Tonix Pharmaceuticals Holdings Corp (NASDAQ: TNXP) Receives Patent Covering TFF-2 Protein NAd Releases RELIEF Study Results

Tonix Pharmaceuticals Holdings Corp (NASDAQ: TNXP) has announced that the USPTO has given it a US patent No. 11,167,010 on November 9, 2021. The patent titled “Trefoil Family Factor Proteins and Uses Thereof” covers claims on an isolated polypeptide comprising a carboxy-terminal domain of the beta subunit of the human chorionic gonadotropin fused to a TFF2 protein.

The patent will offer market exclusivity in the US until April 2, 2033, without including the patent in terms of extensions.

TNX-1700 is a modified Trefoil Family Factor 2 variant 

Tonix licensed TNX-1700, a stabilized recombinant modified variant of Trefoil Family Factor 2 (rTFF2), from Columbia University in 2019. The company is developing TNX-1700  to treat pancreatic and gastric cancers. TFF2 is a tiny secreted protein that helps to preserve and repair mucosa in the gastrointestinal tract. Most importantly, TFF2 is also shown at low levels in splenic immune cells, and its intravascular functions in the spleen and tumor microenvironment are recently recognized.  Also, gastric cancer epigenetically represses TFF2, suggesting that it may protect against cancer formation through a variety of ways.

In 2020, researchers reported findings from a preclinical study that looked at the role of PD-L1 in colorectal carcinogenesis and tested the effectiveness of targeting myeloid-derived suppressor cells (MDSCs) with TFF2-CTP combined with PD-1 inhibition in colorectal cancer mice models. The findings revealed that anti-PD-1 monotherapy failed to elicit anti-tumor immunity in this colorectal cancer model, whereas TFF2-CTP improved anti-PD-1 therapy’s efficacy. In addition, in PD-L1-overexpressing mice, anti-PD-1 in conjunction with TFF2-CTP had a higher anti-tumor activity.

Tonix announces RELIEF Study of TNX-102

Recently the company announced an oral presentation of encouraging results from its Phase 3 Clinical study, RELIEF of TNX-102 SL for Fibromyalgia treatment.

CEO Seth Lederman said, “Results of the Phase 3 RELIEF trial demonstrated that TNX-102 SL had broad syndromal effects across core fibromyalgia symptoms of widespread pain, fatigue, memory and sleep disturbance. The positive Phase 3 RELIEF study achieved statistical significance on the primary endpoint in December, 2020.”