Cullinan Therapeutics Announces Preclinical Data for CLN-978, a CD19-directed T Cell Engager, to be Presented at ACR Convergence 2024
Cullinan Therapeutics (NASDAQ: CGEM) will present new preclinical data for CLN-978, its CD19xCD3 T cell engager, at ACR Convergence 2024. The in vitro data shows CLN-978 induced similar T cell activation and B cell depletion in samples from SLE and RA patients compared to healthy volunteers. The company received FDA clearance and Australian approval for a global Phase 1b trial in moderate to severe systemic lupus erythematosus patients. The trial will evaluate doses between 10-45 mcg, with initial clinical data expected in Q4 2025. The study aims to assess safety, pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.
Cullinan Therapeutics (NASDAQ: CGEM) presenterà nuovi dati preclinici per CLN-978, il suo attivatore di cellule T CD19xCD3, all'ACR Convergence 2024. I dati in vitro mostrano che CLN-978 ha indotto una simile attivazione delle cellule T e deplezione delle cellule B nei campioni di pazienti con LES e AR rispetto ai volontari sani. L'azienda ha ricevuto l'approvazione della FDA e l'approvazione australiana per uno studio globale di Fase 1b su pazienti con lupus eritematoso sistemico da moderato a grave. Lo studio valuterà dosi comprese tra 10-45 mcg, con i primi dati clinici attesi nel quarto trimestre del 2025. L'obiettivo dello studio è valutare la sicurezza, la farmacocinetica, la cinetica delle cellule B, l'immunogenicità e l'attività clinica.
Cullinan Therapeutics (NASDAQ: CGEM) presentará nuevos datos preclínicos para CLN-978, su activador de células T CD19xCD3, en la ACR Convergence 2024. Los datos in vitro muestran que CLN-978 indujo una activación similar de células T y una depleción de células B en muestras de pacientes con LES y AR en comparación con voluntarios sanos. La compañía recibió la aprobación de la FDA y la aprobación australiana para un ensayo global de Fase 1b en pacientes con lupus eritematoso sistémico de moderado a severo. El ensayo evaluará dosis entre 10-45 mcg, con los primeros datos clínicos esperados para el cuarto trimestre de 2025. El estudio tiene como objetivo evaluar la seguridad, la farmacocinética, la cinética de células B, la inmunogenicidad y la actividad clínica.
컬리난 테라퓨틱스 (NASDAQ: CGEM)는 ACR Convergence 2024에서 CD19xCD3 T 세포 유도제인 CLN-978에 대한 새로운 전임상 데이터를 발표할 예정입니다. 시험관 내 데이터에 따르면, CLN-978는 건강한 지원자에 비해 SLE 및 RA 환자 샘플에서 유사한 T 세포 활성화와 B 세포 감소를 유도했습니다. 이 회사는 중증에서 중등도의 전신 홍반 루푸스 환자를 대상으로 하는 글로벌 1b상 시험에 대해 FDA의 승인을 받았으며 호주에서도 승인을 받았습니다. 이 시험에서는 10-45 mcg 사이의 용량을 평가할 예정이며, 초기 임상 데이터는 2025년 4분기에 예상됩니다. 이 연구는 안전성, 약동학, B 세포 동역학, 면역원성 및 임상 활동성을 평가하는 것을 목표로 하고 있습니다.
Cullinan Therapeutics (NASDAQ: CGEM) présentera de nouvelles données précliniques pour CLN-978, son activateur de cellules T CD19xCD3, lors de l'ACR Convergence 2024. Les données in vitro montrent que CLN-978 a induit une activation similaire des cellules T et une déplétion des cellules B dans des échantillons de patients atteints de LES et d'AR par rapport à des volontaires sains. L'entreprise a reçu l'approbation de la FDA et l'approbation australienne pour un essai mondial de Phase 1b chez des patients atteints de lupus érythémateux systémique modéré à sévère. L'essai évaluera des doses comprises entre 10-45 mcg, les premières données cliniques étant attendues au quatrième trimestre 2025. L'étude vise à évaluer la sécurité, la pharmacocinétique, la cinétique des cellules B, l'immunogénicité et l'activité clinique.
Cullinan Therapeutics (NASDAQ: CGEM) wird auf der ACR Convergence 2024 neue präklinische Daten zu CLN-978, seinem CD19xCD3 T-Zell-Engager, präsentieren. Die in vitro-Daten zeigen, dass CLN-978 eine ähnliche T-Zell-Aktivierung und B-Zell-Depletion in Proben von SLE- und RA-Patienten im Vergleich zu gesunden Freiwilligen induzierte. Das Unternehmen erhielt die FDA-Zulassung und die australische Genehmigung für eine globale Phase-1b-Studie bei Patienten mit mäßigem bis schwerem systemischem lupus erythematodes. Die Studie wird Dosen zwischen 10-45 mcg evaluieren, wobei die ersten klinischen Daten im 4. Quartal 2025 erwartet werden. Ziel der Studie ist es, die Sicherheit, Pharmakokinetik, B-Zell-Kinetik, Immunogenität und klinische Aktivität zu bewerten.
- Received FDA clearance and Australian approval for Phase 1b trial
- Preclinical data shows consistent efficacy across SLE, RA, and healthy samples
- Subcutaneous delivery method offers convenient administration
- Initial clinical data won't be available until Q4 2025
- Early-stage development (Phase 1) indicates long path to potential commercialization
Insights
The preclinical data presentation for CLN-978 shows promising results in autoimmune disease applications, particularly for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). The key findings demonstrate that CLN-978 maintains consistent performance across both healthy volunteers and patients with autoimmune conditions, suggesting reliable therapeutic potential.
The planned Phase 1b trial design is strategically structured with a modified single-ascending dose approach, exploring doses from
The inclusion criteria targeting patients with SLEDAI scores ≥8 and prior treatment failures positions CLN-978 for a significant unmet medical need. The subcutaneous delivery method could provide a competitive advantage in the autoimmune therapeutics market.
Cullinan will present new in vitro preclinical data that provide further strong rationale for broad clinical development of CLN-978 in autoimmune diseases
Cullinan will share details of global Phase 1b study in moderate to severe systemic lupus erythematosus
Company to host in-person investor event on Saturday, November 16, 2024, at 8 p.m. ET
CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, will present new preclinical data for CLN-978, its novel CD19xCD3 T cell engager. These data and the study schema for a planned Phase 1b study in patients with moderate to severe systemic lupus erythematosus (SLE) will be presented at the annual meeting of the American College of Rheumatology (ACR), ACR Convergence 2024, being held in Washington, D.C., November 14-19. These data will be shared in a poster presentation on November 16, 2024, 10:30 a.m.-12:30 p.m. Eastern Time (Poster Session A, Poster Number 0003). Cullinan will also have a Booth (#2304) in the Exhibit Hall.
CLN-978 Preclinical Data
New in vitro preclinical data show CLN-978 induced similar T cell activation, target B cell depletion, and cytokine production in human peripheral blood mononuclear cells (PBMC) derived from patients with SLE (n=12) or rheumatoid arthritis (RA) (n=9) as compared to healthy volunteers (n=11).
These studies collectively suggest that the previously observed cytokine window observed in B-NHL model systems, potentially resulting in a broad therapeutic index, is expected to be preserved in SLE and RA patients.
"These new preclinical data further demonstrate that CLN-978 is a highly potent T cell engager. With the ability to be subcutaneously delivered, CLN-978 offers off-the-shelf convenience while achieving significant B cell depletion, supporting its potential as a promising new therapeutic option for autoimmune diseases,” said Jeffrey Jones, MD, MBA, Chief Medical Officer of Cullinan Therapeutics. "With regulatory clearances in the U.S. and Australia, we are launching a global Phase 1b clinical trial of CLN-978 in SLE, collaborating closely with investigators and the patient community in our mission to establish new standards of care for patients.”
CLN-978 Global Clinical Development Plan
In October, 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 patients with moderate to severe SLE to proceed in the United States. Cullinan previously announced Human Research Ethics Committee approval to initiate the global clinical trial in Australia (NCT06613360).
The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent. Part A is a dose escalation phase using a modified single-ascending dose design to determine a recommended target dose for further development. Part A is planned to explore target dose levels of 10, 20, 30, and 45 micrograms (mcg) in a stepwise ascending fashion, enrolling at least three patients in each cohort. Dose levels above 10 mcg will incorporate a step-up dose of 10 mcg administered on Day 1 followed by administration of the higher cohort target dose on Day 8. Part B is a dose expansion phase which will explore two or more recommended dose schedules informed by data from Part A of the study.
The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE. Secondary objectives include pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. Initial clinical data are expected in the fourth quarter of 2025.
Live Investor Event
Cullinan will host an in-person event for analysts and institutional investors on Saturday, November 16, 2024, at 8 p.m. ET, 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
- Mahajan A et al. Lupus. 2020
- Hocaoglu M et al. Arthritis Rheumatol. 2023
- Tian J et al. Ann Rheum Dis. 2022
- Dall'Era M. In: Imboden J et al. CURRENT Diagnosis & Treatment: Rheumatology. 3rd ed. 2013
FAQ
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