subslover
1年前
Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine
– Antigen-specific T cell responses were observed at all dose levels –
– IFN? and IL-17, immune-mediated biomarkers of T cell activation, increased over time from baseline –
– Vaccine was safe and well tolerated –
– Conference call to commence today at 6:30 p.m. ET –
SAN JOSE, Calif., Dec. 6, 2023 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense.
The data were presented at the 2023 San Antonio Breast Cancer Symposium by G. Thomas Budd, M.D., staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study, in a poster entitled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC."
Patients who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFN? and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect. Data from the 16 patients treated to date showed that:
The majority of patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.
12 (75%) of the women had antigen-specific IFN? and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA antibody responses were observed at Dose Level 2 and higher.
A statistically significant (P = 0.03) increase in IFN? over baseline (Day 0) was observed by Day 56; while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.
Among the doses studied, Dose Level 1 (10 mcg a-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose as well as the maximum tolerated dose (MTD).
No significant side effects were observed, at the MTD, besides irritation at the sites of injection. No myalgias, flu-like symptoms, or aberrant laboratory values were noted.
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, is evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.
The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation positive and are planning prophylactic risk-reducing mastectomies.
"The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. 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," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine. 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 Dr. Budd, Cleveland Clinic. "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 is the exclusive worldwide licensee to the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase 1 trial. The grant from the U.S. Department of Defense was made directly to Cleveland Clinic.
Conference Call Information
Anixa is pleased to invite all interested parties to participate in a conference call, during which this new data will be discussed.
Conference Call Details:
Presentation host:
Anixa management, with special guest speakers
Date and time:
Today, December 6, 2023, at 6:30 p.m. ET
Phone access:
Registration Link to receive your dial-in number and unique PIN
Webcast:
Available at www.anixa.com under "Events & Presentations"
About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
About Anixa Bioscience's Breast Cancer Vaccine
Anixa's breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, a-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express a-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute. Dr. Tuohy was inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. He was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.
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 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 have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on clinical 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.
Contacts:
Stephen KilmerInvestor Relations
skilmer@anixa.com
646-274-3580
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808
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Paullee
4年前
Anixa Biosciences Covid-19 Therapy Demonstrates Comparable Potency to Remdesivir in Pre-Clinical Testing
Mon, December 14, 2020, 9:00 AM EST
SAN JOSE, Calif., Dec. 14, 2020 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced that it and partner OntoChem GmbH have verified that one of their recently discovered compounds is similar in potency to remdesivir, the only approved anti-viral drug against SARS-Cov-2. As previously announced, Anixa and OntoChem had identified multiple compounds that could disrupt the function of a viral enzyme called an endoribonuclease (also known as Non-Structural Protein-15, or NSP-15).
Anixa Biosciences, Inc. (PRNewsfoto/Anixa Biosciences, Inc.)
Anixa Biosciences, Inc. (PRNewsfoto/Anixa Biosciences, Inc.)
Remdesivir is a pro-drug whose metabolite interferes with a SARS-CoV-2 enzyme, RNA-Polymerase. Similarly, Anixa's lead compound interferes with the function of another SARS-Cov-2 enzyme, NSP-15, the noted endoribonuclease. NSP-15 is needed by the virus to process its RNA, it's genetic code. Interfering with this enzyme makes it impossible for the virus to replicate. The comparison of potency with remdesivir was conducted in a human cell line by measuring IC50 in an assay known as a plaque reduction assay. IC50 is a standard measure of the amount of drug needed to inhibit replication (production of plaques) of the virus by 50%.
"Through medicinal chemistry modifications we feel we can improve this compound's potency even more. In the next few months, we will be testing the in vivo potency of this compound in an animal study," stated Dr. Amit Kumar, President and CEO of Anixa. "While we are all excited about the development of Covid-19 vaccines, we still do not know how long immunity is conferred by vaccination, nor do we know what will happen should the virus's spike protein mutate, like the flu virus."
Dr. Kumar added, "Therapies such as remdesivir, monoclonal antibodies and dexamethasone are required to be administered by injection in a hospital setting. Our compound, should it reach the market, is expected to be taken as a pill by patients infected by SARS-CoV-2, to eliminate the disease before symptoms require hospitalization. At the current time, there are no Covid-19 medicines that can be taken in an outpatient setting. Accordingly, we feel there is a need for inexpensive, orally administrable medicines for this viral infection."
Dr. Lutz Weber, CEO of OntoChem, stated, "Our team includes Anixa Biosciences, my team at OntoChem, a team of organic synthetic chemists in Austria and a national laboratory in Italy with a biosafety level 3 (BSL-3) laboratory and capabilities for animal studies. We began this project with Anixa from scratch and are pleased that our collaboration has led to a very potent anti-viral compound. While we take our first compound into proof-of concept animal studies, we will continue synthesizing and testing additional promising compounds."
Paullee
4年前
Anixa Biosciences and Cleveland Clinic File IND Application for Breast Cancer Vaccine
Mon, November 23, 2020, 8:30 AM EST
SAN JOSE, Calif., Nov. 23, 2020 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that an IND (Investigational New Drug) application for its prophylactic breast cancer vaccine has been filed with the U.S. Food and Drug Administration.
Anixa Biosciences, Inc. (PRNewsfoto/Anixa Biosciences, Inc.)
Anixa Biosciences, Inc. (PRNewsfoto/Anixa Biosciences, Inc.)
This vaccine technology was invented by a research team from Cleveland Clinic, led by Dr. Vincent Tuohy, the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute. Anixa has a worldwide, exclusive license to this technology.
The technology takes advantage of self-proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein, alpha-lactalbumin, is expressed only in the mammary glands during lactation and then disappears once lactation ceases. Dr. Tuohy discovered that this protein is abnormally expressed again when a woman contracts breast cancer, especially Triple Negative Breast Cancer (TNBC), the most deadly form of this disease. Dr. Tuohy postulated that if women could be immunized against this protein after their childbearing years, the immune system could be trained to destroy cancer cells as they arise while ignoring normal cells that no longer express this protein, thus making it difficult for the cancer to gain critical mass. Early studies to test this theory demonstrated highly significant prevention of breast cancer in animal models.
The technology is being developed at Cleveland Clinic with funding from the U.S. Department of Defense. The funding is expected to enable completion of two Phase 1 clinical trials.
"This has the potential to be a paradigm-shifting clinical study," said Dr. Tuohy. "If our data demonstrate results similar to the pre-clinical studies, this vaccine could have a significant impact on breast cancer, the most common malignancy in women. Furthermore, the way we think about controlling breast cancer may completely change."
"We look forward to moving this novel technology into the clinical stage of development," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "If the data in humans is comparable to the data in animals, Dr. Tuohy's 'retired' protein hypothesis will usher in a new way to prevent breast cancer, as well as other types of tumors."
"This initial clinical trial will be with women who have been diagnosed with high-risk early stage TNBC and are receiving standard of care at Cleveland Clinic," said Dr. G. Thomas Budd, Department of Medical Oncology at the Taussig Cancer Center at Cleveland Clinic, and the Clinical Investigator who will be conducting the trial. "We look forward to commencing the Phase 1 clinical trial and evaluating these patients."
Paullee
4年前
Anixa’s Breast Cancer Vaccine; A Conversation With Dr. Vince Tuohy
By
Daniel Carlson, Tailwinds research
-
September 22, 2020
This week I had the opportunity to speak with Dr. Vincent Tuohy of the Cleveland Clinic. Dr. Tuohy is the inventor and research leader of the breast cancer vaccine program that has been partnered with Anixa. The program has had very successful animal trials and is in the final stages of prepping for an IND filing. It’s often rare for Key Opinion Leaders (KOLs) to talk to non-scientists, but Dr. Amit Kumar of Anixa helped enable this conversation in anticipation of the IND filing, and the upcoming month of October, which is Breast Cancer awareness month.
I left the conversation very excited about the product, its prospects with the FDA and the implications for Anixa. Here is my summary of the key portions of the conversation (I have bolded what I believe are the highlights), followed by my thoughts on the program.
Tailwinds Research – how does this technology work and why do you think it will be successful?
Dr. Tuohy – In the area of vaccination against infectious disease, scientists have been very successful in battling many diseases like small pox, polio and others. The cancer vaccine story is rife with many failures, and there are many reasons for this. We designed a program that takes lots of lessons from the success of childhood vaccines, the failures of cancer vaccines, and an understanding of autoimmunity. Our program identified an antigen, or target for the immune system, that is no longer around in adult women who are not lactating, but shows up in the breast when cancer develops. We also use a very powerful adjuvant, which helps the immune system mount a strong response to the antigen. Based on my background and understanding of how the immune system can sometimes destroy organs, I identified an approach for the immune system to destroy not the organ but the cancer in that organ. The studies in animals showed a powerful effect, and now this is the most powerful immune response that I could think of creating.
And we’re on the verge now of being able to test it in humans. We’ve generated the vaccine, the adjuvant. We’re submitting the application to the FDA shortly within the current month. And we think that we should be able to start phase one trials for dosage and safety by the beginning of this coming year
Tailwinds Research – What gives you comfort that the FDA will accept an IND for your cancer vaccine?
Dr. Tuohy – We’ve already had two pre-IND meetings with the FDA and we’ve discussed our plans with them extensively, really, I mean, in great detail. And they have indicated very clearly what they wanted from us. And we spent the last, oh, I would say over a year now, dealing with everything that they told us to do. They always have the right to ask for more, but we are hopeful that we have addressed everything they want.
Tailwinds Research – what kind of data do you expect to get out of a Phase one trial? And what specific end points are you using in this trial?
Dr. Tuohy – Well, phase one is a classic phase one. It’s a dosage and safety trial. So, we will increase the dosage until we reach toxicity and then pull back until we have a dose that gives us an effective immune response. We do not expect much toxicity because the protein target is not there in women who are not lactating or who don’t have cancer.
And so far in our toxicology studies and our immunogenicity studies, we haven’t seen anything that is out of the ordinary in terms of the common side effects that you get from any cancer vaccine.
Besides safety we will be monitoring the patients to see if our vaccine has induced antibodies that target our protein and the T-cells that target the protein. These antibodies and T-cells will be measured before vaccination , so if they are there after vaccination, we know our vaccine induced their creation and the vaccine is doing what we want.
We hope we can finish the first trial within 2021, then we will follow up with the second trial.
Tailwinds Research – you did mention that Phase I studies are funded by the government. Do you think there’s any possible possibility, based on success there, that the government will fund phase II studies?
Dr. Tuohy – I think it’s definitely possible if we can show that we have a very active immune response, which I’m very confident about. This is not a weak vaccine. This is the most powerful vaccine I could think of making. And I have no doubts that we’re going to get there.
This is not a critique, but a lot of people are down on cancer vaccines because they haven’t worked and they haven’t worked, in my opinion, because, A, they have been using cryptic antigens that have no high affinity T cell clones in the repertoire available to react to them. And B, they’re not using aggressive Type 1 and Type 17 adjuvants to induce a very, very powerful immune response.
So, I’m confident that we can get a very good immune response. I think if we show the results that I anticipate, there is likely to be a lot of interest in funding to continue the development of the vaccine. The US spends over $40 BB dollars annually for breast cancer. So, yes, I do think the government would be interested when they look at just the finances.
At Tailwinds, as investors, we remain very optimistic about Anixa’s breast cancer vaccine program. There are several key points to keep in mind here when one looks at what Anixa is doing.
• The Cleveland Clinic is a world-class research organization. They are at the top of the pyramid along with others like the Mayo Clinic and Sloan Kettering. It’s easy to dismiss Anixa as a micro-cap company with few employees and a small budget, but their strategy of working with the best possible partners gives them a depth and breadth of research that extends far beyond the normal reach for a company their size.
• The market for vaccines is massive. If this product works, you’re looking at a multi-billion-dollar opportunity. (For a case in point, just look at what happened to Moderna stock recently) We will know if there is a positive response sometime in 2021. So, in less than one year, we’ll know if this $60M market cap company could have a billion-dollar program on their hands.
• For further proof of the market size here in Triple Negative Breast Cancer, look at Gilead’s purchase of Immunomedics. They paid $21 billion for a drug that has only increased survival from 1 ½ months to 5 ½ months. Once again, IF the vaccine works, this is a big opportunity.
The management of Anixa has continually bought shares in the open market, which demonstrates not only their belief in the product pipeline, but the deeply discounted valuation. The risk/reward here seems incredible to me.
By the end of next year, Anixa will have two potential blockbuster programs returning human data. Due to the unique nature of their business model, these programs aren’t costing an arm and a leg. Tremendous upside from a small investment…it’s a great business model.
Anixa is on the cusp of going from pre-clinical to having two simultaneous in-human trials. The first step is an accepted IND submission. We are only a handful of days away from the first IND being submitted and less than two months from learning if it is accepted. Exciting times ahead.
Tailwinds' Disclaimers & Disclosures: Tailwinds may have been compensated for writing this article. For a full list of disclaimers and disclosures, please visit http://tailwindsresearch.com/disclaimer/.
https://tailwindsresearch.com/2020/09/anixas-breast-cancer-vaccine-a-conversation-with-dr-vince-tuohy/
Paullee
5年前
Potential Covid-19 Drugs for Testing in Biological Assays
By Daniel Carlson -June 1, 2020
Tailwinds’ Take: great first steps. Moving successfully through biological assays and into animal testing is the big value driver. Hopefully we start hearing some of those results in the near future.
SAN JOSE, Calif., June 1, 2020 /PRNewswire/ — Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment, prevention, and diagnosis of cancer and infectious diseases, today announced that the Company, together with partner OntoChem GmbH, has synthesized four potential Covid-19 compounds that will advance to biological assay testing. Anixa and OntoChem announced their partnership on April 20, 2020 (https://ir.anixa.com/press-releases/detail/947/) and announced discovery of its first potential Covid-19 candidate two weeks later on May 4, 2020.
The initial phase of this program was designed to screen approximately 1.2 billion chemical compounds, utilizing in silico methods, against two specific enzymes of SARS-CoV-2. As the computer-based screening identified potential compounds, they would be synthesized and tested in biological assays to evaluate their potency as predicted by the molecular modeling algorithms. Should the biological activity be verified, the compounds will be tested in animal studies to further evaluate their candidacy as Covid-19 therapeutics. Assuming animal studies are successful, the compound or compounds can be readied for human testing.
Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, “When we announced our strategic collaboration with OntoChem, we committed to providing frequent updates regarding the progress of our research, because Covid-19 is such an acute public health and economic problem. Therefore, we are pleased to announce that since identifying a lead molecule, we have further identified three similar analog compounds. These molecules target a viral protein, an endoribonuclease, that helps the virus process its genetic material during viral replication. Before the endoribonuclease can function properly, it needs to interact with a human protein in the infected human cell. Our in silico molecular modeling indicates that any of these four molecules might disrupt the ability of the viral endoribonuclease to interact with the human protein. If this is confirmed in our biological testing, we believe the molecules should inhibit the viral replication process and retard the infection.”
Dr. Lutz Weber, President and CEO of OntoChem, stated, “While we continue to screen the full libraries of compounds, we are pleased that our efforts have rapidly identified four compounds. These compounds have been synthesized and we are now engaged in testing these compounds in biological assays to verify the efficacy that was predicted in silico.”
Dr. Kumar continued, “We hope to provide an update regarding the biological testing as soon as we have completed the tests. One of the tests is a viral replication test that utilizes active SARS-CoV-2 virus. This test must be performed in a Biological Safety Level 3 laboratory to maintain safety and confinement.” Dr. Kumar continued, “While we are making incredibly rapid progress in our discovery efforts and hope to continue the pace of research, it’s important to note that we are in the early stages of the program.”
About Anixa Biosciences, Inc.
Anixa is a publicly-traded biotechnology company developing a number of programs addressing cancer and infectious disease. Anixa’s therapeutic portfolio includes a cancer vaccine technology focused on the immunization against a-Lactalbumin to prevent triple negative breast cancer (TNBC), a cancer immunotherapy program which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology, and a Covid-19 therapeutics program focused on inhibiting certain viral protein function. The company’s diagnostic portfolio consists of Cchek™, a liquid biopsy technology for early detection of solid tumors based on the body’s immune response to the presence of a malignancy. Anixa continually examines emerging technologies in complementary fields for further development and commercialization. Additional information is available at www.anixa.com.
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
mcatelani@anixa.com
408-708-9808
Tiberend Strategic Advisors, Inc.
Miriam Miller (Investors)
mmiller@tiberend.com
212-375-2694
Johanna Bennett (Media)
jbennett@tiberend.com
212-375-2686
https://tailwindsresearch.com/2020/06/anixa-biosciences-and-ontochem-have-synthesized-four-potential-covid-19-drugs-for-testing-in-biological-assays/
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