On October 14, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported a presentation of toripalimab data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held October 11-15, 2023 at the Hynes Convention Center in Boston (Press release, Coherus Biosciences, OCT 14, 2023, View Source [SID1234635971]).

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PD-L1, a protein found on the surface of some cancer cells, suppresses T cell activation and inhibits the ability of the body’s immune system to kill cancer cells. Toripalimab is an anti-PD-1 monoclonal antibody that binds with high affinity to a unique site on PD-1, thereby blocking the interaction of PD-1 and PD-L1. Preclinical mechanistic data demonstrate statistically significantly higher activation of T cells and higher expression of key immune system activators with toripalimab compared to pembrolizumab, clinically a widely used anti-PD-1 monoclonal antibody for the treatment of cancer patients. These data may provide a mechanistic explanation for the improvements in overall survival irrespective of PD-L1 expression levels observed in clinical trials in multiple tumor types evaluating toripalimab in combination with chemotherapy. A biologics license application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) is currently under review by the U.S. Food and Drug Administration (FDA).

"PD-1 inhibition has been a significant advancement in cancer treatment across tumor types but better treatments are needed to increase response rates and drive improved outcomes for patients. These data support toripalimab as a next-generation PD-1 inhibitor that, in combination with chemotherapy, may have greater antitumor activity in less inflamed tumors than more commonly used PD-1 inhibitors in certain cancers due to its unique binding properties," said Theresa LaVallee, Ph.D., Coherus’ chief development officer. "We look forward to delivering this important new treatment option to patients, first in NPC, if approved, and continuing to evaluate its efficacy in combination with chemotherapy in multiple cancer types and in combination with novel I-O agents."

Poster presentation data are summarized as follows:

Toripalimab in combination with chemotherapy significantly improved overall survival irrespective of PD-L1 status in post hoc analyses of 3 randomized controlled clinical trials, including in NPC, non-small cell lung cancer (NSCLC) and esophageal squamous-cell carcinoma (ESCC)
Toripalimab exhibits a 12-fold higher binding affinity for PD-1 compared to pembrolizumab that is driven by a slow-off rate
Toripalimab is more potent than pembrolizumab in enhancing levels of Th1 cytokines and cytotoxicity in human peripheral blood mononuclear cells (PBMCs)
In comparison to pembrolizumab, binding of toripalimab to PD-1 induced low levels of SHP1 and SHP2 recruitment, thereby minimizing a key process of T cell suppression
Toripalimab induced and elevated IFN-y gene signature in NSCLC dissociated tumor cells with different kinetics and intensity compared to pembrolizumab
Poster presentation details:

Poster Number C069: Toripalimab, an anti-PD-1 antibody that demonstrates potent T cell activation and enhanced clinical efficacy irrespective of PD-L1 status
Session: Poster Session C
Date and time: Saturday, October 14, 12:30 pm-4:00 pm EDT
Location: Level 2, Exhibit Hall D
About toripalimab
Toripalimab is a next-generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site with high affinity and activates antitumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types. The BLA for toripalimab in combination with chemotherapy as the first-line treatment for recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is under review by the FDA. In Europe, the marketing authorization applications (MAA) for toripalimab for the first-line treatment of NPC and esophageal squamous cell carcinoma (ESCC) are under review by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of ESCC, NPC, mucosal melanoma, soft tissue sarcoma, and small-cell lung cancer (SCLC).

More than 40 company-sponsored toripalimab clinical studies covering over fifteen indications have been conducted globally by Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences), including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.