Anixa Biosciences Announces Submission of Protocol Amendment for CAR-T Trial
Anixa Biosciences (NASDAQ: ANIX) and Moffitt Cancer Center have submitted an amendment to the protocol governing their ongoing CAR-T therapy clinical trial for ovarian cancer. The key change allows for a second dose of therapy to be administered to suitable patients without requiring individual INDs.
This amendment follows the approval of a single patient IND application for a second dose, where the patient showed signs of biologic activity after the initial treatment. Dr. Robert Wenham, principal investigator, noted that higher cell doses are expected to lead to efficacy, but a second dose may be necessary for some patients with solid tumors to improve response rates and durability.
Anixa's CEO, Dr. Amit Kumar, expressed enthusiasm about the trial's progress and anticipates regulatory approval for the amendment soon.
Anixa Biosciences (NASDAQ: ANIX) e il Moffitt Cancer Center hanno presentato un emendamento al protocollo che regola il loro attuale trial clinico per la terapia CAR-T per il cancro ovarico. La modifica principale consente di somministrare una seconda dose di terapia a pazienti idonei senza richiedere IND individuali.
Questo emendamento segue l'approvazione di una domanda IND per un singolo paziente per una seconda dose, in cui il paziente ha mostrato segni di attività biologica dopo il trattamento iniziale. Il Dr. Robert Wenham, investigatore principale, ha osservato che dosi cellulari più elevate dovrebbero portare a una maggiore efficacia, ma una seconda dose potrebbe essere necessaria per alcuni pazienti con tumori solidi per migliorare i tassi di risposta e la durabilità.
Il CEO di Anixa, Dr. Amit Kumar, ha espresso entusiasmo per i progressi dello studio e prevede un'imminente approvazione normativa per l'emendamento.
Anixa Biosciences (NASDAQ: ANIX) y el Moffitt Cancer Center han presentado un modificación al protocolo que rige su actual ensayo clínico de terapia CAR-T para el cáncer de ovario. El cambio clave permite administrar una segunda dosis de terapia a pacientes aptos sin requerir INDs individuales.
Esta modificación sigue a la aprobación de una solicitud IND para un solo paciente para una segunda dosis, donde el paciente mostró signos de actividad biológica tras el tratamiento inicial. El Dr. Robert Wenham, investigador principal, señaló que se espera que dosis celulares más altas conduzcan a una mayor eficacia, pero que una segunda dosis podría ser necesaria para algunos pacientes con tumores sólidos para mejorar las tasas de respuesta y durabilidad.
El CEO de Anixa, Dr. Amit Kumar, expresó su entusiasmo por el progreso del ensayo y anticipa una pronta aprobación regulatoria para el emendamiento.
Anixa Biosciences (NASDAQ: ANIX)와 Moffitt Cancer Center는 난소암에 대한 현재의 CAR-T 요법 임상 시험을 관리하는 프로토콜 수정안을 제출했습니다. 주요 변경 사항은 적합한 환자에게 개별 IND를 요구하지 않고 두 번째 요법 투여를 허용하는 것입니다.
이 수정안은 두 번째 투여에 대한 단일 환자 IND 신청이 승인된 후 나온 것으로, 해당 환자는 초기 치료 후 생물학적 활성이 나타났습니다. 주요 연구원인 Dr. Robert Wenham은 더 높은 세포 용량이 효능으로 이어질 것으로 기대하지만, 일부 고형 종양 환자에게는 반응률과 지속성을 개선하기 위해 두 번째 용량이 필요할 수 있다고 지적했습니다.
Anixa의 CEO인 Dr. Amit Kumar는 시험의 진행 상황에 대한 기대감을 나타내며, 곧 수정안에 대한 규제 승인을 예상하고 있습니다.
Anixa Biosciences (NASDAQ: ANIX) et le Moffitt Cancer Center ont soumis un amendement au protocole régissant leur essai clinique de thérapie CAR-T en cours pour le cancer de l'ovaire. Le changement clé permet d'administrer une deuxième dose de thérapie à des patients appropriés sans exiger d'IND individuels.
Ce amendement fait suite à l'approbation d'une demande IND pour un patient unique pour une deuxième dose, où le patient a montré des signes d'activité biologique après le traitement initial. Le Dr. Robert Wenham, investigateur principal, a noté que des doses cellulaires plus élevées devraient conduire à une efficacité, mais qu'une deuxième dose pourrait être nécessaire pour certains patients atteints de tumeurs solides afin d'améliorer les taux de réponse et la durabilité.
Le PDG d'Anixa, Dr. Amit Kumar, a exprimé son enthousiasme concernant les progrès de l'essai et anticipe une approbation réglementaire pour l'amendement prochainement.
Anixa Biosciences (NASDAQ: ANIX) und das Moffitt Cancer Center haben eine Änderung des Protokolls eingereicht, das ihr laufendes CAR-T-Therapie-Klinikversuch für Eierstockkrebs regelt. Die wichtigste Änderung ermöglicht es, eine zweite Dosis der Therapie an geeignete Patienten zu verabreichen, ohne individuelle INDs zu verlangen.
Diese Änderung folgt der Genehmigung eines IND-Antrags für einen einzelnen Patienten für eine zweite Dosis, bei dem der Patient nach der initialen Behandlung Anzeichen biologischer Aktivität zeigte. Dr. Robert Wenham, der leitende Prüfer, merkte an, dass höhere Zellzahlen voraussichtlich zu einer höheren Wirksamkeit führen werden, bereits eine zweite Dosis für einige Patienten mit soliden Tumoren notwendig sein könnte, um die Ansprechrate und die Dauerhaftigkeit zu verbessern.
Anixas CEO, Dr. Amit Kumar, äußerte Begeisterung über den Fortschritt der Studie und erwartet baldige genehmigende Regulierung für die Änderung.
- Amendment allows for a second dose of CAR-T therapy without individual INDs
- Signs of biologic activity observed in a patient after initial treatment
- Potential for improved efficacy with higher cell doses or second doses
- Initial doses may be subtherapeutic in Phase 1 trials
- Some patients may require multiple doses for effective treatment
- Regulatory approval for the amendment is still pending
Insights
The submission of a protocol amendment for Anixa Biosciences' CAR-T trial in ovarian cancer is a significant development. This amendment allows for a second dose of CAR-T therapy to suitable patients, potentially improving treatment efficacy. The key points are:
- The amendment expands on a previously approved single-patient IND application that showed promising results.
- It eliminates the need for individual INDs for each patient requiring a second dose, streamlining the process.
- Initial low doses in Phase 1 trials are standard for safety, but higher or repeated doses may be necessary for efficacy in solid tumors.
- A patient who received the lowest dose showed stable disease after initial progression, suggesting potential benefit from a higher second dose.
This development could enhance the trial's potential to demonstrate efficacy, particularly important for solid tumors like ovarian cancer where CAR-T therapies have historically been less successful than in blood cancers. The ability to administer a second, potentially higher dose could lead to improved response rates and durability, which are important for the therapy's clinical and commercial prospects.
Amendment will allow a second dose of CAR-T therapy to suitable patients
A key change in the protocol provides a second dose of the therapy to patients who might benefit from an additional dose. Previously, Anixa and Moffitt sought and received approval of a single patient IND application to enable a second dose for a single patient who, upon examination of tumor obtained from a biopsy, exhibited cellular infiltration and necrosis, indicating biologic activity of the CAR-T. This amendment will permit all potential patients to receive another leukapheresis and a second dose of CAR-T, without submitting individual INDs for each patient.
Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt, and the principal investigator of the trial, stated, "In initial Phase 1 clinical trials, it is customary to begin with low, often subtherapeutic cell doses to verify safety, before increasing the dose levels. In our study, the patient approved for a second dose by the individual IND received the starting, lowest dose. While initially meeting the criteria for progression due to size of her predominate tumor, her cancer has since remained relatively stable and she has not received additional therapy since her first infusion. We are hoping a second, higher dose may improve her overall response and outcome. In general, we anticipate that higher cell doses will lead to efficacy, but for solid tumors, a second dose may be needed in a subset of patients to improve the rate and durability of responses."
"We hope to get approval from regulatory agencies shortly, to enable second doses for the appropriate patients. We are clearly enthusiastic about the progress of this trial and are looking forward to treating additional patients," 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 prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – 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 unique 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.
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