ATG-037 / Calithera, Antengene - LARVOL DELTA

A first-in-human phase I/Ib study of ATG-037 monotherapy and combination therapy with pembrolizumab in patients with advanced solid tumors: STAMINA-01. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05205109 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Oncology • Solid Tumor

Antengene to Present Latest Results From Two Clinical Studies at ASCO 2025 (PRNewswire) - "Antengene Corporation Limited...announced that it will release the latest clinical data of the CD73 small molecule inhibitor ATG-037 and the mTORC1/2 small molecule inhibitor ATG-008 in Poster Presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting..."

Clinical data • Cervical Cancer

Antengene Announces 2024 Full-Year Financial Results, Proprietary Programs Advancing to Pivotal Trials with Accelerating Multi-market Revenue Ramp Up (PRNewswire) - P1 | N=98 | STAMINA-01 (NCT05205109) | Sponsor: Antengene Therapeutics Limited | "As of the latest data cut-off date on November 27, 2024, among the 26 evaluable patients with prior anti-PD-1 resistance who received ATG-037 in combination with pembrolizumab, 9 had NSCLC and 11 had melanoma. Among these patients, the ORR is 35% and DCR is 85%. These data indicate that ATG-037 has the potential to reverse anti-PD-1 resistance during the dose-escalation phase."

P1 data • Melanoma • Non Small Cell Lung Cancer

A first-in-human phase I/Ib study of ATG-037 monotherapy and combination therapy with pembrolizumab in patients with advanced solid tumors: STAMINA-01 (ESMO 2024) - P1 | "In relapsed/refractory solid tumor patients, ATG-037 appears to be well tolerated as monotherapy and in combination with pembrolizumab. The preliminary efficacy data is encouraging and suggests that the combination regimen may provide a new therapeutic option for CPI resistant NSCLC and melanoma patients."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD73

Antennova Releases Latest Data of CD73 Inhibitor ATN-037, including a DCR of 89.5%, in a Mini Oral at ESMO Congress 2024 (PRNewswire) - P1/1b | N=98 | STAMINA-01 (NCT05205109) | Sponsor: Antengene Therapeutics Limited | "Antennova...announced 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 Congress (ESMO Congress 2024)....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)."

P1 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

Antennova to Present Latest Data of ATN-037 in a Mini Oral Presentation at ESMO Congress 2024 (PRNewswire) - P1/1b | N=98 | STAMINA-01 (NCT05205109) | Sponsor: Antengene Therapeutics Limited |"As of February 29, 2024, 32 patients have been enrolled, receiving doses ranging from 20mg BID to 600mg BID. 20 of these patients who acquired checkpoint inhibitor (CPI) resistance were treated with combination therapy. Efficacy data showed that in the 32 patients in the monotherapy group who were all evaluable, 14 achieved stable disease (SD) with a 43.8% disease control rate (DCR). In the 15 evaluable patients among the 20 patients in the combination therapy group, 3 patients (2 with melanoma and 1 with NSCLC) achieved confirmed partial response (PR) and 1 patient with non-small cell lung cancer (NSCLC) achieved unconfirmed PR with an overall response rate (ORR) of 20.0%. Additionally, 9 patients achieved SD, contributing to a 65.0% DCR....The updated results as of July 26, 2024 will be presented in the Mini Oral Session of ESMO Congress 2024, scheduled on September 16."

P1 data • Non Small Cell Lung Cancer

Antengene Announces 2024 Interim Financial Results, Highlights Progress in R&D and Commercialization (PRNewswire) - P1/1b | N=98 | STAMINA-01 (NCT05205109) | Sponsor: Antengene Therapeutics Limited | "ATG-037 demonstrated an excellent safety profile during the dose escalation stage. Notably, four partial responses in patients previously treated with a checkpoint inhibitor were observed — two in melanoma patients and two in non-small cell lung cancer patients. With the Phase I dose escalation now complete, the company plans to initiate the Phase II dose-expansion of the STAMINA study in China and Australia in the third quarter of 2024."

P1 data • Trial status • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

Antennova Announces CD73 Small Molecule Inhibitor Accepted for Mini Oral Presentation at ESMO Congress 2024 (PRNewswire) - "Antennova...announced that the orally administered CD73 small molecule inhibitor ATN-037 (also known as ATG-037) has been accepted for Mini Oral presentation at the 2024 European Society of Medical Oncology Congress (EMSO Congress 2024), taking place from September 13th to September 17th at the Fira Barcelona Gran Via in Barcelona, Spain."

P1 data • Oncology • Solid Tumor

Antengene Announces Full Year 2023 Financial Results, Highlights Clinical Progress Across First-in-Class, Best-in-Class Pipeline (PRNewswire) - "Next ATG-022 Milestone: Clinical data readout of Phase I 'CLINCH trial', including preliminary efficacy and safety in H2 2024....Next ATG-037 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2024....Next ATG-101 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2025."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Antengene Presents Encouraging Clinical Data from Four Pipeline Programs at the 2023 R&D Day (PRNewswire) - P1a/1b | N=98 | STAMINA (NCT05205109) | Sponsor: Antengene Therapeutics Limited | "Antengene Corporation Limited...is presenting encouraging clinical data of the Company's four key drugs in clinical development...at its 2023 R&D Day taking place today.....ATG-037 (oral CD73 inhibitor): In the dose escalation portion of the Phase I STAMINA trial, 12 patients, all previously treated with a checkpoint inhibitor (CPI, pembrolizumab or nivolumab), have received ATG-037 in combination with pembrolizumab after at least 2 cycles of ATG-037 monotherapy, with 7 patients still under treatment. PRs were observed in two melanoma patients (with prior anti-PD-1 treatment), and in one patient with non-small cell lung cancer (NSCLC) who had also undergone treatment with chemotherapy in addition to a CPI (anti-PD-1)."

P1 data • Melanoma • Non Small Cell Lung Cancer

Antengene to Host 2023 R&D Day and Discuss Key Data with KOLs (PRNewswire) - "Antengene Corporation Limited...announced that it will host its 2023 R&D Day on November 17, 2023, to update the medical and investor communities on the company's progress with its R&D programs. The session will feature three KOL sessions, and discussions about the data of Antengene's key drugs in clinical development, including ATG-031 (anti-CD24 monoclonal antibody), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor); and updates on its proprietary R&D pipeline and upcoming development for 2024."

Clinical data • Oncology

Targeting CD73-adenosine axis for the treatment of multiple myeloma (AACR 2023) - "The murine myeloma cells were implanted subcutaneously into BALB/c mice, and ATG-037 (100 mg/kg) or vehicle was orally administered BID starting day one post-implantation. ATG-037 demonstrated complete inhibition of CD73 activity without “hook effect”, whereas MEDI9447, a CD73 antibody, did not reach 100% inhibition and with reduced inhibition of CD73 activity at higher antibody concentrations. ATG-037 demonstrated potent and complete CD73 enzyme inhibition without “hook effect”, restoring T cell functions from AMP-mediated suppression. And this is the first report that a CD73 inhibitor demonstrates in vivo efficacy in myeloma animal models. The single agent anti-myeloma efficacy of ATG-037 warrants further clinical investigation."

Hematological Malignancies • Multiple Myeloma • Oncology • ENTPD1

Antengene Announces Five Presentations at the 2023 American Association for Cancer Research Meeting (PRNewswire) - "This preclinical study was designed to evaluate the potential of ATG-037 in treating multiple myeloma (MM)....ATG-037's ability to inhibit the activity of CD73 was evaluated in enzyme inhibition and T cell proliferation and activation assays. In vivo efficacy was assessed in syngeneic myeloma models....Results showed complete inhibition of CD73 with ATG-037, without a "hook effect" compared to another industry benchmark antibody program."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology

Antengene Announces Five Upcoming Presentations at the 2023 American Association for Cancer Research Annual Meeting (PRNewswire) - "Five posters will showcase progress with multiple preclinical and clinical programs, including the clinical results of ATG-008 (mTORC1/2 inhibitor) and preclinical data of ATG-031 (anti-CD24 monoclonal antibody), ATG-037 (small molecule CD73 inhibitor), ATG-017 (ERK1/2 inhibitor), and ATG-034 (LILRB4 antagonist antibody)...Antengene Corporation Limited...announced the publication of abstracts for five posters that will be presented during the upcoming 2023 American Association for Cancer Research Annual Meeting (AACR 2023), taking place from April 14th to 19th at the Orange County Convention Center in Orlando, Florida, the United States."

P2 data • Preclinical • Gastrointestinal Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Multiple Myeloma • Oncology • Solid Tumor

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Antengene Therapeutics Limited | N=36 ➔ 98 | Trial completion date: Aug 2024 ➔ Feb 2028 | Trial primary completion date: Mar 2024 ➔ Aug 2027

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-037 (CD73 Inhibitor) in Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "Antengene Corporation Limited...announced it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) on a multicenter, open-label, Phase I dose-finding study of ATG-037 as a monotherapy and in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with locally advanced or metastatic solid tumors (the STAMINA-001 study)....The clinical trial collaboration will focus on evaluating ATG-037 as a monotherapy and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors. The study of ATG-037 monotherapy started enrolling patients in Q2 2022 and will include the combination with KEYTRUDA® in 2023."

Licensing / partnership • Trial status • Oncology • Solid Tumor

Antengene Announces IND Approval for the Phase I STAMINA-001 Study to Evaluate ATG-037 (CD73 Inhibitor) for the Treatment of Locally Advanced or Metastatic Solid Tumors in China (PRNewswire-Asia) - "Antengene Corporation Limited...announced that the China National Medical Products Administration (NMPA) has approved the Phase I study of ATG-037 for the treatment of locally advanced or metastatic solid tumors (STAMINA-001 Trial). The primary objective of the study is to evaluate the safety, pharmacology, tolerability, and preliminary efficacy of ATG-037 as monotherapy and in combination with pembrolizumab, to determine the appropriate dose for Phase II studies. Secondary objectives include characterization of the pharmacology of ATG-037."

Trial status • Oncology • Solid Tumor

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Antengene Therapeutics Limited | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2022 ➔ Dec 2022

Enrollment open • Trial initiation date • Oncology • Solid Tumor

Antengene Announces First Patient Dosed in the Phase I STAMINA-001 Study of ATG-037 for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors (PRNewswire) - "Antengene Corporation Limited...announced that the first patient has been dosed in the Phase I STAMINA-001 trial to evaluate ATG-037 as a monotherapy or in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors in Australia. The primary objective of the study is to evaluate the safety, tolerability, recommended Phase II dose and preliminary antitumor efficacy of ATG-037 as a monotherapy and in combination with pembrolizumab."

Trial status • Oncology • Solid Tumor

ATG-037, a highly potent small molecule CD73 inhibitor has superior activity of reversing immunosuppression in higher-AMP environments compared with anti-CD73 antibodies (AACR 2022) - "This study compared the ability of ATG-037 and clinical CD73 antibodies in reverting immunosuppression in higher-AMP environments in vitro. The activity of ATG-037 and CD73 antibodies (Hu101-28, MEDI9447) in inhibiting enzyme function of cell surface CD73 was evaluated by measuring the ATP-dependent oxidation of luciferin, which is inhibited by AMP, using Cell Titer Glo assay. ATG-037 demonstrated potent and complete CD73 enzyme inhibition and stronger ability in restoring T cell function from high-level AMP mediated suppression, compared with clinical anti-CD73 antibodies. These data implicate the potential therapeutic advantages of small molecule CD73 inhibitors over blocking antibodies."

Oncology • CD8 • GZMB • IFNG • NT5E

Antengene Announces Publication of Five Posters at the 2022 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Antengene Corporation Limited...announced the publication of five posters that will be presented during the upcoming 2022 American Association for Cancer Research Annual Meeting (AACR 2022)....In vitro assays were used to assess each compound's ability to inhibit CD73 enzyme activity and reverse AMP/adenosine mediated T-cell suppression. ATG-037 demonstrated more potent and complete inhibitory activity of cell surface CD73 in this study....The authors found that ATG-037 had a stronger ability to restore T-cell function in higher-AMP environments compared with other clinical anti-CD73 antibodies."

Preclinical • Oncology

Antengene Announces 2021 Full Year Financial Results and Provides Corporate Updates (PRNewswire) - "Further Selinexor Approvals in 2022: We expect further approvals in Hong Kong and Taiwan markets in 2022....ATG-037 (CD73 small molecule inhibitor):...The Phase 1 STAMINA trial has secured HREC approval in Australia and is planned to begin enrollment in H1:22."

Non-US regulatory • Trial status • Hematological Malignancies • Oncology • Solid Tumor

Antengene Announces Five Upcoming Presentations at the 2022 American Association for Cancer Research Annual Meeting (PRNewswire) - "Antengene Corporation...announced the publication of abstracts for five posters that will be presented during the upcoming 2022 American Association for Cancer Research Meetings (AACR 2022), taking place from April 8th to April 13th in New Orleans via in person or virtual attendance."

Preclinical • Oncology • Solid Tumor

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Immune Checkpoint Inhibitors in Patients (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Antengene Therapeutics Limited

Checkpoint inhibition • Combination therapy • Monotherapy • New P1 trial • Immune Modulation • Inflammation • Oncology • Solid Tumor

Antengene Announces HREC Approval in Australia for the Phase I Trial of the Small Molecule CD73 Inhibitor ATG-037 (PRNewswire) - "Antengene Corporation Limited...announced that ATG-037 has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I STAMINA trial, a first-in-human study of ATG-037 in patients with locally advanced or metastatic solid tumors. The primary objective of the study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with an immune checkpoint inhibitor (CPI), to determine the appropriate dose for Phase II studies, and to assess preliminary signal of activity; the secondary objective is to characterize the pharmacology of ATG-037."

New P1 trial • Oncology • Solid Tumor