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Recent press releases and 8-K filings for ANIX.
Anixa Biosciences Reports Impressive Phase I Breast Cancer Vaccine Data and Outlines Phase II Plans
ANIX
New Projects/Investments
- Anixa Biosciences (ANIX) announced impressive final data from its breast cancer vaccine program's Phase I study, presented at the 2025 San Antonio Breast Cancer Symposium.
- The Phase I study demonstrated the vaccine's safety, with only injection site irritation reported, and showed strong immune responses in 75% of women across three cohorts.
- The vaccine utilizes a novel "retired protein" strategy, targeting a protein expressed only in cancer cells to avoid autoimmune issues.
- Anixa plans to initiate a Phase II study next year (2026) in a neoadjuvant setting, combining the vaccine with Keytruda, enrolling 80-100 women.
- The company aims to secure pharmaceutical partnerships to fund future trials and commercialization, leveraging early data from the open-label Phase II trial.
Dec 15, 2025, 6:00 PM
Anixa Biosciences Reports Positive Phase I Breast Cancer Vaccine Results and Outlines Phase II Strategy
ANIX
New Projects/Investments
- Anixa Biosciences presented impressive final data from its breast cancer vaccine program's Phase I study at the 2025 San Antonio Breast Cancer Symposium, demonstrating the vaccine was safe with only injection site irritation and elicited strong immune responses in 75% of women.
- The breast cancer vaccine utilizes a novel strategy by targeting a protein (alpha-lactalbumin) that is expressed exclusively during lactation and in cancer cells, thereby aiming to prevent autoimmune responses.
- Anixa plans to advance the breast cancer vaccine to a Phase II study in a neoadjuvant setting, combining it with Keytruda, with an anticipated enrollment of 80-100 women and a goal to begin the trial next year (2026).
- The company has transferred the Investigational New Drug (IND) application for the breast cancer vaccine from Cleveland Clinic to Anixa and intends to meet with the FDA early next year to discuss the subsequent steps.
Dec 15, 2025, 6:00 PM
Anixa Presents Positive Phase 1 Breast Cancer Vaccine Data and Outlines Phase 2 Plans
ANIX
New Projects/Investments
Guidance Update
- Anixa presented impressive final data from its breast cancer vaccine program's Phase 1 study at the 2025 San Antonio Breast Cancer Symposium.
- The Phase 1 study confirmed the vaccine's safety, with no side effects beyond injection site irritation, and demonstrated strong immune responses in 75% of women across all cohorts.
- The vaccine utilizes a novel targeted protein strategy by targeting alpha-lactalbumin, a protein expressed only in breast cancer cells (and during lactation), which aims to prevent autoimmune issues.
- Anixa plans to initiate a Phase 2 study next year in a neoadjuvant setting, combining the vaccine with Keytruda, with an anticipated enrollment of 80 to 100 women.
- The Investigational New Drug (IND) sponsorship has been transferred from Cleveland Clinic to Anixa, and regulatory submissions to the FDA are expected early next year to discuss the next steps.
Dec 15, 2025, 6:00 PM
Anixa Biosciences Assumes Breast Cancer Vaccine IND Sponsorship
ANIX
New Projects/Investments
- Anixa Biosciences has completed the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic, making Anixa the new trial sponsor.
- Following encouraging immune response and safety data observed in the completed Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial.
- The vaccine targets α-lactalbumin, aiming to provide both therapeutic and preventive benefits for breast cancer patients.
Dec 15, 2025, 1:45 PM
Anixa Biosciences Announces Positive Phase 1 Data for Breast Cancer Vaccine
ANIX
New Projects/Investments
- Anixa Biosciences announced positive final Phase 1 clinical trial data for its investigational breast cancer vaccine.
- The vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose, and elicited protocol-defined immune responses in 74% of participants.
- These results support the advancement of the program into Phase 2 development.
- A combination of Keytruda and the vaccine also generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients.
Dec 11, 2025, 11:34 PM
Anixa Biosciences Announces Positive Phase 1 Breast Cancer Vaccine Data
ANIX
New Projects/Investments
- Anixa Biosciences announced positive final Phase 1 clinical trial data for its investigational breast cancer vaccine on December 11, 2025.
- The vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose, and elicited protocol-defined immune responses in 74% of participants.
- The combination of the vaccine with Keytruda also generated antigen-specific T cell responses and showed no major additional side effects.
- These results support the advancement of the program into Phase 2 development.
Dec 11, 2025, 11:02 PM
Anixa Biosciences Secures Key U.S. Patent for Breast Cancer Vaccine
ANIX
New Projects/Investments
Product Launch
- Anixa Biosciences announced the upcoming issuance of U.S. Patent Number 12,472,205 on November 18, 2025, which covers key aspects of its breast cancer vaccine technology.
- This patent extends intellectual property protection into the mid-2040s for the breast cancer vaccine program, which targets the α-lactalbumin protein.
- The vaccine, developed with Cleveland Clinic, aims to address the significant unmet need for an FDA-approved vaccine to prevent breast cancer.
Nov 12, 2025, 2:00 PM
Anixa Biosciences Discusses Clinical Programs, Financial Strategy, and Breast Cancer Vaccine Data
ANIX
New Projects/Investments
Guidance Update
- Anixa Biosciences, a clinical-stage biotech company, is developing a novel CAR-T cell therapy for terminally ill ovarian cancer patients and a vaccine for the treatment and prevention of breast cancer.
- The breast cancer vaccine program completed Phase I studies, demonstrating safety (only injection site irritations) and an immune response in the majority of patients. Final data from 35 patients was presented on December 11th, 2025, at the San Antonio Breast Cancer Symposium.
- The company maintains a low annual cash burn of $5 million-$7 million, partly due to strategic partnerships, including the breast cancer vaccine trial being fully funded by the U.S. Department of Defense.
- Anixa has capital for the next two and a half years and plans to secure future funding through additional government grants, partnerships with pharma companies, or raising capital from Wall Street, while emphasizing a clean capital structure with no outstanding warrants.
Nov 11, 2025, 7:00 PM
Anixa Biosciences Provides Update on Clinical Programs and Financial Strategy
ANIX
New Projects/Investments
Guidance Update
- Anixa Biosciences (ANIX) is advancing two clinical-stage programs: a novel CAR-T cell therapy for ovarian cancer and a breast cancer vaccine.
- The breast cancer vaccine completed Phase I studies, with comprehensive data on 35 patients presented on December 11, 2025, at the San Antonio Breast Cancer Symposium. Preliminary data released prior to the presentation indicated the vaccine was safe and induced an immune response.
- The company maintains a low annual cash burn rate of $5 million-$7 million and has capital to fund operations for approximately two and a half years.
- Anixa is committed to a clean capital structure, avoiding warrants and debt, and plans to secure future funding through grants, pharmaceutical partnerships, or capital markets to minimize shareholder dilution.
Nov 11, 2025, 7:00 PM
Anixa Biosciences Executes Data Transfer Agreement with Cleveland Clinic
ANIX
New Projects/Investments
- Anixa Biosciences has executed a Data Transfer Agreement (DTA) with Cleveland Clinic, a key step in transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa.
- This agreement will allow Anixa to assume full sponsorship of the Investigational New Drug (IND) and advance the vaccine into a Phase 2 clinical trial.
- The Phase 1 trial for the breast cancer vaccine observed encouraging immune response data.
- Cleveland Clinic is scheduled to present the final Phase 1 data at the San Antonio Breast Cancer Symposium on December 11.
Nov 5, 2025, 1:55 PM
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