A pancreatic and colorectal cancer trial initiated to address the needs of patients with Immune Checkpoint Inhibitor-resistant disease by combining IAP antagonist Debio 1143 with Keytruda®

Lausanne (ots) - First patient enrolled in the investigator
initiated CATRIPCA study (Combination with an IAP Antagonist To
Reverse Immune resistance in Pancreatic and Colorectal
Adenocarcinoma) at the Léon Bérard Cancer Center in Lyon France

Debiopharm (www.debiopharm.com) announced today the first patient
enrolment in a Phase I study initiated by Dr. Phillippe Cassier,
combining the oral, IAP (Inhibitor of Apoptosis Proteins) antagonist,
Debio 1143, with Merck Sharpe & Dohme's (MSD) anti-PD1 Keytruda®
(pembrolizumab). The CATRIPCA study focuses on two cancer patient
populations with conditions that are intrinsically resistant to
Immune Checkpoint Inhibitors (ICI). More specifically, the trial will
recruit patients without other available therapeutic options in
Non-microsatellite instability (non-MSI)-high colorectal cancer (CRC)
and pancreatic ductal adenocarcinoma cancer (PDAC). Up to 46 patients
will be included in the dose-escalation and expansion parts, to
assess the safety and preliminary efficacy of the combination, with
the primary endpoint of the study extension being the Objective
Response rate.

Expected to become one of the leading causes of overall cancer
mortality by 2025, pancreatic cancer is characterized by early
metastasis and resistance to currently available agents including
recent immunotherapies.1 In CRC, the fourth highest cause of
cancer-related death, the newly developed ICIs have not demonstrated
a substantial benefit as single agents.2,3 The CATRIPCA study focuses
on these two cancer types to address the high unmet need by
potentially enhancing ICI efficacy in these settings. As preclinical
models have demonstrated synergy between Debio 1143 and
immunotherapy, the compound is expected to offer an
immune-sensitizing effect.

"With this combination trial, we're aiming to evaluate if the
addition of Debio 1143 can stimulate the host immune system to revert
primary resistance to ICIs in advanced non-MSI-high CRC or in PDAC
patients." Dr. Philippe Cassier, Principal Investigator

"This study is the third of a series of Immuno-oncology studies
investigating the effect of Debio 1143 in combination with ICIs. The
study will evaluate a particularly difficult patient population,
primarily in the immune-refractory setting with hopes that the Debio
1143-pembrolizumab combination will open up new possibilities for
these patients." Dr. Angela Zubel, Chief Development Officer, at
Debiopharm

About Debio 1143

Debio 1143 is an IAP antagonist with a dual mode of action,
promoting programmed cell death and fostering anti-tumor immunity.
Currently in clinical development in a broad range of cancer types,
the compound is being tested in combination with chemo-radiotherapy
or with ICIs (PD-1/PD-L1), with reported data consistently showing a
favorable and manageable safety profile. Over 200 patients have been
treated so far with Debio 1143, in indications such as non-small cell
lung cancer (NSCLC) and Head & Neck cancer (SCCHN).

About CATRIPCA

Initiated by Dr. Philippe Cassier at the Léon Bérard Center in
France, this Phase I study was designed to test the hypothesis that
combining IAP inhibition and PD1 blockade therapy could induce
responses in non-MSI-high advanced/metastatic PDAC or CRC, conditions
that are intrinsically resistant to ICIs alone.

Debiopharm's commitment to cancer patients

Debiopharm aims to develop innovative therapies that target high
unmet medical needs in oncology. Bridging the gap between disruptive
discovery products and real-world patient reach, we identify
high-potential compounds for in-licensing, clinically demonstrate
their safety and efficacy and then select large pharmaceutical
commercialization partners to maximize patient access across the
globe.

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1. Bilimoria KY et al. Cancer 2007;110:1227-1234.
2. Benson AB III et al. J Natl Compr Canc Netw 2013;11:141-152.
3. Brahmer JR et al. N Engl J Med 2012;366:2455-2465.

Pressekontakt:
Debiopharm Contact
Dawn Haughton - Communication Manager
dawn.haughton@debiopharm.com
Tel: +41 (0)21 321 01 11

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell