Anixa Biosciences Achieves Milestone in Ovarian Cancer CAR-T Therapy Trials
Anixa Biosciences, Inc. has made significant strides in its pursuit of innovative cancer treatments, particularly focusing on its ongoing Phase 1 clinical trial for recurrent ovarian cancer. Recently, the company, in collaboration with the Moffitt Cancer Center, has announced the successful completion of dosing in the fourth cohort of this trial. This advancement is part of a research initiative exploring a novel CAR-T/CER-T therapy specifically designed for recurrent ovarian cancer, with the trial registered under ClinicalTrials.gov as NCT05316129.
The Phase 1 trial aims to assess the safety and efficacy of Anixa's FSHR-targeted CAR-T therapy. The fourth cohort involved administering a treatment dose of 3×10⁶ CAR-positive cells per kilogram, representing a substantial 30-fold increase from the dosage in the initial cohort. Impressively, several patients involved in the trial have surpassed the median survival markers typically associated with their specific disease type. In particular, one patient from the first cohort remains alive an impressive 28 months after treatment. Although these findings are preliminary due to the limited number of patients and doses, they provide a hopeful glimpse into the potential efficacy of this treatment.
As the fourth cohort's safety profile is being monitored, there are currently no reports of dose-limiting toxicities (DLTs), cytokine release syndrome, or associated neurotoxicity affecting immune effector cells. If the routine 30-day safety assessment does not reveal any adverse effects, the trial will advance to dose the fifth cohort, targeting approximately 1×10⁷ cells per kilogram. This shift represents a significant commitment to exploring higher dosage levels, which may enhance therapeutic outcomes for patients.
The CAR-T therapy being evaluated targets the follicle-stimulating hormone receptor (FSHR), a receptor expressed solely on ovarian cells, specific tumor vasculature, and some cancerous cells. The trial aims to enroll adult women diagnosed with recurrent ovarian cancer who have not responded to at least two prior treatments. It is meticulously designed to evaluate safety, determine the maximum tolerated doses, and analyze preliminary activity signals.
Dr. Amit Kumar, Chairman and CEO of Anixa, remarked on the milestone, stating, "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."
The groundwork for this groundbreaking CAR-T technology was laid by Dr. Jose R. Conejo-Garcia from Duke University. The trial is being conducted at the esteemed Moffitt Cancer Center, directed by Dr. Robert Wenham, who chairs the Gynecologic Oncology Program. Anixa holds exclusive worldwide rights to this innovative therapy from The Wistar Institute, underlining a mutually beneficial partnership aimed at significant advancements in cancer treatment.
Anixa Biosciences is not just limited to this ovarian cancer program. The company boasts a diverse therapeutic portfolio, including vaccine development efforts in collaboration with the renowned Cleveland Clinic. These vaccines are targeting breast and ovarian cancers, among others, utilizing a unique approach that immunizes against certain cancer-expressed proteins. Such innovative measures highlight Anixa's commitment to combatting various malignancies and its strategic partnerships with esteemed research institutions to push forward the boundaries of cancer treatment.
Anixa's business model is explicitly centered on collaboration with leading research bodies at all developmental stages, ensuring they are well-positioned to adapt to evolving scientific discoveries. The momentum gained in their ovarian cancer trial is a critical step in the company's journey toward transforming cancer care for patients who have limited options. By tapping into advanced technologies, Anixa aims to provide groundbreaking solutions for an ailment that continues to challenge healthcare professionals worldwide.
In conclusion, as Anixa moves forward with its Phase 1 clinical trial, the early outcomes continue to raise hopes for a more effective treatment paradigm in ovarian cancer and potentially other malignancies. With ongoing safety assessments and forthcoming dosing of the next patient cohort, all eyes are on Anixa Biosciences as they navigate this crucial juncture in scientific innovation.
The Phase 1 trial aims to assess the safety and efficacy of Anixa's FSHR-targeted CAR-T therapy. The fourth cohort involved administering a treatment dose of 3×10⁶ CAR-positive cells per kilogram, representing a substantial 30-fold increase from the dosage in the initial cohort. Impressively, several patients involved in the trial have surpassed the median survival markers typically associated with their specific disease type. In particular, one patient from the first cohort remains alive an impressive 28 months after treatment. Although these findings are preliminary due to the limited number of patients and doses, they provide a hopeful glimpse into the potential efficacy of this treatment.
As the fourth cohort's safety profile is being monitored, there are currently no reports of dose-limiting toxicities (DLTs), cytokine release syndrome, or associated neurotoxicity affecting immune effector cells. If the routine 30-day safety assessment does not reveal any adverse effects, the trial will advance to dose the fifth cohort, targeting approximately 1×10⁷ cells per kilogram. This shift represents a significant commitment to exploring higher dosage levels, which may enhance therapeutic outcomes for patients.
The CAR-T therapy being evaluated targets the follicle-stimulating hormone receptor (FSHR), a receptor expressed solely on ovarian cells, specific tumor vasculature, and some cancerous cells. The trial aims to enroll adult women diagnosed with recurrent ovarian cancer who have not responded to at least two prior treatments. It is meticulously designed to evaluate safety, determine the maximum tolerated doses, and analyze preliminary activity signals.
Dr. Amit Kumar, Chairman and CEO of Anixa, remarked on the milestone, stating, "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."
The groundwork for this groundbreaking CAR-T technology was laid by Dr. Jose R. Conejo-Garcia from Duke University. The trial is being conducted at the esteemed Moffitt Cancer Center, directed by Dr. Robert Wenham, who chairs the Gynecologic Oncology Program. Anixa holds exclusive worldwide rights to this innovative therapy from The Wistar Institute, underlining a mutually beneficial partnership aimed at significant advancements in cancer treatment.
Anixa Biosciences is not just limited to this ovarian cancer program. The company boasts a diverse therapeutic portfolio, including vaccine development efforts in collaboration with the renowned Cleveland Clinic. These vaccines are targeting breast and ovarian cancers, among others, utilizing a unique approach that immunizes against certain cancer-expressed proteins. Such innovative measures highlight Anixa's commitment to combatting various malignancies and its strategic partnerships with esteemed research institutions to push forward the boundaries of cancer treatment.
Anixa's business model is explicitly centered on collaboration with leading research bodies at all developmental stages, ensuring they are well-positioned to adapt to evolving scientific discoveries. The momentum gained in their ovarian cancer trial is a critical step in the company's journey toward transforming cancer care for patients who have limited options. By tapping into advanced technologies, Anixa aims to provide groundbreaking solutions for an ailment that continues to challenge healthcare professionals worldwide.
In conclusion, as Anixa moves forward with its Phase 1 clinical trial, the early outcomes continue to raise hopes for a more effective treatment paradigm in ovarian cancer and potentially other malignancies. With ongoing safety assessments and forthcoming dosing of the next patient cohort, all eyes are on Anixa Biosciences as they navigate this crucial juncture in scientific innovation.
Topics Health）
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