On December 9, 2021 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has entered into a clinical collaboration with Clover Biopharmaceuticals, Ltd. ("Clover"; Stock Code: 2197.HK) to evaluate Ascentage Pharma’s APG-1387, a second mitochondria-derived activator of caspase (SMAC)-mimetic/inhibitor of apoptosis proteins (IAP) antagonist, in combination with Clover’s SCB-313, a recombinant human TRAIL-trimer fusion protein, in a Phase Ib/II study in patients with advanced peritoneal carcinomatosis (Press release, Ascentage Pharma, DEC 9, 2021, View Source [SID1234596720]).

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Ascentage Pharma and Clover will jointly conduct this open-label, multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics (PK/PD), and efficacy of APG-1387 in combination with SCB-313 for the treatment of patients with primary or secondary peritoneal carcinomatosis from different primary tumor origins in China and Australia.

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly specific next-generation IAP antagonist and the first IAP antagonist entering clinical development in China. To advance the clinical development of APG-1387 globally, Ascentage Pharma has completed a Phase I dose-escalation for the treatment of solid tumors in China and Australia, and is currently conducting multiple clinical studies of APG-1387 combinations for the treatment of solid tumors in China and the US. Meanwhile, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

Clover’s SCB-313 is a trimeric fusion protein in clinical development for the treatment of intracavitary malignancies. Based on positive Phase I interim analyses, Clover plans to advance SCB-313 into a Phase II clinical trial for malignant ascites in the first half of 2022. SCB-313 is also in Phase I clinical trials for malignant pleural effusions and peritoneal carcinomatosis. Clover also plans to initiate new Phase I trials for SCB-313 in new indications, such as bladder cancer, in 2022.

"Safe and effective combination therapies represent an increasingly important approach in cancer treatment. We hope APG-1387 in combination with Clover’s SCB-313 will demonstrate synergistic effect," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We look forward to working closely with Clover to advance this clinical collaboration which hopefully will offer a new treatment option to patients with peritoneal carcinomatosis."

"Clover is excited to enter into this partnership with Ascentage Pharma to explore innovative treatment options and alternatives to surgery for patients suffering from peritoneal carcinomatosis," said Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals. "Combination treatment is a cornerstone of cancer therapy. By targeting different nodes within the apoptosis pathway, we believe the combination of SCB-313 and APG-1387 could provide a synergistic benefit to patients."

About APG-1387

Discovered and developed by Ascentage Pharma, APG-1387 is a potent and highly selective next-generation inhibitor of apoptosis proteins (IAP) antagonist that can degrade IAPs by mimicking endogenous second mitochondria-derived activator of caspase (SMAC) molecule to induce programmed cell death or apoptosis. To advance the clinical development of APG-1387 globally, Ascentage Pharma has already completed a Phase I dose-escalation study in patients with solid tumors in China and Australia, and is currently conducting a Phase Ib/II clinical study of the APG-1387 plus pembrolizumab combination in patients with solid tumors in the US, and a Phase Ib/II study of APG-1387 plus nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer in China. Moreover, APG-1387 is also being evaluated in a Phase II study in patients with chronic hepatitis B (HBV) infections in China.

About SCB-313

SCB-313, an innovative, recombinant human TNF-related apoptosis-inducing ligand (TRAIL)-Trimer fusion protein engineered using the Trimer-Tag technology platform to target the extrinsic apoptosis pathway. Binding of SCB-313 to the death receptors (DR4 and DR5) leads to physiologic trimerization and potent activation of the extrinsic apoptosis pathway.