Anixa Biosciences Initiates Dosing in Third Cohort in its Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences (NASDAQ: ANIX) has initiated dosing in the third cohort of its Phase 1 ovarian cancer CAR-T clinical trial, conducted in partnership with Moffitt Cancer Center. The new cohort receives one million CAR-positive cells, a tenfold increase from the initial dose. No dose-limiting toxicity was observed in the first two cohorts. The trial targets the follicle-stimulating hormone receptor (FSHR) in patients with recurrent ovarian cancer who have progressed on at least two prior therapies. Notably, one patient from the first cohort showed unusual stability and mild improvement for over a year post-infusion, with tumor biopsy revealing necrosis and T cell infiltration.
Anixa Biosciences (NASDAQ: ANIX) ha avviato la somministrazione della terapia nella terza coorte del suo studio clinico di fase 1 sul CAR-T per il cancro ovarico, condotto in collaborazione con il Moffitt Cancer Center. La nuova coorte riceve un milione di cellule CAR-positive, un aumento di dieci volte rispetto alla dose iniziale. Non sono state osservate tossicità limitanti da dose nelle prime due coorti. Lo studio mira al recettore dell'ormone follicolo-stimolante (FSHR) in pazienti con cancro ovarico ricorrente che hanno progredito dopo almeno due terapie precedenti. È notevole che un paziente della prima coorte ha mostrato una stabilità insolita e un lieve miglioramento per oltre un anno dopo l'infusione, con una biopsia tumorale che ha rivelato necrosi e infiltrazione di cellule T.
Anixa Biosciences (NASDAQ: ANIX) ha iniciado la dosificación en la tercera cohorte de su ensayo clínico de fase 1 sobre CAR-T para el cáncer de ovario, llevado a cabo en colaboración con el Moffitt Cancer Center. La nueva cohorte recibe un millón de células positivas para CAR, un aumento de diez veces respecto a la dosis inicial. No se observaron toxicidades limitantes de dosis en las dos primeras cohortes. El ensayo tiene como objetivo el receptor de la hormona estimulante del folículo (FSHR) en pacientes con cáncer de ovario recurrente que han progresado después de al menos dos terapias anteriores. Notablemente, un paciente de la primera cohorte mostró una estabilidad inusual y una leve mejoría durante más de un año después de la infusión, con una biopsia tumoral que reveló necrosis e infiltración de células T.
Anixa Biosciences (NASDAQ: ANIX)는 Moffitt Cancer Center와 협력하여 진행 중인 1상 난소암 CAR-T 임상 시험의 세 번째 집단에서 투약을 시작했습니다. 새로운 집단은 초기 용량의 10배인 백만 개의 CAR 양성 세포를 투여받습니다. 첫 두 집단에서 용량 제한 독성은 관찰되지 않았습니다. 이 시험은 최소 두 가지 이전 치료에서 진행된 재발성 난소암 환자의 난포 자극 호르몬 수용체(FSHR)를 타겟으로 합니다. 특히, 첫 번째 집단의 한 환자는 주입 후 1년 이상 매우 안정적인 상태와 경미한 개선을 보였으며, 종양 생검에서 괴사와 T세포 침투가 발견되었습니다.
Anixa Biosciences (NASDAQ: ANIX) a commencé la dose dans la troisième cohorte de son essai clinique de phase 1 sur CAR-T pour le cancer de l'ovaire, mené en partenariat avec le Moffitt Cancer Center. La nouvelle cohorte reçoit un million de cellules positives pour CAR, soit une augmentation de dix fois par rapport à la dose initiale. Aucune toxicité limitant la dose n'a été observée dans les deux premières cohortes. L'essai cible le récepteur de l'hormone folliculo-stimulante (FSHR) chez les patients atteints de cancer de l'ovaire récurrent qui ont progressé après au moins deux traitements précédents. Fait remarquable, un patient de la première cohorte a montré une stabilité inhabituelle et une légère amélioration pendant plus d'un an après l'infusion, avec une biopsie tumorale révélant de la nécrose et une infiltration de cellules T.
Anixa Biosciences (NASDAQ: ANIX) hat die Dosierung in der dritten Kohorte seiner Phase-1-Studie zu CAR-T bei Eierstockkrebs begonnen, die in Zusammenarbeit mit dem Moffitt Cancer Center durchgeführt wird. Die neue Kohorte erhält eine Million CAR-positive Zellen, was einer zehnfachen Erhöhung im Vergleich zur ursprünglichen Dosis entspricht. In den ersten beiden Kohorten wurden keine dosislimitierenden Toxizitäten beobachtet. Die Studie zielt auf den Follikel-stimulierenden Hormonrezeptor (FSHR) bei Patienten mit wiederkehrendem Eierstockkrebs ab, die nach mindestens zwei vorangegangenen Therapien Fortschritte gemacht haben. Bemerkenswert ist, dass ein Patient aus der ersten Kohorte über ein Jahr nach der Infusion eine ungewöhnliche Stabilität und leichte Verbesserung zeigte, wobei eine Tumorbiopsie Nekrose und T-Zell-Infiltration offenbarte.
- No dose-limiting toxicity observed in first two cohorts
- One patient showed unusual stability and improvement for over a year
- Protocol amendment submitted to allow additional dosing for benefiting patients
- Successfully progressing to higher dose levels in clinical trial
- None.
Insights
The advancement to the third cohort with a 10-fold dose increase in this CAR-T trial represents significant progress in developing a novel treatment for recurrent ovarian cancer. The absence of dose-limiting toxicity in previous cohorts and the observation of disease stability in one patient for over a year are particularly noteworthy, especially given the challenging nature of treating solid tumors with CAR-T therapy.
The trial's protocol amendment to allow additional dosing could potentially enhance treatment efficacy. The targeting of FSHR shows promise for specificity, as this receptor is primarily expressed on ovarian cells and tumor vasculature. The progression through dose escalation while maintaining safety is important for establishing the therapeutic window. Early signs of tumor necrosis and T cell infiltration in a patient biopsy suggest biological activity of the treatment.
The preliminary results are encouraging from a clinical perspective. The observation of sustained disease stability in a platinum-resistant, heavily pretreated patient is particularly significant, as this population typically has poor outcomes. The presence of T cell infiltration and tumor necrosis in the biopsy provides mechanistic evidence of the CAR-T cells' activity against the tumor.
The dose escalation to 1 million CAR-positive cells represents a critical phase in determining optimal dosing. The clean safety profile thus far is remarkable, as CAR-T therapies can often present significant toxicity concerns. The protocol amendment for additional dosing aligns with established practices in CAR-T therapy for hematologic malignancies, where multiple doses can enhance response durability.
Third cohort dose is one million CAR positive cells; ten times higher than the first cohort dose
No dose limiting toxicity was observed in the initial three-patient cohort or in the second three-patient cohort, in which patients received a CAR-T cell dose triple that of the first cohort. After the required one-month waiting period to assess the occurrence of dose limiting toxicity and review of all safety data, the trial has now dosed its first patient in the third cohort at a tenfold increase over the initial dose.
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 on at least two prior therapies. The study is designed to evaluate safety and identify the maximum tolerated dose, while monitoring efficacy.
Dr. Robert Wenham, principal investigator of the study and Chair of the Department of Gynecologic Oncology at Moffitt, stated, "With no dose-limiting safety issues observed in the first and second patient cohorts, we have advanced to the next cohort to evaluate a 10x higher dose compared with the starting dose. As the trial continues, our aim is to demonstrate the tolerability of our CAR-T but we are optimistic and hopeful about seeing efficacy in this solid tumor—a challenging area for traditional CAR-T therapies, which have shown efficacy mainly in hematologic tumors and lymphomas. We are very encouraged how the trial has progressed and our observation in one patient from the first cohort who had relative stability and even some mild improvement for well over a year after her infusion. This is highly unusual for a platinum resistant multiply treated ovarian cancer. A tumor biopsy showed necrosis and T cell infiltration. Based on these findings, we recently submitted an amendment to the trial protocol to allow patients who may benefit from an additional dose. Generally, we expect higher cell doses to increase efficacy, although we also anticipate a second dose may further improve response rates and durability. We are proud of the progress to date and look forward to treating additional patients in the third cohort."
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.
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