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Amal Therapeutics S.A.. (5/2/19). "Press Release: Amal Therapeutics Enters Clinical Collaboration with Boehringer Ingelheim to Evaluate ATP128 in Combination with BI754091". Geneva.

	Organisation	Amal Therapeutics S.A.
	Group	Boehringer Ingelheim (Group)
	Organisation 2	Boehringer Ingelheim (Group)
	Product	ATP128 cancer vaccine (Amal Therapeutics)
	Product 2	BI 754091 (anti-PD-1 antibody) (Boehringer)
	Index term	Amal Therapeutics–Boehringer: cancer drugs, 201905– collab clinical research combi study of ATP128 + BI754091 in colorectal cancer
	Person	Derouazi, Madiha (AC Immune 202401–CSO before Speransa Therapeutics + Amal Therapeutics)
	Person 2	Kerouedan, Christelle (Coulter Partners 202109– Marketing Director before Instinctif Partners)

> AMAL’s lead candidate, ATP128, will be evaluated in combination with Boehringer Ingelheim’s antiPD-1 antibody BI754091 in a Phase Ib trial (‘KISIMA-01’)

> Combination will be studied in patients with Microsatellite Stable (MSS) stage IV colorectal cancer

> AMAL retains full development and commercialization rights to ATP128 and the KISIMA technology platform

AMAL Therapeutics (AMAL), a Swiss biotech developing novel, peptide-based therapeutic cancer vaccines, today announces that it 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-tumor 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 commercialization rights to ATP128 and the KISIMA technology platform.

“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” said Madiha Derouazi, Chief Executive Officer and founder of AMAL Therapeutics.

The KISIMA-01 study will begin in the second half of 2019.

-End-

For further information, please contact:

AMAL Therapeutics SA
Dr. Madiha Derouazi
Chief Executive Officer
Tel: +41 (0) 22 379 46 88
contact@amaltherapeutics.com

Instinctif Partners (for International and English-speaking media)
Dr Christelle Kerouedan
Tel: +44 (0) 207 457 2020
amaltherapeutics@instinctif.com

Notes to Editors

About AMAL Therapeutics SA

AMAL Therapeutics SA (AMAL) is a pre-clinical stage Swiss biotechnology company developing peptide/protein-based therapeutic vaccines with a focus on oncology. The Company’s therapeutic vaccines are based on its versatile proprietary technology platform called KISIMA®.

AMAL’s lead program, ATP128 is a therapeutic protein vaccine for metastatic colorectal cancer, a leading cause of mortality. The program is expected to enter phase I clinical trials in 2019. In the longer term, the Company intends to develop a portfolio of program in other cancer indications.

The private Company is headquartered on the medical Campus of the University of Geneva, from which it was spun-out in 2012 and backed by a syndicate of both corporate and institutional investors. AMAL’s technology platform and derived products are protected by a broad portfolio of patents and licenses.

For more information visit the company website: www.amaltherapeutics.com

Record changed: 2023-06-05