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

Rhea-AI Summary

Cullinan Oncology (Nasdaq: CGEM) presented updated findings from its Phase 1/2a clinical trial of CLN-081 at the 2022 ASCO Annual Meeting in Chicago. This oral presentation focused on the drug’s efficacy in patients with EGFR exon 20 insertion mutation positive non-small cell lung cancer (NSCLC). CLN-081, which received Breakthrough Therapy Designation from the FDA, aims to address the limited treatment options available. The trial highlights the potential of CLN-081 as a promising therapy amidst ongoing unmet needs for patients.

Data includes updated findings from Phase 1/2a study, including expanded patient cohort treated at a dose of 100 mg twice daily

CAMBRIDGE, Mass., April 27, 2022 (GLOBE NEWSWIRE) -- 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: 9007
Session: Oral Abstract Session/Lung Cancer—Non-Small Cell Metastatic
Presentation 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 Tumors
Author: John D. Powderly II, et al.
Abstract Number: TPS2688
Session: Poster Session/Developmental Therapeutics—Immunotherapy
Presentation Date/Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

About CLN-081

CLN-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 Oncology

Cullinan 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 Statements

This 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 Relations
Chad Messer
+1 203.464.8900
cmesser@cullinanoncology.com 

Media
Rose Weldon
+1 215.801.7644
rweldon@cullinanoncology.com 

FAQ

What are the key findings presented by Cullinan Oncology about CLN-081?

Cullinan Oncology highlighted updated findings from the Phase 1/2a clinical trial of CLN-081, indicating its promising efficacy in treating patients with EGFR exon 20 insertion mutation positive NSCLC.

When and where was the presentation on CLN-081 made?

The presentation on CLN-081 was made at the 2022 ASCO Annual Meeting in Chicago, from June 3-7, 2022.

What designation has CLN-081 received from the FDA?

CLN-081 has received the Breakthrough Therapy Designation from the FDA, which facilitates its development as a treatment for NSCLC.

What is the significance of CLN-081 for patients with NSCLC?

CLN-081 offers a potential best-in-class treatment option for patients with EGFR exon 20 insertion mutations, which have limited effective therapies available.

Who is the Chief Medical Officer of Cullinan Oncology?

Jeffrey Jones, MD, MPH, MBA, serves as the Chief Medical Officer of Cullinan Oncology.