NY-ESO-1 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

The CTA (Cancer-testis antigens) New York Esophageal Squamous Cell Carcinoma-1 (NY-ES0-1), also known as CTAG1B, is a protein which is encoded by the gene CTGAG1B, and located on the Xq28 region of the X chromosome. NY-ESO-1 is an archetypical example of a CTA with restricted expression to germ cells and placenta cells and re-expression in tumor cells. NY-ESO-1 expression has been reported in a wide range of tumor types, including neuroblastoma, myeloma, metastatic melanoma, synovial sarcoma, bladder cancer, non-small cell lung cancer, esophageal cancer, hepatocellular cancer, head and neck cancer, ovarian cancer, prostate cancer and breast cancer. Additionally, within these tumor types, the expression frequency of NY-ESO-1 differs greatly with the most commonly expressing tumors being myxoid and round liposarcoma (89-100%), neuroblastoma (82%), synovial sarcoma (80%), melanoma (46%), and ovarian cancer (43%), and others (20-40%). Hence, ongoing clinical trials targeting NY-ESO-1, by using a vaccination approach, adoptive cellular therapy, or combination treatment with immune checkpoint inhibitors are being conducted by companies. Merck (MSD), Takara Bio., BioNTech, Marker Therapeutics, GSK, Lyell Immunopharma, Gilead Science, and Axis Therapeutics are some of the pharmaceutical companies with NY-ESO-1 inhibitor in their pipeline.

Key Market Developments:

• In Nov 2021, BioNTech’s BNT 111, a tetravalent RNA-lipoplex cancer vaccine received Fast Track designation for Malignant melanoma in the USA.
• In Dec 2022, Takara Bio announced its intention to submit a BLA (Biologics License Applications) for synovial sarcoma in Japan for Mipetresgene autoleucel (TBI-1301), a NY-ESO-1 antigen-specific gene therapy.

Drugs under the Pipeline for NY-ESO-1 Inhibitors:

• Rasdegafusp alfa (CDX-1401)
• Letetresgene autoleucel (GSK3377794)
• NY-ESO-1 TCR
• TAEST16001
• CMB305
• MultiTAA T cell therapy
• ID-LV305
• Mipetresgene autoleucel (TBI-1301)
• BNT111
• MT-601
• ADXS-503
• GSK2241658A
• GSK3845097
• GSK3901961
• HBI 0201-ESO TCRT
• IDC-G305
• IMM65
• LYL132
• NY-ESO-1 TCR-T cell therapy
• PDC*lung01
• TC-N201
• TCRT-ESO-A2
• VTP-600

Clinical Activity and Developments of NY-ESO-1 Inhibitors:

Currently, there are about 23 drug molecules in ongoing clinical trials, which are being developed by 23 companies for NY-ESO-1 inhibitor.

• In Jan 2022, Lyell Immunopharma announced US FDA has cleared an IND application to initiate a phase-I clinical trial for LY132, an investigational T-cell receptor therapy which the company is developing in collaboration with GSK for patients with solid tumors expressing NY-ESO-1.
• In Jan 2023, Marker Therapeutics conducted phase-I clinical trials for MT-601, a MultiTAA T-cell therapy, in non-Hodgkin lymphoma patients through parenteral administration in the USA.