Anixa Biosciences Advances Breast Cancer Vaccine Toward Phase 2 After Positive Phase 1 Results; Cytovance Selected for cGMP Manufacturing

Anixa Biosciences (NASDAQ: ANIX) reported positive final Phase 1 results for its α-lactalbumin breast cancer vaccine and has engaged Cytovance Biologics to produce cGMP clinical material for a planned Phase 2 trial.

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) reported positive final Phase 1 results for its α-lactalbumin breast cancer vaccine and has engaged Cytovance Biologics to produce cGMP clinical material for a planned Phase 2 trial.

The Phase 1 study met primary endpoints, showed safety and tolerability at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants.

Positive

• 74% immune response rate in Phase 1 participants
• Phase 1 met primary endpoints with safety and tolerability at MTD
• Cytovance agreement for cGMP clinical material to support planned Phase 2
• Advancing to Phase 2 preparations following final Phase 1 data

Negative

• None.

Argus Apr 1 session

+5.43% close to close Open Argus

Details

News Market Reaction – ANIX

On Apr 1, the day this news came out, ANIX closed 5.43% above the previous close.

Data tracked by StockTitan Argus for the Apr 1 session.

Market Context

On Apr 1, the day this news came out, the stock closed 5.4% above the previous close. A strong posit...

Analysis

On Apr 1, the day this news came out, the stock closed 5.4% above the previous close. A strong positive reaction aligns with the clearly favorable Phase 1 data, including protocol-defined immune responses in 74% of participants and a clean safety profile at the maximum tolerated dose. Historically, ANIX’s clinical updates have produced both rallies and sharp drops, so investors watching a big gain may consider that prior breast vaccine data on Dec 11, 2025 coincided with a -25.42% move, highlighting potential volatility as the program advances.

Key Figures

Immune response rate: 74% of participants Trial phase: Phase 2 planned

Immune response rate

74% of participants

Phase 1 breast cancer vaccine trial protocol-defined immune responses

Trial phase

Phase 2 planned

Next-stage clinical trial for breast cancer vaccine following Phase 1 results

Previous Clinical trial Reports

5 past events · Latest: Mar 30

Same Type 5 events

1. Mar 30

   Ovarian CAR-T update

   24h Move

   -2.0%

   Conference presentation update on Phase 1 ovarian cancer CAR-T trial design and status.

2. Dec 11

   Breast vaccine data

   24h Move

   -25.4%

   Positive Phase 1 breast cancer vaccine data with 74% immune responses presented at SABCS.

3. Oct 07

   Trial visit completion

   24h Move

   +26.5%

   Completion of final patient visit in Phase 1 breast cancer vaccine trial with >70% responses.

4. Sep 08

   CAR-T dosing escalation

   24h Move

   +0.3%

   Completion of fourth cohort dosing in ovarian CAR-T trial with higher cell dose and no DLTs.

5. Aug 18

   CAR-T cohort progress

   24h Move

   +0.3%

   Second patient treated in fourth cohort of ovarian cancer CAR-T trial at higher cell dose.

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

Key Terms

cGMP, cdmo, α-lactalbumin, maximum tolerated dose, +1 more

5 terms

cGMP technical

"to produce cGMP clinical materials for its planned Phase 2 clinical trial"

cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

cdmo technical

"a leading full-service contract development and manufacturing organization ("CDMO")"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

α-lactalbumin medical

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

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.

maximum tolerated dose medical

"was safe and well tolerated at the maximum tolerated dose, and generated"

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.

immunotherapy medical

"advance this promising immunotherapy candidate."

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

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

Phase 1 study met primary endpoints, showed safety and tolerability at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants

SAN JOSE, Calif., April 1, 2026 /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 entered into a development and manufacturing agreement with Cytovance Biologics (www.cytovance.com), a leading full-service contract development and manufacturing organization ("CDMO") specializing in mammalian and microbially expressed biologics, to produce cGMP clinical materials for its planned Phase 2 clinical trial of its breast cancer vaccine.

The agreement follows positive final Phase 1 results in which the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. Based on these results, Anixa is advancing preparations for a Phase 2 clinical trial.

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 generating an immune response against α-lactalbumin-expressing cells, the vaccine is designed to potentially provide 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.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "With final Phase 1 data demonstrating safety, tolerability, and strong immune responses in 74% of participants, we are focused on advancing this program toward Phase 2. Our agreement with Cytovance represents an important operational milestone as we work to secure cGMP clinical supply for the next stage of development." Dr. Kumar continued, "As we advance toward the Phase 2 trial, we expect to provide near-term updates on our progress."

"We are pleased to partner with Anixa to manufacture clinical materials for its Phase 2 breast cancer vaccine trial," said Ping Zhang, CEO of Cytovance Biologics. "Our team is committed to delivering high-quality cGMP manufacturing solutions that support innovative biotech programs. We look forward to leveraging our development and production capabilities to help advance this promising immunotherapy candidate."

About Cytovance
Cytovance Biologics is an established CDMO specializing in the expression and production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. For 20 years, Cytovance has offered flexibility and ingenuity across a full range of integrated services, supporting clients on their journey from molecule to commercial manufacturing. Learn more about Cytovance Biologics at www.cytovance.com.

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 liraltagene autoleucel, or lira-cel, an ovarian cancer immunotherapy 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.

Anixa Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

Cytovance Media Contact:
Emily Steinhauer
esteinhauer@cglife.com
203-218-9906

View original content to download multimedia:https://www.prnewswire.com/news-releases/anixa-biosciences-advances-breast-cancer-vaccine-toward-phase-2-after-positive-phase-1-results-cytovance-selected-for-cgmp-manufacturing-302730803.html

SOURCE Anixa Biosciences, Inc.

FAQ

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

What did Anixa (ANIX) announce on April 1, 2026 about its breast cancer vaccine?

Anixa announced positive Phase 1 results and a manufacturing agreement with Cytovance. According to the company, Phase 1 met primary endpoints, was safe at the maximum tolerated dose, and produced protocol-defined immune responses in 74% of participants.

How will the Cytovance agreement affect Anixa (ANIX) Phase 2 plans?

The Cytovance deal secures cGMP clinical material for a planned Phase 2 trial. According to the company, the development and manufacturing agreement supports operational readiness as Anixa advances preparations toward Phase 2.

What clinical result metric did Anixa (ANIX) report from Phase 1 on April 1, 2026?

Anixa reported protocol-defined immune responses in 74% of Phase 1 participants. According to the company, the study also met primary endpoints and showed safety and tolerability at the maximum tolerated dose.

Does the April 1, 2026 announcement confirm a Phase 2 trial start date for Anixa (ANIX)?

No specific Phase 2 start date was announced in the April 1, 2026 release. According to the company, it is advancing preparations and expects to provide near-term updates on progress toward Phase 2.

What is the vaccine target described by Anixa (ANIX) in the April 1, 2026 release?

The vaccine targets α-lactalbumin, a lactation-associated protein re-expressed in many breast cancers. According to the company, the vaccine aims to generate immune responses against α-lactalbumin-expressing tumor cells for therapeutic and preventive potential.