Boris Johnson considered raid on vaccine plant in the Netherlands – The Guardian

Boris Johnson considered raid on vaccine plant in the Netherlands – The Guardian

HIV vaccine trial in Africa halted after disappointing data – Reuters

HIV vaccine trial in Africa halted after disappointing data – Reuters

December 10, 2023

A man places a placard as he prepares a message during an HIV/AIDS awareness campaign on the eve of World AIDS Day in Kolkata, India, November 30, 2017. REUTERS/Rupak De Chowdhuri/ File photo Acquire Licensing Rights

KAMPALA, Dec 7 (Reuters) - A trial of an experimental HIV vaccine in Uganda, Tanzania and South Africa has been stopped early after preliminary data suggested it would not be effective in preventing infection, according to the trial's chief investigator.

The news is the latest blow to efforts to find an effective vaccine against a virus that has so far claimed about 40 million lives globally. Another 39 million are living with HIV, the majority of them in Africa.

The trial for the vaccine, part of a wider initiative called PrEPVacc, began in December 2020 with the enrolment of 1,512 healthy adults aged 18-40 and was due to end in 2024.

Pontiano Kaleebu, chief investigator for the programme, told Reuters on Thursday the programme's independent data and safety monitoring committee had "recommended that even if we continue we will not be able to show that the vaccine can be effective".

While there are drugs that can reduce the risk of getting HIV and treatments that can control the virus and prevent people from developing AIDS, the deadly immune condition resulting from untreated HIV, experts say an HIV vaccine would be an important tool in ending AIDS as a public health threat.

The trial, led by African researchers with support from various European institutions like Imperial College London, was testing two different combinations of experimental HIV vaccines.

It was also testing a new form of oral pre-exposure prophylaxis (PrEP), a drug that reduces the risk of getting HIV, to see if it was as effective as existing drugs. That part of the trial is ongoing.

Participants were mostly drawn from populations at high risk of infection like sex workers, gay men and fishermen.

A statement released on Wednesday by the vaccine trial programme said the failed trial, which was the only remaining active HIV vaccine efficacy trial in the world, underscored "how challenging it is to develop an effective HIV vaccine".

Researchers in South Africa terminated another trial in 2020 after tests of a vaccine in more than 5,000 people failed to show benefits.

Reporting by Elias Biryabarema and Jennifer Rigby Editing by Mark Potter

Our Standards: The Thomson Reuters Trust Principles.


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HIV vaccine trial in Africa halted after disappointing data - Reuters
Study billed as the last chance to soon develop an HIV vaccine fails – STAT

Study billed as the last chance to soon develop an HIV vaccine fails – STAT

December 10, 2023

A study billed as the last chance to develop an HIV vaccine this decade has been shut down, investigators announced Wednesday at a conference in Harare, Zimbabwe.

The trial, known as PrEPVacc, was testing two different vaccine regimens on about 1,500 volunteers in East and Southern Africa. After multiple other high-profile trials failed, a PrEPVacc investigator described the study this summer as the last roll of the dice for an HIV vaccine until the 2030s.

The study has now been halted early after an independent data monitoring committee concluded there was little or no chance the study would demonstrate efficacy, researchers told the International Conference on AIDS and STIs in Africa.

Although disappointing, the news may not surprise many HIV vaccine researchers. PrEPVacc was seen as a pioneering study, both as one of the first large, African-led HIV vaccine trials and one of the first trials to incorporate PrEP, the daily antiviral pills that can dramatically reduce the risk of HIV infection.

But the trial used older vaccine designs some scientists doubted would provide adequate protection.

With the failure, there are now no HIV vaccines being trialled for efficacy anywhere in the world, PrEPVacc investigator Pontiano Kaleebu said in a statement.

Efforts are limited to small, early-stage trials designed to test new technologies that might stand a chance against the wiliest virus humanity has ever encountered. Kaleebu said there now had to be greater urgency to push these technologies forward.

We have come so far in our HIV prevention journey, but we must look to a new generation of vaccine approaches and technology to take us forward again, he said. We must also look to a new generation of leaders. We set up PrEPVacc to grow our capacity in Africa to do future trials ourselves and to develop those who will lead them here in Africa.

The new strategies include sending HIV wanted posters to a specific set of immune cells by encoding them in another, more benign chronic virus. More popular is an approach called germline targeting, where researchers give a series of different jabs designed to nudge the immune system toward making the perfect, HIV-snaring antibodies.

Moderna, the National Institutes of Health, and IAVI (formerly known as the International AIDS Vaccine Initiative) have all invested in the latter.

Despite these results, IAVI remains optimistic that developing an HIV vaccine is possible, said IAVI CEO Mark Feinberg in an emailed statement. We believe that new approaches designed to induce broadly neutralizing antibodies to HIV are the most promising path forward.

Trial director Eugene Ruzagira said he hopes PrEPVacc data will eventually inform new efforts. Although no new volunteers will be dosed, researchers remain blinded to who is on which regimen and will continue following participants into next year. Afterward, theyll look at blood samples and data to try to decode precisely what went wrong.

The option of giving up the work is off the table, Ruzagira said. The work needs to continue.

Some researchers are skeptical, however, that the new technologies will ever lead to an HIV vaccine. Even as the HIV vaccine field has struggled for 40 years, companies have developed other methods of stopping transmission for extended periods: Forms of PrEP that can virtually eliminate the risk of infection with an injection every couple months. Biannual and annual injections are now in development.

Long-acting PrEP could raise the bar for how effective an HIV vaccine has to be, while also making it more difficult to run vaccine trials. Researchers, for example, may no longer be able to compare new shots to placebo.

PrEPVacc had been an early attempt to run a vaccine trial while also offering patients different forms of oral PrEP. And a portion of the study comparing two forms of oral PrEP will continue.

Longtime vaccine researchers say that even more outside-the-box trial designs may be needed for the next vaccine study, should one of the early stage projects prove promising.


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Study billed as the last chance to soon develop an HIV vaccine fails - STAT
HIV vaccine trial in Africa halted after disappointing initial results – The Guardian

HIV vaccine trial in Africa halted after disappointing initial results – The Guardian

December 10, 2023

Fair Access

African-led trial ended a year early as researchers conclude there is little or no chance new combination vaccines cut HIV risk

The first trial in Africa of two combination vaccines to prevent HIV has been halted after researchers concluded it was not working.

The vaccines (part of the PrEPVacc study) were being tested on 1,500 people aged between 18 and 40 in Uganda, Tanzania and South Africa.

The African-led trial, which began in December 2020, was stopped last month after an interim review of progress. The final results are expected to be made public in late 2024.

The trial of a pre-exposure prophylaxis pill running alongside the vaccines tests will continue.

Dr Eugene Ruzagira, trial director from the Uganda Virus Research Institute (UVRI) and assistant professor of epidemiology at the London School of Hygiene & Tropical Medicine, said: Vaccinations to PrEPVacc trial participants have been stopped because an analysis of the data collected so far by our independent data-monitoring committee has led them to conclude that there is little or no chance of demonstrating that the vaccines we are testing are reducing the risk of acquiring HIV.

The PrEPVacc trials, led by African researchers with support from European scientists, tested two different combinations of HIV vaccines to see if either could prevent infection in populations particularly at risk of infection. The trials were funded with a 15m (12.8m) grant from the EUs European & Developing Countries Clinical Trials Partnership.

Prof Jonathan Weber, from Imperial College London, one of the trials sponsors, said: We do clinical trials because we dont know the answer to questions. It was important to find out whether the combination vaccine regimens in PrEPVacc, developed over 20 years, should be ruled out or further developed for preventing HIV.

While we await the final results and analysis of individual products, I believe that our interim result puts this generation of putative HIV vaccines to bed, he said.

Previous trials in South Africa to test the only vaccine that had shown any success in protecting against HIV the RV144 developed in Thailand, was stopped in February 2020 after interim results found it was not working.

Prof Pontiano Kaleebu, PrEPVaccs chief investigator at UVRI, said developing an effective vaccine to prevent HIV infection was a critical goal for Africa.

He said: It is a goal that must have even greater urgency now that no HIV vaccines are being trialled for efficacy anywhere in the world.

We have come so far in our HIV-prevention journey, but we must look to a new generation of vaccine approaches and technology to take us forward again.

About 39 million people worldwide are living with HIV, more than 25 million in sub-Saharan Africa.

Ruzagira told an Aids conference in Zimbabwe on Wednesday that he remained optimistic. The scientific hurdles are high, but I have equally high hopes that an HIV vaccine will be developed one day, he said.

The RV144 vaccine was trialled in Thailand between 2003 and 2006, which after three years reduced infection rates by almost a third.

This article was amended on 8 December 2023 to clarify that the trials involved testing of two different combinations of HIV vaccines, not of HIV, as an earlier version said.

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$1 Billion Supports Vaccine Manufacturing in Africa  Precision Vaccinations News – Precision Vaccinations

$1 Billion Supports Vaccine Manufacturing in Africa Precision Vaccinations News – Precision Vaccinations

December 10, 2023

(Precision Vaccinations News)

The Africa Centres for Disease Control and Prevention (Africa CDC) recently welcomed the announcement from The Global Vaccine Alliance (GAVI) Board for the establishment of the African Vaccine Manufacturing Accelerator (AVMA).

The AVMA is a financing mechanism to create a sustainable vaccine manufacturing industry in Africa. It will make up to $1 billion in funds available to support vaccine manufacturing in Africa.

Dr. Jean Kaseya, Africa CDC Director General, commented in a press release on December 8, 2023,"Today is a significant moment for Africa. The targeted USD 1 Billion from GAVI to African Manufacturers is a game changer for the continent and advances our efforts towards vaccine self-reliance."

"The African Union has set a target for the continent to produce 60% of the vaccines needed by 2040, and theAVMA is indeed an accelerator towards that ambition."

"GAVI has been an incredible partner in this; we will continue to advance together on this journey of self-reliance. Together, we are united with a mission for vaccine equity."

The launch of AVMA is an important message from our partners that Africa will no longer be solely a recipient of vaccines but an active member and contributor to the global vaccine ecosystem.

The collaboration has seen several vaccine manufacturing projects taking shape, and others are in the works to guarantee self-reliance in Africa should any health emergency or outbreak hit the continent.

In addition, Africa CDC remains committed to collaborating with all partners and stakeholders in the vaccine ecosystem to facilitate the full operationalization of AVMA and expedite the attainment of health security, as envisaged in Agenda 2063.


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$1 Billion Supports Vaccine Manufacturing in Africa Precision Vaccinations News - Precision Vaccinations
The African Vaccine Manufacturing Accelerator: what is it and why is it important? – Gavi, the Vaccine Alliance

The African Vaccine Manufacturing Accelerator: what is it and why is it important? – Gavi, the Vaccine Alliance

December 10, 2023

A new instrument has just been approved that could help catalyse the sustainable growth of vaccine manufacturing in Africa. The African Vaccine Manufacturing Accelerator (AVMA) is designed to make up to US$ 1 billion available over the next ten years to support the sustainable growth of Africa's manufacturing base, which has the potential to not only contribute to healthy global vaccine markets, but also benefit outbreak and pandemic prevention, preparedness, response and resilience.

The COVID-19 pandemic brought the strategic importance of access to vaccine manufacturing into the public eye and to the forefront of the minds of policymakers. The countries and regions with the strongest research, manufacturing and regulatory ecosystems were the first to access COVID-19 vaccines. Other regions, by stark contrast, were locked out of access during the early days of the pandemic, as vaccine nationalism and market failure initially held sway.

No region felt the negative effects of COVID-19 vaccine inequity more than Africa. And no region stands to benefit more from sustainable growth in its vaccine manufacturing sector.

At present, demand for vaccines in Africa is valued at over US$ 1 billion annually, with this figure projected to grow along with the continent's population over the next several decades. Africa already accounts for around 20% of the world's population, yet the continent's vaccine industry provides only around 0.2% of global supply.

A sustainable expansion of Africa's vaccine manufacturing capacity would have a double payoff for the continent, contributing to the growth of a high-value biotechnology sector on the continent at the same time as supporting pandemic and outbreak prevention and response. At the same time, a strong vaccine manufacturing sector in Africa could benefit the overall health of vaccine markets globally.

Speaking at the annual International Conference on Public Health in Africa in November 2023, Dr Jean Kaseya, director-general of the Africa Centres for Disease Control and Prevention (Africa CDC), likened this to the continent's 'second independence'. At the same event, Gavi interim CEO David Marlow signalled Gavi's commitment to work with partners to "drive an African vaccine revolution, creating an industry that can boost economies, create jobs and help ensure that when the next pandemic hits, vaccines made in Africa are ready to protect populations".

Since 2001, Gavi has become one of the world's largest buyers of vaccines, working closely with African countries and manufacturers to shape the market for vaccines, and helping to expand the number of manufacturers of Gavi-supported vaccines from 5 producers to 19. So when the African Union (AU) set a bold target for African countries to produce and supply more than 60% of the continent's vaccine requirements by 2040, Gavi was a natural partner to help chart a collective path towards a sustainable manufacturing ecosystem in the region.

Gavi's ten-point plan for developing and strengthening vaccine manufacturing in Africa set out the key actions needed to diversify and secure vaccine supply in Africa and support of the AU's vision, including the need for Gavi to update the Alliance's market shaping model to assign greater value to vaccine supply resilience in Africa.

As part of the ten-point plan, Gavi set out the need for a new financial instrument that would send a powerful signal to global markets that Gavi will support the development of African vaccine manufacturing. And this is where AVMA comes in. AVMA aims to deliver the right balance of incentives to encourage investment in Africa, and the entrance of new African manufacturers at the scale needed to be viable on a long-term basis.

The biotech sector in Africa is still young, and it will take time for new manufacturers to build the production scale required to be sustainable. AVMA works by offering two types of incentive payments that offset some of the initial high costs of production. Some of these payments will be higher for a subset of vaccines (the priority vaccine market group) for which there is an unmet need or a need to boost market health or for which a manufacturer has established a prioritised vaccine technology platform in Africa that could be brought online during a pandemic response.

The first type of payment, known as a 'milestone payment', will be triggered when a manufacturer producing one of the vaccines included in the Gavi priority vaccine market group succeeds in obtaining WHO prequalification (PQ). PQ is a form of regulatory approval that must be obtained before a manufacturer can win a Gavi-UNICEF tender . This payment is targeted to support manufacturers to offset some of the financial burden of meeting the standards for PQ, and helps to bridge the period between this prequalification and production.

Milestone payments are calibrated to provide the greatest incentive to invest in modes of manufacturing most likely to support pandemic preparedness. The highest milestone payments of US$ 25 million will accrue to manufacturers that receive prequalification for vaccines produced with a 'pandemic ready' technology platform, such as the capacity to produce mRNA or viral vector vaccines. At the other end of the scale, the lowest milestone payments of US$ 10 million will accrue to manufacturers that receive PQ for 'fill and finish' manufacturing of one of the vaccines in the priority market category , whereby the final stages of production, vial filling and labelling are undertaken at an African manufacturing facility.

The second type of payment, termed an 'accelerator payment', will be paid as a per-dose 'top-up', in addition to the offered market rate manufacturers receive on winning Gavi-UNICEF tenders. These payments will be highest, at around US$ 0.50 per dose, for the end-to-end manufacture of priority market vaccines , and vaccines produced using 'pandemic ready' technology platforms. At the other end of the scale, lower tiered incentives are paid for lower-cost 'fill and finish' manufacturing, with the overall objective to incentivise a more sustainable end-to-end business model.

AVMA will offer the highest per-dose incentive payments and milestone payment to manufacturers that are able to supply vaccines that have strategic importance for the African continent.

This strategic importance can derive from several factors, including the need to build supply security and resilience for vaccines against certain outbreak-prone diseases, specific opportunities for commercially sustainable new market entrants, or the need to develop and produce vaccines with product profiles optimised to meet African priorities and contexts.

The final list of priority market vaccines is designed to balance these strategic priorities, and ensure that incentives are calibrated to encourage a broad ecosystem without diluting their potential impact. The priority market vaccines are:

With an intended capitalisation of up to US$ 1 billion, AVMA is designed to provide incentives for ten years, with various caps on incentives so that no vaccine type, or single manufacturer, is overrepresented. In addition, the availability of incentives is balanced to offer the best chance of cultivating a broad and resilient manufacturing sector.

Detailed terms and conditions to underpin AVMA and the payment of incentives will be communicated prior to the launch of the facility.

AVMA is a clear signal that the political will to achieve the African Union's vision is now being translated into purposeful and pragmatic action.

The incentive structure for the AVMA was fine-tuned during an intense 12-month period of consultation, design and modelling. This extensive testing and calibration was done with the aim of ensuring that support would maximise the sustainability of African manufacturing capacity and minimise inadvertent market distortions. But building a thriving vaccine manufacturing ecosystem in Africa will take years of steady commitment, coordination and investment.

There are numerous initiatives aimed at strengthening vaccine manufacturing in Africa. Ensuring that this multitude of initiatives and national strategies are aligned will be crucial to developing a diverse ecosystem that meets Africa's strategic economic and pandemic preparedness goals. The speed at which manufacturers can achieve regulatory prequalification will also be a crucial rate-limiting step for the expansion of the sector.

Gavi estimates that AVMA would need to disburse between US$ 750 million to US$ 1 billion to see a solid and sustainable foundation offering both resilient vaccine supply and improved pandemic response. As a minimum, the instrument aims to support at least four African vaccine manufacturers operating sustainably and at scale to win Gavi/UNICEF tenders for the production of well over 800 million vaccine doses over 10 years.

The stage is now set for African vaccine manufacturing to be transformed in the years to come.


Read more: The African Vaccine Manufacturing Accelerator: what is it and why is it important? - Gavi, the Vaccine Alliance
$1.2 Million Supports Under-the-Tongue Vaccine Film Delivery – Precision Vaccinations

$1.2 Million Supports Under-the-Tongue Vaccine Film Delivery – Precision Vaccinations

December 10, 2023

(Precision Vaccinations News)

The Coalition for Epidemic Preparedness Innovations (CEPI) recently announced it hadpartnered with Jurata Thin Film, Inc.to advance development of thermostable under-the-tonguevaccine films as a needle-free vaccine delivery platform.

On December 5, 2023, CEPI confirmed that it will provide up to an initial $1.2 million to support Jurata's proprietary innovative formulation platform, which, if shown to be successful, could help expand access to vaccines in underserved regions and advance the global response to future emerging infectious disease outbreaks.

CEPI's initial funding will support optimizing the composition and process of creatingthin films and preclinical studies.

Under the agreement with CEPI, Jurata will create vaccine films to remain stable at 2-8 degrees, 25 degrees, and 40 degrees.

Jurata will optimise the composition of the films by testing various buffers, pH, stabilizers, sugars, salts, and different drying parameters and assessing how this affects vaccine stability and delivery.

Jurata aims to improve vaccine accessibility by stabilizing the 3D structure of mRNA-containing lipid nanoparticle vaccine materials, provided by Quantoom Biosciences, part of Univercells, into a thin thermostable film, thereby removing frozen storage needs.

The vaccine films are also lightweight and compact, simplifying the transportation process and potentially allowing for more doses to be shipped at any one time compared to current needle-and-syringe distribution.

Dr. Irnela Bajrovic,Chief Scientific Officer, Jurata, commented in a press release, "Our stabilising formulations have the potential to facilitate global access to mRNA vaccines, and our thin film delivery platform could make vaccine administration far easier than needle-and-syringe injections."

"We are grateful to CEPI for supporting our innovative technology and look forward to working with Quantoom to show the breadth of mRNA vaccines our technology can stabilize and deliver."

This is the fourth partner to be announced as part ofCEPI's Call for Proposalsfor thermostable vaccine manufacturing innovations, announced in January 2022.

Thermostable vaccines are also identified as apreferred vaccine characteristicby the World Health Organization.


See original here: $1.2 Million Supports Under-the-Tongue Vaccine Film Delivery - Precision Vaccinations
Rotavirus genotype diversity in Tanzania during Rotavirus vaccine implementation between 2013 and 2018 | Scientific … – Nature.com

Rotavirus genotype diversity in Tanzania during Rotavirus vaccine implementation between 2013 and 2018 | Scientific … – Nature.com

December 10, 2023

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Rotavirus genotype diversity in Tanzania during Rotavirus vaccine implementation between 2013 and 2018 | Scientific ... - Nature.com
J&J to emphasize cancer drugs, stop much of its vaccine research – STAT

J&J to emphasize cancer drugs, stop much of its vaccine research – STAT

December 10, 2023

Eight months into his tenure, Johnson & Johnsons R&D chief is putting a big emphasis on medicines for cancer, treatment-resistant depression, and autoimmune disease.

To sharpen that focus, R&D chief John Reed told STAT that the company is de-emphasizing two areas that have been mainstays for the drug and medical device giant: infectious disease and vaccines, as well as medicines targeting kidney disease and rare eye conditions.

The disclosures were made in an interview ahead of an investor meeting Reed is leading Tuesday aimed at generating excitement about the companys research and development efforts. Fierce Biotech previously reported J&J is cutting vaccine R&D.

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J&J to emphasize cancer drugs, stop much of its vaccine research - STAT
Diphtheria Outbreak Ongoing in Guinea  Precision Vaccinations News – Precision Vaccinations

Diphtheria Outbreak Ongoing in Guinea Precision Vaccinations News – Precision Vaccinations

December 10, 2023

(Precision Vaccinations News)

The U.S. Centers for Disease Control and Prevention (CDC) continues to publish Trave Health Notices regardingdiphtheria outbreaks in various countries in 2023.

On December 7, 2023, the CDC posted aLevel 2 - Practice Enhanced Precautions notice regardingan outbreak of diphtheria in several districts in Guinea, which is located in western Africa.

Diphtheriais a severe infection caused by strains ofCorynebacterium diphtheriaebacteria that make a toxin. The toxin can cause people to get very sick. Diphtheria bacteria spread from person to person through respiratory droplets, like from coughing or sneezing.

People can also get sick from touching open sores or ulcers of people ill with diphtheria, according to the CDC.

Diphtheria is a vaccine-preventable disease.

Unfortunately, an estimated 16% of children worldwide hadno or incomplete vaccination coverage.

The U.S. CDC saysmost travelers visiting outbreak areas should receive an age-appropriate dose of diphtheria toxoid-containing vaccineif they are not fully vaccinatedor have not received a booster dose within five years before departure.

There are 11 vaccines available for use to help protect against diphtheria in 2023. Diphtheria and other travel vaccinesare offered at manyclinics and pharmacies in the U.S.


See more here: Diphtheria Outbreak Ongoing in Guinea Precision Vaccinations News - Precision Vaccinations
Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine – PR Newswire

Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine – PR Newswire

December 10, 2023

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"orthe "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:

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 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 CancerOne 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 VaccineAnixa'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, -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 -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.

AboutAnixa 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 preventbreastcancerspecificallytriple negativebreastcancer (TNBC),themostlethalform 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, Facebookand 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 [emailprotected] 646-274-3580

Mike Catelani President,COO&CFO [emailprotected] 408-708-9808

SOURCE Anixa Biosciences, Inc.


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Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine - PR Newswire