R&D

ABTL0812

ABTL0812
 
ABTL0812 is an anti-cancer compound that causes autophagy-mediated cancer cell death
ABTL0812 is a first-in-class small molecule, orally administered that binds to the nuclear receptors PPARα and PPARγ blocking Akt activation, the central kinase of the PI3K/Akt/mTOR pathway, and inducing PPAR-dependent Endoplasmic Reticular Stress (ER-stress). The combination of inhibition of the PI3K/Akt/mTOR pathway and the ER-Stress induction results in an autophagy-mediated cancer cell death. 

Its unique mechanism of action was published at Clinical Cancer Research in May 2016.
 
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 other targeted therapies, on tumor stem cells and 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 the best safety and tolerability compared to other PI3K/Akt/mTOR pathway inhibitors. The efficacy in patients was comparable to the best PI3K/Akt/mTOR inhibitors in similar clinical trials. 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
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 led by Vall d’Hebron Institute of Oncology (VHIO, Barcelona) and Institut Català d’Oncologia (ICO, Hospitalet, Badalona and Girona). The study also includes the INCLIVA (Valencia), Institut Gustave Roussy (Paris), Centre Léon-Bérard (Lyon), Institut Paoli-Calmettes (Marseille) and Hospital Universitario Virgen del Rocío (Sevilla). 

LATEST NEWS

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
19.09.2018

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Ability Pharmaceuticals anuncia la inclusión del primer paciente en el estudio clínico de la fase 2 de ABTL0812 en Francia + info
24.08.2018

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At AbilityPharma we are very pleased to announce the start of a crowdfunding campaign through de Capital Cell + info
19.02.2018

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AbilityPharma Announces FDA Approval of Phase 1/2 Trial of ABTL0812 for Patients with Advanced Metastatic Pancreatic Cancer + info
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