Press release PEP-Therapy and Institut Curie Announce First Patients Dosedin Phase Ib Clinical Trial Evaluating PEP-010in Ovarian and Pancreatic Cancers Paris (France), April 25, 2024 – PEP-Therapy, a clinical-stage biotechnology company developing first-in-class peptides as targeted therapies in oncology, and Institut Curie, France’s leading cancer center, today announced the dosing of the first patients in a Phase Ib clinical trial evaluating PEP-Therapy’s lead candidate, PEP-010, based on highly encouraging Phase Ia results.

新闻稿PEP Therapy和居里研究所（Institut Curie）于2024年4月25日在巴黎（法国）卵巢癌和胰腺癌评估PEP-010的Ib期临床试验中宣布了首批患者的剂量-PEP Therapy是一家临床阶段的生物技术公司，正在开发一流的肽作为肿瘤学靶向治疗，而法国领先的癌症中心居里研究所（Institut Curie）今天宣布，根据非常令人鼓舞的Ia期结果，在评估PEP Therapy的主要候选者PEP-010的Ib期临床试验中，首批患者的剂量。

This second part ot the Phase I study is evaluating PEP-010 in combination with chemotherapy (paclitaxel or gemcitabine), in advanced or metastatic ovarian cancer (OC) and in metastatic pancreatic ductal adenocarcinoma (PDAC), two indications with high unmet medical need. PEP-010 is a first-in-class bifunctional therapeutic peptide that penetrates cells and specifically disrupts the interaction between Caspase-9 and PP2A, leading to the inhibition of key pathological mechanisms, without altering physiological mechanisms.

I期研究的第二部分是评估PEP-010联合化疗（紫杉醇或吉西他滨），晚期或转移性卵巢癌（OC）和转移性胰腺导管腺癌（PDAC），这是两种未满足医疗需求的适应症。PEP-010是一流的双功能治疗肽，可穿透细胞并特异性破坏Caspase-9和PP2A之间的相互作用，从而抑制关键的病理机制，而不改变生理机制。

PEP-010 is a pro-apoptotic agent which has demonstrated a good safety and tolerability profile and first signals of efficacy in the CLEVer-PEPtide Phase Ia dose escalation clinical trial. The two-cohort, open-label, non-controlled, multicenter Phase Ib program will evaluate the safety and tolerability, complete or assess the pharmacokinetics, and evaluate the anti-tumor activity of intravenous PEP-010 when administered in combination with paclitaxel or gemcitabine.

PEP-010是一种促凋亡剂，在CLEER肽Ia期剂量递增临床试验中表现出良好的安全性和耐受性，并首次显示出有效性信号。这两个队列，开放标签，非对照，多中心的Ib期计划将评估安全性和耐受性，完成或评估药代动力学，并评估静脉注射PEP-010与紫杉醇或吉西他滨联合给药时的抗肿瘤活性。

The first cohort (expansion cohort) will evaluate the efficacy of PEP-010 at the recommended Phase II dose (RP2D) in combination with paclitaxel in patients with metastatic PDAC. The second cohort (dose escalation) will determine the maximum tolerated dose (MTD) and th.

第一个队列（扩展队列）将评估PEP-010在推荐的II期剂量（RP2D）联合紫杉醇治疗转移性PDAC患者的疗效。第二组（剂量递增）将确定最大耐受剂量（MTD）和th。