Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus
Cullinan Therapeutics (Nasdaq: CGEM) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CLN-978, a CD19xCD3 bispecific T cell engager, to treat systemic lupus erythematosus (SLE). This marks a significant step towards advancing their global study of CLN-978 in SLE within the United States.
SLE affects over 160,000 people in the U.S., according to CDC estimates. Current treatments do not typically induce treatment-free remission, with most patients requiring lifelong immune suppression. CLN-978 is a novel, highly potent, half-life extended bispecific T cell engager that could potentially offer a disease-modifying, off-the-shelf option for SLE patients.
Cullinan Therapeutics (Nasdaq: CGEM) ha presentato una richiesta di Nuovo Farmaco Investigativo (IND) alla Food and Drug Administration (FDA) degli Stati Uniti per CLN-978, un engager di cellule T bispecifico CD19xCD3, per trattare il lupus eritematoso sistemico (LES). Questo rappresenta un passo significativo verso il progresso del loro studio globale di CLN-978 nel LES negli Stati Uniti.
Secondo le stime dei CDC, il LES colpisce oltre 160.000 persone negli Stati Uniti. I trattamenti attuali di solito non inducono una remissione senza trattamento, con la maggior parte dei pazienti che necessita di una soppressione immunitaria a vita. CLN-978 è un engager di cellule T bispecifico nuovo, altamente potente e con una vita media estesa che potrebbe offrire un'opzione modificante la malattia, pronta all'uso, per i pazienti affetti da LES.
Cullinan Therapeutics (Nasdaq: CGEM) ha presentado una solicitud de Nuevo Medicamento en Investigación (IND) a la Administración de Alimentos y Medicamentos (FDA) de EE. UU. para CLN-978, un enganche de células T bispecífico CD19xCD3, para tratar l lupus eritematoso sistémico (LES). Este es un paso significativo hacia el avance de su estudio global de CLN-978 en LES dentro de los Estados Unidos.
Según estimaciones de los CDC, el LES afecta a más de 160,000 personas en EE. UU. Los tratamientos actuales no suelen inducir una remisión libre de tratamiento, y la mayoría de los pacientes requieren supresión inmunológica de por vida. CLN-978 es un nuevo enganche de células T bispecífico, altamente potente y con una vida media prolongada que podría ofrecer una opción modificadora de la enfermedad, lista para usar, para los pacientes con LES.
컬리난 테라퓨틱스(Cullinan Therapeutics)(나스닥: CGEM)는 미국 식품의약국(FDA)에 CLN-978이라는 CD19xCD3 이중 특이성 T 세포 결합제에 대한 새로운 약물 승인 신청서(IND)를 제출했습니다. 이는 미국 내에서 SLE(전신성 홍반 루푸스)에 대한 CLN-978의 글로벌 연구를 진행하기 위한 중요한 단계입니다.
CDC 추정에 따르면, SLE는 미국에서 160,000명 이상의 환자에게 영향을 미칩니다. 현재의 치료는 일반적으로 치료 중단 후에도 완전한 관해를 유도하지 않으며, 대부분의 환자는 평생 면역 억제를 필요로 합니다. CLN-978은 새로운 형태의 강력한 이중 특이성 T 세포 결합제로, 질병 수정 작용을 제공할 수 있는 즉시 사용 가능한 옵션이 될 수 있습니다.
Cullinan Therapeutics (Nasdaq: CGEM) a soumis une demande de Nouveau Médicament Expérimental (IND) à la Food and Drug Administration (FDA) des États-Unis pour CLN-978, un engageur de cellules T bispécifique CD19xCD3, afin de traiter le lupus érythémateux systémique (LES). Cela marque une étape importante vers l'avancement de leur étude mondiale sur CLN-978 dans le LES aux États-Unis.
Le LES touche plus de 160 000 personnes aux États-Unis, selon les estimations des CDC. Les traitements actuels ne provoquent généralement pas de rémission sans traitement, la plupart des patients nécessitant une suppression immunitaire à vie. CLN-978 est un engageur de cellules T bispécifique nouveau, très puissant et à demi-vie prolongée, qui pourrait potentiellement offrir une option modifiant la maladie, prête à l'emploi, pour les patients atteints de LES.
Cullinan Therapeutics (Nasdaq: CGEM) hat einen Antrag auf ein Investigational New Drug (IND) bei der U.S. Food and Drug Administration (FDA) für CLN-978 eingereicht, einen CD19xCD3 bispezifischen T-Zellen-Engager zur Behandlung von systemischem Lupus erythematodes (SLE). Dies stellt einen bedeutenden Fortschritt für die globale Studie von CLN-978 im Bereich SLE in den Vereinigten Staaten dar.
Laut Schätzungen der CDC sind in den USA über 160.000 Menschen von SLE betroffen. Die derzeitigen Behandlungen führen in der Regel nicht zu einer remissionsfreien Behandlung, und die meisten Patienten benötigen lebenslang eine Immunsuppression. CLN-978 ist ein neuartiger, hochpotenter, mit verlängerter Halbwertszeit ausgestatteter bispezifischer T-Zellen-Engager, der möglicherweise eine krankheitsmodifizierende, sofort verfügbare Option für SLE-Patienten bieten könnte.
- Submission of IND application to FDA for CLN-978
- Potential to address a market of over 160,000 SLE patients in the U.S.
- CLN-978 could offer a disease-modifying treatment option for SLE
- None.
Insights
The submission of an IND application for CLN-978 marks a significant milestone in Cullinan Therapeutics' pursuit of a novel treatment for systemic lupus erythematosus (SLE). This CD19xCD3 bispecific T cell engager represents a potentially groundbreaking approach to SLE treatment, targeting the root cause rather than just managing symptoms.
The current SLE treatment landscape is characterized by lifelong immunosuppression, which often falls short of inducing treatment-free remission. CLN-978's potential to offer a disease-modifying, off-the-shelf option could revolutionize SLE management, potentially improving long-term outcomes for patients. The half-life extended nature of CLN-978 may also lead to less frequent dosing, enhancing patient convenience and potentially improving adherence.
While this news is promising, it's important to note that the IND submission is just the first step in a long clinical development process. Investors should closely monitor the FDA's response and subsequent clinical trial results to gauge CLN-978's true potential in addressing this significant unmet medical need.
The IND submission for CLN-978 is a positive development for Cullinan Therapeutics, potentially expanding its pipeline in the lucrative autoimmune disease market. With the CDC estimating over 160,000 SLE patients in the U.S. alone, a successful novel therapy could translate into substantial revenue opportunities.
However, investors should exercise caution. The path from IND submission to market approval is long and uncertain, with many candidates failing in clinical trials. Additionally, the competitive landscape for SLE treatments is evolving, with several other companies also developing innovative therapies.
From a financial perspective, while this news doesn't immediately impact Cullinan's bottom line, it does enhance the company's long-term potential. The market for SLE treatments is projected to grow significantly in the coming years and if CLN-978 proves successful, it could become a major revenue driver for Cullinan. Investors should closely monitor the progress of CLN-978 through clinical trials and assess its potential market position relative to competing therapies in development.
CAMBRIDGE, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE).
“We are pleased to take the next step to advance our global study of CLN-978 in SLE in the U.S.,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “The Centers for Disease Control and Prevention (CDC) estimates SLE impacts more than 160,000 people in the U.S., and currently available treatments do not routinely induce treatment-free remission, with most patients requiring lifelong immune suppression that treats symptoms without modifying the course of disease. We are committed to developing new and better treatment options and are focused on advancing CLN-978, a novel, highly potent, half-life extended CD19xCD3 bispecific T cell engager that could offer a potentially disease-modifying, off-the-shelf option for patients.”
About CLN-978
CLN-978 is a novel, highly potent, half-life extended CD19xCD3 bispecific T cell engager construct. CLN-978 potently 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 expressing very low CD19 levels. A human serum albumin (HSA)-binding domain increases the serum half-life of CLN-978 and, with subcutaneous delivery, permits more patient-friendly dosing and potentially reduced toxicity. 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 HSA. 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 therapeutic option for patients with autoimmune diseases such as SLE and rheumatoid arthritis.
About Systemic Lupus Erythematosus (SLE)
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, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, and our research and development activities. 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 our global regulatory submissions, including the IND that we filed for CLN-978; the risk that any INDs or other global regulatory submissions we may file with the United States Food and Drug Administration or other applicable 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
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