Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals has introduced its new antidepressant candidate, TNX-601 ER (tianeptine hemioxalate), which may provide significant therapeutic advantages over current U.S. antidepressants. For over 30 years, tianeptine has been available outside the U.S. and is noted for its efficacy without causing sexual dysfunction or weight gain. This unique mechanism of action promotes neuron connectivity, potentially offering longer-term relief from depression. The company is conducting a Phase 2 study called UPLIFT to evaluate the safety of TNX-601 ER in ~300 patients, with results expected in Q4 2023. The global antidepressant market reached $15 billion in 2020 and is projected to grow to $21 billion by 2030, driven by innovative treatment options.

Tonix Pharmaceuticals (Nasdaq: TNXP) presented research on TNX-1700 at the AACR Annual Meeting (April 14-19, 2023). The studies demonstrated that mTNX-1700, a TFF2-albumin fusion peptide, effectively targeted myeloid-derived suppressor cells (MDSCs) and enhanced anti-tumor immunity when combined with PD-1 blockade therapy in mouse models of colorectal and gastric cancer.

The poster titled “MDSC-targeted TFF2-MSA suppresses tumor growth and increases survival in anti-PD-1 treated MC38 and CT26.wt murine colorectal cancer models” showed significant anti-tumor effects. Another poster focused on diffuse-type gastric cancer, suggesting the potential of mTNX-1700 in combination treatments.

CEO Seth Lederman stated that the results indicate mTNX-1700 offers additive benefits to existing cancer therapies, paving the way for future clinical exploration.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the online publication of two significant papers in the American Journal of Transplantation, detailing the effectiveness of TNX-1500, a monoclonal antibody aimed at preventing organ transplant rejection. The studies conducted in collaboration with Massachusetts General Hospital demonstrated that TNX-1500 successfully prevented organ rejection in non-human primates and was well tolerated, with no thrombosis observed. Tonix plans to initiate a Phase 1 clinical trial for TNX-1500 in human kidney transplant patients in Q2 2023. This promising data supports the potential of TNX-1500 to enhance organ transplant outcomes and addresses the need for new immunomodulatory therapies.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced changes to streamline its clinical trials for fibromyalgia and chronic migraine. The company will eliminate interim analyses in the Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and the Phase 2 PREVENTION study of TNX-1900 for chronic migraine. These modifications aim to expedite timelines, with topline results expected in Q4 2023. Target enrollment for the fibromyalgia study remains at approximately 470 participants, while the chronic migraine study's enrollment has been reduced from 300 to 150 participants. CEO Seth Lederman emphasized the commitment to advancing these central nervous system programs closer to FDA approval.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced promising preclinical results for its vaccine candidate, TNX-801, designed to combat mpox and smallpox. Presented at the World Vaccine Congress, TNX-801 demonstrated full protection against lethal challenges in non-human primates, indicating strong efficacy. The CEO emphasized TNX-801's potential for widespread use without the need for cold storage. A Phase 1 trial for TNX-801 is slated to begin in the second half of 2023. Additionally, TNX-1800, another vaccine candidate targeting SARS-CoV-2, showed effectiveness in protecting airways in animal models. Tonix is committed to developing robust vaccines for emerging infectious diseases, contributing to public health security.

Tonix Pharmaceuticals (NASDAQ: TNXP) will present two posters at the AACR Annual Meeting from April 14-19, 2023, in Orlando, FL. The research focuses on TNX-1700, a recombinant TFF2-albumin fusion peptide, showing effectiveness in targeting myeloid-derived suppressor cells (MDSCs) in murine colorectal and gastric cancer models. The studies highlight the additive benefits of mTNX-1700 combined with PD-1 blockade therapy. Additional details and poster copies will be available on the company’s website following the conference.