n Ibrilatazar’s Phase I/IIa ENDOLUNG
clinical trial was recently published in the prestigious scientific journal Lung Cancer. n The trial evaluated the safety and
efficacy of ibrilatazar (ABTL0812) combined with paclitaxel/carboplatin in 40 patients
with stage III/IV squamous non-small cell lung cancer (sq-NSCLC), at 6 leading
oncology hospitals in Spain and France. n Ibrilatazar in combination with
chemotherapy (paclitaxel/carboplatin) demonstrated improvements across all
efficacy endpoints compared to historical controls including doubling Overall
Survival from 12.3 to 22.5 months. n These results support ibrilatazar as
a potential backbone therapy for patients with one of the most common subtypes
of lung cancer worldwide, addressing a high-unmet need.
AbilityPharma, a clinical stage biopharmaceutical company specializing
in the development of innovative oncology therapies, announced that the data of
its Phase I/IIa ENDOLUNG trial evaluating ibrilatazar (ABTL0812) in combination
with chemotherapy (paclitaxel/carboplatin) for patients with stage III/IV
squamous non-small cell lung cancer (sq-NSCLC) has been published in the Lung Cancer journal.
The trial was conducted at the Catalan Institute of Oncology (ICO) in Badalona, Girona and l’Hospitalet (Barcelona), Paoli-Calmettes Institute in Marseille, Virgen
del Rocío University Hospital in Seville and Clinic University Hospital in Valencia.
The publication
builds upon AbilityPharma’s previous research featured in the International Journal of Cancer (Leary et al.,
2024). These advancements further consolidate the company’s leadership in
the development of autophagy-mediated oncology drugs that selectively kill
cancer cells while sparing normal cells.
Dr. Carles
Domènech, AbilityPharma’s CEO & Co-Founder, stated, “This publication
represents a crucial development in the study of new drugs and combinations for
advanced squamous lung cancer. For AbilityPharma it is a significant milestone
in our mission to deliver transformative treatments to cancer patients”.
Dr. Joaquim Bosch,
medical oncologist from the ICO Girona and researcher from the Dr. Josep Trueta
Biomedical Research Institute of Girona (IDIBGI), and first author of the
article, explained:
Fellow senior
author on the publication Dr. Teresa Morán, medical oncologist at ICO
Badalona and researcher of B·ARGO group at the Germans Trias i Pujol Research
Institute (IGTP), added: “ibrilatazar, when administered in combination with
chemotherapy and subsequently as maintenance therapy, has shown a median overall
survival of over 22 months in sq-NSCLC. These results are highly promising. If
confirmed in a randomized study, ibrilatazar could become a treatment option for
this complex disease.”
Summary of the
main results reported in the publication
n The combination of
ibrilatazar plus paclitaxel/carboplatin demonstrated an increase in all
efficacy endpoints when compared with historical controls: i) overall response
rate (ORR) of 52% versus 31.7% in historical controls which represents a 40%
increase, ii) median progression-free survival (PFS) of 6.2 months (95% CI: 4.4–8.8)
versus 4.2 months in historical controls which represents a 44% increase, and
iii) median overall survival (OS) of 22.5 months (95% CI 10.4-ND) versus 11.3
months in historical controls which represents doubling the survival. n The combination of
ibrilatazar plus paclitaxel/carboplatin exhibited a good safety profile. The safety
profile of the addition of ibrilatazar to paclitaxel/carboplatin aligned with that
of paclitaxel/carboplatin historical controls and did not introduce additional
significant adverse events beyond those associated with paclitaxel/carboplatin.
n Ibrilatazar’s pharmacokinetic
parameters aligned with target engagement observed in preclinical studies, and
blood pharmacodynamic biomarkers indicated sustained target regulation for at
least 28 days following the initiation of treatment.
Reference
articles:
"Squamous cell lung cancer is one of the lung cancer subtypes with the
fewest therapeutic options and the poorest prognosis. That’s why it is
especially relevant that a new molecule like ibrilatazar, with a different
mechanism of action, has shown promising antitumor activity. This molecule
targets the PI3K pathway and autophagy, making it a very attractive and
innovative therapeutic target. Ibrilatazar also demonstrated a favorable
tolerability profile in combination with chemotherapy in this study."