Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring
Cellectar Biosciences (NASDAQ: CLRB) announces strategic changes, including pursuing options for iopofosine I 131 development following FDA communications regarding confirmatory study requirements. The company will shift focus to advancing its alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies.
The FDA indicated that accelerated approval would require major response rate data from CLOVER-WaM study and enrollment in a randomized controlled confirmatory study for progression-free survival data. The company plans to file Investigational New Drug applications for CLR-121225 and CLR-121125 in first half of 2025.
As part of restructuring, Cellectar will reduce headcount by approximately 60% by end of Q4 2024, extending cash runway into Q3 2025.
Cellectar Biosciences (NASDAQ: CLRB) annuncia cambiamenti strategici, compresa la ricerca di opzioni per lo sviluppo di iopofosina I 131, a seguito delle comunicazioni della FDA riguardanti i requisiti per gli studi di conferma. L'azienda concentrerà i suoi sforzi sull'avanzamento dei suoi radio-coniugati emittenti alfa e Auger verso studi sulla fase 1 per tumori solidi.
La FDA ha indicato che l'approvazione accelerata richiederà dati significativi sul tasso di risposta dallo studio CLOVER-WaM e l'arruolamento in uno studio controllato randomizzato di conferma per i dati sulla sopravvivenza libera da progressione. L'azienda prevede di presentare domande per il Nuovo Farmaco Sperimentale per CLR-121225 e CLR-121125 nella prima metà del 2025.
Come parte della ristrutturazione, Cellectar ridurrà il personale di circa il 60% entro la fine del Q4 2024, estendendo la disponibilità di liquidità fino al Q3 2025.
Cellectar Biosciences (NASDAQ: CLRB) anuncia cambios estratégicos, incluyendo la búsqueda de opciones para el desarrollo de iopofosina I 131 tras las comunicaciones de la FDA sobre los requisitos de estudios confirmatorios. La compañía centrará su atención en avanzar sus radio-conjugados emisores de alfa y Auger a estudios en fase 1 para tumores sólidos.
La FDA indicó que la aprobación acelerada requeriría datos significativos sobre la tasa de respuesta del estudio CLOVER-WaM y la inclusión en un estudio controlado aleatorio confirmatorio para datos de supervivencia libre de progresión. La empresa planea presentar solicitudes de Nuevo Medicamento en Investigación para CLR-121225 y CLR-121125 en la primera mitad de 2025.
Como parte de la reestructuración, Cellectar reducirá su plantilla en aproximadamente el 60% para finales del cuarto trimestre de 2024, ampliando su liquidez hasta el tercer trimestre de 2025.
Cellectar Biosciences (NASDAQ: CLRB)는 FDA의 확인 연구 요건에 대한 커뮤니케이션을 바탕으로 iopofosine I 131 개발을 위한 옵션을 모색하는 것을 포함하여 전략적 변화를 발표합니다. 이 회사는 알파 및 오거 방출 방사성 접합체를 1상 고형종양 연구로 나아가는 데 집중할 것입니다.
FDA는 가속 승인이 CLOVER-WaM 연구의 주요 반응률 데이터와 진행 없는 생존 데이터에 대한 무작위 통제 확인 연구에 대한 등록을 요구한다고 밝혔습니다. 이 회사는 2025년 상반기 안에 CLR-121225 및 CLR-121125에 대한 연구 신약 신청서를 제출할 계획입니다.
재구성의 일환으로 Cellectar는 2024년 4분기 말까지 인력을 약 60% 줄이고, 2025년 3분기까지 현금 여유를 연장할 것입니다.
Cellectar Biosciences (NASDAQ: CLRB) annonce des changements stratégiques, y compris la recherche d'options pour le développement de l'iopofosine I 131 suite aux communications de la FDA sur les exigences des études de confirmation. L'entreprise concentrera ses efforts sur la promotion de ses radio-conjugués émetteurs alpha et Auger dans des études de phase 1 sur des tumeurs solides.
La FDA a indiqué que l'approbation accélérée nécessiterait des données significatives sur le taux de réponse provenant de l'étude CLOVER-WaM et l'inscription dans une étude de confirmation contrôlée randomisée pour les données de survie sans progression. L'entreprise prévoit de soumettre des demandes de médicament expérimental pour CLR-121225 et CLR-121125 dans la première moitié de 2025.
Dans le cadre de la réorganisation, Cellectar réduira ses effectifs d'environ 60% d'ici la fin du quatrième trimestre 2024, prolongeant ainsi sa trésorerie jusqu'au troisième trimestre 2025.
Cellectar Biosciences (NASDAQ: CLRB) kündigt strategische Veränderungen an, einschließlich der Verfolgung von Optionen für die Entwicklung von Iopofosine I 131 nach Mitteilungen der FDA zu den Anforderungen an Bestätigungsstudien. Das Unternehmen wird den Fokus darauf richten, seine Alpha- und Auger-emittierenden Radiokonjugate in Phase-1-Studien zu soliden Tumoren voranzubringen.
Die FDA hat darauf hingewiesen, dass eine beschleunigte Zulassung bedeutende Daten zur Ansprechraten aus der CLOVER-WaM-Studie und die Einschreibung in eine randomisierte kontrollierte Bestätigungsstudie zur progressionsfreien Überlebenszeit erfordert. Das Unternehmen plant, in der ersten Hälfte von 2025 Anträge auf ein neues experimentelles Medikament für CLR-121225 und CLR-121125 einzureichen.
Im Rahmen der Umstrukturierung wird Cellectar bis Ende des vierten Quartals 2024 die Mitarbeiterzahl um etwa 60% reduzieren, wodurch der finanzielle Spielraum bis ins dritte Quartal 2025 verlängert wird.
- Planned IND applications for two new programs (CLR-121225 and CLR-121125) in H1 2025
- Restructuring expected to extend cash runway into Q3 2025
- Strong efficacy and good tolerability shown in iopofosine I 131 clinical studies
- 60% workforce reduction by Q4 2024
- Additional FDA requirements for iopofosine I 131 approval pathway
- Need to seek strategic options for iopofosine I 131 due to resource constraints
Insights
This strategic pivot marks a significant shift for Cellectar Biosciences, with both immediate financial and long-term operational implications. The 60% headcount reduction will generate substantial cost savings, extending the cash runway into Q3 2025. However, the decision to seek strategic options for iopofosine I 131 reflects the challenges of funding a comprehensive Phase 3 program as a small-cap biotech.
The restructuring appears prudent given the FDA's requirements for a randomized controlled trial. The pivot to alpha- and Auger-emitting programs aligns with current market trends, as evidenced by recent sector M&A activity. The pipeline refocus on CLR 121225 and CLR 121125 could potentially deliver faster proof-of-concept data with lower development costs.
The FDA's requirement for a randomized controlled trial to confirm progression-free survival represents a significant regulatory hurdle for iopofosine I 131, despite its promising Phase 2 data in Waldenstrom's macroglobulinemia. The shift to alpha- and Auger-emitting radiotherapeutics is strategically sound, as these modalities have shown superior targeting capabilities and potentially better therapeutic windows.
The planned IND filings for CLR-121225 and CLR-121125 in H1 2025 indicate a clear development timeline. The preclinical data showing robust activity and targeting in solid tumors suggests potential therapeutic value, though the transition from WM to solid tumors represents a significant change in therapeutic focus.
Evaluating strategic options for iopofosine I 131 a late-stage clinical program with compelling Phase 2 data and a substantial market opportunity
Focusing on advancing radiotherapeutic assets including alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies
FLORHAM PARK, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform that delivers a broad array of therapeutic modalities to target cancers.
Due to recent communications with the U.S. Food and Drug Administration (FDA, or the Agency) regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of this product candidate. The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end of Phase 2 meeting and from a meeting in early 2024, during which the Company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom’s macroglobulinemia (WM). Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS).
“While iopofosine I 131’s positive WM data along with the high unmet medical need for these patients support further investment, we have determined that such a program may best be brought to market by a larger organization with greater resources. Importantly, partnering or divesting this program supports our commitment to providing this potentially life-saving drug to the patients who need it as quickly as possible,” stated James Caruso, president and CEO of Cellectar. “We believe iopofosine I 131 represents a compelling opportunity as it has shown strong efficacy and good tolerability based on our clinical studies. Moreover, the commercial work we conducted demonstrates iopofosine I 131’s substantial market opportunity based upon the product profile, which includes off-the-shelf global distribution, orphan pricing and existing unmet medical need.”
Cellectar remains confident in the potential of its phospholipid ether drug conjugate platform and the targeted radiotherapies in its development pipeline. Iopofosine I 131’s clinical success validates the platform’s ability to target cancers and Cellectar will leverage its experience to focus on the development of its earlier clinical programs.
Specifically, Cellectar will focus on those assets it believes have the highest therapeutic potential and opportunity for value creation. As highlighted by recent acquisitions and collaborations within the radiopharmaceutical sector, precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest. Consequently, the Company will now focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225 based program, and CLR 121125, its iodine-125 Auger-emitting program into the clinic.
Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers. Both programs have demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models. The Company believes this approach will provide an expedited timeframe to achieve safety and proof-of-concept data in patients.
The Company’s strategic reprioritization will impact all departments and result in an immediate reduction in headcount of approximately
“We are being methodical in our efforts to reorganize the company with the goal of conserving cash while maintaining the flexibility to execute immediate priorities and build for long-term growth and value creation. This reorganization is difficult but necessary for the future growth potential of Cellectar,” said Mr. Caruso. “I want to extend my deepest gratitude to our departing employees for their significant contributions to our work and their dedication to making a difference in the lives of patients.”
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug ConjugateTM (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset, iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer, CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
In addition, iopofosine I 131 is under evaluation in Phase 2b studies for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, alongside the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 Orphan Drug and Fast Track Designations for various cancer indications.
New data from the CLOVER-WaM Phase 2 clinical trial were recently presented in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition (ASH 2024).
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to obtain regulatory exclusivities, the availability of priority review vouchers, our ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
Contacts
MEDIA:
Christy Maginn
Bliss Bio Health
703-297-7194
cmaginn@blissbiohealth.com
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
FAQ
What is Cellectar Biosciences' (CLRB) new strategic focus after the December 2024 announcement?
How many employees will be affected by CLRB's restructuring in Q4 2024?
What are the FDA's requirements for iopofosine I 131's accelerated approval?
When will CLRB file IND applications for CLR-121225 and CLR-121125?
