Investing News NetworkOctober 03, 2024Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce regulatory and manufacturing progress for its B7-H3 targeting radio-antibody, BetaBart.

投资新闻网2024年10月3日Radiopharm Theranostics（ASX:RAD，“Radiopharm”或“公司”）是一家临床阶段的生物制药公司，专注于为高度未满足的医疗需求领域开发创新的肿瘤放射性药物，很高兴宣布其B7-H3靶向放射抗体BetaBart的监管和制造进展。

Pre-IND meeting request with FDA submittedFirst GMP batch of antibody + chelator successfully produced The monoclonal antibody is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics (RAD) and MD Anderson Cancer Center (MDACC).The strong preclinical data package combined with GMP quality production, supported the pre-IND submission to the US Food and Drug Administration (FDA).

与FDA提交的预先IND会议要求成功生产了第一批GMP抗体+螯合剂单克隆抗体是Radiopharm Ventures开发的第一种放射性药物治疗剂，Radiopharm Theranostics（RAD）和MD安德森癌症中心（MDACC）成立的合资企业。强大的临床前数据包与GMP质量生产相结合，支持向美国食品和药物管理局（FDA）提交预先IND。

Preparations are on track to prepare the IND submission with the FDA and subsequently start the Phase I/II First-In-Human (FIH) therapeutic trial with BetaBart in multiple tumour types in the US, expected for mid-2025.B7-H3 is an immune checkpoint molecule that is overexpressed in several tumour types, and represents a highly attractive target for antibody-based cancer immunotherapy.

准备工作正在准备向FDA提交IND，随后开始在美国多种肿瘤类型中使用贝塔巴特进行I/II期首次人体（FIH）治疗试验，预计将于2025年年中进行。B7-H3是一种免疫检查点分子，在几种肿瘤类型中过表达，是基于抗体的癌症免疫治疗的极具吸引力的靶点。

Deregulated B7-H3 expression is linked with tumour aggressiveness and poor outcomes. BetaBart is the first and only targeted radiopharmaceutical in development against the 4Ig subtype of B7-H3, which is the most common subtype expressed on human tumours.Multiple preclinical studies with BetaBart show tumour shrinkage and prolonged survival in animals treated with this radiotherapeutic agent.

失调的B7-H3表达与肿瘤侵袭性和不良结局有关。BetaBart是第一个也是唯一一个针对B7-H3 4Ig亚型的靶向放射性药物，B7-H3是人类肿瘤中最常见的亚型。使用BetaBart进行的多项临床前研究表明，用这种放射治疗剂治疗的动物肿瘤缩小，存活时间延长。

The monoclonal antibody, invented at MDACC, has been specifically engineered with a shorter blood circulation time and reduced affinity for on-target off- tissue toxicity, leading to a final mo.

MDACC发明的单克隆抗体经过专门设计，具有更短的血液循环时间和降低对靶向非组织毒性的亲和力，从而导致最终的mo。