TT-816 / Teon Therap - LARVOL DELTA

Effect of TT-816, a novel immune response modifier targeting cannabinoid CB2 receptor, on antitumor immunity and cancer growth. (ASCO 2024) - "By contrast, anti-PD1 had little effect (TGI 5%). TT-816 is a novel, oral small molecule immune response modifier that selectively blocks CB2R on immune cells and cancer cells. Preclinical data have demonstrated that it stimulates antitumor immune response and inhibits cancer growth in both hot and cold tumor models. TT-816 is currently undergoing phase 1 clinical trials for the treatment of a broad range of solid tumors."

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • CD4 • CD86 • IFNG • IL12A • TNFA

TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88) (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: Teon Therapeutics, Inc. | N=200 ➔ 9 | Trial completion date: Aug 2027 ➔ Sep 2023 | Active, not recruiting ➔ Terminated; Company operational decision. Decision to stop study is not due to safety or efficacy concerns.

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • ROS1

TT-816 as Monotherapy or in Combination With a PD-1 Inhibitor in Patients With Advanced Cancers (SEABEAM) (MK3475-E88) (clinicaltrials.gov) - P1/2 | N=200 | Active, not recruiting | Sponsor: Teon Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • ROS1

TT-816, a novel small molecule immune checkpoint inhibitor targeting cannabinoid CB2 receptor, stimulates innate and adaptive immunity for cancer therapy (SITC 2022) - "Preclinical data have demonstrated that it stimulates antitumor innate and adaptive immune response and inhibits cancer cell proliferation. TT-816 is currently undergoing phase 1 clinical trials for the treatment of a broad range of solid tumors."

Checkpoint inhibition • IO biomarker • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor • CD4 • CD86 • IFNG • IL12A • TNFA

Teon Therapeutics Announces Clinical Trial Collaboration With Merck to Evaluate TT-816, a Novel Oral Immune Response Modifier, in Combination with KEYTRUDA (pembrolizumab) (Businesswire) - "Teon Therapeutics (Teon)...announced that it has entered into the clinical trial collaboration agreement with Merck....The agreement is for the combination arm of Teon’s ongoing, two-armed, open-label, dose escalation and expansion clinical study and will evaluate Teon’s oral, immune response modifier, TT-816, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for patients with advanced solid tumors. The study will include patients with many difficult-to-treat cancers with high unmet medical need who have not responded to the standard-of-care and may have limited treatment options....This clinical trial is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of TT-816 orally administered as monotherapy and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy. An estimated 200 patients will be enrolled."

Licensing / partnership • Oncology • Solid Tumor

Teon Therapeutics Announces First Patient Treated in Phase 1/2 Clinical Trial of TT-816, a Novel Oral Immune Checkpoint Inhibitor, in Patients with Advanced Solid Tumors (Businesswire) - "Multi-center Phase 1/2 study to evaluate safety and efficacy of TT-816, an oral CB2 receptor antagonist acting as an immune checkpoint inhibitor while promoting T cell infiltration of cold tumors and stimulating NK cell tumor killing. Cannabinoid CB2 receptors are found in many difficult-to-treat cancers, including lung, renal, and ovarian cancers. Inhibiting CB2 receptors has the potential to enhance immune response to treat solid tumors...Teon Therapeutics...announced that the first patient has been treated in its Phase 1/2 clinical trial evaluating the safety and efficacy of TT-816, an oral CB2 receptor antagonist acting as an immune checkpoint inhibitor while promoting T cell infiltration of cold tumors and stimulating NK cell tumor killing."

Trial status • Oncology • Solid Tumor

A Study in Patients With Advanced Cancers (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Teon Therapeutics, Inc.

Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor

Teon Therapeutics Announces FDA Acceptance of IND Application for Novel, Oral Immune Checkpoint Inhibitor, TT-816 (Businesswire) - "Teon Therapeutics...announced the acceptance by the U.S. Food and Drug Administration (FDA) of Teon’s Investigational New Drug (IND) application for the study of TT-816...The IND enables Teon to initiate its planned Phase 1/2 clinical trial designed to assess the dosing, tolerability and safety of TT-816 in patients with advanced cancers as a monotherapy and in combination with existing standard of care anti-PD-1 checkpoint inhibitors....Initiation of the Phase 1/2 TT-816 clinical trial is on track for third quarter 2022."

IND • New P1/2 trial • Oncology • Solid Tumor