R&D

ABTL0812

ABTL0812 is an anti-cancer compound that causes autophagy-mediated cancer cell death
ABTL0812 is a targeted therapy drug that kills cancer cells through the induction of robust cytotoxic autophagy. ABTL0812 binds and activates the transcriptional activity of the nuclear receptors PPARα and PPARγ, leading to the induction of endoplasmic reticular stress (ER-stress), and to the blockade of Akt activation, the central kinase of the PI3K/Akt/mTOR pathway. This dual action of ER-stress activation and Akt/mTOR axis blockade converge to strongly induce autophagy, which results in cancer cell death.
 
The first part of its mechanism of action was published at Clinical Cancer Research in May 2016, and the part describing the ER-stress is under peer review, and expected to be published during Q1-2020. 
 
Preclinical efficacy
In animal cancer models ABTL0812 is efficacious as single agent with an excellent safety profile in a broad spectrum of cancer types: lung, endometrial and pancreatic cancer and neuroblastoma. ABTL0812 is also active on cells resistant to chemotherpay, on targeted therapies, on tumor stem cells, and it inhibits metastasis formation. Preliminary results show promising immunomodulatory effects.
 
Phase 1/1b first in human clinical trial
In the first in human phase 1/1b clinical trial (29 patients with advanced solid tumors), ABTL0812 showed and excellent safety and tolerability profile. Remarkably 2 patients had disease stabilizations over one year (14 and 18 months). Additionally, ABTL0812 showed high efficacy on biomarkers in the PI3K/Akt/mTOR pathway with PK/PD correlation. Due to its extremely low toxicity, the recommended phase 2 dose (RP2D) was determined by PK/PD, without reaching any dose limiting toxicity.
 
Phase 1/2a clinical trial in endometrial and lung cancer
With the CTA approved in September 2016, AbilityPharma is conducting a phase 1/2a clinical trial (80 patients) with ABTL0812 (at RP2D) as first-line therapy in endometrial cancer and in squamous NSCLC. After the chemotherapy cycles, the patients remain treated with ABTL0812 chronically. The basis for selecting this design is the high incidence of mutations in the PI3K/Akt/mTOR pathway in both cancer types together with ABTL0812 efficacy and security in preclinical models.

The clinical trial is being conducted in Vall d’Hebron Institute of Oncology (VHIO, Barcelona), Institut Català d’Oncologia (ICO, L'Hospitalet, Badalona and Girona), Institut Gustave Roussy (Paris), Centre Léon-Bérard (Lyon), Institut Paoli-Calmettes (Marseille), the INCLIVA (Valencia), and Hospital Universitario Virgen del Rocío (Sevilla). 

Phase 2 clinical trial in pancreatic cancer
The company plans to start the development of ABTL0812 in pancreatic cancer during 2020, and the IND has already been approved by th FDA in USA and by the NMPA in China with this protocol. The CTA in Europe is under preparation. 
 

LATEST NEWS

22.09.2020

News

ABILITYPHARMA PRESENTS THE RESULTS OF A NEW FIRST-LINE TREATMENT FOR ENDOMETRIAL CANCER + info
09.06.2020

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AbilityPharma publishes full characterization of mechanism of action of ABTL0812, a Phase II clinical inducer of cytotoxic autophagy in cancer cells, in Autophagy journal + info
25.03.2020

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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 + info
12.09.2019

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AbilityPharma rises € 3.5 million in a financing round to complete the current oncologic phase 2 clinical trial and license ABTL0812 to an international pharmaceutical company + info
31.05.2019

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Ability Pharmaceuticals Announces the Presentation of the First Results of ABTL0812 as First Line in Patients with Endometrial or Lung Cancer at 2019 ASCO Annual Meeting + info
04.02.2019

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Ability Pharmaceuticals Announces the Approval in China of a Clinical Study in Pancreatic Cancer with ABTL0812 + info
30.01.2019

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Ability Pharmaceuticals is attending the BIOMED EVENT® by INVEST SECURITIES and the Cholangiocarcinoma Foundation Annual Conference + info
05.12.2018

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AbilityPharma ha superado el millón de euros en la ronda de crowdfunding que abrió el pasado mes de septiembre + info
07.11.2018

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Ability Pharmaceuticals Announces FDA-Orphan Drug Designation for ABTL0812 in Biliary Tract Cancer + info
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