Anixa Biosciences Announces Positive Phase 1 Data for Investigational Breast Cancer Vaccine; Primary Endpoints Were Met and Immune Response Observed in 74% of Participants

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) announced final Phase 1 data for its investigational α-lactalbumin (aLA) breast cancer vaccine presented at SABCS on Dec 11, 2025. The trial enrolled 35 participants across three cohorts and met all major primary endpoints. The vaccine was safe and well tolerated at the maximum tolerated dose (MTD), eliciting protocol-defined immune responses in 74% of participants. Combination dosing with pembrolizumab (Keytruda) generated antigen-specific T cell responses with no major additional side effects. Results support advancing to a planned Phase 2 neoadjuvant combination study; participants will be followed for five years. Data were collected in collaboration with Cleveland Clinic and funded by a U.S. Department of Defense grant.

Positive

• 74% of participants showed protocol-defined immune responses
• Vaccine safe and well tolerated at the MTD
• Combination with Keytruda produced antigen-specific T cell responses
• Study funded by a U.S. Department of Defense grant

Negative

• Small Phase 1 sample size of 35 participants
• aLA expression varied from absent to strong in tumor IHC
• Two participants experienced Grade 3 injection-site adverse events
• Phase 2 timing and regulatory path not specified; longer follow-up required

Key Figures

Immune response rate 74% Phase 1 breast cancer vaccine participants with protocol-defined immune responses

Phase 1 enrollment 35 participants Total participants across three vaccine trial cohorts

Cohort Ia size 26 women Early-stage TNBC, post standard-of-care, elevated recurrence risk

Cohort Ib size 4 women Cancer-free, BRCA1/BRCA2/PALB2 mutation carriers pre-preventive mastectomy

Cohort Ic size 5 women TNBC patients receiving pembrolizumab with vaccine in adjuvant setting

Grade 3 events 2 patients Cohort Ic participants with Grade 3 injection-site irritation

Follow-up duration 5 years Planned follow-up period after completing Phase 1 study

Phase 1 endpoints All major primary endpoints met Safety and immune response at maximum tolerated dose

Market Reality Check

$4.80 Last Close

Volume Volume 582,509 is 2.28x the 20-day average of 255,557, indicating elevated trading interest pre-news. high

Technical Shares at $4.80 are trading above the 200-day MA of $3.34, despite a -6.43% move.

Peers on Argus 1 Down

ANIX fell 6.43% while sector peers were mixed; only PYXS appeared in momentum screens, down 5.90%, suggesting ANIX’s move was more stock-specific than a broad biotech rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 10	Investor event	Neutral	+1.4%	CEO fireside chat to discuss final Phase 1 breast cancer vaccine data.
Dec 09	Conference preview	Positive	-3.1%	Announcement of upcoming Phase 1 aLA vaccine data presentation at SABCS.
Nov 17	Regulatory naming win	Positive	+2.2%	WHO approval of INN for FSHR-targeted CAR-T therapy and Phase 1 progress.
Nov 12	IP expansion	Positive	-4.6%	New U.S. patent issuance extending breast cancer vaccine IP into mid-2040s.
Nov 10	Investor outreach	Neutral	+0.0%	Announcement of fireside chat covering company overview and clinical programs.

Pattern Detected

Recent catalysts show mixed reactions: some positive developments (IP, trial and naming milestones) led to gains, while others, including vaccine-related updates, coincided with short-term pullbacks, indicating inconsistent trading responses to news.

Recent Company History

Over the last two months, ANIX has highlighted multiple pipeline and visibility milestones. Breast cancer vaccine updates, from IP expansion on Nov 18, 2025 to symposium preview and investor events, produced both gains and pullbacks. The ovarian cancer CAR-T program also advanced with WHO naming and ongoing Phase 1 dosing. Today’s Phase 1 breast cancer vaccine data, confirming primary endpoints and safety at the MTD, follows October’s announcement that the final patient visit was completed and >70% showed immune responses, reinforcing continuity of this program’s clinical narrative.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-09-10

ANIX filed an active Form S-3 shelf on Sep 10, 2025, allowing potential offerings of common and preferred stock, warrants, subscription rights, depositary shares, purchase contracts, and units. The prospectus indicates net tangible book value per share of $0.46 as of Jul 31, 2025 and outlines estimated total offering expenses of $96,146, providing a framework for future capital-raising flexibility.

Market Pulse Summary

The stock is surging +36.7% following this news. A strong positive reaction aligns with ANIX’s history of sizable moves on clinical headlines, where prior trial updates averaged about 10.72% moves. The Phase 1 breast cancer vaccine data confirmed safety at the MTD and a 74% immune response rate, extending earlier preliminary signals. However, an effective Form S-3 shelf and the company’s development-stage profile mean investors have to weigh potential future equity issuance and typical biotech volatility when assessing durability of any sharp advance.

Key Terms

triple-negative breast cancer medical

""Triple-negative breast cancer remains one of the most challenging subtypes...""

Triple-negative breast cancer is a type of breast cancer that lacks three common markers used to identify and treat the disease effectively. Because it doesn’t respond to some targeted therapies, it can be more difficult to treat and may have a more aggressive progression. This impacts the development of new treatments and can influence the outlook for healthcare companies involved in cancer research and pharmaceuticals.

maximum tolerated dose medical

"was safe and well tolerated at the maximum tolerated dose (MTD)"

Maximum tolerated dose is the highest amount of a substance, such as a medication or chemical, that can be used without causing unacceptable side effects or harm. It’s like finding the maximum speed you can drive without risking a ticket or accident. For investors, understanding this concept helps gauge how much risk or exposure is safe or sustainable in a given situation.

pembrolizumab medical

"women with TNBC receiving pembrolizumab (Keytruda) in the adjuvant setting"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

neoadjuvant medical

"plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer"

"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.

adjuvant medical

"pembrolizumab (Keytruda) in the adjuvant (post-surgery) setting"

An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.

AI-generated analysis. Not financial advice.

Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose

Results Support Advancement of the Program into Phase 2 Development

Combination of Keytruda^® and the vaccine 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

SAN JOSE, Calif., Dec. 11, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the presentation of final data from the Phase 1 clinical trial of its investigational breast cancer vaccine (NCT04674306) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The trial was conducted in collaboration with Cleveland Clinic and funded by a grant from the U.S. Department of Defense.

Final Phase 1 findings showed the investigational vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose (MTD), and elicited protocol-defined immune responses in 74% of participants. The presentation, titled "Final Results of a Phase I Trial of Alpha-lactalbumin (aLA) Vaccine for Breast Cancer," was delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the breast cancer vaccine technology. The SABCS poster presentation is available at https://ir.anixa.com/events.

"Triple-negative breast cancer remains one of the most challenging subtypes to address, and Phase 1 trials are an important step in determining whether a new approach can be administered safely and activate the immune system as intended," said G. Thomas Budd, M.D., of Cleveland Clinic's Cancer Institute and principal investigator of the study. "In this trial, the investigational α-lactalbumin vaccine was safe and well tolerated at the maximum tolerated dose and generated protocol-defined immune responses in 74% of participants—results that support continued clinical evaluation."

Topline Phase 1 results:

• All major primary endpoints were met
• 74% of participants demonstrated protocol-defined immune responses; α-lactalbumin (aLA)-specific T cell responses were observed per protocol-defined criteria
• Vaccine was safe and well tolerated at the MTD, with adverse events primarily injection-site irritation
• Preliminary Immunohistochemistry (IHC) of primary tumors showed aLA expression ranging from absent to strong; analyses correlating expression to immune response and clinical outcomes are ongoing
• Participants will be followed for five years after completing the study
• Combination of Keytruda and the vaccine also generated antigen-specific T cell responses and showed no major additional side effects
• Data will inform planned Phase 2 study design, including a potential Phase 2 combination study with Keytruda in the neoadjuvant setting among newly diagnosed breast cancer patients

The Phase 1 study evaluated safety and monitored immune response to an investigational vaccine targeting α-lactalbumin (aLA). The trial enrolled 35 participants across three cohorts: Cohort Ia (n=26), women who completed standard-of-care treatment, including surgery, for early-stage TNBC within three years and were tumor-free but at elevated risk of recurrence; Cohort Ib (n=4), cancer-free women with BRCA1, BRCA2, or PALB2 mutations who elected preventive mastectomy and were vaccinated prior to surgery; and Cohort Ic (n=5), women with TNBC receiving pembrolizumab (Keytruda) in the adjuvant (post-surgery) setting, with evaluation of safety of combination administration and immune responses.

In Cohort Ia, at the MTD, the vaccine was reported as safe, with no flu-like symptoms (fever and myalgias), no abnormal clinical laboratory tests, and no other observed adverse side effects in this cohort; the primary notable adverse event was injection-site irritation. Participants demonstrated aLA-specific T cell responses, including production of interferon gamma and interleukin-17.

In Cohort Ib, safety and tolerability were similar to Cohort Ia. Immunohistochemistry analyses of resected breast tissue are ongoing and will be presented in a future scientific presentation.

In Cohort Ic, a key objective was to assess whether administration of the investigational vaccine in combination with pembrolizumab could create intolerable side effects. No major adverse side effects were reported; as in other cohorts, the primary adverse event was injection-site irritation. Two participants experienced Grade 3 adverse events consisting of greater irritation at an injection site.

The investigational vaccine targets α-lactalbumin, a lactation protein generally expressed in the breast during lactation but not at other times in life or in other normal tissues. In many breast cancers, malignant cells express α-lactalbumin. The vaccine is designed to activate the immune system to direct cytotoxic T cells toward tumor cells expressing α-lactalbumin, with the goal of providing preemptive immune protection against emerging tumors that express this antigen.

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.

"It was Dr. Tuohy's hope that this vaccine would demonstrate the potential of immunization as a new way to combat breast cancer, and that a similar approach could someday be applied to other types of malignancies," said Dr. Johnson. "Our findings that the majority of participants across all three cohorts demonstrated an immune response to α-lactalbumin is an encouraging sign."

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are very encouraged that the final Phase 1 data met all major primary endpoints, with the vaccine demonstrating a favorable tolerability profile at the MTD and protocol-defined immune responses in the majority of participants. We appreciate the support provided through the U.S. Department of Defense grant that enabled this study in collaboration with Cleveland Clinic, and we look forward to engaging with regulators and advancing plans for a Phase 2 study."

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

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SOURCE Anixa Biosciences, Inc.

FAQ

What did Anixa announce about the aLA breast cancer vaccine on Dec 11, 2025 (ANIX)?

Anixa reported Phase 1 final data showing primary endpoints met, safety at the MTD, and 74% immune responses in 35 participants.

How did the aLA vaccine perform with Keytruda in the ANIX Phase 1 trial?

Combination dosing with pembrolizumab (Keytruda) generated antigen-specific T cell responses and showed no major additional side effects.

What safety signals emerged from Anixa's Phase 1 aLA vaccine trial (ANIX)?

The vaccine was generally well tolerated at the MTD; adverse events were mainly injection-site irritation and two Grade 3 injection-site events.

Does Anixa plan a Phase 2 study for the aLA vaccine (ANIX)?

Yes; the company said Phase 1 data will inform a planned Phase 2 neoadjuvant combination study with Keytruda in newly diagnosed breast cancer patients.

How many participants were in Anixa's Phase 1 aLA vaccine trial (ANIX) and how long will they be followed?

The trial enrolled 35 participants across three cohorts; participants will be followed for five years after study completion.