Cullinan Therapeutics to Present Preclinical Data for CLN-978, a CD19-directed T Cell Engager, at ACR Convergence 2024
Cullinan Therapeutics announced upcoming presentation of preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at ACR Convergence 2024 in Washington, D.C. The data demonstrates CLN-978's high potency in B cell depletion, supporting its development for autoimmune diseases. The company recently received FDA clearance for its Phase 1 clinical trial investigating CLN-978 for systemic lupus erythematosus (SLE) in the U.S., following previous HREC approval in Australia. An investor event featuring management discussions and clinical thought leaders will be held on November 16, 2024.
Cullinan Therapeutics ha annunciato la prossima presentazione dei dati preclinici per CLN-978, un engager di cellule T bispecifico CD19xCD3, che si terrà durante ACR Convergence 2024 a Washington, D.C. I dati dimostrano l'alta potenza di CLN-978 nella deplezione delle cellule B, supportando il suo sviluppo per le malattie autoimmuni. L'azienda ha recentemente ricevuto l'approvazione della FDA per il suo studio clinico di fase 1 che valuta CLN-978 per il lupus eritematoso sistemico (LES) negli Stati Uniti, dopo aver ottenuto precedentemente l'approvazione dall'HREC in Australia. Un evento per investitori con discussioni della direzione e leader di pensiero clinico si terrà il 16 novembre 2024.
Cullinan Therapeutics anunció la presentación de datos preclínicos para CLN-978, un enganchador de células T bispecífico CD19xCD3, en ACR Convergence 2024 en Washington, D.C. Los datos demuestran la alta potencia de CLN-978 en la depleción de células B, respaldando su desarrollo para enfermedades autoinmunes. La compañía recibió recientemente la autorización de la FDA para su ensayo clínico de fase 1 que investiga CLN-978 para el lupus eritematoso sistémico (LES) en los EE. UU., luego de la aprobación previa de HREC en Australia. Un evento para inversores con discusiones de la gerencia y líderes de pensamiento clínico se llevará a cabo el 16 de noviembre de 2024.
컬리난 테라퓨틱스는 ACR Convergence 2024에서 CLN-978의 전임상 데이터 발표를 예정하고 있다고 발표했습니다. CLN-978은 CD19xCD3 이중 특이적 T 세포 결합제입니다. 데이터는 B 세포 제거에서 CLN-978의 높은 효능을 보여주며, 자가면역 질환 개발을 지원합니다. 회사는 최근 미국에서 전신 루푸스 에리테마토수스(SLE)를 위해 CLN-978을 조사하는 1상 임상 시험에 대한 FDA 승인을 받았으며, 호주에서는 이전에 HREC 승인을 받았습니다. 경영진과 임상 전문가들이 논의하는 투자자 행사 는 2024년 11월 16일에 개최될 예정입니다.
Cullinan Therapeutics a annoncé la prochaine présentation de données précliniques concernant CLN-978, un engageur de cellules T bispécifique CD19xCD3, lors de ACR Convergence 2024 à Washington, D.C. Ces données démontrent la haute puissance de CLN-978 dans la déplétion des cellules B, soutenant son développement pour les maladies auto-immunes. La société a récemment reçu l'approbation de la FDA pour son essai clinique de phase 1 investiguant CLN-978 pour le lupus érythémateux systémique (LES) aux États-Unis, après avoir obtenu l'approbation précédente de l'HREC en Australie. Un événement pour investisseurs, comprenant des discussions avec la direction et des leaders d'opinion clinique, aura lieu le 16 novembre 2024.
Cullinan Therapeutics gab die bevorstehende Präsentation präklinischer Daten für CLN-978, einen bispezifischen T-Zell-Engager CD19xCD3, auf ACR Convergence 2024 in Washington, D.C. bekannt. Die Daten zeigen die hohe Wirksamkeit von CLN-978 bei der Depletion von B-Zellen und unterstützen die Entwicklung für autoimmune Erkrankungen. Das Unternehmen erhielt kürzlich die FDA-Zulassung für seine Phase-1-Studie zur Untersuchung von CLN-978 bei systemischem Lupus erythematodes (SLE) in den USA, nachdem zuvor die HREC in Australien zugestimmt hatte. Eine Investorenveranstaltung mit Diskussionen der Unternehmensleitung und klinischen Meinungsführern findet am 16. November 2024 statt.
- FDA clearance received for Phase 1 clinical trial of CLN-978
- Preclinical data shows high potency in B cell depletion
- Global trial expansion with approvals in both US and Australia
- None.
Insights
The presentation of preclinical data for CLN-978 at ACR Convergence 2024 is a routine scientific conference update that does not provide substantial new information for investors. While the company received FDA IND clearance for CLN-978's Phase 1 trial in SLE last month, this upcoming conference presentation focuses on already known preclinical findings. The investor event, while providing access to management, is a standard corporate communications activity.
The development of CLN-978 as a CD19xCD3 bispecific T cell engager for autoimmune diseases represents an interesting therapeutic approach, but without new clinical data or significant business developments, this news has minimal immediate impact on the company's valuation or near-term prospects.
CAMBRIDGE, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced the upcoming presentation of preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, at American College of Rheumatology (ACR) Convergence 2024, taking place in Washington, D.C. from November 14-19, 2024.
“These preclinical data show that CLN-978 is a highly potent T cell engager that leads to deep B cell depletion, supporting the broad development of CLN-978 as a potential new therapeutic option for patients with autoimmune diseases,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “We look forward to continued collaboration with investigators and the patient community as we initiate our global Phase 1 clinical trial of CLN-978 in systemic lupus erythematosus and deliver on our mission to bring new standards of care to patients.”
The details of the presentation include:
Title: CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases
Presenting Author: Stephen Wax, MD, PhD, Vice President, Clinical Development, Cullinan Therapeutics
Poster Number: 0003
Session Type: Poster Session A
Session Date and Time: November 16, 2024, 10:30 AM-12:30 PM Eastern Time
Session Title: B Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster
On October 15, Cullinan Therapeutics announced U.S. Food and Drug Administration clearance of an Investigational New Drug Application for its global Phase 1 clinical trial to evaluate CLN-978 for the treatment of SLE to proceed in the U.S. Cullinan previously announced Human Research Ethics Committee (HREC) approval to initiate the global clinical trial in Australia (NCT06613360).
Live Investor Event
Cullinan will host an in-person event for analysts and institutional investors on Saturday, November 16, 2024, at 8:00 PM Eastern Time during which members of Cullinan’s management team will be available for discussion. The event will also feature a clinician and thought leader discussion, followed by a question-and-answer session. Investors and analysts are invited to register to attend in person by emailing Nick Smith, Director of Investor Relations (nsmith@cullinantx.com).
About CLN-978
CLN-978 is a novel, highly potent CD19xCD3 bispecific T cell engager. CLN-978 triggers redirected lysis of CD19-expressing target cells in vitro and in vivo. CLN-978 is engineered to achieve very high affinity binding to CD19 to efficiently target B cells, including those with very low CD19 levels. Small in molecular size (65 kDa), CLN-978 contains two single-chain variable fragments, one binding with very high affinity to the CD19 target and the other binding to CD3 on T cells, and a single-domain antibody binding to human serum albumin to extend serum half-life. CLN-978 was developed by an internal Cullinan team and is a wholly owned asset. CLN-978 has the potential to offer a convenient, off-the-shelf, subcutaneously delivered therapeutic option for patients with autoimmune diseases such as SLE and rheumatoid arthritis.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, heterogeneous autoimmune disease in which the immune system attacks a patient’s own tissues. The most common manifestations of SLE include skin rashes, arthritis, swelling in the feet, and around the eyes, extreme fatigue, and low fevers. Lupus nephritis (LN) is a kidney disease and the most common severe manifestation of SLE. Approximately
About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has 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 autoimmune diseases and cancer. Cullinan’s 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 autoimmune and cancer 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 Cullinan 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 the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for CLN-978, the clinical and therapeutic potential of CLN-978, our plans regarding future data presentations, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” 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 future results, performance or achievements 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; the risk that any INDs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; 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 the 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 the company 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:
Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com
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| 1. | Mahajan A et al. Lupus. 2020 | |
| 2. | Hocaoglu M et al. Arthritis Rheumatol. 2023 | |
| 3. | Tian J et al. Ann Rheum Dis. 2022 | |
| 4. | Dall'Era M. In: Imboden J et al. CURRENT Diagnosis & Treatment: Rheumatology. 3rd ed. 2013 | |
FAQ
What is the purpose of Cullinan Therapeutics' CLN-978 clinical trial (CGEM)?
When will Cullinan Therapeutics (CGEM) present CLN-978 data at ACR Convergence 2024?
What regulatory approvals has CLN-978 (CGEM) received in 2024?
