CER T cell(CERo Therapeutics)

近日，Anixa Biosciences宣布，其合作者莫菲特癌症中心（Moffitt）已经获得美国FDA对个体患者的研究性新药申请（IND）的批准，允许对初剂治疗表现出临床活性的患者给药第二剂CAR-T。 该IND是基于该卵巢癌患者的肿瘤活检中表现出的坏死、炎症反应和T细胞浸润，表明CAR-T初剂治疗具有积极的治疗效果。 新型CAR-T治疗卵巢癌 根据公开信息，Anixa公司的卵巢癌CAR-T项目是一种新型的嵌合内分泌受体T细胞（CER-T），不同于传统的嵌合抗原受体T细胞（CAR-T）通过抗原识别结构域实现对肿瘤抗原的特异性靶向。 这款卵巢癌CER-T的胞外结构域采用的是全长FSH（促卵泡激素），去识别并结合一种内分泌受体FSHR（卵泡刺激激素受体）——FSHR在卵巢癌或某些肿瘤细胞上高表达，正常组织中少见。 这种特异性靶向FSHR的CER-T细胞，在临床前显示出能够提高卵巢癌小鼠模型的存活率，可以对抗广泛的卵巢恶性肿瘤。另外，在无卵巢肿瘤但存在同源靶点的情况下，CER-T的毒性可以忽略不计。 目前，该疗法正在进行1期临床试验，旨在评估治疗标准护理失败的复发性卵巢癌患者的安全性和有效性。迄今为止，已经有6名患者在剂量递增试验中接受治疗，其中3名为第1队列，3名为第2队列。 给药第二剂CAR-T 获得该IND批准的个体患者，是1期临床试验中第1队列（最低剂量）的一名患者。 该患者在接受最低剂量的CER-T给药后，一开始肿瘤有所增大（符合进展标准），但是随后数个月内肿瘤停止进展，最初升高的肿瘤标志物也开始下降。同时，活检显示肿瘤伴坏死、炎症反应和T细胞浸润。 基于该发现，研究团队开始寻求FDA的批准，对该名患者进行第二剂治疗，旨在增加部分或完全缓解的可能。 小结 在血液瘤中，CAR-T的重复给药比较不容易实现，在患者肿瘤复发后通常会出现肿瘤抗原丢失的情况，从而导致重复给药同靶点CAR-T效果不佳。 参考资料： 1.https://ir.anixa.com/press-releases/detail/1046/anixa-biosciences-announces-fda-approval-of-individual 2.https://www.anixa.com/technologies/car-t/science 3.https://aacrjournals.org/clincancerres/article/23/2/441/275013/Follicle-Stimulating-Hormone-Receptor-Is-Expressed 本周好文推荐 如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

This patient is expected to be the final patient in the second dosage cohort of the trial SAN JOSE, Calif., June 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 that it has treated the sixth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. This patient is expected to be the last patient in the second dosage cohort. If there continue to be no adverse effects experienced by the second cohort participants, enrollment of the third dosage cohort may commence within the next month. The study is being conducted through a research partnership with Moffitt Cancer Center. Anixa's FSHR-mediated CAR-T technology, also known as chimeric endocrine receptor T-cell (CER-T), differs from traditional CAR-T therapy by targeting the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, including the vasculature of tumors. The first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who have progressed on at least two prior therapies. The study is designed to evaluate safety and identify the maximum tolerated dose, while monitoring efficacy. Safety was previously confirmed in the first three-patient cohort. The fourth through sixth patients, enrolled in the second cohort of the Phase 1 clinical trial, received triple the dose of CAR-T cells compared with the dose of the first cohort, with no dose-limiting toxicities observed. Following the requisite wait time, of one month after dosing, enabling confirmation that it is safe to escalate, the trial will immediately begin enrolling patients in the third dose cohort, which will be at a ten times higher dose than the initial dosage. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We are highly encouraged by the favorable safety profile observed thus far in both the first and second patient cohorts, and are eager to evaluate a higher dose in the next cohort. We are particularly encouraged by a notable response in one of the patients in the first cohort, even though the dosage was considered a subtherapeutic level. Our aim is to maintain a positive safety profile as we escalate dosing, with the goal of demonstrating additional objective evidence of efficacy. Unlike conventional CAR-T cell therapies, which have achieved amazing results in various hematological cancers, they have not been effective in solid tumors. In contrast, we believe Anixa's novel technology has the potential to make CAR-T effective in ovarian cancer and perhaps across multiple solid tumor types. Our unique and highly targeted CER-T approach targets the FSHR, which is exclusively expressed on ovarian cells. A potential dual mechanism of action is operating with our therapy targeting tumor vasculature by starving or shrinking the tumor from the inside out, as well as direct targeting of ovarian cells." Dr. Kumar continued, "We believe that intraperitoneal (IP) delivery may also be a significant advantage of our therapy, as it allows direct trafficking of the CAR-T cells to the tumor sites, which helps to minimize side effects such as cytokine release syndrome (CRS). We believe this method of delivery not only enhances the targeting of the tumor but also improves the overall safety profile of the treatment. We expect that IP delivery may enable us to use dosages that are much higher than possible with intravenous delivery." 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 or follow Anixa on Twitter, LinkedIn, Facebook and 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. Contact: Mike Catelani President, COO & CFO [email protected] 408-708-9808 SOURCE Anixa Biosciences, Inc.