Summary
ABTL0812 is a first-in-class fully differentiated oral targeted anticancer compound that produces autophagy-mediated cytotoxicity selectively in cancer cells.
In preclinical studies, ABTL0812 showed efficacy as a single agent and in combination with current standard-of-care treatments in in vitro and animal models of pancreatic cancer, an orphan disease with an urgent unmet clinical need for new efficacious and safe therapies. Treatment with ABTL0812 induced tumor regression without increasing the toxicity associated with chemotherapy. 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, designed to evaluate ABTL0812 in 29 cancer patients with advanced solid tumors, demonstrated that the drug was safe and well tolerated and no dose-limiting toxicities were reported. In addition, two patients showed 14-month and 18-month disease stabilization (TRL7).
AbilityPharma’s objectives for the present project are to complete the next stage of the clinical development of its first drug candidate ABTL0812, a potential game changer in the treatment of pancreatic cancer, and to commercialize the results of the study through a licensing agreement. AbilityPharma will start a phase 2 clinical trial in pancreatic cancer to investigate ABTL0812 in combination with the standard-of-care chemotherapy, which has the potential to address this urgent unmet medical need by providing a safe and efficacious treatment. After finishing the clinical trial (TRL8), we will establish a partnership (licensing deal) with a big pharma partner which will further develop ABTL0812 to make it available to pancreatic cancer patients (TRL9). Finally, once the company has licensed its first candidate, the company will continue focusing in the development of new anti-cancer candidates based on the induction of cytotoxic autophagy in cancer cells.
In preclinical studies, ABTL0812 showed efficacy as a single agent and in combination with current standard-of-care treatments in in vitro and animal models of pancreatic cancer, an orphan disease with an urgent unmet clinical need for new efficacious and safe therapies. Treatment with ABTL0812 induced tumor regression without increasing the toxicity associated with chemotherapy. 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, designed to evaluate ABTL0812 in 29 cancer patients with advanced solid tumors, demonstrated that the drug was safe and well tolerated and no dose-limiting toxicities were reported. In addition, two patients showed 14-month and 18-month disease stabilization (TRL7).
AbilityPharma’s objectives for the present project are to complete the next stage of the clinical development of its first drug candidate ABTL0812, a potential game changer in the treatment of pancreatic cancer, and to commercialize the results of the study through a licensing agreement. AbilityPharma will start a phase 2 clinical trial in pancreatic cancer to investigate ABTL0812 in combination with the standard-of-care chemotherapy, which has the potential to address this urgent unmet medical need by providing a safe and efficacious treatment. After finishing the clinical trial (TRL8), we will establish a partnership (licensing deal) with a big pharma partner which will further develop ABTL0812 to make it available to pancreatic cancer patients (TRL9). Finally, once the company has licensed its first candidate, the company will continue focusing in the development of new anti-cancer candidates based on the induction of cytotoxic autophagy in cancer cells.
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/954825 |
| Start date: | 01-07-2020 |
| End date: | 30-06-2023 |
| Total budget - Public funding: | 3 322 666,00 Euro - 2 325 865,00 Euro |
Cordis data
Original description
ABTL0812 is a first-in-class fully differentiated oral targeted anticancer compound that produces autophagy-mediated cytotoxicity selectively in cancer cells.In preclinical studies, ABTL0812 showed efficacy as a single agent and in combination with current standard-of-care treatments in in vitro and animal models of pancreatic cancer, an orphan disease with an urgent unmet clinical need for new efficacious and safe therapies. Treatment with ABTL0812 induced tumor regression without increasing the toxicity associated with chemotherapy. 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, designed to evaluate ABTL0812 in 29 cancer patients with advanced solid tumors, demonstrated that the drug was safe and well tolerated and no dose-limiting toxicities were reported. In addition, two patients showed 14-month and 18-month disease stabilization (TRL7).
AbilityPharma’s objectives for the present project are to complete the next stage of the clinical development of its first drug candidate ABTL0812, a potential game changer in the treatment of pancreatic cancer, and to commercialize the results of the study through a licensing agreement. AbilityPharma will start a phase 2 clinical trial in pancreatic cancer to investigate ABTL0812 in combination with the standard-of-care chemotherapy, which has the potential to address this urgent unmet medical need by providing a safe and efficacious treatment. After finishing the clinical trial (TRL8), we will establish a partnership (licensing deal) with a big pharma partner which will further develop ABTL0812 to make it available to pancreatic cancer patients (TRL9). Finally, once the company has licensed its first candidate, the company will continue focusing in the development of new anti-cancer candidates based on the induction of cytotoxic autophagy in cancer cells.
Status
CLOSEDCall topic
EIC-SMEInst-2018-2020Update Date
27-10-2022
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