SR-8541A / TGen, Stingray Therap - LARVOL DELTA

A phase 2 study of SR-8541A in combination with botensilimab and balstilimab in subjects with refractory metastatic microsatellite stable colorectal cancer (MSS-CRC). (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06589440 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Combination therapy • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor

A phase 2 study of SR-8541A in combination with botensilimab and balstilimab in subjects with refractory metastatic microsatellite stable colorectal cancer (MSS-CRC) (AACR 2025) - P1, P2 | "SR-8541A is administered orally twice daily (BID) in 28-day cycles. Blood samples are being collected for PK assessment, target engagement, and biomarker assessment."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • CGAS • CTLA4 • ENPP1 • MSI • STING

StingrayTx: A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: Stingray Therapeutics | N=18 ➔ 25 | Trial completion date: Aug 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2025

Checkpoint inhibition • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Phase 2 Study of SR-8541A in Combination with Botensilimab and Balstilimab in Subjects with Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Stingray Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Fc-enhanced anti-CTLA-4 antibody, botensilimabms, enhances the efficacy of multiple therapeutic modalities in immunotherapy-refractory tumor models (SITC 2024) - "In patients with advanced solid tumors, botensilimab +/- balstilimab (anti-PD-1), demonstrates durable clinical responses across nine different immunotherapy-resistant or poorly immunogenic tumor types...Combination agents/modalities included focal radiotherapy, chemotherapy (doxorubicin, etoposide, gemcitabine and nab-paclitaxel), iNKT activation (αaGalCer), QS-21 saponin adjuvant, vaccines, ENPP1 inhibitor and immune checkpoint/co-stimulatory therapy (anti-PD-1 and anti-CD137 agonist antibodies)...In the CT26 model, combination of botensilimabms with an ENPP1 inhibitor, SR-8541A, produced superior tumor growth inhibition compared to the respective individual therapies, and was associated with enhanced T cell infiltration...Conclusions These studies highlight the versatility of botensilimab to combine with a broad range of therapeutic agents and modalities to enhance anti-tumor immunity in difficult-to-treat mouse tumor models. Clinical trials exploring botensilimab..."

Preclinical • Brain Cancer • Breast Cancer • CNS Tumor • Colorectal Cancer • Glioblastoma • Melanoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD8 • ENPP1

A phase 1 multi-center, open-label, dose escalation study to evaluate the safety and pharmacokinetics of oral SR-8541A, an ENPP1 inhibitor, in patients with advanced solid tumors (SITC 2024) - P1 | "This data supports continued assessment of SR-8541A in the clinic. Ethics Approval This study obtained the appropriate ethics committee, in Australia: Bellberry Human Research Ethics Committee, approval is 2023-08-953 Monash Health Human Research Ethics Committee, approval is 102763."

Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor • ENPP1 • STING

Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Stingray Therapeutics

Combination therapy • Metastases • New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

First-in-human study of ENPP1 inhibitor, SR-8541A, for the treatment of solid tumors (AACR 2024) - P1 | "The first evaluated dose of SR-8541A has shown to be safe and well tolerated. Pharmacokinetic data shows strong oral bioavailability and supports escalation in the phase I trial and continued assessment of SR-8541A in the clinic."

P1 data • Oncology • Solid Tumor • ENPP1 • STING

A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Stingray Therapeutics

Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Stingray Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Oncology • Solid Tumor

SR-8541A, a small molecule inhibitor of ENPP1, enhances the effect of immune checkpoint inhibitors in a colorectal cancer model (SITC 2023) - "Conclusions Use of ENPP1 inhibition may sensitize colorectal cancers to immune checkpoint inhibition. We intend to explore this combination in the clinic."

Checkpoint inhibition • IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • CGAS • CTLA4 • STING

A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Stingray Therapeutics

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

Inhibition of ENPP1 using small molecule, SR-8541A, enhances the effect of checkpoint inhibition in cancer models (AACR 2023) - "In summary, we show that combination of ENPP1 inhibition with checkpoint inhibition promotes a robust antitumor activity by stimulating both innate and adaptive immune response."

Checkpoint inhibition • IO biomarker • Late-breaking abstract • Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • CTLA4 • CXCL10 • PD-1