Anixa Biosciences and Moffitt Cancer Center Complete Dosing of Fourth Cohort in Ovarian Cancer CAR-T Clinical Trial; Multiple Patients Surpassing Median Expected Survival
Anixa Biosciences (NASDAQ: ANIX) has completed dosing the fourth cohort in its Phase 1 clinical trial for a novel FSHR-targeted CAR-T therapy treating recurrent ovarian cancer. The fourth cohort received 3×10⁶ CAR-positive cells per kilogram, a 30-fold increase from the first cohort, with no dose-limiting toxicities observed.
Several treated patients have surpassed median survival expectations, with one patient from the first cohort remaining alive 28 months post-treatment. The fifth cohort is planned to receive approximately 1×10⁷ cells/kg following a 30-day safety review. The therapy targets the follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells.
Anixa Biosciences (NASDAQ: ANIX) ha completato la somministrazione del quarto gruppo nel suo trial di Fase 1 per una nuova terapia CAR-T mirata a FSHR contro il carcinoma ovarico ricorrente. Il quarto gruppo ha ricevuto 3×10⁶ cellule CAR-positive per chilogrammo, un aumento di 30 volte rispetto al primo gruppo, senza tossicità limitante dose.
Diversi pazienti trattati hanno superato le aspettative mediane di sopravvivenza, incluso un paziente del primo gruppo ancora vivo a 28 mesi dal trattamento. È previsto che il quinto gruppo riceva circa 1×10⁷ cellule/kg dopo una revisione di sicurezza di 30 giorni. La terapia è diretta contro il recettore dell'ormone follicolo-stimolante (FSHR), espresso esclusivamente sulle cellule ovariche, sulla vascolarizzazione tumorale e su alcune cellule cancerose.
Anixa Biosciences (NASDAQ: ANIX) ha completado la dosificación del cuarto cohorte en su ensayo clínico de Fase 1 para una nueva terapia CAR-T dirigida a FSHR para cáncer de ovario recurrente. El cuarto cohorte recibió 3×10⁶ células CAR-positivas por kilogramo, un incremento de 30 veces respecto al primer cohorte, sin toxicidades limitantes de dosis observadas.
Varios pacientes tratados han superado la supervivencia media esperada, y un paciente del primer cohorte sigue vivo 28 meses tras el tratamiento. Está previsto que el quinto cohorte reciba aproximadamente 1×10⁷ células/kg tras una revisión de seguridad de 30 días. La terapia se dirige al receptor de la hormona estimulante del folículo (FSHR), que se expresa exclusivamente en las células ováricas, la vasculatura tumoral y ciertas células cancerosas.
Anixa Biosciences (NASDAQ: ANIX)는 재발성 난소암을 치료하기 위한 새로운 FSHR 표적 CAR-T 치료제의 1상 임상시험에서 네 번째 코호트의 투약을 완료했습니다. 네 번째 코호트는 체중 kg당 3×10⁶ CAR 양성 세포를 투여받았으며, 이는 첫 번째 코호트보다 30배 증가한 용량으로 약물 용량 제한 독성은 관찰되지 않았습니다.
여러 환자가 중앙 생존 기대치를 넘겼고, 첫 번째 코호트의 한 환자는 치료 후 28개월째 생존해 있습니다. 다섯 번째 코호트는 30일간의 안전성 검토 후 약 체중 kg당 1×10⁷ 세포를 투여받을 예정입니다. 이 치료법은 난소 세포, 종양 혈관 및 일부 암세포에만 발현되는 난포자극호르몬 수용체(FSHR)를 표적합니다.
Anixa Biosciences (NASDAQ: ANIX) a achevé la perfusion de la quatrième cohorte de son essai clinique de phase 1 pour une nouvelle thérapie CAR‑T ciblant le FSHR contre le cancer ovarien récidivant. La quatrième cohorte a reçu 3×10⁶ cellules CAR‑positives par kilogramme, soit un accroissement de 30 fois par rapport à la première cohorte, sans toxicités limitantes liées à la dose.
Plusieurs patients traités ont dépassé la survie médiane attendue, et un patient de la première cohorte est toujours vivant 28 mois après le traitement. La cinquième cohorte devrait recevoir environ 1×10⁷ cellules/kg après une revue de sécurité de 30 jours. La thérapie cible le récepteur de l’hormone folliculo‑stimulante (FSHR), exprimé exclusivement sur les cellules ovariennes, la vascularisation tumorale et certaines cellules cancéreuses.
Anixa Biosciences (NASDAQ: ANIX) hat die Dosierung der vierten Kohorte in der Phase‑1‑Studie für eine neuartige FSHR‑gerichtete CAR‑T‑Therapie bei rezidivierendem Eierstockkrebs abgeschlossen. Die vierte Kohorte erhielt 3×10⁶ CAR‑positive Zellen pro Kilogramm, eine 30‑fache Erhöhung gegenüber der ersten Kohorte, wobei keine dosislimitierenden Toxizitäten festgestellt wurden.
Mehrere behandelte Patienten übertreffen die erwartete mittlere Überlebenszeit, darunter ein Patient aus der ersten Kohorte, der 28 Monate nach der Behandlung noch lebt. Die fünfte Kohorte soll nach einer 30‑tägigen Sicherheitsprüfung etwa 1×10⁷ Zellen/kg erhalten. Die Therapie zielt auf den follikelstimulierenden Hormonrezeptor (FSHR) ab, der ausschließlich auf Ovarialzellen, Tumorgefäßstrukturen und bestimmten Krebszellen exprimiert wird.
- Multiple patients surpassing median expected survival benchmarks
- One patient from first cohort still alive after 28 months post-treatment
- No dose-limiting toxicities observed despite 30-fold dose increase
- Trial progressing to fifth cohort with higher dosage
- Observations are preliminary and from a small number of patients
- Results limited to early-stage Phase 1 trial focused primarily on safety
Insights
Anixa's ovarian cancer CAR-T trial shows encouraging safety at higher doses with some patients exceeding median survival expectations.
Anixa's Phase 1 trial of their FSHR-targeted CAR-T therapy for recurrent ovarian cancer has completed dosing of the fourth cohort, with no dose-limiting toxicities (DLTs) observed at the significantly escalated dose of 3×10⁶ CAR-positive cells per kilogram - approximately
The trial is now poised to advance to the fifth cohort at an even higher dose of 1×10⁷ cells/kg, following a standard 30-day safety verification period. While efficacy is not the primary endpoint of this Phase 1 study, the preliminary survival data is intriguing. Multiple patients have surpassed the median expected survival for recurrent ovarian cancer, with one patient from the first cohort still alive 28 months post-treatment. This is particularly meaningful considering the trial targets heavily pretreated patients who have progressed after at least two prior therapies – a population with typically poor prognosis.
The mechanism targeting the follicle-stimulating hormone receptor (FSHR) is scientifically sound, as this receptor is predominantly expressed on ovarian cells, tumor vasculature, and certain cancer cells, potentially allowing for targeted therapy with reduced off-target effects. This approach represents a novel application of CAR-T technology beyond the hematological malignancies where it has shown the most success to date.
While these results are preliminary and from a small patient population, the successful completion of higher-dose cohorts without safety concerns is a significant milestone that increases the probability of identifying an effective therapeutic dose in this difficult-to-treat cancer.
Continue to observe a positive safety profile—no dose limiting toxicities, cytokine
release syndrome or immune effector cell-associated neurotoxicity
To date several treated patients remain alive beyond disease-specific median survival benchmarks. Notably, one patient from the 1st cohort remains alive 28 months post-treatment. These observations are preliminary and from a small number of patients and dose levels.
The fourth cohort in the trial received 3×10⁶ CAR-positive cells per kilogram of body weight—approximately a 30-fold increase versus the first cohort (1×10⁵ cells/kg). No dose-limiting toxicities (DLTs) have been observed to date in the fourth cohort. Pending safety review, the fifth cohort is planned at approximately 1×10⁷ cells/kg.
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. This first-in-human trial is enrolling adult women with recurrent ovarian cancer who have progressed following at least two prior therapies and is designed to evaluate safety, identify the maximum tolerated dose, and explore preliminary signals of activity.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With the completion of the fourth cohort, we are gaining important insights into the potential of our CAR-T therapy for ovarian cancer at higher dose levels. While this study is primarily designed to assess safety, we are encouraged by the early indications of potential efficacy, and look forward to initiating the next dose cohort following the standard safety review."
Anixa's CAR-T technology was invented by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. The ongoing clinical trial is being conducted at Moffitt under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program. Anixa holds an exclusive worldwide license to the FSHR-targeting CAR-T technology from The Wistar Institute.
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. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. 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. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. 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 LinkedIn, X, 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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