Press Release

AbilityPharma receives the approval from the FDA and the AEMPS to start the clinical trial of its molecule against pancreatic cancer in the US and Spain

November 5, 2020

  • The US FDA and the Spanish Medicines Agency have granted authorization to start the clinical trial, and the documentation to carry out the study in France and Israel will soon submitted
  • Pancreatic cancer is considered an “orphan disease” with urgent clinical need: it is expected to be the second leading cause of cancer death in Europe by 2020
Barcelona, November 5, 2020.- The biopharmaceutical company AbilityPharma, focused on the development of innovative oral anticancer compounds, has received authorization to initiate a clinical trial of its treatment against pancreatic cancer in Spain and the United States (US), based on the development of a new antitumor compound, the ABTL0812.

The Spanish Agency for Medicines and Health Products (AEMPS) has authorized this week the protocol presented by AbilityPharma to carry out the trial. This authorization follows the one granted by the United States Food and Drug Administration (FDA) to AbilityPharma to advance in the validation of its new molecule.

The company will also soon submit the necessary documentation to conduct the study in France and Israel.

This is an international, multicenter, double-blind, placebo-controlled phase 2 clinical trial in pancreatic cancer to investigate ABTL0812 in combination with FOLFIRINOX chemotherapy.

The clinical trial will include 140 patients with advanced and metastatic pancreatic cancer. Of these, 45% will be American, 45% European (from Spain and France), and 15% Israeli.

In Spain, the first part of the study will be carried out at Hospital Universitario Vall d'Hebron in Barcelona, at the Hospital Universitario Dr. Josep Trueta in Girona and at the Hospital Germans Trias i Pujol de Badalona (Barcelona).

Upon completion of the clinical trial in 2022, AbilityPharma's goal is to establish a license agreement with a multinational pharmaceutical company to further develop ABTL0812, with the aim of making it available to pancreatic cancer patients by 2024 and further developing it for others cancer types.

Dr. Carles Domènech, Scientific Director, Co-founder and Executive President of AbilityPharma stated that “The approval by the AEMPS and the FDA to carry out the phase 2b clinical study in pancreatic cancer with ABTL0812 is a very important step for the development of this innovative drug, which has the potential to become a new therapy for patients affected by this aggressive cancer." Carles added, "We are very happy to have achieved this great milestone, being one of the first Spanish biotech companies to obtain the approval of a phase 2b study in the US, rewarding the great work and effort of the AbilityPharma team. "

Dra. Teresa Macarulla, medical oncologist at Vall d'Hebron University Hospital and principal investigator of the Group of Gastrointestinal and Endocrine Tumors of the Vall d'Hebron Institute of Oncology (VHIO), and Principal Investigator of the study in Spain has stated that "Pancreatic cancer is one of the tumor types with less advancements in the recent years, and it maintains an unfortunate prognosis. We need to continue researching new strategies to improve the survival of our patients. In this sense it is very good news the opening of this study with the molecule ABTL0812 in combination with FOLFIRINOX. The goal is to improve the results that chemotherapy treatment has given us so far, which is the treatment we currently have to treat most of our patients."



Financial round

AbilityPharma is in the last stage of the financial round of a total of 9.2 million euros to finance its research. Last March, the company obtained 5 million euros from the Horizon 2020 Pilot Program, European Innovation Council (EIC) Accelerator; (Of this figure, 2.8 million will be a direct investment in the company's capital, managed through an EIB fund).

In parallel, the US FDA has also awarded a 1.6 million euros (1.9 million dollars) grant to AbilityPharma for the clinical development of this molecule. Likewise, AbilityPharma is finalizing an agreement with an international industrial partner that will contribute 1 million dollars in this phase.

During 2018 and 2019, AbilityPharma attracted 4.4 million euros from investors such as Inveready, Fitalent (Everis Group), private investors through Capital Cell, the founding partners and public funds of the CDTI. In total, since its founding in 2009, AbilityPharma has raised a total of 13.8 million, of which 6.5 are in capital, 2.7 are in public aid and 4.6 are as credits, in addition to payments for milestones from technology partners.

With these investments, AbilityPharma accelerates the process to advance in the validation of its new investigational molecule. The company, based in Cerdanyola del Vallès (Barcelona), has developed an innovative molecule, ABTL0812, capable of transforming the paradigm of first-line treatment of pancreatic cancer. This new molecule causes autophagy selective in cancer cells without affecting healthy cells. ABTL0812 has been positively tested in phase 2 clinical trials, as first-line therapy in patients with endometrial cancer or squamous lung cancer, in Europe.


Crowdfunding in Capital Cell

To complete the development of the clinical study, AbilityPharma started a campaign in mid-October 2020 to raise 1.6 million euros on the crowdfunding platform Capital Cell  https://capitalcell.es/campaign/ability-pharmaceuticals-2020/ .
 
 
An orphan disease

Pancreatic cancer is considered an "orphan disease" with an urgent clinical need for new, safe and effective therapies. Until now, chemotherapy has been the main treatment for all stages of pancreatic cancer. With ABTL0812, however, the effects of various types of chemotherapy are enhanced without increasing their toxicity.
Pancreatic cancer mostly affects people between 65 and 70 years of age and is a difficult to diagnose tumor with high mortality. In other words, pancreatic cancer is not the most common, but it is the one with the lowest survival rate among the main types of cancer: lung, colorectal, breast and prostate.

In recent years, its incidence has increased and, in Spain alone, it is estimated that in 2030 there will be some 9,000 new cases per year, representing an increase of 40%. In 2020, it is expected to be the second leading cause of cancer death in Europe, where an annual mortality of 128,000 people from this type of cancer is estimated. Globally, pancreatic cancer is already the seventh leading cause of cancer-related death.


About AbilityPharma​

AbilityPharma is a biopharmaceutical company founded in 2009, based in Cerdanyola del Vallès (Barcelona), and focused on the development of innovative oral anticancer compounds, which produce selective autophagy-mediated cytotoxicity in cancer cells. ABTL0812 is the most advanced active ingredient and has already been tested positively in phase 2 clinical trials, as a first-line therapy in patients with endometrial cancer or squamous lung cancer, in Europe. Current shareholders include the venture capital funds Inveready, Fitalent (Grupo Everis) and SODENA, the CDTI, its founders and private investors, and has the financial support of ACCIO (Generalitat de Catalunya), the European Commission (EIC Accelerator) and CDTI, ENISA and MINECO (Government of Spain).
 
 

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