Anixa BiosciencesNASDAQ: ANIX

Using the immune system to treat and prevent cancer.

Anixa is a clinical-stage biotechnology company working on cancers that have been difficult to treat. Two programs are in the clinic: a CAR-T therapy for recurrent and resistant ovarian cancer and a vaccine for the treatment and prevention of breast cancer.

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An approach built around the immune system.

Our work is focused on cancers where current treatment options are limited. We develop our programs alongside leading research and clinical institutions, which lets us advance several different scientific approaches at the same time.

Two programs in the clinic

A CAR-T therapy for ovarian cancer and a vaccine for breast cancer. Both have generated human data.

Developed with leading institutions

Active and previous collaborations with Cleveland Clinic, Moffitt Cancer Center, The Wistar Institute, the U.S. Department of Defense, and the National Cancer Institute.

Treatment and prevention

The breast cancer vaccine is being studied for treating existing cancer, preventing recurrence in cancer survivors, and for reducing the chance that it develops in the first place.

Technologies

Two programs, two ways of using the immune system.

A laboratory microscope examining a cell-culture flask
Lira-cel (liraltagene-autoleucel)

An FSHR-targeted CAR-T therapy for ovarian cancer

Ovarian cancer  ·  Phase 1, dose escalation

A therapy that reprograms a patient’s own T-cells to recognize Follicle-Stimulating Hormone Receptor (FSHR), a receptor found on ovarian tumors. It is delivered directly into the abdominal cavity so it can act on tumors there.

  • FSHR targeting. Uses follicle-stimulating hormone as a natural ligand to find tumor cells.
  • Intraperitoneal delivery. Administered into the abdomen rather than the bloodstream.
  • Dose escalation underway. The protocol has been amended to allow higher dose levels.
Read about the CAR-T program
A tray of labelled laboratory sample vials
Breast cancer vaccine

A vaccine that targets a protein linked to breast cancer

The vaccine targets “retired” proteins: ones the body makes only at certain life stages and no longer needs in most adults, but that reappear in certain cancers. It has completed Phase 1.

  • Breast cancer vaccine. Targets alpha-lactalbumin and is being prepared for Phase 2.
  • Studied with Keytruda. No added side effects were seen in the combination.
Read about the breast cancer vaccine program
Pipeline

How far each program has come.

A short summary of each program and the stage it has reached. See the pipeline page for more details.

DiscoveryPreclinicalPhase 1Phase 2/3
Lira-celCAR-T · Ovarian cancer
Phase 1 · dose escalation
Breast cancer vaccineVaccine · Breast cancer
Phase 1 · preparing Phase 2
Status reflects most recent public disclosure.See the full pipeline
Clinical progress

What we have learned in patients so far.

Both programs have been studied in people, not only in the lab. The figures below come from what has been publicly disclosed about the trials to date.

Lira-cel · Ovarian cancer CAR-T

Phase 1, dose escalation in progress

An FSHR-targeted CAR-T therapy delivered directly into the abdominal cavity, studied in heavily pre-treated women with recurrent ovarian cancer.

14patients treated across four dose levels
  • Encouraging survival observations have been reported.
  • Multiple patients survived more than a year past treatment.
  • Therapy has been safe and well tolerated. No observations of cytokine release syndrome.
Breast cancer vaccine

Phase 1 complete, preparing for Phase 2

An alpha-lactalbumin vaccine being studied to treat breast cancer, to prevent recurrence in survivors, and to lower the risk of disease in people at high risk.

35patients dosed across three cohorts
  • Phase 1 study met primary endpoints.
  • Protocol-defined immune responses were observed in 74% of trial participants.
  • Vaccine demonstrated safety and tolerability and combination with Keytruda did not create additional side effects.

For more detail on the company and its clinical trials, see the corporate presentation.

View the corporate presentation

A breast cancer vaccine that could one day prevent the disease before it starts.

Fox NewsFox News · on Anixa's breast cancer vaccine
Partners

Developed with leading cancer institutions and partners.

Each program is developed with a research or clinical institution and partner that brings deep scientific expertise and access to patient care, so Anixa can advance more than one program at a time.

Moffitt Cancer CenterThe Wistar InstituteCleveland Clinic
U.S. Department of DefenseNational Cancer Institute

FAQs

A few things investors and newcomers ask most often. For filings and disclosures, visit the investor relations site.

What stage are Anixa's programs in?
Two programs are in human trials. The ovarian cancer CAR-T (lira-cel) is in Phase 1 with dose escalation underway. The breast cancer vaccine has completed Phase 1 and is preparing for Phase 2.
How is the vaccine meant to prevent cancer?
The vaccine trains the immune system to recognize “retired” proteins, ones the body makes only at certain life stages and no longer needs in most adults, but that reappear in certain cancers. It is being studied to treat existing cancer, to prevent recurrence in survivors, and to lower risk in people at high risk.
Who does Anixa develop its programs with?
Each program is developed alongside a leading research or clinical institution and partner, including Cleveland Clinic, Moffitt Cancer Center, The Wistar Institute, the National Cancer Institute, and the U.S. Department of Defense. This lets Anixa advance several approaches at once without building all of the infrastructure in-house.
Where can I find financial filings and disclosures?
Anixa trades on the NASDAQ under ANIX. SEC filings, press releases, and stock information are available on the investor relations site at ir.anixa.com.

Follow Anixa's programs as they progress.

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