Cullinan Oncology to Present Updated Data Demonstrating 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
May 31 2022 - 7:00AM
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical
company focused on developing a diversified pipeline of targeted
therapies for patients with cancer, today announced positive
updated clinical research highlighting the therapeutic potential of
CLN-081 in patients with epidermal growth factor receptor (EGFR)
exon 20 insertion mutation positive non-small cell lung cancer
(NSCLC). Findings will be presented on Friday, June 3 at the 2022
American Society of Clinical Oncology (ASCO) Annual Meeting as an
oral presentation during the “Lung Cancer – Non-Small Cell
Metastatic” session from 4:12- 4:24 p.m. CT (Abstract #9007).
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.
Summary of Key Clinical Results from Phase 1/2a Study of CLN-081
in NSCLC Patients with EGFR Exon 20 Insertion Mutations:
- As of May 2022, 73 patients have been treated across doses
ranging from 30 to 150 mg twice daily (BID). Of the patients
enrolled, 66% of patients had received two or more prior lines of
treatment; 36% of patients had prior EGFR tyrosine kinase inhibitor
(TKI) treatment, 55% of patients had received prior immunotherapy.
- Among the 73 patients treated across all dose levels, 28 (38%)
had confirmed partial response, 42 (58%) had stable disease and 3
(4%) had progressive disease according to RECIST guidelines
(version 1.1).
- Of the 39 patients in the 100 mg BID dose group:
- 16 (41%) had a confirmed partial response.
- The estimated median duration of response (DOR) was greater
than 21 months.
- Median progression-free survival (PFS) was 12 months.
- The safety profile of CLN-081 was amenable for long-term
treatment. The most common treatment-related adverse events in
greater than 10% of patients were rash (80%), paronychia (32%),
diarrhea (30%), fatigue (21%), anemia (19%), dry skin (18%), and
nausea (16%), the majority of which were Grade 1/2. No Grade ≥3
rash or diarrhea occurred at doses <150 mg BID and
discontinuations were uncommon.
“These data demonstrate a high response rate, improved response
durability over standard of care treatment, and favorable safety
and tolerability, supporting the rationale for CLN-081 in patients
with NSCLC whose tumors harbor EGFR exon 20 insertion mutations,”
said Helena Yu, MD, Memorial Sloan Kettering. “These data
demonstrate the potential for improvement upon the standard of care
with effective and less toxic novel therapies to treat NSCLC
harboring EGFR exon 20 insertion mutations where patients tend to
have poorer outcomes than those with more common EGFR
mutations.”
“We believe CLN-081 has the potential to be a best-in-class
treatment option for patients with NSCLC whose tumors harbor EGFR
exon 20 insertion mutations with persisting unmet need. With an
established high response rate and favorable safety and
tolerability profile, we are encouraged to now see an updated
durability of response profile that continues to improve,” said
Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan
Oncology. “We look forward to expeditiously advancing CLN-081
together with our collaborators at Taiho Pharmaceutical.”
Cullinan Oncology will also present data on CLN-619
(Anti-MICA/MICB Antibody) in a poster presentation during the
Developmental Therapeutics – Immunotherapy Poster Session (Abstract
#TPS2688). The poster, “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 Tumors,” will be available on June 5 between 8:00 AM
CDT-11:00 AM CDT.
Virtual and Live Investor Event
Cullinan Oncology will host an Investor Event on Saturday, June
4, 2022, at 7:00 a.m. CT, during which Dr. Helena Yu will present
an overview of CLN-081 data shared at the 2022 ASCO Annual Meeting.
Investors are invited to register to attend in-person or virtually
through https://investors.cullinanoncology.com/news-events/events.
A replay of the event will be available shortly after the
conclusion of the event.
About CLN-081 CLN-081/ TAS6417 is an orally
available small molecule being developed in collaboration with
Taiho Pharmaceutical Co., Ltd. CLN-081 is designed as a next
generation, irreversible EGFR inhibitor for the treatment of a
genetically defined subset of patients with non-small cell lung
cancer (NSCLC). CLN-081 is being investigated in a Phase 1/2a dose
escalation and expansion trial evaluating oral, twice-daily, or
BID, administration of various doses in patients with NSCLC
harboring EGFRex20ins mutations, who have had at least one prior
treatment with platinum-based chemotherapy or another approved
standard 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 product 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
Cullinan Therapeutics (NASDAQ:CGEM)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cullinan Therapeutics (NASDAQ:CGEM)
Historical Stock Chart
From Jul 2023 to Jul 2024