R&D

ABTL0812

ABTL0812
 
A fully differentiated anti-cancer agent inhibiting the PI3K/Akt/mTOR pathway
ABTL0812, is a First in Class small molecule, orally administered, targeted anticancer compound inhibiting the PI3K/Akt/mTOR pathway without being a direct kinase inhibitor. ABTL0812 induces the overexpression of TRIB3, an endogenous negative regulator of Akt, with subsequent induction of cell death by autophagy. 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

18.09.2017

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Ability Pharmaceuticals Announces EMA-Orphan Drug Designation for ABTL0812 in Pancreatic Cancer + info
07.03.2017

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Ability Pharma sponsors the 37th National Meeting of the Spanish Society of Pharmacology + info
20.02.2017

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Ability Pharmaceuticals launches a new updated website with a fresh design + info
15.12.2016

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Ability Pharmaceuticals Announces FDA-Orphan Drug Designation for ABTL0812 in Pancreatic Cancer + info
22.11.2016

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Ability Pharmaceuticals Initiates Phase 2 Combination Trial with ABTL0812 as First Line Therapy in Patients with Endometrial or Squamous Lung Cancer Patients + info
11.05.2016

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Ability Pharmaceuticals Enters into a Licensing Agreement with SciClone Pharmaceuticals for the Novel Anticancer Agent ABTL0812 for the China Market. + info
07.04.2015

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Ability Pharmaceuticals Receives Positive Opinion from EMA for Orphan Drug Status of ABTL0812 in Pediatric Cancer Neuroblastoma. + info
14.02.2014

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Ability Pharmaceuticals to Present at the 7th Annual European Life Sciences CEO Forum in Zurich, March 4-5, 2014. + info
05.02.2014

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ABILITY PHARMACEUTICALS Initiates Clinical Trial with its Dual mTORC1/C2 Inhibitor ABTL0812 in Patients with Lung and Pancreatic Cancer + info
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