Anixa Biosciences Enters Letter of Intent with VERDI Solutions to Develop Artificial Intelligence-Guided Personalized and Off-the-Shelf Cancer Vaccines

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) has entered into a letter of intent with VERDI Solutions to develop AI-guided personalized and off-the-shelf peptide vaccines for cancer patients. VERDI's cloud-computing platform enables rapid development of personalized vaccines tailored to individual cancer patients.

The agreement grants Anixa a six-month exclusive right to negotiate the research, development, and commercialization of VERDI's cancer vaccines. VERDI has already demonstrated success in three patients with bone metastases under Europe's Individueller Heilversuch program, where patients experienced clinical benefits including significant pain relief and improved quality of life.

VERDI's proprietary algorithm predicts vaccine efficacy in recognizing and eliminating tumor cells at an individual level. While VERDI continues developing personalized vaccines in Europe, both companies plan to initiate clinical trials in the United States.

Positive

• Initial clinical benefits demonstrated in three patients with bone metastases
• Six-month exclusive negotiation rights secured for research and commercialization
• AI and cloud computing platform enables rapid personalized vaccine development
• Existing regulatory pathway in Europe allows for real-world treatment data collection

Negative

• Further clinical validation still required to prove efficacy
• Only preliminary data from three patients available
• Final agreement terms not yet established - only letter of intent signed

VERDI's personalized vaccines have demonstrated safety and efficacy in cancer patients

SAN JOSE, Calif., March 25, 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 entered into a letter of intent with VERDI Solutions, GmbH to develop personalized and off-the-shelf peptide vaccines for cancer patients.

VERDI Solutions, headquartered in Vienna, Austria, is pioneering personalized cancer treatment by integrating artificial intelligence (AI) and advanced cloud computing to accelerate the development and implementation of personalized cancer vaccines. By combining computerized vaccine design with real-world data collection and clinical trials, VERDI is making personalized cancer vaccines accessible to more patients worldwide. At the core of VERDI's innovation is its cloud-computing platform, which enables the rapid development of personalized peptide vaccines tailored to individual cancer patients. Additionally, the company is developing off-the-shelf cancer vaccines, paired with companion diagnostics to identify likely responders and optimize treatment outcomes.

In some European countries, oncologists may administer personalized cancer vaccines under Individueller Heilversuch (Individual Healing Attempt), which allows physicians to prescribe individualized treatments for patients with life-threatening conditions who lack satisfactory therapeutic alternatives. Unlike clinical trials, where only a limited number of eligible patients can be enrolled, Heilversuch offers an innovative treatment option for any cancer patient, potentially providing valuable insights into the efficacy and safety of personalized vaccines in real-world settings. Moreover, Heilversuch aligns with the increasing recognition by global regulatory agencies of real-world evidence (RWE) as a critical component of drug development. VERDI is pioneering a data-driven approach to accelerating regulatory validation and commercialization of personalized cancer vaccines.

VERDI has successfully developed personalized vaccines using sequence data from the primary tumors for three patients with bone metastases, which were administered by their oncologists under Heilversuch. These patients experienced clinical benefits, including significant pain relief caused by bone metastases and improved quality of life. While these outcomes highlight the potential of VERDI's platform to scale personalized cancer care, further clinical validation is needed.

Under the letter of intent, VERDI has granted Anixa a six-month exclusive right to negotiate a transaction for the research, development, and commercialization of VERDI's cancer vaccines. While VERDI continues to develop personalized vaccines for individual treatment attempts in Europe, VERDI and Anixa plan to initiate clinical trials in the United States.

"We utilize advanced cloud computing to develop a set of personalized VERDI vaccines for each patient from their sequence data. Our proprietary algorithm predicts the efficacy of the vaccines to recognize and eliminate tumor cells in the individual patient. Our unique approach models the complex mechanisms of tumor-specific immune responses at an individual level, potentially enabling faster and more effective personalized vaccine development using state-of-the-art science compared to existing neoantigen-based cancer vaccines. Our initial results in three patients are highly encouraging, and we are eager to demonstrate broader clinical benefits in additional patients," stated Dr. Julianna Lisziewicz, Founder and CEO of VERDI.

Dr. Amit Kumar, Chairman and CEO of Anixa stated, "We are very pleased to be working with VERDI Solutions on this exciting technology that has already demonstrated benefit to terminally ill patients. The letter of intent with VERDI provides us with the optionality to collaborate on the further development of VERDI's technology, while preserving our ability to structure the relationship in a way that is mutually beneficial to both parties. Additionally, partnering with VERDI aligns with our strategy of implementing a capital-efficient business model for personalized cancer care."

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. 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. 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 Twitter, LinkedIn, 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 is the partnership between Anixa Biosciences (ANIX) and VERDI Solutions?

Anixa has secured a 6-month exclusive right to negotiate the research, development, and commercialization of VERDI's AI-guided cancer vaccines, both personalized and off-the-shelf versions.

What clinical results has VERDI Solutions shown for their cancer vaccines?

VERDI has treated three patients with bone metastases, who experienced clinical benefits including significant pain relief and improved quality of life.

How does VERDI's cancer vaccine technology work?

VERDI uses AI and cloud computing to develop personalized peptide vaccines based on individual patient tumor sequence data, with an algorithm predicting vaccine efficacy.

What are the next steps for Anixa (ANIX) and VERDI's cancer vaccine development?

While VERDI continues treatments in Europe, both companies plan to initiate clinical trials in the United States.

What is the significance of the Individueller Heilversuch program for VERDI's vaccine development?

This European program allows physicians to prescribe individualized treatments for life-threatening conditions, enabling VERDI to collect real-world evidence on their vaccines' efficacy.