On November 9, 2021 Ascendis Pharma A/S (Nasdaq: ASND) reported two poster presentations featuring new non-clinical data for its investigational TransCon TLR7/8 Agonist product candidate at SITC (Free SITC Whitepaper) 2021, the annual meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place virtually and in person November 10-14 in Washington, D.C (Press release, Ascendis Pharma, NOV 9, 2021, View Source [SID1234594982]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The data show that, as designed, TransCon TLR7/8 Agonist, which leverages the Company’s innovative TransCon hydrogel technology, provides sustained activation of both innate and adaptive immune mechanisms with low systemic cytokine levels.
The posters being presented at SITC (Free SITC Whitepaper) 2021 are:
Poster #769
Friday,
November 12 A Single Dose of Intratumoral TransCon TLR7/8 Agonist Monotherapy Promoted Sustained Activation of Antigen Presenting Cells Resulting in CD4+ and CD8+
T Cell Activation and Tumor Growth Inhibition
Poster #16
Saturday,
November 13
Tumor Growth Inhibition Mediated by a Single Dose of Intratumoral TransCon TLR7/8 Agonist Associated with Activated Circulating T and B cells and Sustained Low Levels of Systemic Cytokines
"We are designing TransCon TLR7/8 Agonist for sustained and controlled release of resiquimod, a potent TLR7/8 agonist, with the goal of maximizing therapeutic benefit and addressing the known limitations of current approaches, including serious systemic toxicity and rapid effusion from the tumor," said Juha Punnonen, Ascendis Pharma’s Senior Vice President and Head of Oncology. "We are incredibly pleased to confirm with these non-clinical studies that a single intratumoral injection of sustained release unmodified resiquimod delivered through our unique hydrogel technology worked in the expected way. We look forward to sharing initial data from our Phase 1/2 clinical trial soon."
About TransCon TLR7/8 Agonist
TransCon TLR7/8 Agonist is an investigational long-acting prodrug of resiquimod, a small molecule agonist of Toll-like receptors (TLR) 7 and 8 designed to provide sustained activation of intratumoral antigen-presenting cells driving tumor antigen presentation and induction of immune stimulatory cytokines for weeks or months with a single intratumoral injection.
Ascendis Pharma is currently conducting a Phase 1/2 study, called the transcendIT-101 Study (ClinicalTrials.gov Identifier: NCT04799054), to evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion cohorts. The primary objectives are to evaluate safety and tolerability and to define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab.