Cellectar Biosciences to Highlight 2025 Strategic Initiatives at Upcoming Biotech Showcase during the JP Morgan Healthcare Conference
Cellectar Biosciences (NASDAQ: CLRB) announced its 2025 strategic initiatives, highlighting significant progress with its cancer treatment drug Iopofosine I 131. The company reported impressive Phase 2 CLOVER-WaM study results, achieving an 83.6% overall response rate and exceeding primary endpoints in treating Waldenstrom's Macroglobulinemia.
The company is finalizing its confirmatory study for FDA accelerated approval and EMA authorization, expecting to enroll 40-60 patients per arm with completion projected within 18 months. Cellectar's cash runway extends into Q4 2025, and they're exploring various approaches to commercialize Iopofosine.
Additionally, Cellectar is advancing two other radiotherapeutic assets: CLR 121225, an alpha-emitting radioconjugate showing promising results in solid tumor models, with IND filing planned for Q1 2025, and CLR 121125, an Auger-emitting PRC with IND clearance for triple-negative breast cancer trials.
Cellectar Biosciences (NASDAQ: CLRB) ha annunciato le sue iniziative strategiche per il 2025, evidenziando i progressi significativi con il suo farmaco per il trattamento del cancro, Iopofosine I 131. L'azienda ha riportato risultati impressionanti dallo studio di Fase 2 CLOVER-WaM, raggiungendo un 83,6% di tasso di risposta totale e superando gli obiettivi primari nel trattamento della macroglobulinemia di Waldenström.
L'azienda sta finalizzando il suo studio di conferma per l'approvazione accelerata della FDA e l'autorizzazione dell'EMA, prevedendo di arruolare 40-60 pazienti per braccio, con una conclusione prevista entro 18 mesi. La liquidità di Cellectar si estende fino al quarto trimestre del 2025 e stanno esplorando vari approcci per commercializzare Iopofosine.
Inoltre, Cellectar sta avanzando con altri due asset radioterapici: CLR 121225, un radioconjugato emettitore di alfa che mostra risultati promettenti nei modelli di tumori solidi, con una presentazione IND pianificata per il primo trimestre del 2025, e CLR 121125, un PRC emettitore di Auger con approvazione IND per studi sul cancro al seno triplo negativo.
Cellectar Biosciences (NASDAQ: CLRB) anunció sus iniciativas estratégicas para 2025, destacando avances significativos con su medicamento para el tratamiento del cáncer, Iopofosine I 131. La compañía reportó resultados impresionantes del estudio de Fase 2 CLOVER-WaM, logrando un 83.6% de tasa de respuesta global y superando los objetivos primarios en el tratamiento de la macroglobulinemia de Waldenström.
La compañía está finalizando su estudio de confirmación para la aprobación acelerada de la FDA y la autorización de la EMA, esperando inscribir de 40 a 60 pacientes por brazo, con una finalización proyectada dentro de 18 meses. El capital disponible de Cellectar se extiende hasta el cuarto trimestre de 2025, y están explorando diversas maneras de comercializar Iopofosine.
Adicionalmente, Cellectar está avanzando en otros dos activos radioterapéuticos: CLR 121225, un radioconjugado emisor de alfa que muestra resultados prometedores en modelos de tumores sólidos, con presentación de IND planificada para el primer trimestre de 2025, y CLR 121125, un PRC emisor de Auger con autorización IND para ensayos de cáncer de mama triple negativo.
셀렉타 바이오사이언스 (NASDAQ: CLRB)는 2025년 전략 이니셔티브를 발표하며 암 치료제 Iopofosine I 131에 대한 중요한 진전을 강조했습니다. 이 회사는 2상 CLOVER-WaM 연구에서 83.6%의 전체 반응률을 달성하며 월덴스트롬의 대단백혈증 치료에 대한 주요 목표를 초과 달성한 인상적인 결과를 보고했습니다.
회사는 FDA 가속 승인을 위한 확인 연구와 EMA 인가를 최종 조율 중이며, 각 팔에 40-60명의 환자를 모집할 계획이며 18개월 이내에 완료될 것으로 예상하고 있습니다. 셀렉타의 현금 유예는 2025년 4분기까지 지속되며, Iopofosine 상용화를 위한 다양한 접근 방식을 탐색하고 있습니다.
추가로, 셀렉타는 두 개의 다른 방사선 치료 자산을 발전시키고 있습니다: CLR 121225, 고형 종양 모델에서 유망한 결과를 보이는 알파 방사선 방출 이중체로, 2025년 1분기 IND 제출이 계획되어 있으며, CLR 121125, 삼중 음성 유방암 임상 시험을 위한 IND 승인을 받은 Auger 방출 PRC입니다.
Cellectar Biosciences (NASDAQ: CLRB) a annoncé ses initiatives stratégiques pour 2025, mettant en lumière des avancées significatives avec son médicament de traitement du cancer, Iopofosine I 131. L'entreprise a rapporté des résultats impressionnants de l'étude de Phase 2 CLOVER-WaM, atteignant un taux de réponse global de 83,6% et dépassant les objectifs principaux dans le traitement de la macroglobulinémie de Waldenström.
L'entreprise finalise son étude de confirmation pour l'approbation accélérée par la FDA et l'autorisation de l'EMA, s'attendant à inscrire 40-60 patients par bras, avec une conclusion prévue dans les 18 mois. La liquidité de Cellectar s'étend jusqu'au quatrième trimestre 2025 et ils explorent diverses approches pour commercialiser Iopofosine.
De plus, Cellectar fait progresser deux autres actifs radiothérapeutiques : CLR 121225, un radioconjugat émetteur d'alpha affichant des résultats prometteurs dans des modèles de tumeurs solides, avec un dépôt IND prévu pour le premier trimestre 2025, et CLR 121125, un PRC émetteur d'Auger ayant reçu l'approbation IND pour des essais de cancer du sein triple négatif.
Cellectar Biosciences (NASDAQ: CLRB) hat seine strategischen Initiativen für 2025 bekannt gegeben und erhebliche Fortschritte mit seinem Krebsmedikament Iopofosine I 131 hervorgehoben. Das Unternehmen berichtete von beeindruckenden Ergebnissen der Phase-2-Studie CLOVER-WaM, mit einer gesamtansprechrate von 83,6% und übertroffenem primären Ziel im Umgang mit der Waldenstrom-Makroglobulinämie.
Das Unternehmen finalisiert derzeit seine Bestätigungsstudie für die beschleunigte Zulassung durch die FDA und die Genehmigung durch die EMA und erwartet, 40-60 Patienten pro Arm zu rekrutieren, wobei der Abschluss innerhalb von 18 Monaten vorgesehen ist. Die finanzielle Mittel von Cellectar reichen bis ins vierte Quartal 2025, und sie erkunden verschiedene Ansätze zur Kommerzialisierung von Iopofosine.
Darüber hinaus entwickelt Cellectar zwei weitere radiotherapeutische Vermögenswerte: CLR 121225, ein alpha-emittierendes Radiokonjugat, das vielversprechende Ergebnisse in Modellen solider Tumoren zeigt, mit einer IND-Einreichung, die für das erste Quartal 2025 geplant ist, sowie CLR 121125, ein Auger-emittierendes PRC mit IND-Freigabe für klinische Versuche bei triple-negativem Brustkrebs.
- Phase 2 CLOVER-WaM study achieved 83.6% overall response rate (ORR) and 58.2% major response rate (MRR)
- FDA and EMA showing positive signals for potential accelerated/conditional approval pathway
- Cash runway extends into Q4 2025
- IND clearance received for CLR 121125
- Planned IND filing for CLR 121225 in Q1 2025
- Additional funding likely needed beyond Q4 2025
- Confirmatory study still requires 18 months for full enrollment
- Company exploring various commercialization approaches, indicating potential need for partnerships
Insights
The Phase 2 CLOVER-WaM study results represent a remarkable breakthrough in Waldenstrom's Macroglobulinemia treatment. The 83.6% overall response rate and 58.2% major response rate significantly exceeded the primary endpoint threshold of 20% MRR. For context, these efficacy metrics are exceptional in the WM treatment landscape, where current therapies typically show lower response rates.
The harmonization of FDA and EMA approval pathways through a confirmatory study with 40-60 patients per arm is strategically sound. The projected 18-month enrollment timeline is ambitious but achievable given the orphan disease status. The development of alpha-emitting (CLR 121225) and Auger-emitting (CLR 121125) radioconjugates represents a sophisticated expansion into precision oncology, particularly promising for solid tumors where targeted delivery remains challenging.
With a market cap of just
The parallel development of multiple radioconjugate assets (iopofosine, CLR 121225, CLR 121125) creates multiple value-creation opportunities. However, the cash runway relative to development timelines suggests a near-term capital raise or strategic transaction may be necessary. The upcoming FDA alignment in H1 2025 could serve as a critical catalyst for partnership discussions or capital markets activity.
Oral Presentation Presented at ASH 2024 Showed Iopofosine I 131 Achieved an
Plans to Advance Iopofosine I 131 Internally, Through Strategic Partnerships and Other Approaches; Finalizing Confirmatory Study and Pathway for US FDA Accelerated Approval and EMA Prime Marketing Authorization
Advancing Radiotherapeutic Assets including Alpha- and Auger-emitting Radioconjugates into Phase 1/2a Solid Tumor Studies
FLORHAM PARK, N.J., Jan. 12, 2025 (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 plans to highlight the Company’s 2025 strategic initiatives at Biotech Showcase, taking place January 13-15, 2025 in San Francisco during the 43rd Annual JP Morgan Healthcare Conference. James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 11:30 am Pacific Time.
Iopofosine I 131 (iopofosine) is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The CLOVER-WaM study (NCT02952508) results demonstrated an overall response rate (ORR) of
“We remain committed to bringing iopofosine to WM patients, who have limited treatment options for this incurable disease,” said James Caruso, president and CEO of Cellectar. “We believe our ongoing communications with the U.S. Food and Drug Administration (FDA) indicate there is a path forward for a conditional U.S. market approval as part of the accelerated approval process. This aligns with our understanding of feedback provided by the European Medicines Agency for conditional EU market authorization, and we are harmonizing recommendations from both agencies for a global approval strategy.”
The Company expects the confirmatory study to be a comparator, randomized controlled study with 40-60 patients per arm and full patient enrollment projected within 18 months of the first patient admitted to the study. The Company anticipates alignment with the FDA in the first half of 2025. With a current cash runway extending into the fourth quarter of 2025, the Company is assessing a variety of approaches to bring iopofosine to patients.
Mr. Caruso continued, “We believe iopofosine represents a compelling partnership opportunity for many reasons including the results observed from our clinical studies. The commercial work we conducted in WM provides strong evidence that iopofosine possesses a substantial market opportunity based upon patient outcomes, convenient fixed dosing, off-the-shelf global distribution, and orphan pricing. Cellectar’s goal to bringi lifesaving radioconjugates, such as iopofosine, CLR 121225, and CLR 121125, to patients remains steadfast and we look forward to advancing our objectives throughout 2025.”
Beyond iopofosine, the Company is focused on the development of its radioconjugate Phospholipid Drug Conjugate™ (PDC) programs, also known as phospholipid radioconjugates or PRCs. CLR 121225 is Cellectar’s lead alpha-emitting actinium-225 radioconjugate PRC. It has demonstrated activity and has been well tolerated in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer. It has also shown excellent biodistribution and uptake into tumors. In animal models of pancreatic adenocarcinoma, the single lowest dose tested provided tumor stasis, and the highest dose provided tumor volume reduction. The Company plans to file an Investigational New Drug (IND) application in the first quarter of 2025.
Cellectar’s lead Auger-emitting (iodine-125) PRC, CLR 121125, has demonstrated tolerability and activity in multiple animal models including triple negative breast cancer. Auger- emitters provide the greatest precision in targeted radiotherapy as the emissions only travel a few nanometers, therefore it is necessary for the isotope to be delivered intracellularly. The Company’s novel PDC platform uniquely provides the required targeted delivery. CLR121125 has received IND clearance and a Phase 1b/2a dose finding study in triple-negative breast cancer is planned.
The Company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125.
Biotech Showcase
A live webcast and a replay of Mr. Caruso’s presentation at Biotech Showcase will be available on the Company’s investor relations website.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization 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 Conjugate™ (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 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 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and 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 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications.
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 and EMA review processes 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.
Investor Contact:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
FAQ
What were the Phase 2 CLOVER-WaM study results for CLRB's Iopofosine I 131?
When will CLRB file the IND application for CLR 121225?
How long is CLRB's current cash runway?
What is the size of CLRB's planned confirmatory study for Iopofosine?
When does CLRB expect FDA alignment for Iopofosine's confirmatory study?
