Folate Receptor Market: Competitive Landscape, Pipeline, and Market Analysis 2023

Folate receptors bind folate and reduce folic acid derivatives and mediate delivery of tetrahydrofolate to the interior of cells. Folate receptors (FRs) are glycoproteins that exist in several isoforms (1, 2). The FR-α and the FR-β are both anchored in the cell membrane by a glycosyl-phosphatidyl-inositol domain. The FR-α is expressed at a few sites of normal epithelial membranes. For instance, in the proximal tubule cells of the kidneys and in a variety of solid cancer types of epithelial origin. Cancer types with the highest frequency of FR-α expression are ovarian cancer(90%), endometrial cancer (90%), brain (90%), lung cancer (78%), and renal carcinomas (75%). Moreover, FR-expression in cancer of the head and neck (52%), breast (48%), stomach (38%), and colon-rectum (32%) was found at intermediate frequencies. The mechanism of action (MOA) of the Folate Receptor antagonists is directed against folate receptor alpha (FRα). The small molecule, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, they internalized followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death. Folate Receptor antagonists are used in the treatment of endocrine disorders, ovarian cancer, adenoma, carcinoma, and lung and respiratory disorders among others. Increased prevalence of endocrine diseases and ovarian cancer are the key drivers for the Folate Receptor market. For instance, according to the World Health Organization 2020, around there were more than 3 lakhs cases of ovarian cancer worldwide. The introduction of newer products by market players may look for opportunities that have a big impact on comprehensive research and development in Folate Receptor antagonists. For instance, ImmunoGene’s Elahere injection launched for the treatment of ovarian cancer.  Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instances, Novartis Vynfinit (Vintafolide) for the indication of ovarian cancer is under the various stages of clinical studies.

Key Market Developments:

• In November 2022, ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) injection has received accelerated FDA approval for the treatment of adults with FRα positive, platinum-resistant ovarian.
• In December 2022, ImmunoGene conducting phase 2 and phase 3 clinical trial for platinum-sensitive ovarian cancer; PICCOLO (NCT05041257) and GLORIOSA (NCT05445778) in which mirvetuximab soravtansine-gynx is administered in combination with Avastin.

Approved Drug Molecules and Brand Names for Folate Receptor:

• Elahere (Mirvetuximab Soravtansine-Gynx) Injection

Drugs under the Pipeline for Folate Receptor:

• (MORAB-003)
• Vynfinit (Vintafolide)
• TPIV200
• Farletuzumab Ecteribulin (Morab-202)
• Luveltamab Tazevibulin (STRO-002)
• ELU001
• Epofolate (BMS-753493)
• Folate-Tubulysin (EC1456)
• AMT-151
• AZD5335
• BAT8006
• CBP-1008
• CBP-1018
• EC0489
• IMGN151
• ITIL-306
• Mov18 Ige
• Idetrexed (CT900)
• Rinatabart Sesutecan (PRO1184)

Clinical Activity and Developments of Folate Receptor:

Up until July 2023, there will be about 16 companies with over 34 compounds that focus on various forms of cancers and endocrine disorders. For these molecules, hundreds of clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In October 2020, Eisai Co Ltd has completed phase 2, a randomized, double-blind, placebo-controlled trial of Farletuzumab (MORAB-003) to assess the efficacy and safety in combination with Carboplatin plus Paclitaxel or Carboplatin in subjects with low Ca125 platinum-sensitive ovarian cancer.
• In November 2022, Eisai Co Ltd has completed phase 1 clinical trial of Farletuzumab Ecteribulin (Morab-202) to evaluate the pharmacodynamics and adverse reaction in subjects with solid tumors.