Anixa Biosciences Announces Second Dose Administered to Patient in Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences (NASDAQ: ANIX) has administered a second dose of its CAR-T therapy to a patient in its ongoing Phase 1 clinical trial for ovarian cancer. This follows a positive response after the initial treatment, where the patient's tumor biopsy showed necrosis, inflammation, and T cell infiltration. The patient remained stable for nearly 18 months after the first infusion, maintaining a good quality of life.
The trial, conducted in collaboration with Moffitt Cancer Center, has treated six patients to date in two cohorts. The encouraging results have led to an amendment in the trial protocol to allow for second doses in patients who may benefit. Dr. Robert Wenham, the principal investigator, expressed optimism about the therapy's potential long-term benefits for ovarian cancer patients.
Anixa Biosciences (NASDAQ: ANIX) ha somministrato una seconda dose della sua terapia CAR-T a un paziente nel corso del suo studio clinico di Fase 1 per il cancro ovarico. Questo segue una risposta positiva dopo il trattamento iniziale, durante il quale la biopsia del tumore del paziente ha mostrato necrosi, infiammazione e infiltrazione di cellule T. Il paziente è rimasto stabile per quasi 18 mesi dopo la prima infusione, mantenendo una buona qualità della vita.
Lo studio, condotto in collaborazione con il Moffitt Cancer Center, ha trattato fino ad oggi sei pazienti in due coorti. I risultati incoraggianti hanno portato a una modifica del protocollo dello studio per consentire seconde dosi ai pazienti che potrebbero beneficiarne. Il Dr. Robert Wenham, il ricercatore principale, ha espresso ottimismo riguardo ai potenziali benefici a lungo termine della terapia per i pazienti affetti da cancro ovarico.
Anixa Biosciences (NASDAQ: ANIX) ha administrado una segunda dosis de su terapia CAR-T a un paciente en su ensayo clínico de Fase 1 para el cáncer de ovario. Esto es después de una respuesta positiva tras el tratamiento inicial, donde la biopsia del tumor del paciente mostró necrosis, inflamación e infiltración de células T. El paciente se mantuvo estable durante casi 18 meses después de la primera infusión, manteniendo una buena calidad de vida.
El ensayo, realizado en colaboración con el Moffitt Cancer Center, ha tratado hasta la fecha a seis pacientes en dos cohortes. Los resultados alentadores han llevado a una enmienda en el protocolo del ensayo para permitir segundas dosis en pacientes que podrían beneficiarse. El Dr. Robert Wenham, investigador principal, expresó optimismo sobre los posibles beneficios a largo plazo de la terapia para los pacientes con cáncer de ovario.
Anixa Biosciences (NASDAQ: ANIX)는 현재 진행 중인 1상 임상 시험에서 난소암 환자에게 CAR-T 요법의 두 번째 용량을 투여하였습니다. 이는 초기 치료 후 긍정적인 반응을 보인 후 이루어졌으며, 환자의 종양 생검은 괴사, 염증 및 T 세포 침윤을 보여주었습니다. 이 환자는 첫 번째 주입 후 거의 18개월 동안 안정적인 상태를 유지하며 양호한 삶의 질을 유지했습니다.
이 시험은 Moffitt Cancer Center와 협력하여 진행되었으며, 현재까지 두 개의 집단에서 여섯 명의 환자를 치료했습니다. 희망적인 결과는 환자에게 이익이 될 수 있는 두 번째 용량을 허용하기 위한 시험 프로토콜의 수정으로 이어졌습니다. 주요 연구자인 로버트 웬햄 박사는 이 요법이 난소암 환자에게 장기적인 혜택을 줄 수 있을 것이라는 낙관적인 견해를 나타냈습니다.
Anixa Biosciences (NASDAQ: ANIX) a administré une seconde dose de sa thérapie CAR-T à un patient dans le cadre de son essai clinique de Phase 1 pour le cancer de l'ovaire. Cela fait suite à une réponse positive après le traitement initial, où la biopsie tumorale du patient a montré nécrose, inflammation et infiltration des cellules T. Le patient est resté stable pendant près de 18 mois après la première infusion, maintenant une bonne qualité de vie.
L'essai, réalisé en collaboration avec le Moffitt Cancer Center, a traité jusqu'à présent six patients dans deux cohortes. Les résultats encourageants ont conduit à une modification du protocole de l'essai pour permettre des secondes doses aux patients qui pourraient en bénéficier. Le Dr Robert Wenham, chercheur principal, a exprimé son optimisme quant aux potentiels bienfaits à long terme de la thérapie pour les patients atteints de cancer de l'ovaire.
Anixa Biosciences (NASDAQ: ANIX) hat einem Patienten in seiner laufenden Phase-1-Studie gegen Eierstockkrebs eine zweite Dosis seiner CAR-T-Therapie verabreicht. Dies folgte auf eine positive Reaktion nach der Erstbehandlung, bei der die Tumorbiopsie des Patienten Nekrose, Entzündung und T-Zell-Infiltration zeigte. Der Patient blieb fast 18 Monate nach der ersten Infusion stabil und wies eine gute Lebensqualität auf.
Die Studie, die in Zusammenarbeit mit dem Moffitt Cancer Center durchgeführt wird, hat bislang sechs Patienten in zwei Kohorten behandelt. Die ermutigenden Ergebnisse haben zu einer Änderung des Prüfprotokolls geführt, um zweite Dosen für Patienten zuzulassen, die möglicherweise profitieren. Dr. Robert Wenham, der leitende Forschungsleiter, äußerte sich optimistisch über die potenziellen langfristigen Vorteile der Therapie für Eierstockkrebspatienten.
- Positive clinical activity observed in patient after initial CAR-T therapy dose
- Patient remained stable for 18 months without requiring alternative treatment
- Amendment to trial protocol allows for second doses in potentially benefiting patients
- Six patients treated so far in two cohorts of the Phase 1 trial
- None.
Insights
This news is highly significant for Anixa Biosciences and the field of ovarian cancer treatment. The administration of a second dose of CAR-T therapy to a patient who showed positive response after the initial treatment is a promising development. Key points to note:
- The patient's tumor biopsy revealed necrosis, inflammation and T cell infiltration after the lowest dose, indicating biological activity of the therapy.
- The patient remained stable for 18 months without requiring alternative treatment, suggesting potential long-term efficacy.
- The protocol amendment to allow second doses for benefiting patients is a strategic move that could enhance treatment outcomes.
- With six patients treated so far in two cohorts, the ongoing dose escalation trial is progressing well.
While it's important to remember this is still a Phase 1 trial, these results are encouraging for Anixa's CAR-T therapy as a potential breakthrough in ovarian cancer treatment, particularly for patients who have failed standard therapies.
This development is potentially significant for Anixa Biosciences (NASDAQ: ANIX) from a financial perspective:
- Positive early-stage results could increase investor confidence and potentially drive up the stock price.
- The company's market cap of
$97,503,861 suggests it's a small-cap biotech, where positive clinical news can have outsized effects on valuation. - The amendment to allow second doses could extend the treatment course and potentially increase the therapy's commercial value if approved.
- Collaboration with Moffitt Cancer Center adds credibility and may reduce R&D costs for Anixa.
- Success in ovarian cancer could open doors for applying the CAR-T technology to other cancer types, expanding the company's pipeline and potential market.
However, investors should remain cautious as Phase 1 results are preliminary and the path to commercialization is long and uncertain in biotech. The company's cash position and burn rate will be critical factors to monitor as the trial progresses.
Patient showed clinical activity after initial treatment, with necrosis, inflammation, and T cell infiltration observed in tumor biopsy from the lowest dose
Previously, Anixa and Moffitt received approval for a single-patient IND application, allowing the administration of a second dose to a patient whose tumor biopsy revealed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy.
After the first infusion, the patient remained stable, did not require alternative treatment and her quality of life was good, leading to the decision to administer a second dose to further enhance these positive results. These findings offer promising indications that the CAR-T therapy may serve as a successful long-term treatment option, highlighting its potential effectiveness in the fight against ovarian cancer.
"While this is a single patient, the positive clinical activity observed, including necrosis and T cell infiltration, is an encouraging sign of the therapy's potential effectiveness," stated Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial. "Based on these results, we recently submitted an amendment to the current trial protocol to allow patients who may benefit to receive a second dose. We are excited to continue evaluating this treatment in our ongoing trial, and we are optimistic about the potential long-term benefits it may offer to patients with ovarian cancer."
Dr. Monica Avila, the patient's treating oncologist, stated, "My patient received her first infusion in May 2023. We are now nearly 18 months from that date, and she is doing well and is now receiving this second dose. I am thrilled with her status and look forward to observing further progress."
Dr. Amit Kumar, CEO of Anixa Biosciences, stated, "We are proud to have an outstanding team, including Dr. Wenham and Dr. Avila, and we are encouraged by the positive response seen in this patient following the initial dose of our CAR-T therapy. The continued clinical improvements reinforce our confidence in the potential of this groundbreaking treatment to provide hope for patients battling ovarian cancer. We remain committed to advancing this innovative therapy and bringing new, effective treatment options to the forefront."
The Phase 1 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 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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