AbilityPharma will secure 7 million euros with a collective investment campaign in Capital Cell of up to 2 million to finance itself until the results of its international phase 2b study in pancreatic cancer

The Catalan biopharmaceutical company Ability Pharmaceuticals, SA (AbilityPharma), focused on the development of innovative oral anticancer compounds, undertakes a collective investment campaign of up to 2 million on the Capital Cell platform, the last stage of the investment round of 7 million euros in 2023 to fully finance its phase 2b clinical study of its treatment against pancreatic cancer based on the development of the new antitumor compound ABTL0812.

AbilityPharma is currently at a key moment in its growth and development, having the important challenge of completing an international Phase 2b clinical trial with its product ABTL0812 in patients with metastatic pancreatic cancer, a disease with a very low survival rate, with the aim of demonstrating greater efficacy than the current standard treatment FOLFIRINOX. This is a double-blind, placebo-controlled, first-line study in combination with FOLFIRINOX chemotherapy, ongoing in 23 hospitals in Spain, the US, France, and Israel. 80% of the study patients have already been recruited. At the end of 2023, an independent committee of experts will carry out an interim analysis of the study, and during the second half of 2024 the final results will be obtained.

Positive clinical trial results may allow AbilityPharma to license ABTL0812 to an international Big Pharma pharmaceutical company that completes development of ABTL0812, with the goal of making it available to pancreatic cancer patients in 2026.

AbilityPharma plans to raise a total of 7 million euros in 2023 to obtain the results of the clinical trial, which will have a collective investment campaign (Crowdfunding) of up to 2 million on the Capital Cell platform, which launches on August 30, 2023.

The current round, mostly internal, already has an investment commitment of up to 3 million euros that includes the participation of the founding shareholders, Inveready Biotech, FiTalent, the INNVIERTE program of the CDTI (Ministry of Science and Innovation) and the EIC fund European Innovation Council Fund (European Commission). These funds are added to the 2 million euros of non-diluting funds granted to the company in 2023 by the Ministry of Science and Innovation through the Public-Private Collaborations and Strategic Lines programs with contributions from Next Generation funds from the European Union.

The 7 million euros will also allow to accelerate the regulatory path of ABTL0812 with additional toxicological studies as well as studying its antitumor immunomodulatory effects, and to initiate a program to identify new molecules with immunomodulatory properties through autophagy.

"Obtaining public support of 2 million and the continued commitment of our shareholders is a recognition of our efforts to develop ABTL0812 internationally," stated Carles Domènech, Executive Chairman and CEO of AbilityPharma. Carles added, "With the start of the campaign of up to 2 million euros of collective investment in Capital Cell, we want to give small investors the opportunity to be part of our business project, with the expectation of a license to a pharmaceutical multinational in the next two years.

An orphan disease

Pancreatic cancer is considered an orphan disease with an urgent clinical need for new effective and safe 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 old and is a tumor that is difficult to diagnose and has high mortality. In other words, pancreatic cancer is not the most frequent, 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 by 2030 there will be around 9,000 new cases per year, representing an increase of 40%. It is currently the third leading cause of cancer death in Europe, where an annual mortality of 130,000 people is estimated for this type of cancer. Globally, pancreatic cancer is already the seventh leading cause of cancer-related death.

About ABTL0812

ABTL0812 may transform the paradigm of first-line pancreatic cancer treatment. This new molecule for oral administration, with a completely innovative mechanism of action, causes the selective death of tumor cells through autophagy (self-digestion) without affecting healthy cells.

ABTL0812 has demonstrated clinical efficacy in an open-label Phase 2 clinical study in patients with endometrial cancer or squamous non-small cell lung cancer (sqNSCLC), as first-line treatment in combination with chemotherapy (CT) and as maintenance treatment after QT cycles. In the case of lung cancer, patient survival doubled compared to historical controls. The results show a significant increase in efficacy over first-line standard of care (carboplatin + paclitaxel) in both overall response rate (ORR) and progression-free survival (PFS). Patients in the endometrial cancer group had an increase greater than 30% in ORR compared with standard of care treatment (66% ABTL0812 + chemotherapy vs. 51% chemotherapy alone) and a 38% increase in PFS (7.1 months vs. 9.8 months). In the sqNSCLC group, ORR increased by more than 40% compared to standard treatment (53% vs. 32%) and PFS increased by 44% (4.2 months vs. 6.2 months). Furthermore, overall survival (OS) analysis shows a 100% increase from 11.3 months in the best historical control to 22.5 months in patients with sqNSCLC treated with ABTL0812 + Chemotherapy. The study was led by Vall d'Hebron Institute of Oncology, VHIO (Barcelona), Institut Gustave-Roussy (Paris) and Centre Léon Bérard (Lyon) and included other sites in Spain and France.

ABTL0812 has also received Orphan Drug Designation (ODD) for pancreatic cancer, biliary cancer and pediatric neuroblastoma by the FDA in the US and the EMA in Europe.

The mechanism of action of ABTL0812 is unique and novel. ABTL0812 is a first-in-class, orally administered, molecule that binds to the nuclear receptors PPARα and PPARγ, inducing PPAR-dependent endoplasmic reticular stress (ER-stress) and blocking the activation of Akt, the central kinase of the PI3K/Akt/mTOR pathway. The combination of the inhibition of the PI3K/Akt/mTOR pathway and the induction of ER-Stress results in autophagy-mediated cancer cell death. The mechanism of action was published in Clinical Cancer Research in May 2016 and in Autophagy in May 2020. Additionally, ABTL0812 presents immunomodulatory antitumor effects by transforming "cold" tumors into immunogenic "hot" tumors. These effects were presented at the AACR meeting in April 2021. Final publication is ongoing.

In preclinical cancer models, ABTL0812 is effective as a single agent with an excellent safety profile in a broad spectrum of cancer types, including lung, endometrial and pancreatic cancer, neuroblastoma and glioblastoma. Likewise, ABTL0812 synergizes with chemotherapy and immunotherapies, while promoting a pro-inflammatory antitumor microenvironment. Translational results have been published in Gynecologic Oncology (2019), International Journal of Cancer and Cell Death and Disease (2020), Cancer Communications (2022), and Frontiers in Oncology (2022).

About Ability Pharmaceuticals

Ability Pharmaceuticals (www.abilitypharma.com) is a biopharmaceutical company with one product, ABTL0812, in Phase 2b clinical trials, focused on improving the future of oncology by developing innovative therapies that address unmet medical needs. In April 2016, AbilityPharma signed a territorial license agreement for ABTL0812 with SciClone Pharmaceuticals (Hong Kong) Development Co. Limited to develop and commercialize the product in China.

Ability Pharmaceuticals is headquartered in the Parc Tecnològic del Vallès y Parc de Recerca UAB (Cerdanyola del Vallès, Barcelona, Catalonia, Spain). Among its current shareholders are its founders, private investors, Inveready, Fitalent, Innvierte (CDTI), SODENA, the EIC Fund and SciClone Pharmaceuticals, and it has the financial support of ACCIO (Government of Catalonia), CDTI, ICO, ENISA, the Ministry of Science and Innovation (Government of Spain) and the European Commission (H2020 program, European Innovation Council).