Anixa Biosciences and Moffitt Cancer Center Complete Dosing in Third Cohort in Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences (NASDAQ: ANIX) has completed dosing the final patient in the third cohort of its Phase 1 clinical trial for a novel CAR-T therapy targeting recurrent ovarian cancer, conducted in partnership with Moffitt Cancer Center. The third cohort received one million CAR-positive cells per kilogram, a tenfold increase from the first cohort.
The trial's fourth cohort is set to begin after a 30-day safety verification period, with plans to increase dosage by another factor of three. The therapy targets the follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells.
A recent protocol amendment allows eligible patients to receive a second dose if beneficial and expands enrollment criteria to include rare ovarian cancer subtypes. The first-in-human trial (NCT05316129) focuses on adult women with recurrent ovarian cancer who have progressed after at least two prior therapies, evaluating safety, maximum tolerated dose, and efficacy.
Anixa Biosciences (NASDAQ: ANIX) ha completato la somministrazione dell'ultimo paziente nel terzo gruppo della sua sperimentazione clinica di fase 1 per una nuova terapia CAR-T mirata al cancro ovarico ricorrente, condotta in collaborazione con il Moffitt Cancer Center. Il terzo gruppo ha ricevuto un milione di cellule CAR-positive per chilogrammo, un aumento di dieci volte rispetto al primo gruppo.
Il quarto gruppo della sperimentazione è previsto per iniziare dopo un periodo di verifica della sicurezza di 30 giorni, con piani per aumentare la dose di un ulteriore fattore di tre. La terapia mira al recettore dell'ormone follicolo-stimolante (FSHR), che è espresso esclusivamente sulle cellule ovariche, sulla vascolarizzazione tumorale e su alcune cellule cancerose.
Una recente modifica del protocollo consente ai pazienti idonei di ricevere una seconda dose se benefica e amplia i criteri di arruolamento per includere sottotipi rari di cancro ovarico. Lo studio clinico di prima in umani (NCT05316129) si concentra su donne adulte con cancro ovarico ricorrente che sono progredite dopo almeno due terapie precedenti, valutando sicurezza, dose massima tollerata ed efficacia.
Anixa Biosciences (NASDAQ: ANIX) ha completado la dosificación del último paciente en el tercer grupo de su ensayo clínico de fase 1 para una nueva terapia CAR-T dirigida al cáncer de ovario recurrente, realizado en colaboración con el Moffitt Cancer Center. El tercer grupo recibió un millón de células CAR-positivas por kilogramo, un aumento de diez veces en comparación con el primer grupo.
El cuarto grupo del ensayo comenzará después de un período de verificación de seguridad de 30 días, con planes de aumentar la dosis por un factor adicional de tres. La terapia se dirige al receptor de hormona estimulante del folículo (FSHR), que se expresa exclusivamente en las células ováricas, la vasculatura tumoral y ciertas células cancerosas.
Una reciente enmienda al protocolo permite a los pacientes elegibles recibir una segunda dosis si es beneficiosa y amplía los criterios de inclusión para incluir subtipos raros de cáncer de ovario. El ensayo de primera en humanos (NCT05316129) se centra en mujeres adultas con cáncer de ovario recurrente que han progresado después de al menos dos terapias previas, evaluando la seguridad, la dosis máxima tolerada y la eficacia.
아닉사 바이오사이언스(나스닥: ANIX)는 모피트 암 센터와 협력하여 재발성 난소암을 표적으로 하는 새로운 CAR-T 치료법에 대한 1상 임상 시험의 세 번째 코호트에서 마지막 환자의 투약을 완료했습니다. 세 번째 코호트는 킬로그램당 100만 개의 CAR 양성 세포를 받았으며, 이는 첫 번째 코호트에 비해 10배 증가한 수치입니다.
시험의 네 번째 코호트는 30일의 안전성 검증 기간 후에 시작될 예정이며, 용량을 추가로 3배 늘릴 계획입니다. 이 치료법은 난소 세포, 종양 혈관 및 특정 암 세포에서만 발현되는 여포 자극 호르몬 수용체(FSHR)를 표적으로 합니다.
최근 프로토콜 수정으로 적격 환자는 이점이 있을 경우 두 번째 용량을 받을 수 있으며, 드문 난소암 아형을 포함하도록 등록 기준이 확대되었습니다. 최초의 인간 임상 시험(NCT05316129)은 최소 두 번의 이전 치료 후 진행된 재발성 난소암을 가진 성인 여성에 초점을 맞추고 있으며, 안전성, 최대 허용 용량 및 효능을 평가합니다.
Anixa Biosciences (NASDAQ: ANIX) a terminé l'administration du dernier patient dans la troisième cohorte de son essai clinique de phase 1 pour une nouvelle thérapie CAR-T ciblant le cancer de l'ovaire récurrent, menée en partenariat avec le Moffitt Cancer Center. La troisième cohorte a reçu un million de cellules CAR-positives par kilogramme, ce qui représente une augmentation de dix fois par rapport à la première cohorte.
La quatrième cohorte de l'essai doit commencer après une période de vérification de sécurité de 30 jours, avec des plans pour augmenter la dose par un facteur supplémentaire de trois. La thérapie cible le récepteur de l'hormone folliculo-stimulante (FSHR), qui est exprimé exclusivement sur les cellules ovariennes, la vascularisation tumorale et certaines cellules cancéreuses.
Un amendement récent au protocole permet aux patients éligibles de recevoir une deuxième dose si cela est bénéfique et élargit les critères d'inscription pour inclure des sous-types rares de cancer de l'ovaire. L'essai de première humaine (NCT05316129) se concentre sur des femmes adultes atteintes de cancer de l'ovaire récurrent ayant progressé après au moins deux thérapies antérieures, évaluant la sécurité, la dose maximale tolérée et l'efficacité.
Anixa Biosciences (NASDAQ: ANIX) hat die Dosierung des letzten Patienten in der dritten Kohorte seiner klinischen Phase-1-Studie für eine neuartige CAR-T-Therapie zur Behandlung von wiederkehrendem Eierstockkrebs abgeschlossen, die in Partnerschaft mit dem Moffitt Cancer Center durchgeführt wird. Die dritte Kohorte erhielt eine Million CAR-positive Zellen pro Kilogramm, was einer zehnfachen Erhöhung gegenüber der ersten Kohorte entspricht.
Die vierte Kohorte der Studie soll nach einer 30-tägigen Sicherheitsüberprüfungsperiode beginnen, wobei geplant ist, die Dosierung um einen weiteren Faktor von drei zu erhöhen. Die Therapie zielt auf den follikelstimulierenden Hormonrezeptor (FSHR), der ausschließlich auf Eierstockzellen, Tumorvasculatur und bestimmten Krebszellen exprimiert wird.
Eine kürzliche Protokolländerung ermöglicht es berechtigten Patienten, eine zweite Dosis zu erhalten, wenn dies vorteilhaft ist, und erweitert die Einschlusskriterien um seltene Subtypen von Eierstockkrebs. Die erste menschliche Studie (NCT05316129) konzentriert sich auf erwachsene Frauen mit wiederkehrendem Eierstockkrebs, die nach mindestens zwei vorherigen Therapien fortgeschritten sind, und bewertet Sicherheit, maximale tolerierte Dosis und Wirksamkeit.
- Successful completion of third cohort dosing
- 10x dose increase achieved with no reported adverse effects
- Protocol amendment enables second dosing without separate IND approvals
- Expanded patient eligibility to rare ovarian cancer subtypes
- Phase 1 trial still in early stages
- 30-day waiting period required before fourth cohort can begin
Insights
Anixa's completion of the third dosing cohort in its ovarian cancer CAR-T trial represents a significant advancement in solid tumor immunotherapy. This trial has now successfully administered one million CAR-positive cells per kilogram - a tenfold increase from initial dosing - with plans to escalate by another factor of three in the fourth cohort.
The targeting mechanism deserves particular attention: unlike most CAR-T therapies that target CD19 or BCMA for blood cancers, Anixa's approach targets the follicle-stimulating hormone receptor (FSHR). This receptor's highly selective expression pattern on ovarian cells and tumor vasculature potentially addresses one of the fundamental challenges in solid tumor CAR-T therapy - finding targets with sufficient tumor specificity to avoid off-tumor toxicity.
The protocol amendment allowing second doses without separate IND approvals is particularly noteworthy for two reasons: it suggests confidence in the therapy's safety profile thus far, and it acknowledges the potential need for repeated administration to achieve durable responses in solid tumors - a recognized limitation of current CAR-T approaches.
The expansion to include rare ovarian cancer subtypes addresses a critical gap in clinical development. Patients with clear cell, mucinous, or low-grade serous ovarian cancers typically respond poorly to standard platinum-based chemotherapy and have been underrepresented in clinical trials.
For context, recurrent ovarian cancer patients who have failed multiple therapy lines have dismal prognoses, with median survival often measured in months. The continued absence of dose-limiting toxicities through three cohorts is encouraging, though the true efficacy signal will likely emerge only at higher doses where CAR-T cell expansion and persistence reach therapeutic thresholds.
The third cohort in the trial received a dose of one million CAR-positive cells per kilogram of patient weight, which represents a tenfold increase compared to the first cohort. This escalation is an important step in evaluating the safety and efficacy of CAR-T therapy for ovarian cancer patients. The fourth cohort will increase the dosage by another factor of three.
Anixa's FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With the completion of the third cohort, we are gaining important insights into the potential of CAR-T therapy for ovarian cancer. Increasing the dose is a key step in evaluating the therapy's effectiveness while ensuring patient safety. Additionally, the recent approval of our protocol amendment allows eligible patients to receive a second dose if they may benefit from it. This amendment also expands enrollment criteria to include rare ovarian cancer subtypes, making the therapy accessible to more patients. Now, all eligible participants can receive a second dose without requiring separate IND approvals, helping us better assess the full potential of this treatment. As we move forward with the fourth cohort, we remain committed to advancing our CAR-T program with the goal of improving treatment options for ovarian cancer patients."
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 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.
FAQ
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