Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences (NASDAQ: ANIX) and Moffitt Cancer Center have received approval for a protocol amendment in their ongoing ovarian cancer CAR-T therapy clinical trial. The amendment brings two significant changes: it allows eligible patients to receive a second dose of CAR-T therapy without requiring individual IND approvals, and expands enrollment eligibility to include patients with sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs).
Previously, Anixa and Moffitt had secured a single patient IND approval for an additional dose for a patient whose biopsy showed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy. The amendment aims to optimize treatment outcomes for patients with ovarian cancer by providing more flexibility in dosing and expanding the types of ovarian cancers that can be treated.
Anixa Biosciences (NASDAQ: ANIX) e il Moffitt Cancer Center hanno ricevuto l'approvazione per una modifica del protocollo nel loro studio clinico in corso sulla terapia CAR-T per il cancro ovarico. La modifica introduce due cambiamenti significativi: consente ai pazienti idonei di ricevere una seconda dose di terapia CAR-T senza la necessità di approvazioni IND individuali e amplia l'idoneità all'arruolamento per includere pazienti con tumori cord-stromali sessuali (SCST) e tumori delle cellule di Sertoli e Leydig (SLCT).
In precedenza, Anixa e Moffitt avevano ottenuto un'approvazione IND per un singolo paziente per una dose aggiuntiva per un paziente la cui biopsia mostrava infiltrazione cellulare e necrosi, indicando un'attività biologica della terapia CAR-T. La modifica mira a ottimizzare i risultati del trattamento per i pazienti con cancro ovarico fornendo maggiore flessibilità nel dosaggio e ampliando i tipi di cancro ovarico che possono essere trattati.
Anixa Biosciences (NASDAQ: ANIX) y el Moffitt Cancer Center han recibido aprobación para una enmienda del protocolo en su ensayo clínico en curso sobre terapia CAR-T para el cáncer de ovario. La enmienda trae dos cambios significativos: permite a los pacientes elegibles recibir una segunda dosis de terapia CAR-T sin necesidad de aprobaciones IND individuales, y amplía la elegibilidad para el reclutamiento para incluir pacientes con tumores de cordones estromales sexuales (SCST) y tumores de células de Sertoli y Leydig (SLCT).
Anteriormente, Anixa y Moffitt habían asegurado una aprobación IND para un paciente único para una dosis adicional para un paciente cuya biopsia mostró infiltración celular y necrosis, indicando actividad biológica de la terapia CAR-T. La enmienda tiene como objetivo optimizar los resultados del tratamiento para los pacientes con cáncer de ovario al proporcionar más flexibilidad en la dosificación y ampliar los tipos de cáncer de ovario que pueden ser tratados.
Anixa Biosciences (NASDAQ: ANIX)와 Moffitt Cancer Center는 진행 중인 난소암 CAR-T 치료 임상 시험에서 프로토콜 수정 승인을 받았습니다. 이 수정안은 두 가지 중요한 변화를 가져옵니다: 자격이 있는 환자가 개별 IND 승인을 요구하지 않고 두 번째 용량의 CAR-T 치료를 받을 수 있도록 하며, 성 cord-stromal 종양(SCST) 및 Sertoli Leydig 세포 종양(SLCT) 환자를 포함하도록 등록 자격을 확대합니다.
이전에는 Anixa와 Moffitt가 세포 침윤과 괴사가 나타난 생검을 가진 환자를 위해 추가 용량에 대한 단일 환자 IND 승인을 확보했습니다. 이 수정안은 난소암 환자에게 치료 결과를 최적화하기 위해 용량의 유연성을 높이고 치료할 수 있는 난소암의 종류를 확장하는 것을 목표로 합니다.
Anixa Biosciences (NASDAQ: ANIX) et le Moffitt Cancer Center ont reçu l'approbation d'un amendement de protocole dans leur essai clinique en cours sur la thérapie CAR-T pour le cancer de l'ovaire. Cet amendement apporte deux changements significatifs : il permet aux patients éligibles de recevoir une deuxième dose de thérapie CAR-T sans nécessiter d'approbations IND individuelles et élargit l'éligibilité à l'inscription pour inclure des patients atteints de tumeurs cord-stromales sexuelles (SCST) et de tumeurs des cellules de Sertoli et Leydig (SLCT).
Auparavant, Anixa et Moffitt avaient obtenu une approbation IND pour un patient unique pour une dose supplémentaire pour un patient dont la biopsie montrait une infiltration cellulaire et une nécrose, indiquant une activité biologique de la thérapie CAR-T. L'amendement vise à optimiser les résultats du traitement pour les patients atteints de cancer de l'ovaire en offrant plus de flexibilité dans le dosage et en élargissant les types de cancers de l'ovaire qui peuvent être traités.
Anixa Biosciences (NASDAQ: ANIX) und das Moffitt Cancer Center haben die Genehmigung für eine Protokolländerung in ihrer laufenden klinischen Studie zur CAR-T-Therapie bei Eierstockkrebs erhalten. Die Änderung bringt zwei wesentliche Veränderungen mit sich: Sie ermöglicht es berechtigten Patienten, eine zweite Dosis der CAR-T-Therapie zu erhalten, ohne individuelle IND-Genehmigungen zu benötigen, und erweitert die Einschlusskriterien, um Patienten mit Sexualcord-Stroma-Tumoren (SCST) und Sertoli-Leydig-Zelltumoren (SLCT) einzubeziehen.
Zuvor hatten Anixa und Moffitt eine IND-Genehmigung für einen einzelnen Patienten für eine zusätzliche Dosis erhalten, nachdem eine Biopsie zelluläre Infiltration und Nekrose gezeigt hatte, was auf die biologische Aktivität der CAR-T-Therapie hinweist. Die Änderung zielt darauf ab, die Behandlungsergebnisse für Patienten mit Eierstockkrebs zu optimieren, indem mehr Flexibilität bei der Dosierung geboten und die Arten von Eierstockkrebs, die behandelt werden können, erweitert werden.
- Protocol amendment approval expands treatment flexibility with second dose option
- Broader patient eligibility including additional rare ovarian cancer types
- Evidence of biological activity in previous patient's biopsy
- None.
Insights
The protocol amendment for Anixa's ovarian cancer CAR-T trial represents a strategically significant development with multiple positive implications. The approval for second dosing without individual INDs substantially streamlines the clinical process, potentially accelerating the development timeline while reducing regulatory burden and associated costs.
The biological rationale for second dosing is particularly compelling. The observation of cellular infiltration and necrosis in previous patients indicates meaningful biological activity of the CAR-T therapy - these are classic markers of immune-mediated tumor response. The ability to administer a second dose could potentially deepen and extend therapeutic responses, addressing a common limitation of single-dose CAR-T approaches where initial responses may not be sustained.
The expansion to include sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs) is strategically astute. These rare ovarian cancer subtypes often have treatment options, creating potential opportunities for:
- Orphan drug designations and associated benefits
- Expedited regulatory pathways
- Premium pricing potential
- competition in these niche indications
From a clinical development perspective, this amendment optimizes the trial's potential to demonstrate efficacy by allowing dose optimization and expanding the treatable patient population. The flexibility to administer second doses based on clinical response, rather than requiring individual IND applications, will enable more agile and responsive patient treatment strategies.
Amendment expands the potential benefits of CAR-T therapy allowing a second dose and includes more ovarian cancer histologies
The key changes in the protocol allows patients who may benefit from a second dose of the CAR-T therapy to receive it and expands enrollment eligibility to include patients with sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs). Previously, Anixa and Moffitt had secured a single patient IND approval for an additional dose for a patient whose biopsy showed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy. With this amendment, all eligible patients in the trial can receive a second dose of the CAR-T therapy without the need to submit individual INDs for each case.
Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial, stated, "This amendment is a crucial development in our ongoing efforts to advance the treatment of ovarian cancer with CAR-T therapy. The ability to administer a second dose to patients who show potential for additional benefit provides us with more flexibility and an opportunity to further evaluate the effectiveness of this innovative therapy."
"We are excited about the approval of this protocol amendment, as it allows us to potentially enhance the efficacy of our CAR-T therapy by providing a second dose to patients who might benefit from it and to treat additional rare types of ovarian cancer. This is a significant step in optimizing the treatment for ovarian cancer, and we look forward to continuing our work with Moffitt Cancer Center as we strive to improve outcomes for patients facing this difficult disease," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.
About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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SOURCE Anixa Biosciences, Inc.
FAQ
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