ANIX HAS TWO VACCINES AIMED TO PREVENT BREAST CANCER AND OVARIAN CANCER
ANIX HAD $24 MILLION IN CASH AS OF OCTOBER 2023
We Saw More Insider Buying Over the Past Few Months
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Coming in only after cardiovascular disease, cancer is the second leading cause of death worldwide; unsurprisingly, oncology is one of the biggest sectors around.
As devastating as cancer is, it’s also a big business. And when cancer and Wall Street collide, it can lead to substantial opportunities to capitalize. It’s no wonder investors are turning their eyes toward healthcare companies specializing in oncology
Precedence Research projects that the global oncology market will increase at a compound annual growth rate of 8.2 percent to reach US$581.25 billion in 2030.
Players in the oncology sector are thriving. Biotech stocks experienced a lift in early December after it was learned that AbbVie will be buying cancer developer ImmunoGen for $10 billion!
Scientific advances are creating new and previously only imaginable ways to treat and prevent diseases.
Anixa Biosciences, Inc. is developing therapies and vaccines that are focused on critical unmet needs in oncology.
ANIX is a clinical-stage biotechnology company developing first-in-class products for cancer treatment and prevention. Anixa’s programs use the body’s immune system to take multiple approaches in fighting cancer—vaccines to prevent cancer, and a CAR-T cell therapy to treat cancer.
The Company’s vaccines focus on immunizing against “retired” proteins found to be expressed in certain forms of cancer. This mechanism has never before been utilized for cancer vaccine development. Anixa’s lead vaccine program targets triple negative breast cancer (TNBC), the most aggressive and lethal form of the disease. Anixa’s second preventative vaccine targets ovarian cancer. The breast cancer vaccine is being studied in a Phase 1 clinical trial with Cleveland Clinic, while the ovarian cancer vaccine is in pre-clinical development. Anixa’s cancer treatment program, also targeting ovarian cancer, explores an immunotherapy using a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology. This therapy is in a Phase 1 clinical trial with Moffitt Cancer Center.
By partnering with world-renowned research institutions on clinical development, Anixa maintains a capital- efficient and low-cost business model that facilitates ongoing identification and examination of emerging technologies in complementary fields for potential development and commercialization.
Check out the Insider Buying from Last Month Which Sparked a Double Digit Rally in ANIX
Investment Highlights
Robust pipeline in oncology/immunology. Multiple value-creating catalysts for clinical programs over next 12 months: 3 candidates, 2 modalities, 3 indications, 2 clinical trials.
Positive Phase 1 clinical data. Breast cancer vaccine: 75% of women showed immune responses with responses observed at all dose levels. Ovarian cancer immunotherapy: no dose-limiting toxicities observed in 1st cohort.
Strong financial profile. Capital-efficient, low-cost business model with research support from key partners. ~$5-6M annual cash burn since 2017. Cash and equivalents of $24M and $0 debt (10/31/23).
Clean capital structure. 31M common shares outstanding, no preferred shares, and no warrants.
High-value partnerships. Licensing, funding, and collaboration with top-tier, world- renowned research organizations and institutions.
Significant TAM opportunity. ~3.8M breast cancer survivors1. ~230,000 women living with ovarian cancer1. All women potentially eligible for vaccines: ~168M in the U.S. alone.
Proven management and board. Decades of success in starting, building, managing, and investing in technology-related companies. Scientific advisory from renowned doctors in oncology research.
Consistent Insider Buying. Consistent stock purchases by CEO and Board insiders.
The Company’s vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple-negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer.
These vaccine technologies focus on immunizing against “retired” proteins that are expressed in certain forms of cancer.
THE CAR-T METHOD:
The exciting field known as immunotherapy has enabled the development of drugs that modulate the immune system to battle cancer.We know that our bodies, through the function of our immune systems, are able to “cure” cancer. It is now known that some number of cells in our bodies are becoming cancerous all the time. These transformations are driven by many factors including genetics and environment.
Most of the time without us being consciously aware, these cells are destroyed and cleared by our immune system. As our immune function declines with age, some cells are able to survive and eventually become tumors, either liquid or solid. We also know that the tumors themselves have developed mechanisms to suppress immune cell function. Such is the case with pediatric tumors as well adult cancers.
Considering this understanding, the field of immunotherapy tries to boost the ability of our immune cells to battle the cancer. There are a number of methods that scientists have devised to induce our immune systems to battle cancer. One of those approaches is known a Chimeric Antigen Receptor T-cell technology, better known by the acronym, CAR-T.
CAR-T therapy is a treatment where a patient’s T-cells, a type of immune cell, are removed from the body. These cells are then modified in a laboratory through the advanced techniques of genetic engineering, and increased in number, and then infused back into the patient. In many ways, this is the ultimate personalized medicine. The specific genetic engineering is what makes the patient’s own T-cells even more powerful as a tumor fighter. This genetic engineering causes a special receptor to be present on the surface of the T-cell. This receptor is known as the CAR—the Chimeric Antigen Receptor.
The pharmaceutical industry continues to be a hotbed of innovation and CAR-T cell-based compositions are a key innovation area in immuno-oncology!
CAR-T THERAPY FOR OVARIAN CANCER:
The markets for solid tumors are much larger than the markets for leukemias and lymphomas, especially B-cell cancers. Therefore, ANIXfeels that the scope of opportunities for its CAR- T therapy is very large should the company demonstrate efficacy in solid tumors.
ANIX’S FIRST INDICATION WILL BE OVARIAN CANCER, FOLLOWED BY OTHER TUMOR TYPES.
- ↪Ovarian cancer is the sixth most common cancer in the world, and one of the most aggressive reproductive cancers among women. Most ovarian cancers are diagnosed at late stages (stage 3 or 4) due to the typical absence of symptoms and lack of screening approaches.
- ↪Late-stage diagnosis results in relatively high risks of recurrence and often poor prognosis. While the five-year survival rate for stage 1 ovarian cancer is over 80%, the corresponding survival rate for Stage 4 cancer is 20%. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually.
THE FIRST POTENTIAL ANTI-ANGIOGENIC CAR-T THERAPY:
ANIX has an exclusive worldwide license from The Wistar Institute.
The company believes its CER-T approach will work in solid tumors, especially ovarian cancer, where others have failed.
- ↪FSHR is a unique target
- ↪FSH is a natural ligand (not synthetic)
- ↪The company’s approach may provide anti-angiogenic synergy
- ↪The company’s CAR-T may execute a dual mechanism of action in destroying the tumor
PREVIOUS CHALLENGES:
- ↪The CAR-T cells may not br susceptible to the highly suppressive tumor microenvironment
- ↪As the CAR-T cells are destroying vasculature, they make it leakier, enabling simultaneous, localized delivery of oher agents including chemotherapy
- ↪CAR-T mediated cell death may be more powerful than ther anti-angiogensis drugs
COLLABORATORS INCLUDE:
MOFFITT CANCER CENTER:
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999.
THE WISTAR INSTITUTE CANCER CENTER:
Founded in 1892 as the nation’s first independent biomedical research institute and located on the campus of the University of Pennsylvania, Wistar is an international leader in the biomedical research fields of cancer, immunology and infectious diseases, a National Cancer Institute (NCI)-designated Cancer Center, and part of the NCI’s select network of national cancer research centers, holding an ‘Exceptional’ rating — the highest possible ranking awarded.
CANCER VACCINES:
Vaccines harness the immune system to keep people safe from infectious diseases. Thanks to broad-based vaccination programs, some of the most terrifying diseases in history, small pox and polio among them, have been eliminated from existence.
Unfortunately, there’s been little success in developing a preventative (prophylactic) vaccine against cancer.
Most vaccines attack pathogens, such as viruses and bacteria. The immune system is better able to assail these agents because they come from outside the body. Cancer, however, is a different matter. The disease is caused by aberrant cells that arise out of our resident cells. That can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system. Once these aberrant cells gain critical mass, they become cancer.
Despite the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of revolutionary immuno-therapy drugs. These drugs do not attack cancer directly, but rather modulate the immune system in ways that enable it to destroy or dramatically impair cancer cells.
Imagine if we could train the immune system to kill cancer cells as they arise before they form into tumors. Perhaps, we could eliminate the onset of cancer. The difficulty has been to identify an agent that allows the immune system to target malignant cells without harming healthy tissue.
- ↪Cleveland Clinic researchers have identified a protein called alpha-lactalbumin that is present in healthy breast tissue only when a woman is lactating and disappears when she stops nursing her child. Alpha-lactalbumin is never present on any other cell in the body. However, it does show up in many types of breast cancer, including an aggressive and deadly form of the disease known as Triple Negative Breast Cancer (TNBC).
- ↪In addition, Cleveland Clinic researchers have identified that the extracellular domain of anti-Mullerian hormone receptor II (AMHR2-ED) is expressed in normal ovaries, and nowhere else in the body, with this expression ceasing after menopause. However, this protein is also expressed in cancerous ovary cells.
- ↪Cleveland Clinic, has received an “Intention to Grant” notice from the European Patent Office (“EPO”) for the patent application titled “Ovarian Cancer Vaccines.”
BY DEVELOPING VACCINES THAT TARGET ALPHA-LACTALBUMIN AND AMHR2-ED, ANIX FEELS THE IMMUNE SYSTEM CAN DESTROY BREAST CANCER CELLS AND OVARIAN CANCER CELLS, RESPECTIVELY, AS THEY ARISE AND ULTIMATELY PREVENT TUMORS FROM FORMING!
Anixa’s ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. However, AMHR2-ED is expressed again in the majority of ovarian cancers.
THE MARKET FOR PROPHYLACTIC CANCER VACCINES IS SIZABLE, BIGGER IN FACT THAN THE MARKET FOR ANY TYPE OF CANCER THERAPEUTIC. AFTER ALL, DOCTORS ADMINISTER CANCER DRUGS ONLY AFTER A PATIENT HAS BEEN DIAGNOSED, WHILE A VACCINE CAN BE ADMINISTERED TO A FAR WIDER POPULATION.
BREAST CANCER:
In the U.S., nearly 300,000 women are expected to be diagnosed with breast cancer this year.
OVARIAN CANCER:
Ovarian cancer is the sixth most common cancer in the world, and one of the most aggressive reproductive cancers among women. Most ovarian cancers are diagnosed at late stages (stage 3 or 4) due to the typical absence of symptoms and lack of screening approaches. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually.
PHASE 1 TRIAL FOR BREAST CANCER VACCINE: CONDUCTED BY CLEVELAND CLINIC, FUNDED BY U.S. DEPARTMENT OF DEFENSE (DOD)
AN OPEN-LABEL PHASE 1 DOSE-ESCALATION TRIAL
DESIGN
Participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response
PHASE 1A
(IN PROGRESS)
- ↪18-24 Patients who have been treated for TNBC
- ↪Safety will be monitored
- ↪Immune Response will be monitored
- ↪Maximum Tolerated Dose (“MTD”) determined
PHASE 1B
(ENROLLMENT OPEN)
- ↪Healthy women w/mutations
- ↪Chosen to undergo prophylactic mastectomy
- ↪Vaccinate before surgery and evaluate immune response and resected tissue
- ↪Unique opportunity to garner supplemental data after studying breast tissue to determine if T cells are surveilling the tissue without any visible cancer tumors
PHASE 1C
(ENROLLMENT OPEN)
- ↪Additional cohort combining vaccine with Keytruda
- ↪Patients treated for TNBC
- ↪Combine Keytruda w/ vaccine to evaluate if there is synergy
POSITIVE CLINICAL RESULTS AS OF APRIL 2023:
- ↪Enrollment of women who have had TNBC and have undergone standard of care, but are at risk of recurrence
- ↪42% of TNBC survivors will relapse within 5 years
- ↪MTD reached in Q4 2022 § Data from all vaccinated women tested to date presented at AACR in April 2023
- ↪16 patients dosed through July 2023
- ↪No safety concerns
- ↪Immune responses observed at all dose levels
- ↪All patients had some immune response
- ↪Intensity of responses varied with patients
IN SUMMARY…
One of the most aggressive and difficult-to-treat ailments, cancer is a disease that involves the uncontrolled division and growth of malignant cells.The goal to prevent the disease or eradicate it has been monumental in big pharma for decades.
With multiple catalysts over the next 12 months across its clinical pipeline, now is a pivotal time to have Anixa Biosciences, Inc. (NASDAQ: ANIX) on your radar. The company has 2 clinical trials in progress, showing positive results!
ANIX highlights:
- ↪A low-cost business model
- ↪Developing programs with partners
- ↪Leveraging existing infrastructure of partners
- ↪Maintaining low overhead and cash burn
- ↪Potential to out-license programs to pharma for late stage clinical development and commercialization
NEWS
Anixa Biosciences Welcomes Celebrity Oncologist Dr. Sanjay Juneja to its Cancer Business Advisory Board
APRIL 18, 2024
Anixa Biosciences 2024 Annual Meeting of Stockholders to Include Investor Presentation Open to All Interested Parties
MARCH 14, 2024
Anixa Biosciences Announces Presentation at 24th Annual World Vaccine Congress
MARCH 11, 2024
Anixa Biosciences Initiates Dosing in Second Cohort of Ovarian Cancer CAR-T Clinical Trial
FEBRUARY 12, 2024
Anixa Biosciences Announces Participation in 2024 NeauxCancer Oncology Conference
JANUARY 29, 2024
Anixa Biosciences Announces Japanese Patent on Ovarian Cancer Vaccine Technology
JANUARY 23, 2024
Anixa Biosciences to Present at Sidoti Micro-Cap Virtual Conference on January 17, 2024
JANUARY 10, 2024
Anixa Biosciences to Present at Biotech Showcase 2024
DECEMBER 14, 2023
Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine
DECEMBER 6, 2023
Anixa Biosciences to Host Conference Call This Evening to Discuss Positive New Data from Ongoing Phase 1 Study of Breast Cancer Vaccine
DECEMBER 6, 2023
MANAGEMENT TEAM
AMIT KUMAR, PH.D.
Chairman & Chief Executive OfficerDr. Kumar has been an investor, founder, director and CEO of several technology enterprises, both public and private. As CEO, he took CombiMatrix Corporation public and ran it for a decade while listed on the NASDAQ Global Market. He has worked in venture capital with OAK Investment Partners, and has been an advisor to investment funds, venture capital firms, and Fortune 500 companies. He was on the Board of Directors of Acacia Research Corporation from 2002-2008. Dr. Kumar is currently Chairman and CEO of Anixa Biosciences and he sits on the Board of other public and private companies. He has served on the Board of the American Cancer Society since 2016. He received his AB in Chemistry from Occidental College. After graduate studies at Stanford University and Caltech, he received his Ph.D. from Caltech and followed that with a post-doctoral fellowship at Harvard.
MICHAEL CATELANI
President, COO & CFOMr. Catelani is a seasoned executive with over 30 years of finance and operations management experience. He currently serves as President, Chief Operation Officer & Chief Financial Officer of Anixa Biosciences. Previously, Mike cofounded Tacere Therapeutics, Inc., a privately held biotech company, and served as its Chairman, President & Chief Financial Officer until its sale. Prior to Tacere, Mike served on the Board of Directors and was the Chief Financial Officer of Benitec Biopharma Limited, an Australian Stock Exchange-listed biotech company. Mike was Vice President and Chief Financial Officer at Axon Instruments, a leading designer and manufacturer of instrumentation and software systems for biotechnology and diagnostics research. Axon was a U.S. corporation publicly traded on the Australian Stock Exchange. Previously, he was the Vice President of Finance for Media Arts Group, Inc., an NYSE-listed company. Mike has also worked with several early-stage start-ups in a variety of industries, including biotechnology, cleantech and retail, in both advisory and management roles and has served as a contract CFO for a number of established businesses in the biotech field. Mike began his professional career at Ernst & Young and is a CPA (Inactive). He received his BS degree in business administration, with a concentration in accountancy from Sacramento State University and earned his MBA from the University of California, Davis.
PAMELA D. GARZONE, PH.D.
Chief Development OfficerDr. Garzone is a senior pharmaceutical executive with over 25 years of diverse experience in the industry and is recognized for her strategic, scientific, clinical and regulatory leadership in drug development. Prior to joining Anixa, Dr. Garzone held executive roles in clinical development with several companies, including Calibr, a division of the Scripps Research Institute, and Pfizer. She previously held positions of increasing responsibility at companies such as Elan Pharmaceuticals and Genetics Institute, starting her industry career at Genentech. Prior to her industry experience, she was an Assistant Professor, Pharmacy and Therapeutics at the University of Pittsburgh School of Pharmacy. She earned a B.S. degree in Pharmacy from Purdue University and an M.S. in Pharmacy Practice from the University of Pittsburgh. She received her Ph.D. in Clinical Science from the University of Pittsburgh.
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