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Cullinan Therapeutics to Present Clinical Data from Phase 1 Study Evaluating Novel Anti-MICA/B Antibody, CLN-619, as Monotherapy and in Combination with a Checkpoint Inhibitor in Patients with Advanced Solid Tumors at ASCO 2024

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Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is set to present clinical data from its Phase 1 trial of CLN-619, a novel anti-MICA/B antibody, at the 2024 ASCO Annual Meeting. The data will include results from the dose escalation cohort of CLN-619 in combination with pembrolizumab and updated results from the monotherapy dose escalation cohort in patients with advanced solid tumors. CLN-619 targets stress-induced ligands to activate immune cells and shows potential for synergistic effects when combined with checkpoint inhibitors.
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) presenterà i dati clinici del suo studio di Fase 1 su CLN-619, un nuovo anticorpo anti-MICA/B, durante il Meeting Annuale ASCO del 2024. I dati includeranno i risultati del gruppo di escalation della dose di CLN-619 in combinazione con pembrolizumab e i risultati aggiornati del gruppo di monoterapia di escalation della dose in pazienti con tumori solidi avanzati. CLN-619 agisce sui ligandi indotti da stress per attivare le cellule immunitarie e mostra un potenziale di effetti sinergici quando combinato con inibitori di checkpoint.
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) está programado para presentar datos clínicos de su ensayo de Fase 1 de CLN-619, un nuevo anticuerpo anti-MICA/B, en la Reunión Anual de ASCO de 2024. Los datos incluirán resultados del grupo de escalada de dosis de CLN-619 en combinación con pembrolizumab y resultados actualizados del grupo de monoterapia de escalada de dosis en pacientes con tumores sólidos avanzados. CLN-619 tiene como objetivo los ligandos inducidos por estrés para activar las células inmunes y muestra potencial para efectos sinérgicos cuando se combina con inhibidores de puntos de control.
컬리난 테라퓨틱스, Inc.(나스닥: CGEM)는 2024년 ASCO 연례 회의에서 CLN-619의 1단계 임상 시험 결과를 발표할 예정입니다. 이 데이터는 펨브롤리주맙과 결합한 CLN-619의 용량 상향 코호트 결과와 진행성 고형 종양 환자에서의 단독 요법 용량 상향 코호트의 최신 결과를 포함할 것입니다. CLN-619은 스트레스 유도 리간드를 대상으로 면역 세포를 활성화하며, 체크포인트 억제제와 결합할 때 시너지 효과를 나타낼 가능성을 보여줍니다.
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) est prévu pour présenter des données cliniques de son essai de phase 1 sur CLN-619, un nouvel anticorps anti-MICA/B, lors de la réunion annuelle de l'ASCO en 2024. Les données comprendront les résultats de la cohorte d'escalade de dose de CLN-619 en combinaison avec le pembrolizumab et les résultats actualisés de la cohorte d'escalade de dose en monothérapie chez des patients atteints de tumeurs solides avancées. CLN-619 cible les ligands induits par le stress pour activer les cellules immunitaires et montre un potentiel pour des effets synergiques lorsqu'il est combiné avec des inhibiteurs de points de contrôle.
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) wird auf der Jahrestagung der ASCO 2024 klinische Daten aus seiner Phase-1-Studie zu CLN-619, einem neuartigen Anti-MICA/B-Antikörper, vorstellen. Die Daten umfassen Ergebnisse aus der Dosissteigerungs-Kohorte von CLN-619 in Kombination mit Pembrolizumab und aktualisierte Ergebnisse aus der Monotherapie-Dosissteigerungs-Kohorte bei Patienten mit fortgeschrittenen soliden Tumoren. CLN-619 zielt auf durch Stress induzierte Liganden ab, um Immunzellen zu aktivieren und zeigt Potenzial für synergistische Effekte in Kombination mit Checkpoint-Inhibitoren.
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CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced that clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31-June 4, 2024. The data will include first results from the dose escalation cohort of CLN-619 in combination with checkpoint inhibitor pembrolizumab and updated results from the monotherapy dose escalation cohort in patients with advanced solid tumors.

“We are pleased to present our initial clinical findings for CLN-619 plus pembrolizumab in patients with solid tumors at ASCO 2024, along with updated results from our monotherapy dose escalation study. 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. CLN-619 exerts its effects through multiple mechanisms, providing an opportunity to combine CLN-619 with immunotherapies that target potentially synergistic immune activation pathways, such as checkpoint inhibitors,” said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan Therapeutics.

The details of the presentation include:

Poster Title: CLN-619 (anti-MICA/B antibody) alone and in combination with pembrolizumab for advanced solid tumors: Updated results of a Ph1 study

Author: Dr. Ignacio Melero, et al.

Poster Number: 2588

Session: Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1, 2024, 9:00 AM-12:00 PM 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 hematologic 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 to reinvigorate NKG2D-mediated immune activation, and by inducing antibody-dependent cellular toxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), together promoting anti-tumor activity via multiple immune-mediated mechanisms. CLN-619 is being studied in an ongoing Phase 1 clinical trial (NCT05117476) both as a monotherapy and in combination with pembrolizumab. The study design allows dose level extensions as well as expansion in tumor-specific cohorts. CLN-619 will also be studied in a Phase 1 clinical trial (NCT06381141) in patients with relapsed/refractory multiple myeloma.

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune diseases. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about our Company at https://cullinantherapeutics.com/, and follow us on LinkedIn and X.

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@cullinantx.com

Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com


FAQ

What clinical data will Cullinan Therapeutics present at ASCO 2024?

Cullinan Therapeutics will present clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors at ASCO 2024.

What is the mechanism of action of CLN-619?

CLN-619 is a novel antibody that binds to MICA and MICB stress-induced ligands, engaging the activating receptor NKG2D on immune cells.

Who is the Chief Medical Officer of Cullinan Therapeutics?

Dr. Jeffrey Jones, MD, MPH, MBA, is the Chief Medical Officer of Cullinan Therapeutics.

When and where will the presentation of CLN-619 data take place?

The presentation of CLN-619 data will take place at the ASCO Annual Meeting in Chicago from May 31-June 4, 2024.

What are the potential synergistic effects of combining CLN-619 with checkpoint inhibitors?

CLN-619 provides an opportunity to combine with immunotherapies that target synergistic immune activation pathways, such as checkpoint inhibitors.

Cullinan Therapeutics, Inc.

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