Press Release

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

February 19, 2018


BARCELONA, Catalonia, Spain - February 19th, 2018 – Ability Pharmaceuticals SL, a biopharmaceutical company announced today that the United States Food and Drug Administration (FDA) has approved a phase 1/2 study to assess the efficacy and safety of ABTL0812 in combination with gemcitabine and nab-paclitaxel in patients with advanced metastatic pancreatic cancer at first line therapy and as maintenance therapy after chemotherapy. This milestone comes after FDA approval of the Investigational New Drug (IND) for endometrial cancer or squamous non-small cell lung cancer last December, which validated the protocol of the Phas 1/2 study with ABTL0812 currently ongoing in Spain and France.  
 
In preclinical studies, ABTL0812 has shown efficacy in pancreatic cancer models as single agent, and in combination with nab-paclitaxel and gemcitabine, with synergistic effect, with induction of tumor regression without increasing the toxicity associated with chemotherapy. First-line therapy with ABTL0812 in combination with chemotherapy could greatly improve the treatment outcome.
 
Carles Domènech, PhD, Chief Executive Officer said: “FDA approval of the phase 1/2 trial in pancreatic cancer with ABTL0812 is an important step forward in the development of our novel drug with the potential to become a transformational therapy for patients affected with this cancer. “ We are now working with the medical community to start the clinical development of ABTL0812 in this condition” Carles Domènech added.
 
 
About ABTL0812
 
ABTL0812 causes cell death by autophagy through the overexpression of TRIB3, an endogenous Akt regulator. It is a first-in-class fully differentiated oral targeted anticancer compound inhibiting the PI3K/Akt/mTOR pathway without being a direct kinase inhibitor. Its unique mechanism of action was published at Clinical Cancer Research in 2016.
 
In preclinical cancer models ABTL0812 is efficacious as single agent with an excellent safety profile in a broad spectrum of cancer types: lung, endometrial and pancreatic cancers, and neuroblastoma. In these models the compound has also synergistic effect with chemotherapy (taxanes, platinum compounds and gemcitabine) without increasing its toxicity.
 
In Europe, ABTL0812 is currently in phase 2 as first line therapy in combination with chemotherapy in patients with endometrial or squamous lung cancer. The study includes centers in Spain and France.
 
In the phase 1/1b clinical trial (29 patients with advanced solid tumors), ABTL0812 showed the best safety and tolerability compared to other inhibitors of the pathway; no dose-limiting toxicities were identified. The efficacy in patients was comparable to the best PI3K/Akt/mTOR inhibitors in similar clinical trials. Remarkably 2 patients had extremely long disease stabilizations over one year (14 and 18 months). Additionally, ABTL0812 showed high efficacy on biomarkers of the pathway with dose-response effect.
 
 
About Ability Pharmaceuticals
 
Ability Pharmaceuticals (www.abilitypharma.com) is a clinical-stage biopharmaceutical company focused on creating the future of oncology by developing innovative therapies that address unmet medical needs. Established in 2009 and with two drug candidates in development: ABTL0812, a targeted therapy already in phase 2 clinical trials and ABTL0815 in preclinical development, AbilityPharma is positioning itself as one of the fast growers in the Catalan and Spanish biotech sector.
 
In April 2016, AbilityPharma signed a territorial license agreement for ABTL0812 with the NASDAQ US company SciClone Pharmaceuticals, Inc. to develop and market the product in Greater China.
 
Ability Pharmaceuticals has headquarters in Cerdanyola del Vallès (Barcelona, Catalonia, Spain) at Parc Tecnològic del Vallès and Parc de Recerca UAB. Current shareholders include the biotech venture firms Inveready and SODENA, its founders and private investors, and has the financial support from ACCIO (Government of Catalonia), CDTI, ENISA and MINECO (Government of Spain).

LATEST NEWS

11.03.2024

Press Release

AbilityPharma Announces € 7 Million Financing Round to Advance Development of its Clinical Phase 2b Autophagy Inducer ABTL0812 in Metastatic Pancreatic Cancer + info
02.06.2023

Press Release

Ability Pharmaceuticals announces the presentation of the phase 2a results of ABTL0812 as first-line therapy in patients with lung cancer at the ASCO 2023 Annual Meeting in Chicago + info
14.12.2022

Press Release

AbilityPharma Achieves the 30% of the Estimated Recruitment for their Phase 2b Clinical Trial with ABTL0812 + FOLFIRINOX as a First-Line Therapy Treatment in Advanced Pancreatic Cancer + info
21.11.2022

Press Release

AbilityPharma Obtains 1,5M € of Non-Dilutive Funding from Next Generation EU Funds to Further Study the Anticancer Immunomodulatory Effects of ABTL0812 + info
10.11.2022

Press Release

AbilityPharma will attend LSX investical showcase in London to meet with key investors and venture capital firms + info
02.11.2022

Press Release

ABTL0812 shows potential against glioblastoma brain tumors + info
07.10.2022

Press Release

AbilityPharma Secures 2,2M € of Non-Dilutive Funding from the Ministry of Science & Innovation of the Government of Spain to Accelerate the Clinical Development and Regulatory Path of ABTL0812 + info
07.09.2022

Press Release

Carles Domènech, Executive Chairman & CEO of AbilityPharma, Will Attend ESMO Congress in Paris for a Meeting with some of the most Relevant Key Opinion Leaders (KOLs) in the Treatment of Pancreatic Cancer + info
29.06.2022

Press Release

AbilityPharma Will Attend ESMO World Congress on Gastrointestinal Cancer 2022 in Barcelona + info
© 2012 Ability Pharma / All Rights Reserved / Legal Notice / Privacy Police
NEORG