Announces focus on therapeutic approach; resulting in a faster and more cost-effective path to approval

宣布关注治疗方法；实现更快、更具成本效益的审批途径

SAN JOSE, Calif., Sept. 24, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ('Anixa' or the 'Company') (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced its strategic plan for a Phase 2 study for its breast cancer vaccine. The Phase 1 trial is being conducted at Cleveland Clinic, funded by a grant from the U.S.

加利福尼亚州圣何塞，2024年9月24日，专注于癌症治疗和预防的生物技术公司Anixa Biosciences，Inc.（“Anixa”或“公司”）（纳斯达克：ANIX）今天宣布了其乳腺癌疫苗二期研究的战略计划。第一阶段试验正在克利夫兰诊所进行，由美国政府资助。

Department of Defense..

国防部。。

The proposed Phase 2 trial will evaluate the efficacy of the vaccine administered in the neoadjuvant (before surgery) setting, in combination with chemotherapy and Keytruda (pembrolizumab). The goal of neoadjuvant therapy is to reduce tumor burden and to prevent tumor recurrence with the intent to improve survival.

拟议的2期临床试验将评估新辅助（手术前）环境中接种的疫苗与化疗和Keytruda（pembrolizumab）联合使用的疗效。新辅助治疗的目标是减轻肿瘤负担并预防肿瘤复发，以提高生存率。

This clinical trial approach allows Anixa to enroll a broader range of patients, encompassing multiple types of breast cancer. The therapeutic market for breast cancer is large due to the increase in prevalence of breast cancer and an increase in screening resulting in a demand for treatment. Compared with primary prevention, the development path for breast cancer treatment is expected to have a shorter path to approval.

这种临床试验方法允许Anixa招募更广泛的患者，包括多种类型的乳腺癌。由于乳腺癌患病率的增加和筛查的增加导致对治疗的需求，乳腺癌的治疗市场很大。与一级预防相比，乳腺癌治疗的发展路径有望获得更短的批准。

The therapeutic market covers all stages of breast cancer, from early to advanced and metastatic cases. In 2023, the market was valued at approximately $38.35 billion and is projected to reach $89.67 billion by 2030, growing at a compound annual growth rate (CAGR) of 12.9% (Maximize Market Research)..

治疗市场涵盖乳腺癌的所有阶段，从早期到晚期和转移病例。2023年，市场价值约为383.5亿美元，预计到2030年将达到896.7亿美元，复合年增长率（CAGR）为12.9%（最大化市场研究）。。

The key objectives of the trial include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy. A key component of this trial will be the evaluation of breast cancer tissue and the validation of the immunological mechanism of action of the vaccine..

该试验的关键目标包括评估对疫苗的免疫反应，并比较单独标准护理疗法与疫苗加标准护理疗法的临床疗效。该试验的一个关键组成部分将是乳腺癌组织的评估和疫苗免疫作用机制的验证。。

The trial is expected to commence in 2025 and is projected to last approximately two to three years. Immunological responses to the vaccine will be made available as the trial advances, providing a faster and more cost-effective path toward potential approval and/or partnerships with pharmaceutical companies..

该试验预计将于2025年开始，预计持续约2至3年。随着试验的进展，将提供对疫苗的免疫反应，为潜在的批准和/或与制药公司的合作提供更快，更具成本效益的途径。。

'We are excited to unveil our Phase 2 study plan, bringing us one step closer to a potentially transformative therapy for breast cancer patients,' said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. 'By targeting treatment rather than prevention, we can reach a broader patient population and potentially expedite the process of regulatory approval and partnerships.

Anixa Biosciences董事长兼首席执行官阿米特·库马尔（Amit Kumar）博士说：“我们很高兴公布我们的第二阶段研究计划，使我们离乳腺癌患者的潜在变革疗法又近了一步。”通过针对治疗而不是预防，我们可以覆盖更广泛的患者群体，并可能加快监管部门的批准和合作进程。

This trial marks a key milestone in advancing our mission to fight cancer through innovative therapies. While our Phase 2 trial focuses on the therapeutic market, with the data obtained in this trial, we expect to conduct additional, more informed studies for both recurrence prevention and primary prevention with partners in the future.'.

这项试验标志着我们通过创新疗法推进抗癌使命的关键里程碑。虽然我们的第二阶段试验侧重于治疗市场，但根据本试验获得的数据，我们预计未来将与合作伙伴进行更多，更知情的复发预防和一级预防研究。”。

Initial Phase 1 data was presented at the San Antonio Breast Cancer Symposium in December 2023. The data showed no safety concerns, with protocol defined immune responses observed in a majority of patients. Additional data from the Phase 1 trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in early November 2024..

最初的第一阶段数据于2023年12月在圣安东尼奥乳腺癌研讨会上发表。数据显示没有安全问题，在大多数患者中观察到方案定义的免疫反应。第一阶段试验的其他数据将于2024年11月初在癌症免疫治疗学会（SITC）年会上提交。。

The Phase 1 trial is conducted in collaboration with Cleveland Clinic and is funded by a grant from the U.S. Department of Defense. Anixa is the exclusive worldwide licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic. The grant funding from the U.S. Department of Defense was provided to Cleveland Clinic..

第一阶段试验是与克利夫兰诊所合作进行的，由美国国防部拨款资助。Anixa是克利夫兰诊所开发的新型乳腺癌疫苗技术的全球独家许可证持有人。。。

About Anixa Bioscience's Breast Cancer Vaccine

关于Anixa Bioscience的乳腺癌疫苗

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, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in certain breast cancers.

Anixa的乳腺癌疫苗利用了内源性产生的蛋白质，这些蛋白质在生命的某些时期具有功能，但随后会“退休”并从体内消失。其中一种蛋白质是乳腺特异性泌乳蛋白α-乳清蛋白，在正常的衰老组织中泌乳后不再发现，但存在于某些乳腺癌中。

Activating the immune system against this 'retired' protein provides preemptive immune protection against emerging breast tumors that express α-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..

。该疫苗还含有一种佐剂，可激活先天免疫反应，从而使免疫系统对新出现的肿瘤产生反应，防止其生长。。

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. Cleveland Clinic exclusively licensed this technology to Anixa Biosciences.

这种疫苗技术是由已故的Vincent Tuohy博士发明的，他是克利夫兰诊所勒纳研究所炎症与免疫系创新乳腺癌研究的Mort and Iris-Novel杰出主席。克利夫兰诊所将该技术独家许可给Anixa Biosciences。

Dr. Tuohy was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa..

Tuohy博士有权获得克利夫兰诊所获得的部分商业化收入，并持有Anixa的股权。。

About Anixa Biosciences, Inc.

关于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.

Anixa是一家临床阶段生物技术公司，专注于癌症的治疗和预防。Anixa的治疗组合包括与Moffitt癌症中心合作开发的卵巢癌免疫治疗计划，该计划使用一种新型CAR-T，称为嵌合内分泌受体-T细胞（CER-T）技术。

The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate.

该公司的疫苗组合包括与克利夫兰诊所（Cleveland Clinic）合作开发的预防乳腺癌（特别是三阴性乳腺癌（TNBC）和卵巢癌的疫苗，以及用于治疗许多难治性癌症的其他癌症疫苗，包括肺癌，结肠癌和前列腺癌的高发恶性肿瘤。

These vaccine technologies focus on immunizing against 'retired' proteins that have been found to be expressed in certain forms of cancer. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization.

这些疫苗技术的重点是针对已发现在某些形式的癌症中表达的“退役”蛋白质进行免疫。Anixa在各个发展阶段与世界知名研究机构合作的独特商业模式使公司能够不断研究互补领域的新兴技术，以进一步开发和商业化。

To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube..

要了解更多信息，请访问www.anixa.com或在Twitter、LinkedIn、Facebook和YouTube上关注anixa。。

Forward-Looking StatementsStatements 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.

前瞻性陈述非历史事实的陈述可被视为1995年《私人证券诉讼改革法案》所指的前瞻性陈述。前瞻性陈述不是对历史事实的陈述，而是反映了安妮莎目前对未来事件和结果的期望。

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.

我们通常使用“相信”、“期望”、“打算”、“计划”、“预期”、“可能”、“意志”等词语来识别前瞻性陈述。此类前瞻性声明，包括与我们的预期有关的声明，涉及风险、不确定性和其他因素，其中一些因素超出了我们的控制范围，这可能导致我们的实际结果、业绩或成就或行业结果与此类前瞻性声明明示或暗示的任何未来结果、业绩或成就存在重大差异。

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.

这些风险、不确定性和因素包括但不限于“第1A项-风险因素”和我们最近的10-K表年度报告其他章节以及10-Q表季度报告和8-K表当前报告中规定的因素。除法律要求外，我们没有义务公开更新或修订任何前瞻性声明，无论是由于新信息、未来事件还是其他原因。

You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release..

在评估本新闻稿中提供的信息时，请注意不要过度依赖此类前瞻性声明。。

Contact:Mike CatelaniPresident, COO & CFOmcatelani@anixa.com408-708-9808

联系人：Mike Catelani总裁兼首席运营官&CFOmcatelani@anixa.com408-708-9808

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SOURCE Anixa Biosciences, Inc.

来源Anixa Biosciences，Inc。