SEATTLE , Feb. 5, 2024 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced dosing has initiated in the Phase 1/2 first-in-human clinical trial of PRO1107 (NCT06171789).

2024年2月5日，西雅图/PRNewswire/--开发新型抗体-药物偶联物（ADC）癌症治疗药物的临床阶段生物技术公司ProfoundBio今天宣布，在PRO1107（NCT06171789）的1/2期首次人体临床试验中开始给药。

'By bringing the first ADC with our next generation MMAE linker-drug platform to the clinic, we are furthering our commitment to developing ADCs with the potential for improved outcomes for patients,' said Naomi Hunder, MD, chief medical officer of ProfoundBio. 'We believe our preclinical data support the potential of PRO1107 to provide much improved safety and activity compared to prior PTK7 ADCs, demonstrating the compelling attributes of our LD343 platform, which incorporates our novel highly hydrophilic linker combined with the clinically validated MMAE payload conjugated at a high drug-antibody ratio of 8.

“通过将第一个ADC与我们的下一代MMAE linker药物平台一起带到诊所，我们进一步致力于开发ADC，并有可能改善患者的预后，”ProfoundBio首席医疗官Naomi Hunder医学博士说我们相信，与之前的PTK7 ADC相比，我们的临床前数据支持PRO1107提供更高安全性和活性的潜力，证明了我们的LD343平台的引人注目的属性，该平台结合了我们的新型高亲水性接头和临床验证的MMAE有效载荷，以8的高药物抗体比缀合。

We look forward to evaluating PRO1107 as a treatment for the broad population of patients with PTK7-expressing tumors, and we are thankful to the investigators and patients who make this research possible.'.

我们期待着评估PRO1107作为广泛表达PTK7的肿瘤患者的治疗方法，我们感谢使这项研究成为可能的研究人员和患者。”。

PRO1107 is being evaluated in a global, open-label, multicenter Phase 1/2 trial. This trial is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in patients with advanced solid tumors, including non-small cell lung, breast, and ovarian cancer. It is designed as a two part study: Part A, which is aimed at determining the recommended optimal dose regimen(s) through dose escalation and expansion, and Part B, which focuses on the expansion of treatment to specific tumor types..

PRO1107正在一项全球、开放标签、多中心的1/2期试验中进行评估。该试验旨在确定PRO1107在晚期实体瘤（包括非小细胞肺癌，乳腺癌和卵巢癌）患者中的安全性，耐受性，药代动力学和抗肿瘤活性。它被设计为一项分为两部分的研究：a部分旨在通过剂量递增和扩大来确定推荐的最佳剂量方案，B部分侧重于将治疗扩展到特定的肿瘤类型。。

'With three clinical-stage programs derived from two distinct proprietary ADC technology platforms, ProfoundBio is demonstrating our capability to efficiently bring innovative ADCs with best- and/or first-in-class potential to patients with unmet medical need.  We first showcased this program and the LD343 linker-drug technology in our preclinical presentations at SITC 2023, and we are thrilled to potentially provide benefit to patients across a wide range of PTK7-expressing tumors,' said Baiteng Zhao, PhD, chief executive officer of ProfoundBio..

“凭借来自两个不同专有ADC技术平台的三个临床阶段项目，ProfoundBio正在证明我们能够有效地为未满足医疗需求的患者带来具有最佳和/或一流潜力的创新ADC。“我们首先在SITC 2023的临床前演示中展示了这个项目和LD343接头药物技术，我们很高兴能够为广泛表达PTK7的肿瘤患者提供潜在的益处，”ProfoundBio首席执行官赵白腾博士说。。

About PRO1107PRO1107 is an ADC consisting of a Protein Tyrosine Kinase 7 (PTK7)-targeted antibody conjugated to ProfoundBio's novel, proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous drug-antibody ratio (DAR) of 8. MMAE is a potent, membrane permeable microtubule inhibitor that has been clinically validated as an ADC payload by multiple vedotin-based ADCs incorporating MMAE at a DAR of ~4.

关于PRO1107PRO1107是一种ADC，由蛋白酪氨酸激酶7（PTK7）靶向抗体组成，该抗体与ProfoundBio的新型专有亲水性基于MMAE的接头药物LD343偶联，均相药物抗体比（DAR）为8。MMAE是一种有效的膜渗透性微管抑制剂，已被多种基于vedotin的ADC以约4的DAR掺入MMAE临床验证为ADC有效载荷。

LD343 incorporates a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of conjugated MMAE on the ADC, enabling high DAR and efficient delivery of the MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC..

LD343结合了一种高度亲水稳定，可切割的接头，旨在掩盖ADC上共轭MMAE的疏水性，从而能够将MMAE有效载荷高DAR和有效递送至肿瘤，同时保持ADC良好的物理化学和药代动力学特性。。

About ProfoundBioProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple antibody-drug conjugate (ADC) drug candidates targeting solid tumors and hematological malignancies.

关于ProfoundBioProfoundBio是一家临床阶段的生物技术公司，专注于为癌症患者开发新型基于抗体的疗法。ProfoundBio建立在内部开发的创新和专有技术平台上，开发了一条由针对实体瘤和血液系统恶性肿瘤的多种抗体-药物偶联物（ADC）候选药物组成的管道。

The company's disclosed development pipeline consists of rinatabart sesutecan (Rina-S; PRO1184), an ADC targeting folate receptor-alpha; PRO1160, an ADC targeting CD70; PRO1107, an ADC targeting PTK7; and PRO1286, a bispecific ADC targeting two clinically validated, broadly expressed solid tumor antigens.

该公司公开的开发管道包括rinatabart sesutecan（Rina-s；PRO1184），一种靶向叶酸受体α的ADC；PRO1160，一种靶向CD70的ADC；PRO1107，一种针对PTK7的ADC；和PRO1286，一种靶向两种临床验证的广泛表达的实体瘤抗原的双特异性ADC。

ProfoundBio is headquartered in Seattle, Washington..

ProfoundBio总部位于华盛顿州西雅图。。

For more information, please visit www.profoundbio.com and follow us on LinkedIn.

有关更多信息，请访问www.defoundbio.com并在LinkedIn上关注我们。

SOURCE ProfoundBio

来源：DefoundBio