Anixa Biosciences Announces Transfer of IND for Breast Cancer Vaccine from Cleveland Clinic

Anixa Biosciences (NASDAQ: ANIX) announced completion of the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic and is now the trial sponsor for future development.

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) announced completion of the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic and is now the trial sponsor for future development.

Enrollment was completed in Phase 1 with encouraging immune response and safety data, and Anixa plans to advance the vaccine into a Phase 2 clinical trial using multiple clinical sites, including Cleveland Clinic. The vaccine targets α-lactalbumin, a lactation-associated protein re-expressed in many breast cancers. Phase 1 findings were presented on December 11, 2025 at the San Antonio Breast Cancer Symposium.

Positive

• IND transfer completed; Anixa now IND sponsor
• Phase 1 enrollment completed
• Phase 1 showed encouraging immune response
• Phase 1 showed encouraging safety data
• Plan to advance into a Phase 2 clinical trial
• Phase 2 to use multiple clinical sites including Cleveland Clinic

Negative

• None.

Argus Dec 15 session

-8.94% close to close Open Argus

Details

News Market Reaction – ANIX

On Dec 15, the day this news came out, ANIX closed 8.94% below the previous close.

Data tracked by StockTitan Argus for the Dec 15 session.

Market Context

On Dec 15, the day this news came out, the stock closed 8.9% below the previous close. The decline r...

Analysis

On Dec 15, the day this news came out, the stock closed 8.9% below the previous close. The decline reflects a divergence pattern where ANIX has often traded lower after positive clinical or strategic news. The IND transfer makes Anixa the sponsor as it plans a Phase 2 trial, following encouraging Phase 1 results. Yet the stock fell 25.42% on very heavy volume of 2,146,871 shares, suggesting investors may have focused on execution and funding needs, especially given an unused Form S-3 shelf filed on 2025-09-10 that enables future offerings.

Key Figures

Current trial phase: Phase 1 completed Next trial phase: Planned Phase 2

Current trial phase

Phase 1 completed

Breast cancer vaccine clinical development status

Next trial phase

Planned Phase 2

Planned advancement of breast cancer vaccine program

Historical Context

5 past events · Latest: Dec 11

5 events

1. Dec 11

   Phase 1 data update

   24h Move

   -6.4%

   Final Phase 1 vaccine data met endpoints with 74% immune response.

2. Dec 10

   Investor event notice

   24h Move

   +1.4%

   CEO scheduled for fireside chat to discuss Phase 1 data and strategy.

3. Dec 09

   Conference presentation

   24h Move

   -3.1%

   Announcement of upcoming Phase 1 vaccine data presentation at SABCS.

4. Nov 17

   CAR-T naming milestone

   24h Move

   +2.2%

   WHO approved INN ‘liraltagene autoleucel’ for FSHR-targeted CAR-T.

5. Nov 12

   Patent protection

   24h Move

   -4.6%

   New U.S. patent extended breast cancer vaccine IP into the 2040s.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug, phase 1, phase 2, α-lactalbumin

4 terms

investigational new drug regulatory

"completed the transfer of the Investigational New Drug application ("IND") for its breast cancer vaccine"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

phase 1 medical

"With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

phase 2 medical

"Anixa plans to advance the vaccine into a Phase 2 clinical trial"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

α-lactalbumin medical

"targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue"

α-lactalbumin is a naturally occurring protein found in mammalian milk that supplies essential building blocks and supports nutrient absorption; think of it as a concentrated, high-quality protein ingredient used to boost the nutritional value of infant formula, medical nutrition and some supplements. Investors care because its use, purity, and supply affect product claims, regulatory approvals, patent positions and consumer demand in nutrition and health markets—factors that influence revenue and margins.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SAN JOSE, Calif., Dec. 15, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has completed the transfer of the Investigational New Drug application ("IND") for its breast cancer vaccine from Cleveland Clinic. Anixa is now the trial sponsor for future development of its breast cancer vaccine. The transfer of the IND is a natural and planned step in the progresson of the vaccine's development.

With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and has assumed full sponsorship of the IND. Anixa plans to utilize multiple clinical sites, including Cleveland Clinic, for the Phase 2 and other clinical trials.

Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein. The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

"We are excited about assuming sponsorship of the breast cancer vaccine IND, and we look forward to advancing this potentially game-changing cancer vaccine into future clinical trials," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We are pleased with the progress and findings from our Phase 1 clinical trial, which were presented at the San Antonio Breast Cancer Symposium on December 11."

A discussion of the Phase 1 data can be reviewed at https://ir.anixa.com/press-releases.

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. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. 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. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. 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 LinkedIn, X, 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/anixa-biosciences-announces-transfer-of-ind-for-breast-cancer-vaccine-from-cleveland-clinic-302640576.html

SOURCE Anixa Biosciences, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Anixa (ANIX) announce on December 15, 2025 regarding its breast cancer vaccine?

Anixa completed the IND transfer from Cleveland Clinic and assumed sponsorship for future trials.

What were the Phase 1 results for Anixa's breast cancer vaccine (ANIX)?

Phase 1 enrollment was completed and showed encouraging immune response and safety data.

What are Anixa's next steps for the breast cancer vaccine (ANIX)?

Anixa plans to advance into a Phase 2 clinical trial using multiple clinical sites.

Which target does Anixa's breast cancer vaccine (ANIX) focus on?

The vaccine targets α-lactalbumin, a lactation-associated protein re-expressed in many breast cancers.

Will Cleveland Clinic remain involved in Anixa's breast cancer trials (ANIX)?

Yes; Anixa plans to utilize Cleveland Clinic among multiple clinical sites for Phase 2 and other trials.

When were the Phase 1 findings for Anixa's vaccine presented (ANIX)?

Phase 1 findings were presented at the San Antonio Breast Cancer Symposium on December 11, 2025.