Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus
Cullinan Therapeutics (Nasdaq: CGEM) announced FDA clearance of its Investigational New Drug (IND) Application for CLN-978, allowing its global Phase 1 clinical trial to proceed in the U.S. for patients with moderate to severe systemic lupus erythematosus (SLE). CLN-978 is the first development stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.
The trial will enroll patients with a SLEDAI score of 8 or greater who have had inadequate response to at least two treatments. It consists of Part A (dose escalation) and Part B (dose expansion). The primary objective is to evaluate CLN-978's safety, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.
Cullinan Therapeutics aims to address the unmet medical need in SLE patients, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978 offers a novel approach with off-the-shelf access and convenient subcutaneous dosing.
Cullinan Therapeutics (Nasdaq: CGEM) ha annunciato l'approvazione da parte della FDA della sua domanda di farmaco investigativo (IND) per CLN-978, permettendo l'avvio della sua sperimentazione clinica globale di Fase 1 negli Stati Uniti per pazienti con lupus eritematoso sistemico (LES) da moderato a grave. CLN-978 è il primo farmaco in fase di sviluppo come ingaggiante delle cellule T CD19 ad ottenere l'approvazione IND dalla FDA per le malattie autoimmuni.
Lo studio arruolerà pazienti con un punteggio SLEDAI di 8 o superiore che hanno mostrato una risposta inadeguata a almeno due trattamenti. Esso si compone di Parte A (aumento della dose) e Parte B (espansione della dose). L'obiettivo principale è valutare la sicurezza di CLN-978, con obiettivi secondari che includono farmacocinetica, cinetica delle cellule B, immunogenicità e attività clinica.
Cullinan Therapeutics mira a soddisfare il bisogno medico non soddisfatto nei pazienti con LES, poiché le terapie attuali spesso non riescono a controllare completamente l'attività della malattia e prevenire danni permanenti agli organi. CLN-978 offre un approccio innovativo con accesso immediato e somministrazione sottocutanea conveniente.
Cullinan Therapeutics (Nasdaq: CGEM) anunció la aprobación de la FDA de su Solicitud de Medicamento en Investigación (IND) para CLN-978, lo que permite que su ensayo clínico global de Fase 1 continúe en EE. UU. para pacientes con lupus eritematoso sistémico (LES) de moderado a severo. CLN-978 es el primer enganchador de células T CD19 en etapa de desarrollo que recibe la aprobación IND de la FDA para enfermedades autoinmunitarias.
El ensayo reclutará pacientes con un puntaje SLEDAI de 8 o más que no han respondido adecuadamente a al menos dos tratamientos. Consiste en Parte A (escalada de dosis) y Parte B (expansión de dosis). El objetivo principal es evaluar la seguridad de CLN-978, con objetivos secundarios que incluyen farmacocinética, cinética de células B, inmunogenicidad y actividad clínica.
Cullinan Therapeutics busca abordar la necesidad médica no satisfecha en pacientes con LES, ya que las terapias actuales a menudo no logran controlar completamente la actividad de la enfermedad y prevenir daños orgánicos a largo plazo. CLN-978 ofrece un enfoque novedoso con acceso inmediato y dosificación subcutánea conveniente.
큘리난 치료제(Cullinan Therapeutics)(나스닥: CGEM)가 CLN-978의 임상시험 신약(IND) 신청서가 FDA 승인을 받았다고 발표했습니다. 이로 인해 미국에서 중등도에서 중증의 전신 홍반 루푸스(SLE) 환자를 대상으로 글로벌 1상 임상 시험이 진행될 수 있게 되었습니다. CLN-978은 자가면역 질환에서 FDA의 IND 승인을 받은 최초의 개발 단계 CD19 T 세포 결합제입니다.
이 시험은 SLEDAI 점수가 8 이상인 환자를 등록하며, 이들은 최소 두 가지 치료에 대해 불충분한 반응을 보였습니다. 이 시험은 A부분(용량 증가)과 B부분(용량 확대)으로 구성됩니다. 주요 목표는 CLN-978의 안전성을 평가하는 것이며, 2차 목표로는 약리학적 동태, B 세포 동태, 면역원성 및 임상적 활동성이 포함됩니다.
큘리난 치료제는 현재 치료법들이 질병 활동을 완전히 조절하거나 장기 손상을 예방하지 못하는 경우가 많기 때문에 SLE 환자들의 미충족 의료 수요를 해결하려고 합니다. CLN-978은 즉각적인 접근성과 편리한 피하 투여를 제공하는 혁신적인 접근 방식을 제공합니다.
Cullinan Therapeutics (Nasdaq: CGEM) a annoncé l'approbation par la FDA de sa demande de médicament d'investigation (IND) pour CLN-978, permettant le lancement de son essai clinique mondial de phase 1 aux États-Unis pour des patients atteints de lupus érythémateux systémique (LES) modéré à grave. CLN-978 est le premier engageant de cellules T CD19 en phase de développement à recevoir l'approbation IND de la FDA pour les maladies auto-immunes.
L'essai recrutera des patients ayant un score SLEDAI de 8 ou plus qui n'ont pas répondu de manière adéquate à au moins deux traitements. Il comprend la Partie A (escalade de dose) et la Partie B (expansion de dose). L'objectif principal est d'évaluer la sécurité de CLN-978, avec des objectifs secondaires comprenant la pharmacocinétique, la cinétique des cellules B, l'immunogénicité et l'activité clinique.
Cullinan Therapeutics vise à répondre au besoin médical non satisfait chez les patients atteints de LES, car les thérapies actuelles échouent souvent à contrôler entièrement l'activité de la maladie et à prévenir les dommages organiques à long terme. CLN-978 offre une approche novatrice avec un accès prêt à l'emploi et une administration sous-cutanée pratique.
Cullinan Therapeutics (Nasdaq: CGEM) gab die Zulassung der FDA für seinen Antrag auf ein neues Medikament (IND) für CLN-978 bekannt, was es ermöglicht, die weltweiten Phase 1-Studien in den USA für Patienten mit moderatem bis schwerem systemischem Lupus erythematodes (SLE) fortzusetzen. CLN-978 ist der erste Entwicklungsstufen-CD19-T-Zellen-Engager, der die IND-Zulassung der FDA für Autoimmunerkrankungen erhalten hat.
Die Studie wird Patienten mit einem SLEDAI-Score von 8 oder höher einschließen, die auf mindestens zwei Behandlungen unzureichend reagiert haben. Sie besteht aus Teil A (Dosissteigerung) und Teil B (Dosiserweiterung). Das Hauptziel besteht darin, die Sicherheit von CLN-978 zu bewerten, während sekundäre Ziele Pharmakokinetik, B-Zell-Kinetik, Immunogenität und klinische Aktivität umfassen.
Cullinan Therapeutics zielt darauf ab, den ungedeckten medizinischen Bedarf bei SLE-Patienten zu decken, da die aktuellen Therapien häufig nicht in der Lage sind, die Krankheitsaktivität vollständig zu kontrollieren und langfristige Organschäden zu verhindern. CLN-978 bietet einen neuartigen Ansatz mit sofortigem Zugang und bequemer subkutaner Dosierung.
- FDA clearance of IND Application for CLN-978 in systemic lupus erythematosus
- First development stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases
- Global Phase 1 clinical trial to proceed in the U.S.
- Novel bispecific T cell engager targeting CD19 with potential for off-the-shelf access and convenient subcutaneous dosing
- None.
Insights
The FDA clearance of Cullinan Therapeutics' IND for CLN-978 in systemic lupus erythematosus (SLE) is a significant milestone. This novel CD19 T cell engager is the first of its kind to receive IND clearance for autoimmune diseases, potentially opening a new treatment avenue for SLE patients.
The global Phase 1 trial design is robust, targeting patients with moderate to severe SLE who have inadequate responses to current treatments. The study's two-part structure (dose escalation and expansion) is well-planned to determine optimal dosing and schedules. Key aspects to watch:
- Safety profile, given the novel mechanism of action
- B cell depletion kinetics as a marker of efficacy
- Clinical activity in reducing SLEDAI scores
- Pharmacokinetics of subcutaneous administration
If successful, CLN-978 could address the significant unmet need in SLE treatment, potentially offering a more targeted and convenient option compared to current therapies. However, investors should note that this is an early-stage trial and efficacy and safety data are yet to be established.
This FDA clearance represents a positive development for Cullinan Therapeutics (NASDAQ: CGEM), potentially enhancing its market position and long-term value proposition. Key financial implications include:
- Expanded pipeline value: CLN-978 adds depth to Cullinan's autoimmune disease portfolio.
- Market opportunity: The SLE market is substantial, with high unmet needs and effective treatments.
- Competitive advantage: Being first-in-class for CD19 T cell engagers in autoimmune diseases could provide a significant edge.
- Resource allocation: Investors should monitor increased R&D expenses as the trial progresses.
- Partnership potential: Successful early data could attract collaboration interest from larger pharma companies.
With a market cap of
CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases
CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE).
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 that will determine the target dose for further development, with a starting dose of 10 micrograms. Part B is a dose expansion phase which will explore multiple 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.
“We are pleased to continue progressing our global Phase 1 clinical trial in the U.S. with FDA clearance of our IND Application,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “There remains a significant unmet medical need among patients with systemic lupus erythematosus, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978, our novel bispecific T cell engager, targets CD19, offering a highly differentiated approach to deliver the potency of T cell redirecting therapy with off-the-shelf access and convenient dosing through subcutaneous administration.”
The Company previously announced in September that it was cleared to initiate its global clinical trial in Australia (NCT06613360).
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 systemic lupus erythematosus 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 clinical development plan and timeline for CLN-978, the clinical and therapeutic potential of CLN-978, and the study design of our clinical trial for CLN-978. 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 FDA 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
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Nsmith@cullinantx.com
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Rose Weldon
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- 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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