Anixa Biosciences, A New Type Of Biotech Company: Could It Disrupt The Cancer Landscape?

Anixa Biosciences ANIX is an interesting, undiscovered biotech company that seeks to disrupt the cancer landscape by working with some highly credible partners. The company is undiscovered for many reasons including its history. The company was previously a failed company that was repositioned as biotech roughly 6 years ago by new management.  Since that time, management has developed assets that are now in clinical testing and producing promising data which they feel is putting the company on the radar screens of many investors.  

First and foremost, when evaluating a development-stage biotech company, it is always important to analyze past and projected cash burn relative to cash on the balance sheet. In this respect, Anixa reports that it is extremely satisfied with its performance. While most biotech companies, even small ones, are burning tens to hundreds of millions annually, since current management took over, Anixa reports that it has been burning about $5-6 million annually even though two of its programs have jumped from laboratory testing to human trials in the last couple of years. Management has stated that the burn will increase as the clinical trials progress, but only modestly. Considering the company has $25+ million on the balance sheet, the company reports that it has multiple years of cash, well enough to see it through some major inflection points. The company has no debt and no warrant overhangs and has a little over 31 million shares outstanding.  

While the company is working on three notable programs, which are detailed on their website, there has been a lot of recent excitement for and coverage of their breast cancer vaccine. This vaccine has been in development at the vaunted Cleveland Clinic for the last two decades. In 2019 Anixa exclusively licensed this technology and partnered with Cleveland Clinic to further develop and commercialize this vaccine.  The vaccine focuses on the prevention of a particularly deadly form of breast cancer known as Triple Negative Breast Cancer (TNBC). This vaccine work is being funded by a grant from the U.S. Department of Defense to the Cleveland Clinic.  

On December 6, 2023, Cleveland Clinic (CC) presented data from the results of vaccination of the first 16 women to whom the vaccine was administered. The data was characterized by CC and Anixa as incredibly promising and exceeding all expectations. The 16 patients were TNBC survivors who have a high risk of the cancer recurring. Anixa states that studies show that 42% of TNBC survivors will have a recurrence within 5 years. The goal is to determine if the vaccine can prevent those recurrences. Anixa says the intent is to evaluate the vaccine’s ability to prevent cancer recurrence in TNBC survivors, and then to evaluate whether similar effects are seen in survivors of other types of breast cancer and then eventually to prevent breast cancer in women who have never had breast cancer. In the study, the majority of women exhibited a protocol-specified immune response, with a measurable but lesser response in the remaining patients. Notably, none of the participants exhibited any major side effects besides injection site irritation. Anixa stated that this data enables them to plan and execute an adaptive phase 2/3 trial which is expected to begin next year.  The phase 2 trial will evaluate the ability of the vaccine to prevent TNBC in a study with a control arm and a larger number of patients.

“This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development,” Anixa CEO Dr. Amit Kumar said. “Our goal is to initially evaluate the vaccine's ability to prevent recurrence of cancer in survivors, and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC.”

“There is a large unmet need for preventing TNBC, an aggressive form of breast cancer with few targeted treatment options available,” said G. Thomas Budd, M.D., staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study. “We are encouraged by the data gathered to date and look forward to determining the optimal vaccine dose in additional patient cohorts. Our hope is that future studies will demonstrate that the antigen-specific T cell responses we observed translate to the prevention of breast cancer recurrence.”

Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine's safety and immunologic effects in two additional patient cohorts. The first cohort, which opened for enrollment in August 2023, will combine the breast cancer vaccine with Keytruda® (pembrolizumab) and evaluate the response from post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy. 

Another cohort will investigate the safety and immunologic effects of the vaccine in patients with positive BRCA1, BRCA2 or PALB2 mutations who plan to receive prophylactic, risk-reducing mastectomies.

While clinical trials can take time, Anixa’s strategy is to work with highly credible partners to develop its products to a stage where they can be partnered with large pharmaceutical companies for further development. By doing so, Anixa plans to monetize its programs for shareholders much earlier than the completion of trials and for more rapid commercialization.  If the data continues to be positive in the trials, Anixa expects big pharma to come knocking as the markets for this and its other products are large.

Another interesting development may be worth noting. Some months ago, the company formed a Cancer Business Advisory Board (CBAB). The formation of this type of board to advise the company is not unusual in itself, except that the members of this CBAB are all current and former highly-placed members of the American Cancer Society (ACS). The ACS is the largest cancer-focused non-profit organization with tremendous influence across the cancer spectrum.  Anixa’s CBAB includes the current and former CEOs of the ACS, several Board Chairpersons of the ACS, and others. Amit Kumar, the CEO of Anixa, and Arnold Baskies, a board director of Anixa, were both on the Board of the American Cancer Society. This goes to show that the connections that Anixa has and the interest from people like this will be helpful as the company progresses with its programs.

Anixa reports that its company insiders, including the CEO and board members, have consistently been significant buyers of the stock. Additionally, expectations of improvement in this industry sector, along with continued positive progress from Anixa’s programs, could bode well for Anixa in 2024. Investors in the small-cap biotech sectors may want to consider putting Anixa on their watch list.

Featured photo by Mufid Majnun on Unsplash.

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