<p>, /PRNewswire/ -- Anixa Biosciences, Inc.（&#34;Anixa&#34;或&#34;公司&#34;）（NASDAQ: ANIX）是一家专注于癌症治疗和预防的生物技术公司，今天宣布已完成从克利夫兰诊所转移其乳腺癌疫苗的研究性新药申请（&#34;IND&#34;）。Anixa 现在是其乳腺癌疫苗未来开发的试验赞助商。IND 的转移是疫苗开发进程中的一个自然和计划步骤。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/602982/ITUS_Corporation_Logo.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/602982/ITUS_Corporation_Logo.jpg"/></p>
<p>随着招募工作的完成以及在第一阶段试验中观察到的令人鼓舞的免疫反应和安全性数据，Anixa 计划将疫苗推进至第二阶段临床试验，并已全面承担 IND 的赞助。Anixa 计划在包括克利夫兰诊所在内的多个临床地点进行第二阶段及其他临床试验。</p>
<p>Anixa 的乳腺癌疫苗是与克利夫兰诊所合作开发的，针对α-乳白蛋白——一种通常仅在哺乳期间在乳腺组织中表达的乳汁相关蛋白，但在许多形式的乳腺癌中重新出现。通过建立针对表达α-乳白蛋白细胞的免疫反应，该疫苗可能为表达这种蛋白的肿瘤患者提供治疗和预防的双重益处。该疫苗基于已故的 Vincent Tuohy 博士主导的前临床研究，他曾担任克利夫兰诊所创新乳腺癌研究的 Mort 和 Iris November 杰出讲席教授。</p>
<p>&#34;我们对承担乳腺癌疫苗 IND 的赞助感到兴奋，并期待将这一潜在改变游戏规则的癌症疫苗推进到未来的临床试验中，&#34; Anixa Biosciences 的董事长兼首席执行官 Amit Kumar 博士表示。&#34;我们对第一阶段临床试验的进展和发现感到满意，这些结果已于 12 月 11 日在圣安东尼奥乳腺癌研讨会上发布。&#34;</p>
<p>第一阶段数据的讨论可以在 https://ir.anixa.com/press-releases 中查看。</p>
<p><strong>关于 Anixa Biosciences, Inc.</strong> Anixa 是一家临床阶段的生物技术公司，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疗法项目，该项目使用一种新型的 CAR-T，称为嵌合内分泌受体-T 细胞（CER-T）技术。这项技术与其他细胞疗法不同，因为 FSHR 受体的天然配体 FSH 与肿瘤细胞上的 FSHR 受体结合，而不是与抗体片段结合。Moffitt 是癌症免疫疗法治疗的世界领导者，开创了下一代细胞疗法，如 CAR-T 和肿瘤浸润淋巴细胞（TILs），以利用免疫系统的力量。公司的疫苗组合包括与克利夫兰诊所合作开发的疫苗，以治疗和预防乳腺癌和卵巢癌，以及针对许多难治性癌症的其他癌症疫苗，包括肺癌、结肠癌和前列腺癌等高发恶性肿瘤。这些疫苗技术专注于针对在某些癌症形式中发现的 “退休” 蛋白进行免疫。乳腺癌和卵巢癌疫苗是在克利夫兰诊所开发并独家授权给 Anixa 的。克利夫兰诊所有权从与这些疫苗技术相关的公司获得版税和其他商业化收入。Anixa 独特的商业模式是与世界知名的研究机构在所有开发阶段进行合作，使公司能够不断审查新兴技术在互补领域的进一步开发和商业化。要了解更多信息，请访问 www.anixa.com 或在 LinkedIn、X、Facebook 和 YouTube 上关注 Anixa。</p>
<p><strong>前瞻性声明</strong></p>
<p>不属于历史事实的陈述可能被视为 1995 年《私人证券诉讼改革法》意义上的前瞻性声明。前瞻性声明不是历史事实的陈述，而是反映 Anixa 对未来事件和结果的当前预期。我们通常使用&#34;相信&#34;、&#34;期望&#34;、&#34;打算&#34;、&#34;计划&#34;、&#34;预期&#34;、&#34;可能&#34;、&#34;将&#34;和类似表达来识别前瞻性声明。这些前瞻性声明，包括那些关于我们期望的声明，涉及风险、不确定性和其他因素，其中一些超出我们的控制，可能导致我们的实际结果、表现或成就，或行业结果，与这些前瞻性声明所表达或暗示的任何未来结果、表现或成就有实质性差异。这些风险、不确定性和因素包括但不限于我们最近的 10-K 表格年报中&#34;第 1A 项 - 风险因素&#34;和其他部分中列出的因素，以及我们的 10-Q 表格季度报告和 8-K 表格当前报告中列出的因素。除非法律要求，否则我们不承担公开更新或修订任何前瞻性声明的义务，无论是由于新信息、未来事件还是其他原因。在评估本新闻稿中提供的信息时，请谨慎对待不应过度依赖这些前瞻性声明。</p>
<p><strong>联系方式：</strong></p>
<p>Mike Catelani</p>
<p>总裁、首席运营官兼首席财务官</p>
<p>mcatelani@anixa.com</p>
<p>408-708-9808</p>
<p>来源 Anixa Biosciences, Inc.</p>

ANIX

<p>Anixa Biosciences 已完成其乳腺癌疫苗的 IND 转让，成为未来开发的试验赞助商。凭借有希望的第一阶段试验结果，Anixa 计划推进到第二阶段试验，利用多个临床试验地点。该疫苗针对 α-乳白蛋白，提供治疗和预防的益处。Anixa 与克利夫兰诊所共同开发，其独特的商业模式涉及与知名研究机构合作进行癌症治疗和预防</p>

<p>, /PRNewswire/ -- Anixa Biosciences, Inc. (&#34;Anixa&#34; or the &#34;Company&#34;) (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has completed the transfer of the Investigational New Drug application (&#34;IND&#34;) for its breast cancer vaccine from Cleveland Clinic. Anixa is now the trial sponsor for future development of its breast cancer vaccine. The transfer of the IND is a natural and planned step in the progresson of the vaccine's development.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- Anixa Biosciences, Inc.（&#34;Anixa&#34;或&#34;公司&#34;）（NASDAQ: ANIX）是一家专注于癌症治疗和预防的生物技术公司，今天宣布已完成从克利夫兰诊所转移其乳腺癌疫苗的研究性新药申请（&#34;IND&#34;）。Anixa 现在是其乳腺癌疫苗未来开发的试验赞助商。IND 的转移是疫苗开发进程中的一个自然和计划步骤。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/602982/ITUS_Corporation_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/602982/ITUS_Corporation_Logo.jpg"/></p>
<p>With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and has assumed full sponsorship of the IND. Anixa plans to utilize multiple clinical sites, including Cleveland Clinic, for the Phase 2 and other clinical trials.</p>
<div class="lb-trans"><p>随着招募工作的完成以及在第一阶段试验中观察到的令人鼓舞的免疫反应和安全性数据，Anixa 计划将疫苗推进至第二阶段临床试验，并已全面承担 IND 的赞助。Anixa 计划在包括克利夫兰诊所在内的多个临床地点进行第二阶段及其他临床试验。</p>
</div><p>Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein. The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.</p>
<div class="lb-trans"><p>Anixa 的乳腺癌疫苗是与克利夫兰诊所合作开发的，针对α-乳白蛋白——一种通常仅在哺乳期间在乳腺组织中表达的乳汁相关蛋白，但在许多形式的乳腺癌中重新出现。通过建立针对表达α-乳白蛋白细胞的免疫反应，该疫苗可能为表达这种蛋白的肿瘤患者提供治疗和预防的双重益处。该疫苗基于已故的 Vincent Tuohy 博士主导的前临床研究，他曾担任克利夫兰诊所创新乳腺癌研究的 Mort 和 Iris November 杰出讲席教授。</p>
</div><p>&#34;We are excited about assuming sponsorship of the breast cancer vaccine IND, and we look forward to advancing this potentially game-changing cancer vaccine into future clinical trials,&#34; stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. &#34;We are pleased with the progress and findings from our Phase 1 clinical trial, which were presented at the San Antonio Breast Cancer Symposium on December 11.&#34;</p>
<div class="lb-trans"><p>&#34;我们对承担乳腺癌疫苗 IND 的赞助感到兴奋，并期待将这一潜在改变游戏规则的癌症疫苗推进到未来的临床试验中，&#34; Anixa Biosciences 的董事长兼首席执行官 Amit Kumar 博士表示。&#34;我们对第一阶段临床试验的进展和发现感到满意，这些结果已于 12 月 11 日在圣安东尼奥乳腺癌研讨会上发布。&#34;</p>
</div><p>A discussion of the Phase 1 data can be reviewed at https://ir.anixa.com/press-releases.</p>
<div class="lb-trans"><p>第一阶段数据的讨论可以在 https://ir.anixa.com/press-releases 中查看。</p>
</div><p><strong>About Anixa Biosciences, Inc.</strong> 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. 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. 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. These vaccine technologies focus on immunizing against &#34;retired&#34; 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. 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 www.anixa.com or follow Anixa on LinkedIn, X, Facebook and YouTube.</p>
<div class="lb-trans"><p><strong>关于 Anixa Biosciences, Inc.</strong> Anixa 是一家临床阶段的生物技术公司，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疗法项目，该项目使用一种新型的 CAR-T，称为嵌合内分泌受体-T 细胞（CER-T）技术。这项技术与其他细胞疗法不同，因为 FSHR 受体的天然配体 FSH 与肿瘤细胞上的 FSHR 受体结合，而不是与抗体片段结合。Moffitt 是癌症免疫疗法治疗的世界领导者，开创了下一代细胞疗法，如 CAR-T 和肿瘤浸润淋巴细胞（TILs），以利用免疫系统的力量。公司的疫苗组合包括与克利夫兰诊所合作开发的疫苗，以治疗和预防乳腺癌和卵巢癌，以及针对许多难治性癌症的其他癌症疫苗，包括肺癌、结肠癌和前列腺癌等高发恶性肿瘤。这些疫苗技术专注于针对在某些癌症形式中发现的 “退休” 蛋白进行免疫。乳腺癌和卵巢癌疫苗是在克利夫兰诊所开发并独家授权给 Anixa 的。克利夫兰诊所有权从与这些疫苗技术相关的公司获得版税和其他商业化收入。Anixa 独特的商业模式是与世界知名的研究机构在所有开发阶段进行合作，使公司能够不断审查新兴技术在互补领域的进一步开发和商业化。要了解更多信息，请访问 www.anixa.com 或在 LinkedIn、X、Facebook 和 YouTube 上关注 Anixa。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>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 &#34;believes,&#34; &#34;expects,&#34; &#34;intends,&#34; &#34;plans,&#34; &#34;anticipates,&#34; &#34;likely,&#34; &#34;will&#34; 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 &#34;Item 1A - Risk Factors&#34; 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.</p>
<div class="lb-trans"><p>不属于历史事实的陈述可能被视为 1995 年《私人证券诉讼改革法》意义上的前瞻性声明。前瞻性声明不是历史事实的陈述，而是反映 Anixa 对未来事件和结果的当前预期。我们通常使用&#34;相信&#34;、&#34;期望&#34;、&#34;打算&#34;、&#34;计划&#34;、&#34;预期&#34;、&#34;可能&#34;、&#34;将&#34;和类似表达来识别前瞻性声明。这些前瞻性声明，包括那些关于我们期望的声明，涉及风险、不确定性和其他因素，其中一些超出我们的控制，可能导致我们的实际结果、表现或成就，或行业结果，与这些前瞻性声明所表达或暗示的任何未来结果、表现或成就有实质性差异。这些风险、不确定性和因素包括但不限于我们最近的 10-K 表格年报中&#34;第 1A 项 - 风险因素&#34;和其他部分中列出的因素，以及我们的 10-Q 表格季度报告和 8-K 表格当前报告中列出的因素。除非法律要求，否则我们不承担公开更新或修订任何前瞻性声明的义务，无论是由于新信息、未来事件还是其他原因。在评估本新闻稿中提供的信息时，请谨慎对待不应过度依赖这些前瞻性声明。</p>
</div><p><strong>Contact:</strong></p>
<div class="lb-trans"><p><strong>联系方式：</strong></p>
</div><p>Mike Catelani</p>
<div class="lb-trans"><p>Mike Catelani</p>
</div><p>President, COO &amp; CFO</p>
<div class="lb-trans"><p>总裁、首席运营官兼首席财务官</p>
</div><p>mcatelani@anixa.com</p>
<div class="lb-trans"><p>mcatelani@anixa.com</p>
</div><p>408-708-9808</p>
<div class="lb-trans"><p>408-708-9808</p>
</div><p>SOURCE Anixa Biosciences, Inc.</p>
<div class="lb-trans"><p>来源 Anixa Biosciences, Inc.</p>
</div>

Anixa Biosciences 宣布将乳腺癌疫苗的 IND 申请从克利夫兰诊所转移 | ANIX 股票新闻