Anixa Biosciences Announces FDA Approval of Individual Patient IND for its Ovarian Cancer CAR-T Therapy
Anixa Biosciences (NASDAQ: ANIX) announced FDA approval of an individual patient IND for a second dose of its ovarian cancer CAR-T therapy. This follows encouraging findings in a patient from the lowest dose cohort, including tumor necrosis, inflammation, and T cell infiltration. The patient has remained off new therapy for months with no new disease, and her tumor marker began to fall after initial elevation.
The Phase I clinical trial at Moffitt Cancer Center is treating recurrent ovarian cancer patients who have failed standard therapies. Six patients have been treated so far in two cohorts. Dr. Robert Wenham, principal investigator, expressed optimism about the potential for increased response with successive dosing. Anixa's CEO, Dr. Amit Kumar, noted surprise and encouragement at seeing a notable response at such a low initial dose.
Anixa Biosciences (NASDAQ: ANIX) ha annunciato l'approvazione da parte della FDA di un'indagine clinica individuale per una seconda dose della sua terapia CAR-T per il cancro ovarico. Questo seguito a risultati incoraggianti in un paziente del gruppo a dose più bassa, che hanno incluso necrosi tumorale, infiammazione e infiltrazione di cellule T. La paziente è rimasta senza nuova terapia per mesi senza sviluppo di nuova malattia, e il suo marcatore tumorale ha iniziato a diminuire dopo un'iniziale elevazione.
Lo studio clinico di Fase I presso il Moffitt Cancer Center sta trattando pazienti con cancro ovarico recidivante che hanno fallito le terapie standard. Finora sei pazienti sono stati trattati in due gruppi. Il Dr. Robert Wenham, investigatore principale, ha espresso ottimismo riguardo al potenziale di una risposta aumentata con dosi successive. Il CEO di Anixa, Dr. Amit Kumar, ha notato sorpresa e incoraggiamento nel vedere una risposta significativa a una dose iniziale così bassa.
Anixa Biosciences (NASDAQ: ANIX) anunció la aprobación de la FDA para un IND de paciente individual para una segunda dosis de su terapia CAR-T para el cáncer de ovario. Esto sigue a hallazgos alentadores en un paciente del grupo de dosis más baja, que incluyeron necrosis tumoral, inflamación e infiltración de células T. La paciente ha permanecido sin nueva terapia durante meses sin nueva enfermedad, y su marcador tumoral comenzó a disminuir después de una elevación inicial.
El ensayo clínico de Fase I en el Moffitt Cancer Center está tratando a pacientes con cáncer de ovario recurrente que han fallado en las terapias estándar. Seis pacientes han sido tratados hasta ahora en dos cohortes. El Dr. Robert Wenham, investigador principal, expresó optimismo sobre el potencial de una mayor respuesta con dosis sucesivas. El CEO de Anixa, Dr. Amit Kumar, señaló sorpresa y aliento al ver una respuesta notable a una dosis inicial tan baja.
아닉사 바이오사이언스( NASDAQ: ANIX)는 난소암 CAR-T 치료제의 두 번째 용량에 대한 개인 환자 IND가 FDA의 승인을 받았다고 발표했습니다. 이는 가장 낮은 용량 그룹의 환자에게서 나타난 낙관적인 결과에 따른 것으로, 여기에는 종양 괴사, 염증, T 세포 침투가 포함됩니다. 환자는 새로운 질병 없이 몇 달 동안 새로운 요법을 받지 않았으며, 초기 상승 후 종양 마커가 감소하기 시작했습니다.
Moffitt 암 센터에서 진행 중인 1상 임상시험은 표준 치료에 실패한 재발성 난소암 환자들을 대상으로 하고 있습니다. 지금까지 두 개의 그룹에서 여섯 명의 환자가 치료를 받았습니다. 주요 연구자인 로버트 웬햄 박사는 연속 요법으로 반응이 증가할 가능성에 대해 낙관적인 입장을 표명했습니다. 아닉사의 CEO인 아밋 쿠마르 박사는 초기 용량이 이렇게 낮음에도 불구하고 상당한 반응을 보인 것에 놀라움과 격려를 표명했습니다.
Anixa Biosciences (NASDAQ: ANIX) a annoncé l'approbation par la FDA d'un IND pour un patient individuel pour une seconde dose de sa thérapie CAR-T contre le cancer de l'ovaire. Cela fait suite à des résultats encourageants chez un patient du groupe à la plus faible dose, notamment nécrose tumorale, inflammation et infiltration de cellules T. La patiente est restée sans nouvelle thérapie pendant des mois sans nouvelle maladie, et son marqueur tumoral a commencé à diminuer après une élévation initiale.
Le programme de phase I au Moffitt Cancer Center traite des patients atteints de cancer de l'ovaire récurrent qui ont échoué aux thérapies standard. Six patients ont été traités jusqu'à présent dans deux cohortes. Le Dr Robert Wenham, investigateur principal, a exprimé son optimisme quant au potentiel d'une réponse accrue avec des doses successives. Le PDG d'Anixa, Dr Amit Kumar, a souligné sa surprise et son encouragement de voir une réponse significative à une si faible dose initiale.
Anixa Biosciences (NASDAQ: ANIX) hat die Genehmigung der FDA für eine individuelle Patienten-IND für eine zweite Dosis seiner CAR-T-Therapie gegen Eierstockkrebs bekannt gegeben. Dies folgt ermutigenden Ergebnissen bei einem Patienten aus der niedrigsten Dosierungsgruppe, einschließlich Tumorgewebsnerose, Entzündung und T-Zell-Infiltration. Die Patientin hat monatelang keine neue Therapie erhalten und ihre Tumormarker begannen nach einer anfänglichen Erhöhung zu sinken.
Die Phase-I-Studie am Moffitt Cancer Center behandelt Patienten mit rezidiviertem Eierstockkrebs, die bei Standardtherapien gescheitert sind. Bisher wurden sechs Patienten in zwei Gruppen behandelt. Dr. Robert Wenham, der Hauptversorger, äußerte Optimismus über das Potenzial für eine erhöhte Reaktion mit nachfolgenden Dosen. Dr. Amit Kumar, der CEO von Anixa, merkte überrascht und ermutigt an, dass bei einer so niedrigen Anfangsdosis eine deutliche Reaktion zu beobachten war.
- FDA approval for second dose of CAR-T therapy in individual patient
- Encouraging tumor response in lowest dose cohort patient
- Patient remained off new therapy for months with no new disease
- Tumor marker began to fall after initial elevation
- Potential for increased response with successive dosing
- Initial increase in tumor size meeting criteria for progression
- Only one patient showing notable response so far
- Trial still in early Phase I stage
Insights
The FDA's approval of an individual patient IND for Anixa Biosciences represents a critical milestone in the development of their ovarian cancer CAR-T therapy. This approval is particularly significant given the early signs of efficacy observed even at the lowest dose cohort. The findings of necrosis, inflammation and T cell infiltration in the tumor biopsy indicate a positive immune response, suggesting that the therapy is actively engaging the patient's immune system to target cancer cells. Such early positive results can often accelerate the clinical development process, potentially leading to earlier availability for other patients in need. However, it is important to manage expectations, as this is still in the early phases of clinical trials and broader efficacy and safety will need to be established.
As an oncology expert, I see the FDA approval for a second dose in this patient as a promising step forward in ovarian cancer treatment. The patient's prolonged period without new disease and the reduction in tumor markers are encouraging signs. These types of responses, especially in patients who have no other treatment options, can pave the way for more individualized and effective cancer therapies. However, these results are preliminary and pertain to a single patient. Comprehensive data from a larger cohort will be necessary to confirm the efficacy and safety of this CAR-T therapy for widespread use. Patients and investors alike should watch for further updates as the trial progresses to higher dose cohorts.
From a financial perspective, the FDA approval for Anixa's CAR-T therapy represents a significant value driver for the company. Early-stage biotech firms often experience volatility and notable clinical trial progress can lead to substantial stock price movements. This approval, along with the preliminary positive patient response, could attract investor interest and potentially lead to upward stock movement. However, it's important for investors to remain cautious. The therapy is still in Phase I trials and the ultimate success will depend on further clinical results and eventual market approval. Investors should keep an eye on upcoming clinical data releases and any strategic partnerships or funding activities that Anixa might pursue to support the continued development of their therapy.
IND follows encouraging findings of necrosis, inflammation and T cell infiltration in tumor biopsy of patient in lowest dose cohort
Dr. Robert Wenham, Chair, Department of Gynecologic Oncology at Moffitt, and the principal investigator of the trial, stated, "In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T cell infiltration by Immunohistochemistry (IHC). Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA."
"I am pleased with the very long duration absent of any further disease and the possible response that my patient has exhibited with this innovative therapy, as she had no other realistic options. I look forward to evaluating her progress with successive dosing, as well as future patients who have no other alternatives," stated Dr. Monica Avila, the patient's treating oncologist.
Dr. Amit Kumar, CEO of Anixa Biosciences commented, "We were somewhat surprised and quite encouraged to see such a notable response this early, given the low dose in the first cohort. We truly hope we can help this patient, as well as all other women fighting this terrible disease."
The Phase I clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial, three in the first cohort and three in the second cohort. Dose escalation will continue after confirming the previous dosages are safe.
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.
FAQ
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