Can Cannabinoid CB2 Receptor Antagonist Combined With KEYTRUDA Be Effective In Patients With Advanced Solid Tumors? These Two Companies Aim To Find Out

Teon Therapeutics a clinical-stage biopharmaceutical company targeting metabolic signaling pathways and development of G-Protein Coupled Receptor immuno-oncology therapies in difficult-to-treat cancers, has entered into the clinical trial collaboration agreement with Merck MRK, an in immuno-oncology company.

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.

“We are fortunate to have the opportunity to collaborate with Merck for this phase 1/2 trial. The collaboration of the combination arm of our TT-816 clinical trial represents an important advancement in our comprehensive development program and further supports our mission to invent new hope for patients by potentially providing meaningful treatments to those with few remaining alternatives,” stated Serge Messerlian, CEO of Teon Therapeutics.

About Teon’s Multicenter TT-816 Phase 1/2 Clinical Trial

This clinical trial is an open-label, phase 1/2, first-in-human, 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. Phase 1 will evaluate safety, tolerability, pharmacokinetics, preliminary clinical activity and establish a recommended dose of TT-816 to be used as a monotherapy and in a combination therapy for phase 2. Phase 2 will continue to evaluate safety and define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs including non-small cell lung cancer, ovarian cancer and renal cell carcinoma.

About TT-816

TT-816 is an oral cannabinoid CB₂ receptor antagonist acting as a novel immune response modifier for the treatment of a broad range of solid tumors and is highly selective for the CB₂ receptor versus the CB₁ receptor. By inhibiting the actions of the CB₂ receptors on immune cells in many difficult-to-treat cancers, including lung, renal, and ovarian, TT-816 has the potential to enhance T cell and NK cell activity and directly promote T cell infiltration into solid tumors.

Preclinical results indicate that TT-816 enhances both the effect of NK cell tumor killing and T cell activation in vitro, increases both tumor infiltrating T cells and NK cells in vivo and prevents broad-based T cell exhaustion. TT-816 dose-dependently inhibits tumor growth in animal models, has an additive effect with anti-PD-1 in the ‘hot’ tumor model and acts synergistically with anti-PD-1 in the ‘cold’ tumor model where the anti-PD-1 alone had no effect.

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