SAN JOSE, Calif.

加利福尼亚州圣何塞

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June 2, 2025

2025年6月2日

/PRNewswire/ --

/PRNewswire/ --

Anixa Biosciences, Inc.

安尼萨生物科学公司

('Anixa' or the 'Company') (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of enrollment in the Phase 1 clinical trial of its breast cancer vaccine. This novel vaccine, invented at Cleveland Clinic, is also being developed in partnership with Cleveland Clinic and the Phase 1 trial is fully funded by a grant from the U.S.

('Anixa'或'公司') (NASDAQ: ANIX)，一家专注于癌症治疗和预防的生物技术公司，今天宣布其乳腺癌疫苗的1期临床试验已完成入组。这款新型疫苗由克利夫兰诊所发明，同时也正在与克利夫兰诊所合作开发，1期试验由美国的一项拨款全额资助。

Department of Defense (DoD)..

国防部 (DoD)。

The vaccine is designed to stimulate the immune system to target breast cancer before it can recur or develop. A total of 35 women have received the vaccine in the trial, including 26 in the triple-negative breast cancer ('TNBC') group, four in the prevention group, and five in the pembrolizumab group.

该疫苗旨在刺激免疫系统在乳腺癌复发或发展之前对其靶向治疗。试验共有35名女性接种了疫苗，其中包括26名三阴性乳腺癌（“TNBC”）组患者、4名预防组患者和5名pembrolizumab组患者。

These participants represent three distinct patient cohorts:.

这些参与者代表了三个不同的患者队列：

TNBC Group: Women who have completed treatment for triple-negative breast cancer, are currently cancer-free, and are at risk of recurrence.

TNBC组：已完成三阴性乳腺癌治疗、目前无癌且有复发风险的女性。

Prevention Group: Women who are cancer-free but carry genetic mutations that place them at high risk of developing breast cancer and have elected to undergo preventative mastectomy to lower their risk.

预防组：未患癌症但携带使其乳腺癌高风险的基因突变，并选择接受预防性乳房切除术以降低风险的女性。

Pembrolizumab (Keytruda) Group: Women who are receiving pembrolizumab in a post-operative setting. These women are receiving the vaccine concurrently with pembrolizumab.

Pembrolizumab（Keytruda）组：在术后环境中接受Pembrolizumab治疗的女性。这些女性同时正在接受与Pembrolizumab一起使用的疫苗。

The final patient visits are scheduled for August 2025. Once completed, the final study report will be submitted to the Department of Defense. A Clinical Study Report (CSR) will then be prepared for submission to the U.S. Food and Drug Administration. As part of the continued development process, the Investigational New Drug (IND) application will be transferred from Cleveland Clinic to Anixa..

最后的患者访问计划于2025年8月进行。完成后，最终研究报告将提交给国防部。随后将准备一份临床研究报告（CSR）并提交给美国食品药品监督管理局（FDA）。作为持续开发过程的一部分，研究性新药（IND）申请将从克利夫兰诊所转移至Anixa。

Anixa and Cleveland Clinic plan to submit for presentation all trial data at a major upcoming scientific meeting.

Anixa和克利夫兰诊所计划在即将召开的一个重要科学会议上提交所有试验数据进行展示。

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, 'We are very encouraged by the data we are seeing from this trial. Preliminary results show that our breast cancer vaccine is well tolerated, with more than 70% of patients demonstrating protocol-defined immune responses. These encouraging findings are guiding our planning for Phase 2 trials, which will include discussions with the FDA, protocol development, manufacturing, and clinical site selection.

Anixa Biosciences董事长兼首席执行官阿米特·库马尔博士评论道：“我们从这项试验中看到的数据让我们备受鼓舞。初步结果显示，我们的乳腺癌疫苗耐受性良好，超过70%的患者表现出方案定义的免疫反应。这些令人鼓舞的发现正指导我们规划第二阶段试验，其中包括与FDA的讨论、方案开发、生产以及临床试验地点的选择。”

While cancer vaccines have traditionally faced significant hurdles, our approach is aimed at a novel target that has not been previously explored in this context. We believe this could represent a new paradigm in immuno-oncology. The breast cancer market, particularly for triple-negative breast cancer and genetically high-risk populations, continues to face a major unmet need.

虽然癌症疫苗传统上面临重大障碍，但我们的方法瞄准了一个在此背景下尚未被探索过的新靶点。我们相信这可能代表了免疫肿瘤学领域的新范式。乳腺癌市场，特别是三阴性乳腺癌和基因高风险人群，仍然存在重大的未满足需求。

Our vaccine may offer a unique, immunologic pathway for both prevention and treatment.'.

我们的疫苗可能提供了一种独特的免疫途径，既可用于预防也可用于治疗。

About Anixa Biosciences, Inc.

关于Anixa生物科学公司

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是一家专注于癌症治疗和预防的临床阶段生物技术公司。Anixa的治疗产品组合包括与莫菲特癌症中心合作开发的卵巢癌免疫疗法项目，该项目采用一种新型CAR-T，称为嵌合内分泌受体T细胞（CER-T）技术。

This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system.

该技术不同于其他细胞疗法，因为 FSHR 受体的天然配体 FSH 与肿瘤细胞上的 FSHR 受体结合，而不是抗体片段。莫菲特是癌症免疫治疗领域的世界领导者，率先开发了下一代细胞疗法，如 CAR-T 和肿瘤浸润淋巴细胞 (TIL)，以利用免疫系统的力量。

The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate.

公司的疫苗组合包括与克利夫兰诊所合作开发的用于治疗和预防乳腺癌及卵巢癌的疫苗，以及针对许多难治性癌症（包括肺癌、结肠癌和前列腺癌等高发恶性肿瘤）的其他癌症疫苗。

These vaccine technologies focus on immunizing against 'retired' proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies.

这些疫苗技术专注于免疫那些已被发现在某些形式的癌症中表达的“退役”蛋白。乳腺癌和卵巢癌疫苗由克利夫兰诊所开发，并独家授权给Anixa。克利夫兰诊所有权从公司获得与这些疫苗技术相关的版税和其他商业化收入。

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. To learn more, visit .

Anixa独特的商业模式是与世界知名研究机构在开发的各个阶段进行合作，这使得公司能够不断考察互补领域的新兴技术，以进一步开发和商业化。欲了解更多信息，请访问。

www.anixa.com

www.anixa.com

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或关注Anixa

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Forward-Looking Statements

前瞻性声明

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.

非历史事实的陈述可能被视为1995年私人证券诉讼改革法案意义下的前瞻性陈述。前瞻性陈述并非历史事实的陈述，而是反映Anixa对未来事件和结果的当前预期。

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”、“预期”、“打算”、“计划”、“预计”、“可能”、“将”等词语以及类似表述来识别前瞻性声明。这些前瞻性声明，包括与我们的预期相关的声明，涉及风险、不确定性和其他因素，其中某些因素超出我们的控制范围，可能导致我们的实际结果、表现或成就，或行业结果，与这些前瞻性声明明示或暗示的任何未来结果、表现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我们最近的年度报告Form 10-K中的“第1A项 - 风险因素”以及其他部分，以及我们的季度报告Form 10-Q和当前报告Form 8-K中列出的因素。我们没有义务公开更新或修改任何前瞻性声明，无论是由于新信息、未来事件或其他原因，除非法律要求。

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

您在评估本新闻稿中提供的信息时，务请注意不要过度依赖此类前瞻性陈述。

Contact:

联系人：

Mike Catelani

迈克·卡特兰尼

President, COO & CFO

总裁、首席运营官和首席财务官

mcatelani@anixa.com

mcatelani@anixa.com

408-708-9808

408-708-9808

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SOURCE Anixa Biosciences, Inc.

来源：Anixa Biosciences, Inc.