AbilityPharma: Accelerating Solutions for Pancreatic Cancer

(PanC-ASAP)

The project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 954825.
   
PanC-ASAP is a project that aims to develop ABTL0812, a first-in-class autophagy inducer drug, for the treatment of metastatic pancreatic cancer by performing a phase 2 multicenter double-blind placebo-controlled clinical trial to investigate ABTL0812 in combination with the chemotherapy combo FOLFIRINOX.
 
The Problem:

• Pancreatic cancer, sometimes referred as the ‘’neglected cancer’’, is the seventh leading cause of cancer-related deaths worldwide and third in EU.
• The high mortality rates of pancreatic cancer are due to lack of appropriate diagnosis, treatment and cataloging of cancer cases.
• Due to its high lethality, it is an orphan disease with an urgent unmet clinical need for new efficacious and safe therapies.

The solution:

ABTL0812 is a first-in-class fully differentiated oral targeted anticancer compound that induces autophagy-mediated cytotoxicity selectively in cancer cells.

In preclinical in vitro and animal pancreatic cancer models, ABTL0812 showed efficacy as a single agent and in combination with current standard-of-care treatments without additional toxicity. These results granted an Orphan Drug Designation (ODD) to ABTL0812 for pancreatic cancer treatment from the EMA and the FDA.

Moreover, ABTL0812 is a clinical stage drug. A first-in-human phase 1/1b clinical trial demonstrated that ABTL0812 oral treatment is safe and well tolerated. Subsequently, a phase 1/2 showed the superiority of combining ABTL0812 with standard of care chemotherapy over chemotherapy alone in endometrial and lung cancer.
 
 

ABTL0812 mechanism of action and synergy with chemotherapy. A) ABTL0812 has a dual anticancer action: 1) ER stress activation and 2) Akt-mTOR blockade. Both actions converge in the induction of a robust cytotoxic autophagy that leads to cancer cell death B) The main chemotherapy mechanism resistance is the activation of Akt/mTOR that prevents cancer cell death; ABTL0812 avoids the activation of Akt/mTOR and thus potentiates the efficacy of chemotherapy.

Overall strategy:

AbilityPharma will perform a phase 2 clinical trial in pancreatic cancer to investigate the safety and efficacy ABTL0812 in combination with the standard-of-care chemotherapy FOLFIRINOX.

This proof of concept study has the potential to lead to a further development of the treatment and/or its early conditional approval and, therefore, address this urgent unmet medical by making the treatment available to pancreatic cancer patients.
 

---

News about the project: 

March 25, 2020 - AbilityPharma awarded €5 million from the Horizon Europe EIC Accelerator Pilot Program to conduct a Phase 2b clinical trial with ABTL0812 in patients with advanced pancreatic cancer