AMAL Therapeutics (AMAL), a Swiss biotech developing novel, peptide-based therapeutic cancer vaccines, has entered into a collaborative agreement with Boehringer Ingelheim.
AMAL will conduct an international Phase Ib clinical study, referred to as KISIMA-01, to evaluate the combination of its lead candidate, ATP128, with Boehringer Ingelheim’s anti-PD1 compound, BI754091, in Microsatellite Stable (MSS) patients with stage IV colorectal cancer.
AMAL’s lead candidate, ATP128, is a chimeric recombinant protein designed using AMAL’s proprietary vaccine technology platform, KISIMA®. ATP128 comprises of a cell penetrating peptide (CPP) for antigen delivery, a TLR peptide agonist for self-adjuvanticity and a multiple antigenic domain (Mad). ATP128 is designed to treat colorectal cancer.
The first-in-human (FIH) study will investigate the safety and tolerability of ATP128 as single agent and in combination with BI754091 as its primary objective whilst the anti-tumour activity and the characteristics of the immune response will be evaluated as secondary and exploratory objectives.
The clinical study will be sponsored by AMAL while Boehringer Ingelheim will provide the trial with BI754091. The study results shall be jointly owned. AMAL retains full development and commercialisation rights to ATP128 and the KISIMA technology platform.
Madiha Derouazi, Chief Executive Officer and founder of AMAL Therapeutics, said: “Our strong in-vivo data package for combination therapies demonstrated synergies between ATP128 and immune checkpoint inhibitors, which laid the basis for this first-in-human clinical study.
“We are excited to evaluate ATP128 in combination with BI754091 in different patient populations with stage IV colorectal cancer, and to show the value of our lead candidate and the potential of the KISIMA platform.”
The KISIMA-01 study will begin in the second half of 2019.