Cullinan Oncology to Present First Clinical Data Evaluating Novel Anti-MICA/B Antibody, CLN-619, in Patients with Advanced Solid Tumors at ASCO 2023

Rhea-AI Summary

Cullinan Oncology, Inc. (Nasdaq: CGEM) announced the presentation of initial clinical data for its drug CLN-619 at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6. CLN-619 is a novel antibody targeting MICA and MICB, ligands that interact with immune cells to induce anti-tumor responses. The Phase 1 study focuses on evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of CLN-619, both as a standalone treatment and in combination with pembrolizumab, in patients with advanced solid tumors. The clinical data presentation will take place on June 3, 2023, and aims to showcase the therapeutic potential of CLN-619 across various cancer types.

Positive

• Presentation of initial clinical data for CLN-619 at ASCO 2023 highlights potential therapeutic benefits.
• CLN-619 may treat a range of solid tumors and hematological malignancies through multiple immune-mediated mechanisms.
• The trial allows for dose level extensions and tumor-specific cohorts, indicating adaptability.

Negative

• Uncertainty regarding the timing and results of future clinical trials may affect investor confidence.
• Clinical trials may not predict future results, posing risks to the anticipated success of CLN-619.

CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced that the first clinical data from its Phase 1 clinical study of CLN-619 in patients with advanced solid tumors will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from June 2-6.

“We are pleased to present our initial clinical findings for CLN-619 at ASCO 2023. CLN-619 is a novel, potential first-in-class antibody that binds to MICA and MICB, stress-induced ligands that engage the activating receptor NKG2D present on both innate and adaptive immune cells. MICA and MICB are expressed on a wide variety of solid tumors and hematological malignancies, and we believe CLN-619 has potential to treat a range of tumors,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Oncology.

The details of the presentation include:

Poster Title: A phase 1 dose-escalation study to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamic activity of CLN-619 (Anti-MICA/B antibody) alone and in combination with pembrolizumab in patients with advanced solid tumors.

Author: Dr. Judy Wang, et al.

Poster Number: 2532

Session: Developmental Therapeutics—Immunotherapy

Session Date and Time: June 3, 2023, 8:00 AM-11:00 AM Central Time

About CLN-619

CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to the stress induced ligands, MICA and MICB, which are expressed on a wide variety of solid tumors and hematological malignancies. Engagement of MICA/B by the activating receptor NKG2D, present on both cytotoxic innate and adaptive immune cells, results in target cell lysis. However, tumor cells can shed MICA/B via proteases they release into the tumor microenvironment, resulting in evasion of immune-mediated destruction. CLN-619 functions by restoring MICA/B expression on the surface of tumor cells, enhancing the interaction between MICA and NKG2D, and inducing antibody-dependent cellular toxicity (ADCC), together promoting anti-tumor activity via multiple immune-mediated mechanisms. CLN-619 is being studied in an ongoing Phase 1 clinical trial both as a monotherapy and in combination with pembrolizumab. The study design allows dose level extensions as well as expansion in tumor-specific cohorts.

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 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 the potential benefits and therapeutic potential of CLN-619; our clinical development plans and timelines; our plans regarding future data presentations and other statements that are not historical facts. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

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, 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. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of 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.

Contacts:

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

Media
Rose Weldon
+1 215.801.7644
rweldon@cullinanoncology.com

FAQ

What is the purpose of the CLN-619 clinical trial presented by CGEM?

The CLN-619 clinical trial aims to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of the drug in patients with advanced solid tumors.

When will the CLN-619 clinical data be presented at ASCO 2023?

The CLN-619 clinical data will be presented on June 3, 2023, during the ASCO Annual Meeting.

What type of drug is CLN-619 and what does it target?

CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that targets the ligands MICA and MICB to engage immune cells in attacking tumors.

What are the implications of the CLN-619 trial results for CGEM's market potential?

Positive results from the CLN-619 trial could enhance CGEM's market potential by validating its therapeutic approach to treating various cancers.

What combination therapy is being studied alongside CLN-619?

CLN-619 is being studied both as a standalone treatment and in combination with pembrolizumab in the clinical trial.