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Anixa Biosciences Commences Treatment of Fifth Patient in Ovarian Cancer CAR-T Clinical Trial

Anixa Biosciences Commences Treatment of Fifth Patient in Ovarian Cancer CAR-T Clinical Trial

Anixa Biosciences开始治疗卵巢癌CAR-T临床试验中的第五名患者
Anixa Biosciences ·  05/21 00:00

Novel and proprietary CAR-T approach holds potential to be first effective CAR-T therapy for solid tumors

新的专有CAR-T方法有可能成为第一种有效的实体瘤CAR-T疗法

SAN JOSE, Calif., May 21, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that treatment has commenced for the fifth patient in its ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center.

加利福尼亚州圣何塞,2024 年 5 月 21 日 /PRNewswire/-- Anixa Biosciences, Inc (“Anixa” 或 “公司”)(纳斯达克股票代码:ANIX)是一家专注于癌症治疗和预防的临床阶段生物技术公司,今天宣布,正在进行的卵巢癌新型嵌合抗原受体T细胞(CAR-T)疗法的1期临床试验中,第五名患者的治疗已经开始。该研究是通过与莫菲特癌症中心的研究合作进行的。

Anixa's first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who were unresponsive to at least two prior therapies. Safety was confirmed in the first three-patient cohort. The patients in the second cohort, including patient #5, receive triple the dose of engineered T-cells compared with the first cohort of three patients. The study will identify the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR), found only on ovarian cells

Anixa 的首次人体试验 (NCT05316129)正在招收对至少两种先前疗法没有反应的复发/进展性卵巢癌的女性成年患者。在前三名患者中,安全性得到证实。与第一组三名患者相比,第二组患者,包括患者 #5,接受的工程T细胞剂量是第一组患者的三倍。该研究将确定靶向卵泡刺激素受体(FSHR)的T细胞的最大耐受剂量,该受体仅存在于卵巢细胞上

"With our fifth patient treated, our trial is progressing, and we continue to see that our therapy appears to be safe and well-tolerated," said Dr. Amit Kumar, Chairman and CEO of Anixa. "The technology behind our novel CAR-T therapy differs from traditional CAR-T therapies by targeting the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. We developed this approach to tackle preexisting difficulties with CAR-T cell therapies in solid ovarian tumors. In our trial, we will also explore several parameters for applying our CAR-T therapy to solid tumors in general."

Anixa董事长兼首席执行官阿米特·库马尔博士说:“随着我们的第五名患者接受了治疗,我们的试验正在取得进展,我们继续看到我们的疗法似乎是安全且耐受性良好的。”“我们的新型CAR-T疗法背后的技术与传统的CAR-T疗法不同,它以FSHR为目标,研究表明,FSHR仅在健康成年女性的卵巢细胞上表达。我们开发这种方法是为了解决实体卵巢肿瘤中CAR-T细胞疗法先前存在的困难。在我们的试验中,我们还将探索将我们的CAR-T疗法应用于一般实体瘤的几个参数。”

Anixa's FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

Anixa的FSHR介导的CAR-T技术由杜克大学医学院综合免疫生物学系免疫学教授何塞·科内霍-加西亚医学博士、博士开发。Anixa持有Wistar研究所对该技术的全球独家许可。

About Anixa's CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa's chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

关于 Anixa 的 CER-T 方法(卵泡刺激激素受体介导的 CAR-T 技术)
Anixa 的嵌合抗原受体 T 细胞 (CAR-T) 技术方法是一种自体细胞疗法,由靶向卵泡刺激激素受体 (FSHR) 的工程化 T 细胞组成。FSHR 仅存在于卵巢颗粒细胞的免疫学相关水平。由于靶点是激素(嵌合内分泌)受体,并且靶结合域源自其天然配体,因此该技术被称为 CER-T(嵌合内分泌受体 T 细胞)疗法,一种新型的 CAR-T。

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

关于 Anixa Biosciences, Inc.
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计划,该计划使用一种新型的CAR-T,即嵌合内分泌受体T细胞(CER-T)技术。该公司的疫苗产品组合包括与克利夫兰诊所合作开发的预防乳腺癌(特别是三阴性乳腺癌(TNBC),该疾病中最致命的形式)和卵巢癌的疫苗,以及其他用于治疗许多难治癌症的癌症疫苗,包括肺部、结肠和前列腺的高发恶性肿瘤。这些疫苗技术侧重于对已发现可在某些形式的癌症中表达的 “退役” 蛋白进行免疫接种。Anixa在各个开发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。要了解更多信息,请访问 www.anixa.com 或者继续关注 Anixa 推特领英Facebook优酷

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.

前瞻性陈述:根据1995年《私人证券诉讼改革法》,非历史事实的陈述可能被视为前瞻性陈述。前瞻性陈述不是对历史事实的陈述,而是反映了Anixa当前对未来事件和结果的预期。我们通常使用 “相信”、“期望”、“打算”、“计划”、“预期”、“可能”、“将” 等词语以及类似的表述来识别前瞻性陈述。此类前瞻性陈述,包括与我们的预期有关的陈述,涉及风险、不确定性和其他因素,其中一些因素是我们无法控制的,这可能导致我们的实际业绩、业绩或成就或行业业绩与此类前瞻性陈述所表达或暗示的任何未来业绩、业绩或成就存在重大差异。这些风险、不确定性和因素包括但不限于 “项目1A——风险因素” 和我们最新的10-K表年度报告以及我们的10-Q表季度报告和8-K表最新报告的其他部分中列出的因素。除非法律要求,否则我们没有义务公开更新或修改任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。提醒您在评估本新闻稿中提供的信息时不要过度依赖此类前瞻性陈述。

Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

联系人:
迈克·卡特拉尼
总裁、首席运营官兼首席财务官
mcatelani@anixa.com
408-708-9808

SOURCE  Anixa Biosciences, Inc.

来源 Anixa Biosciences, Inc.

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