresentation Date/Time:
Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
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,
Inc.(NASDAQ: CGEM) is a biopharmaceutical company dedicated to
creating new standards of care for patients with cancer. We
innovate without borders to find the most promising clinic-ready
cancer therapies, whether from our own discovery efforts or through
exceptional engagement with our academic and industry partners.
Anchored in a deep understanding of immuno-oncology and
translational cancer medicine, we leverage our scientific
excellence in small molecules and biologics to create
differentiated ideas, identify unique targets, and select the
optimal modality to develop transformative therapeutics across
cancer indications. Powered by our novel research model, we push
conventional boundaries from candidate selection to cancer
therapeutic, applying rigorous early experimentation to fast-track
only the most promising assets to the clinic and ultimately
commercialization. As a result, our diversified pipeline is
strategically built with assets that activate the immune system or
inhibit key oncogenic drivers across a wide range of modalities,
each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation
openly, and exercise creativity and urgency to deliver on our
promise to bring new therapeutic solutions to patients with cancer.
Learn more about our Company at www.cullinanoncology.com, and
follow us on LinkedIn and Twitter.
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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