Anixa Biosciences CEO Calls 2026 “Pivotal” as Breast Cancer Vaccine, Ovarian CAR-T Advance

Key Points

• 2026 “pivotal”: Anixa expects to advance its Cleveland Clinic– and DoD-backed breast cancer vaccine into Phase II after submitting an FDA report and meeting with the agency, while scaling manufacturing and adding U.S. clinical sites with a Phase II start targeted in about a year.
• Ovarian CAR‑T (locireddir) shows early, encouraging survival signals in heavily pretreated patients using peritoneal delivery with no major dose‑limiting toxicities so far; the dose‑escalation trial will evaluate higher doses and lymphodepletion with materially more data expected in 2026.
• $15 million cash, no debt: Management projects modest burn (~$8M next year) giving over two years of runway, is pursuing government grants, and says additional positive data could enable a partnership with a larger pharma to fund further development.

Anixa Biosciences NASDAQ: ANIX Chairman and CEO Dr. Amit Kumar said the company views 2026 as a “pivotal year” as it advances two clinical-stage programs: a breast cancer vaccine being developed with the Cleveland Clinic and the U.S. Department of Defense, and a CAR-T cell therapy for terminally ill ovarian cancer patients being studied with Moffitt Cancer Center.

2025 milestones highlighted: Phase I breast cancer vaccine completion and CAR-T patient outcomes

In a fireside chat hosted by Water Tower Research healthcare analyst Robert Sassoon, Kumar pointed to two major achievements in 2025. First, the company completed its Phase I breast cancer vaccine trial and presented data from that study in December. Second, Anixa continued progressing its ovarian cancer CAR-T program and reported what Kumar described as “amazing results with patient outcomes,” which he said were recently highlighted in a company press release.

Kumar also noted additional milestones in 2025, including multiple patent approvals in the U.S. and other countries and the approval of the CAR-T therapy’s non-proprietary name by domestic and international organizations.

Breast cancer vaccine: Steps underway before Phase II start

Looking ahead, Kumar said the next major step for the breast cancer vaccine is transitioning into a Phase II trial, but that several items must be completed before initiation. Those include submitting a report to the FDA and meeting with the agency to discuss Phase II design. He added that the company has applied for U.S. government research grants that could partially fund the Phase II effort.

Operationally, Kumar said Anixa is working with a manufacturer to produce larger quantities of the vaccine under more rigorous conditions so it can be distributed to multiple clinical sites beyond the Cleveland Clinic. He said the company will be identifying and signing up additional sites across the U.S.

Kumar reiterated that the Phase II vaccine trial is expected to be an open-label study, allowing results to be observed on an ongoing basis. When asked about timing, he said the company believes the Phase II trial will be able to begin “in about a year.”

Cash burn expectations and partnering outlook

Sassoon highlighted the company’s relatively low cash burn while running two clinical trials, noting $15 million in cash and no debt at the end of the last fiscal year. Kumar said Anixa has structured operations to keep spending low and expects cash burn in the next fiscal year to increase modestly from about $7 million to roughly $8 million, “plus or minus.” He said that budget is expected to support continued progress in both clinical programs and provides “over two years of cash” on the balance sheet.

Kumar said the company believes that generating additional positive data over that timeframe could support a potential partnership with a large pharmaceutical company to fund further trial work and eventual commercialization. He also said Anixa has applied for government funding sources, while acknowledging uncertainty around grant outcomes.

Ovarian cancer CAR-T: Naming progress, trial design, and early signals

On the CAR-T program, Kumar said Anixa received non-proprietary name approvals from the World Health Organization and the U.S. Adopted Names (USAN) Council. He described this as a necessary step toward commercialization and said the company expects to transition over time to using the therapy’s name, “locireddir,” while continuing to describe it as Anixa’s CAR-T therapy for ovarian cancer.

Kumar outlined the Phase I trial as primarily a safety study designed to enroll up to 48 patients, split between two delivery methods:

• 24 patients receiving intravenous (IV) delivery
• 24 patients receiving intraperitoneal delivery into the peritoneum, where ovarian cancer lesions typically remain

To date, Kumar said the company has only used peritoneal delivery and plans IV delivery “as a comparator.” He said the peritoneal approach has produced “amazing results,” with no major dose-limiting toxicity observed so far. The study is a dose-escalation trial, and Kumar said Anixa is currently at the fourth dose level and hopes to begin the fifth dose level shortly.

Although Phase I dose levels were expected to be “somewhat subtherapeutic,” Kumar said the company is beginning to see encouraging indicators of efficacy, particularly in overall survival. He emphasized that enrolled patients have failed other therapies and are “essentially terminal,” with a median life expectancy he placed at about 12 weeks. He said some patients have lived substantially longer than expected, including one patient who lived 28 months, and several others in the teens (such as 17, 15, and 14 months), with additional patients at or nearing one year. He also noted that some patients have died within the first three months.

Dose escalation, lymphodepletion, and what Anixa expects to learn in 2026

Kumar said Anixa has sought regulatory and Institutional Review Board (IRB) approval to increase dosing because it has not seen major side effects and hopes higher doses could potentially eliminate tumor lesions. He also said the company is monitoring typical CAR-T safety risks, including cytokine release syndrome and neurological issues known as ICANS, along with laboratory values and overall patient status.

When asked about what is driving outcomes at low doses, Kumar cautioned that only 12 patients have been treated so far and said the sample size is too small to draw statistically meaningful correlations. He nevertheless cited several factors the company believes may contribute:

• A target he described as unique to the cancer cells being attacked, unlike other solid-tumor CAR-T efforts that may also target proteins found on healthy tissues
• A potential anti-angiogenesis effect, in which the CAR-T may be disrupting tumor vasculature
• Peritoneal delivery that keeps therapy localized within the abdominal cavity and may reduce systemic exposure

Kumar also discussed lymphodepletion, a chemotherapy regimen intended to reduce a patient’s existing immune cells to support CAR-T cell engraftment and proliferation. He said lymphodepletion was included in the original protocol but was planned for later cohorts, allowing Anixa, Moffitt, and the FDA to evaluate whether it improves outcomes in solid tumors. He acknowledged that lymphodepletion adds risk—particularly susceptibility to infection—but said the process is routinely managed in leukemia and lymphoma CAR-T treatment and could be justified if it improves overall survival.

For 2026, Kumar said Anixa expects substantially more information from the ovarian cancer CAR-T program, including higher-dose cohorts and lymphodepletion data. He added that the updated protocol allows dosing as high as the highest levels ever tried and approved in CAR-T therapy, and said further escalation could be considered depending on safety and results. On the breast cancer vaccine, he said 2026 will include steps toward initiating Phase II and, once underway, evaluating efficacy via a control arm in which half of participants receive the vaccine and half do not.

About Anixa Biosciences NASDAQ: ANIX

Anixa Biosciences is a clinical-stage immuno-oncology and infectious disease company developing novel cell-based immunotherapies and vaccine platforms. Through its Anixa Therapeutics division, the company is advancing antibody and T-cell modalities, including an ovarian cancer immunotherapy candidate and a COVID-19 vaccine leveraging a proprietary virus-like particle (VLP) technology. Its research pipeline emphasizes modular vaccine design and personalized cancer cell therapy aimed at inducing durable immune responses against solid tumors.

In parallel, Anixa Diagnostics is developing the ADAPT diagnostic platform, a high-throughput proteomics approach using engineered peptides derived from spider venom.

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