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July 7, 2021

LoA Update: Ability Pharmaceuticals’ potential to drive Phase I/IIa endometrial cancer drug to next development stage increases to 47%

Ability Pharmaceuticals’ targeted drug ABTL-0812 improved its chances to transition to the next development stage by 14 points after a Phase I/IIa trial was completed, as of 29 June.

By Manasi Vaidya

Ability Pharmaceuticals’ targeted drug ABTL-0812 improved its chances to transition to the next development stage by 14 points after a Phase I/IIa trial was completed, as of 29 June.

The Phase I/IIa study (NCT03366480) evaluated ABTL-0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous non-small cell lung cancer (NSCLC). The drug’s Phase Transition Success Rate (PTSR) in endometrial cancer reached 47% after the trial was completed, as per a 22 June update on its entry.

While the full results have yet been released, Barcelona, Spain-based Ability had presented results on the endometrial cancer cohort at last year’s European Society of Medical Oncology (ESMO) Virtual Congress. In this update, 34 evaluable patients advanced or recurrent endometrial carcinoma, except carcinosarcoma and leiomyosarcoma, were treated with ABTL-0812 with carboplatin/paclitaxel every three weeks as a frontline therapy, followed by ABT-0812 as a maintenance therapy. In this group, the overall response rate (ORR) was 66%, and the duration of response was 7.8 months (Leary et al, Annals of Oncology, volume 31, supplement 4, S639-S640). At the time, Ability had stated that these results will provide the foundation for conducting a Phase IIb/III trial in endometrial cancer, as per a 22 September press release.

ABTL0812 is a targeted drug that binds and activates the transcriptional activity of certain nuclear receptors setting off a cascade that induces endoplasmic reticular stress and blocks Akt activation. Both these actions then induce cytotoxic autophagy resulting in cancer cell death. ABTL-0812 is also being studied in a few other trials, including one for advanced pancreatic cancer which was initiated in May.

PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. PTSR is one of the metrics used to calculate a drug’s Likelihood of Approval (LoA), which for LoA rose by five points to 15%. The LoA score is calculated by GlobalData’s analysis and uses a combination of machine learning and a proprietary algorithm.

Manasi Vaidya is a Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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