On September 16, 2024 Antennova, a clinical-stage biotech company focused on oncology reported that it presented the latest data of CD73 small molecule inhibitor ATN-037 in a Mini Oral presentation at the 2024 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO Congress 2024) (Press release, Antennova, SEP 16, 2024, View Source;including-a-dcr-of-89-5-in-a-mini-oral-at-esmo-congress-2024–302247371.html [SID1234646676]).

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Details of the Presentation:
ATN-037 (also known as ATG-037, CD73 Oral Small Molecule Inhibitor)
Title: A First-In-Human Phase I/Ib study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Advanced Solid Tumours – STAMINA-01
Abstract: 6067
Presentation Number: 997MO

ATN-037 is a highly potent oral small molecule inhibitor of CD73. The STAMINA-01 Phase I/II study was designed to evaluate the safety, pharmacokinetics and optimal dose of ATN-037 as a monotherapy or in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with refractory/relapsed solid tumors. Antennova has initiated the dose optimization and dose expansion portion of the Phase II STAMINA trial of ATN-037 in Australia and plans to initiate the study in China at the end of October 2024.

As of July 26, 2024, a total of 43 patients were enrolled and treated with ATN-037 monotherapy. 26 of these patients with acquired resistance to CPIs also received ATN-037 in combination with pembrolizumab. Since the beginning of the treatment (C1D1), 42 patients have received at least one tumor evaluation (1 patient was unevaluable).

Efficacy data show that among the 42 evaluable patients who were on the monotherapy, 23 have achieved stable disease (SD).

The 26 evaluable patients who received ATN-037 in combination with pembrolizumab include 9 patients with NSCLC and 10 patients with melanoma. 4 of these patients (2 with NSCLC and 2 with melanoma) have achieved confirmed partial response (PR). In the 19 patients with NSCLC or melanoma, the ORR was 21.1% (4/19) and the DCR was 89.5% (17/19).

During the study, 43 (100%) patients experienced treatment-emergent adverse events (TEAEs); 62.3% were treatment-related). Among them, 16 patients experienced treatment-emergent serious adverse events (TE-SAEs), and 2 of them were treatment related; 18 patients experienced Grade 3 or higher TEAEs, and 4 of them were treatment-related. At 400 mg twice-daily (BID), the study observed one dose-limiting toxicity (DLT) of Grade 3 rash. No Grade 5 treatment-related adverse events (TRAEs) were reported.
Preliminary data observed from Phase I dose escalation of STAMINA study has shown encouraging PR in patients treated with ATN-037 in combination with pembrolizumab with excellent safety profile. The combination of ATN-037 with Pembrolizumab may provide a new therapeutic option for CPI resistant NSCLC and melanoma patients.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.