CEL-SCI’s Head and Neck Cancer Registration Study Protocol Clears FDA Review—in Talks with Potential Partners Interested in Commercialization of Multikine
CEL-SCI (NYSE: CVM) has received FDA clearance for its head and neck cancer Registration Study protocol for Multikine treatment. The FDA required no response to their comments on the Statistical Analysis Plan (SAP) submitted in December 2024.
The company's 73,000 square foot Multikine manufacturing facility can produce over 12,000 treatments annually, representing a $200 million investment in facility and processes. CEL-SCI is currently in discussions with potential partners for non-dilutive funding of the 212-patient confirmatory Registration Study.
The company's previous Phase 3 study involving 928 patients across 23 countries showed significant results: 73% five-year survival rate in the target patient population treated with Multikine before standard care, compared to 45% in the control group. Notably, Multikine shows promise for approximately 70% of head and neck cancer patients with low PD-L1 tumor expression, where current PD-L1 inhibitors are ineffective.
CEL-SCI (NYSE: CVM) ha ricevuto l'approvazione della FDA per il protocollo dello studio di registrazione sul cancro della testa e del collo per il trattamento con Multikine. La FDA non ha richiesto alcuna risposta ai loro commenti sul Piano di Analisi Statistica (SAP) presentato a dicembre 2024.
La struttura di produzione di Multikine di 6.800 metri quadrati dell'azienda può produrre oltre 12.000 trattamenti all'anno, rappresentando un investimento di 200 milioni di dollari in strutture e processi. CEL-SCI è attualmente in trattative con potenziali partner per un finanziamento non diluitivo dello studio di registrazione di conferma su 212 pazienti.
Il precedente studio di Fase 3 dell'azienda, che ha coinvolto 928 pazienti in 23 paesi, ha mostrato risultati significativi: un tasso di sopravvivenza del 73% a cinque anni nella popolazione di pazienti target trattati con Multikine prima delle cure standard, rispetto al 45% nel gruppo di controllo. È notevole che Multikine mostri promesse per circa il 70% dei pazienti con cancro della testa e del collo con bassa espressione del tumore PD-L1, dove gli attuali inibitori PD-L1 sono inefficaci.
CEL-SCI (NYSE: CVM) ha recibido la aprobación de la FDA para el protocolo del estudio de registro sobre el cáncer de cabeza y cuello para el tratamiento con Multikine. La FDA no requirió ninguna respuesta a sus comentarios sobre el Plan de Análisis Estadístico (SAP) presentado en diciembre de 2024.
La instalación de fabricación de Multikine de 6,800 pies cuadrados de la compañía puede producir más de 12,000 tratamientos anuales, representando una inversión de 200 millones de dólares en instalaciones y procesos. CEL-SCI está actualmente en conversaciones con socios potenciales para financiamiento no dilutivo del estudio de registro de confirmación de 212 pacientes.
El estudio de Fase 3 anterior de la compañía, que involucró a 928 pacientes en 23 países, mostró resultados significativos: un tasa de supervivencia del 73% a cinco años en la población de pacientes objetivo tratados con Multikine antes de la atención estándar, en comparación con el 45% en el grupo de control. Es notable que Multikine muestra promesas para aproximadamente el 70% de los pacientes con cáncer de cabeza y cuello con baja expresión de PD-L1, donde los actuales inhibidores de PD-L1 son ineficaces.
CEL-SCI (NYSE: CVM)는 다국적 치료를 위한 두경부암 등록 연구 프로토콜에 대해 FDA 승인을 받았습니다. FDA는 2024년 12월에 제출된 통계 분석 계획(SAP)에 대한 의견에 대해 응답을 요구하지 않았습니다.
회사의 6,800 제곱미터 규모의 Multikine 생산 시설은 연간 12,000건 이상의 치료를 생산할 수 있으며, 이는 시설과 프로세스에 대한 2억 달러의 투자를 나타냅니다. CEL-SCI는 현재 212명의 환자를 대상으로 하는 확인 등록 연구에 대한 비희석 자금 조달을 위해 잠재적인 파트너와 논의 중입니다.
회사의 이전 3상 연구는 23개국에서 928명의 환자를 포함하여 중요한 결과를 보여주었습니다: Multikine으로 표준 치료 전에 치료받은 대상 환자군에서 5년 생존율 73%을 기록했으며, 대조군의 45%와 비교됩니다. 특히, Multikine은 현재 PD-L1 억제제가 효과가 없는 낮은 PD-L1 종양 발현을 가진 두경부암 환자의 약 70%에게 가능성을 보여줍니다.
CEL-SCI (NYSE: CVM) a reçu l'approbation de la FDA pour le protocole de son étude d'enregistrement sur le cancer de la tête et du cou pour le traitement avec Multikine. La FDA n'a pas exigé de réponse à ses commentaires concernant le plan d'analyse statistique (SAP) soumis en décembre 2024.
La structure de production de Multikine de 6 800 pieds carrés de l'entreprise peut produire plus de 12 000 traitements par an, représentant un investissement de 200 millions de dollars dans les installations et les processus. CEL-SCI est actuellement en pourparlers avec des partenaires potentiels pour un financement non dilutif de l'étude d'enregistrement de confirmation de 212 patients.
L'étude de Phase 3 précédente de l'entreprise, impliquant 928 patients dans 23 pays, a montré des résultats significatifs : un taux de survie à cinq ans de 73% dans la population de patients cible traités avec Multikine avant les soins standard, contre 45 % dans le groupe témoin. Il est à noter que Multikine montre des promesses pour environ 70 % des patients atteints de cancer de la tête et du cou avec une faible expression du PD-L1, où les inhibiteurs de PD-L1 actuels sont inefficaces.
CEL-SCI (NYSE: CVM) hat die Genehmigung der FDA für das Protokoll der Registrierungsstudie zu Kopf- und Halskrebs für die Behandlung mit Multikine erhalten. Die FDA forderte keine Antwort auf ihre Kommentare zum statistischen Analyseplan (SAP), der im Dezember 2024 eingereicht wurde.
Die 6.800 Quadratmeter große Multikine-Produktionsanlage des Unternehmens kann jährlich über 12.000 Behandlungen produzieren, was einer Investition von 200 Millionen Dollar in Einrichtungen und Prozesse entspricht. CEL-SCI befindet sich derzeit in Gesprächen mit potenziellen Partnern zur nicht verwässernden Finanzierung der 212-Patienten-bestätigenden Registrierungsstudie.
Die vorherige Phase-3-Studie des Unternehmens, die 928 Patienten in 23 Ländern umfasste, zeigte signifikante Ergebnisse: eine 5-Jahres-Überlebensrate von 73% in der Zielpatientenpopulation, die mit Multikine vor der Standardbehandlung behandelt wurde, im Vergleich zu 45% in der Kontrollgruppe. Bemerkenswert ist, dass Multikine vielversprechend für etwa 70% der Patienten mit Kopf- und Halskrebs mit niedriger PD-L1-Tumorexpression ist, bei denen die aktuellen PD-L1-Inhibitoren nicht wirksam sind.
- FDA cleared the Registration Study protocol with no required responses
- Manufacturing facility capable of producing 12,000+ treatments annually
- Phase 3 results showed 28% higher 5-year survival rate vs control group
- Potential to treat 70% of head and neck cancer patients with low PD-L1 expression
- Discussions ongoing for non-dilutive funding through partnerships
- Additional 212-patient confirmatory study required before marketing approval
- Requires external funding to complete final Registration Study
Insights
CEL-SCI's announcement represents a significant regulatory milestone for Multikine in head and neck cancer treatment. The FDA's review without requiring further response to their comments on the Statistical Analysis Plan (SAP) and having no comments on the confirmatory study protocol suggests a clear regulatory pathway for their upcoming 212-patient Registration Study.
The company's previous Phase 3 study demonstrated impressive survival outcomes, with
CEL-SCI's manufacturing infrastructure represents substantial preparation for potential commercialization. Their 73,000 square foot facility can produce over 12,000 Multikine treatments annually, reflecting the
The company's pursuit of partnership discussions for non-dilutive funding of the final confirmatory study is important given their current financial position. A successful partnership could provide the necessary resources to complete the final study required for potential marketing approval without further shareholder dilution.
CEL-SCI's regulatory progress with Multikine comes at a strategic moment in cancer immunotherapy development. The FDA's feedback on their confirmatory Registration Study protocol effectively clears a key hurdle in advancing this treatment toward potential approval for head and neck cancer.
The company's focus on patients with low PD-L1 tumor expression is particularly noteworthy. This represents approximately
Their phase 3 data demonstrating a
The manufacturing readiness with capacity for 12,000+ treatments annually demonstrates operational foresight but also represents ongoing operational costs. Securing non-dilutive partnership funding for the final 212-patient study would be a critical milestone for a company with a market capitalization of under
Growing body of data on PD-L1 as a cancer biomarker spurs interest
Working towards partnership for non-dilutive funding of the final confirmatory head and neck cancer Registration Study
CEL-SCI’s 73,000 square foot Multikine manufacturing facility presently has the capacity to produce over 12,000 Multikine treatments per year. Over
“Given Multikine’s excellent survival data, strong statistics and the recent focus on PD-L1 as a diagnostic biomarker for predicting the most effective treatment strategy for head and neck cancer, we are pursuing discussions with key parties to help CEL-SCI complete the last study needed in order to pursue marketing approval for Multikine,” stated CEL-SCI CEO Geert Kersten.
“These discussions may lead to potential partnerships involving non-dilutive funding for the 212-patient confirmatory Registration Study designed to bring Multikine to market. We are seeing new interest from highly placed individuals and commercial entities that recognize that Multikine, based on its different mechanism of action, is uniquely positioned to treat about
CEL-SCI completed a randomized controlled Phase 3 study conducted in 928 locally advanced, resectable head and neck cancer stage 3 and 4a patients in 23 countries on 3 continents. The Phase 3 study demonstrated strong statistical results and improved survival with Multikine neoadjuvant treatment over control. The 5-year survival rate of the target patient population that will be treated in the confirmatory Registration Study increased to
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.
The Company has operations in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital, inability to finalize a partnering agreement and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2024. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
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Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
Source: CEL-SCI Corporation
FAQ
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