Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma
Checkpoint Therapeutics (Nasdaq: CKPT) announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 antibody, for treating advanced cutaneous squamous cell carcinoma (cSCC). The FDA set a PDUFA goal date of December 28, 2024. This resubmission addresses the complete response letter (CRL) issued in December 2023, which only cited issues with the third-party contract manufacturing organization. Notably, the CRL did not raise concerns about the clinical data package, safety, or labeling for cosibelimab's approvability. Checkpoint's CEO expressed satisfaction with the FDA's acceptance and looks forward to potentially delivering cosibelimab's unique dual mechanism of action to cSCC patients.
Checkpoint Therapeutics (Nasdaq: CKPT) ha annunciato che la FDA ha accettato la sua domanda di licenza biologica (BLA) ripresentata per cosibelimab, un anticorpo anti-PD-L1, per il trattamento del carcinoma squamoso cutaneo avanzato (cSCC). La FDA ha fissato una data obiettivo PDUFA per il 28 dicembre 2024. Questa ripresentazione affronta la lettera di risposta completa (CRL) emessa a dicembre 2023, che ha citato solo problemi con l'organizzazione di produzione sotto contratto di terze parti. È importante notare che la CRL non ha sollevato preoccupazioni riguardo al pacchetto di dati clinici, alla sicurezza o all'etichettatura per l'approvazione di cosibelimab. Il CEO di Checkpoint ha espresso soddisfazione per l'accettazione della FDA e si aspetta di poter offrire il meccanismo d'azione unico e doppio di cosibelimab ai pazienti con cSCC.
Checkpoint Therapeutics (Nasdaq: CKPT) anunció que la FDA ha aceptado su solicitud de nueva licencia biológica (BLA) para cosibelimab, un anticuerpo anti-PD-L1, para el tratamiento del carcinoma de células escamosas de piel avanzado (cSCC). La FDA estableció una fecha objetivo de PDUFA del 28 de diciembre de 2024. Esta nueva presentación aborda la carta de respuesta completa (CRL) emitida en diciembre de 2023, que solo citó problemas con la organización de fabricación contratada de terceros. Es notable que la CRL no planteó preocupaciones sobre el paquete de datos clínicos, la seguridad o el etiquetado para la aprobación de cosibelimab. El CEO de Checkpoint expresó su satisfacción por la aceptación de la FDA y espera poder ofrecer el mecanismo de acción dual y único de cosibelimab a los pacientes con cSCC.
Checkpoint Therapeutics (Nasdaq: CKPT)는 FDA가 cosibelimab에 대한 수정된 생물학적 라이센스 신청서(BLA)를 승인했다고 발표했습니다. 이는 고형PD-L1 항체로, 진행성 피부 편평세포 암(cSCC) 치료를 위한 것입니다. FDA는 2024년 12월 28일로 PDUFA 목표 날짜를 설정하였습니다. 이 수정 제출은 2023년 12월에 발행된 완전 응답서(CRL)를 다루며, 해당 서신에서는 제3자 계약 제조 조직과 관련된 문제만 언급되었습니다. 특히, CRL에서는 cosibelimab의 승인 가능성을 위한 임상 데이터 패키지, 안전성 또는 라벨링에 대한 우려는 제기되지 않았습니다. Checkpoint의 CEO는 FDA의 승인 소식에 만족감을 표현하며, cSCC 환자들에게 cosibelimab의 독특한 이중 작용 메커니즘을 제공할 수 있기를 기대하고 있습니다.
Checkpoint Therapeutics (Nasdaq: CKPT) a annoncé que la FDA a accepté sa demande de licence biologique (BLA) réintroduite pour cosibelimab, un anticorps anti-PD-L1, destiné au traitement du carcinome à cellules squameuses cutanées avancé (cSCC). La FDA a fixé un date cible PDUFA au 28 décembre 2024. Cette nouvelle soumission répond à la lettre de réponse complète (CRL) émise en décembre 2023, qui n'a signalé que des problèmes liés à l'organisation de fabrication sous contrat tierce partie. Notamment, la CRL n'a pas soulevé de préoccupations concernant le paquet de données cliniques, la sécurité ou l'étiquetage pour l'approbation de cosibelimab. Le PDG de Checkpoint a exprimé sa satisfaction quant à l'acceptation par la FDA et est impatient de pouvoir offrir le mécanisme d'action unique et dual de cosibelimab aux patients atteints de cSCC.
Checkpoint Therapeutics (Nasdaq: CKPT) hat bekannt gegeben, dass die FDA seinen erneut eingereichten Antrag auf eine biologische Lizenz (BLA) für cosibelimab, einen anti-PD-L1-Antikörper zur Behandlung von fortgeschrittenem plattenepithelialem Hautkrebs (cSCC), akzeptiert hat. Die FDA hat ein PDUFA-Zieldatum vom 28. Dezember 2024 festgelegt. Diese erneute Einreichung bezieht sich auf das vollständige Antwortschreiben (CRL), das im Dezember 2023 ausgestellt wurde und nur Probleme mit der Vertragsherstellung durch Dritte ansprach. Auffällig ist, dass die CRL keine Bedenken hinsichtlich des klinischen Datenpakets, der Sicherheit oder der Kennzeichnung für die Zulassungsfähigkeit von cosibelimab äußerte. Der CEO von Checkpoint äußerte seine Zufriedenheit mit der Annahme durch die FDA und freut sich darauf, möglicherweise den einzigartigen dualen Wirkmechanismus von cosibelimab an cSCC-Patienten zu liefern.
- FDA accepted Checkpoint's BLA resubmission for cosibelimab
- PDUFA goal date set for December 28, 2024
- No concerns raised about clinical data package, safety, or labeling in previous CRL
- Previous CRL cited issues with third-party contract manufacturing organization
- Potential approval delayed due to resubmission process
Insights
The FDA's acceptance of Checkpoint Therapeutics' BLA resubmission for cosibelimab is a significant milestone in the development of new treatments for advanced cutaneous squamous cell carcinoma (cSCC). As an oncologist, I find several aspects of this news particularly noteworthy:
- Cosibelimab's unique dual mechanism of action as an anti-PD-L1 antibody could potentially offer improved efficacy compared to existing treatments. This approach targets the immune checkpoint pathway, which has shown promise in various cancer types.
- The FDA's PDUFA date of December 28, 2024, provides a clear timeline for potential market entry. This gives healthcare providers and patients a concrete timeframe to anticipate a possible new treatment option.
- The fact that the CRL did not raise concerns about the clinical data package, safety, or labeling is encouraging. It suggests that the efficacy and safety profile of cosibelimab may be robust, pending final review.
However, it's important to note that the initial CRL was due to issues with the third-party contract manufacturing organization. While these concerns appear to have been addressed in the resubmission, manufacturing consistency and quality will likely be a key focus during the FDA's review process.
The potential approval of cosibelimab could be particularly impactful for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation. These patients often have treatment options and a new immunotherapy approach could significantly improve their prognosis and quality of life.
Checkpoint Therapeutics' progress with cosibelimab's BLA resubmission is a positive development for the company and the broader oncology market. Here are key points to consider:
- The FDA's acceptance of the resubmission indicates that Checkpoint has likely addressed the manufacturing issues raised in the previous CRL. This demonstrates the company's ability to navigate regulatory challenges effectively.
- The PDUFA date of December 28, 2024, sets a clear timeline for potential commercialization. This allows Checkpoint to plan its market entry strategy and gives investors a concrete milestone to monitor.
- If approved, cosibelimab would enter the competitive immune checkpoint inhibitor market. Its success will depend on its efficacy, safety profile and pricing strategy compared to established players like Merck's Keytruda and Bristol Myers Squibb's Opdivo.
- The focus on cSCC represents a targeted approach to a specific market need. While not as large as some cancer indications, it still represents a significant opportunity, especially given the lack of options for patients ineligible for surgery or radiation.
From a financial perspective, potential approval could significantly impact Checkpoint's revenue streams. However, investors should be aware that the company will face challenges in market penetration and competition from larger, established pharmaceutical companies.
The absence of clinical or safety concerns in the CRL is a positive sign, but it's important to note that regulatory approval is never guaranteed. The next
PDUFA goal date of December 28, 2024 set by FDA
WALTHAM, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review Checkpoint’s resubmission of its Biologics License Application (“BLA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or curative radiation. The resubmission has been accepted as a complete response to the FDA’s December 2023 complete response letter (“CRL”) and the FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of December 28, 2024.
James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab’s unique dual mechanism of action to patients suffering from cSCC.”
In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization (“CMO”) as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
About Cosibelimab
Cosibelimab is a potential differentiated, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to PD-L1 and blocks the PD-L1 interaction with the programmed death receptor-1 (“PD-1”) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained high tumor target occupancy of PD-L1 to reactivate an antitumor immune response and the additional potential benefit of a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity (“ADCC”) for potential enhanced efficacy.
About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential differentiated anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, as a potential new treatment for patients with selected recurrent or metastatic cancers, including metastatic and locally advanced cSCC. Checkpoint is also evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.
Forward‐Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our resubmission of our BLA for cosibelimab and review thereof, our belief that the BLA resubmission addresses all the issues in the CRL, our belief about the comprehensive nature of our BLA resubmission and reaching alignment with the FDA on our cosibelimab BLA resubmission strategy, our ability to work with our third-party CMO and the FDA to adequately address the issues raised in the CRL and execute on a pathway forward for the potential marketing approval of cosibelimab, the adequacy of the responses to the inspection issues submitted to FDA by our third-party CMO, our projections of regulatory review timelines, the commercial potential of cosibelimab, if approved, and the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies and the dual mechanism of action of cosibelimab translating into potential enhanced efficacy. Factors that could cause our actual results to differ materially include the following: the risks and uncertainties associated with the regulatory review process; uncertainties regarding the timeline of FDA review of the resubmitted BLA; any inability to successfully work with the FDA to find a satisfactory solution to address any concerns in a timely manner or at all during the review process for the BLA, including any inability to provide the FDA with data, analysis or other information sufficient to support an approval of the BLA; our, and our third party CMO’s, ability to adequately address the issues raised in the CRL; any facility inspection or re-inspection required for our third party CMO or otherwise during the review process for the BLA; whether the FDA accepts the data and results as included in the BLA resubmission at levels consistent with the published results, or at all; our ability to execute a partnering relationship for the commercialization of cosibelimab, if approved, on acceptable terms, if at all; the risk that our third-party CMO will not meet deadlines, and/or comply with applicable regulations; the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Company Contact:
Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
ir@checkpointtx.com
Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
(617) 430-7577
arr@lifesciadvisors.com
Media Relations Contact:
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Gregory FCA
610-731-1045
checkpoint@gregoryfca.com
FAQ
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