Ascendis Pharma A/S (NASDAQ:ASND) reported the filing of an investigational new drug application with the U.S. Food and Drug Administration to initiate the TransCon TLR7/8 Agonist clinical program.
The Copenhagen-based Ascendis, a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, today announced the filing of an investigational new drug (IND) application with the FDA to initiate the clinical program of TransCon TLR7/8 Agonist.
TransCon TLR7/8 Agonist is a long-acting prodrug of resiquimod, a small molecule agonist of Toll-like receptors (TLR) 7 and 8. Administered as an intratumoral injection, TransCon TLR7/8 Agonist is designed to provide sustained activation of intratumoral antigen presenting cells driving tumor antigen presentation and induction of immune stimulatory cytokines in the tumor.
According to Juha Punnonen, Ascendis head of oncology, "The filing of our first oncology IND for TransCon TLR7/8 Agonist – which is designed to provide intratumoral, sustained release of resiquimod over several weeks from a single administration with minimal systemic exposure and potent immune response against cancer cells – is a major milestone for Ascendis.
"We believe TransCon TLR7/8 Agonist represents a potential paradigm shift in the treatment of cancer through sustained release of an immunostimulatory molecule over several weeks inside the tumor, thereby employing the patients’ own immune systems to destroy cancer cells with reduced risk of systemic adverse events."
ASND shares toppled $3.22, or 1.9%, to $166.97.
