On December 15, 2021 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," and "our") (Nasdaq: IDRA) reported clinical updates regarding tilsotolimod, its synthetic Toll-like receptor 9 agonist (Press release, Idera Pharmaceuticals, DEC 15, 2021, View Source [SID1234597194]).
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!
ILLUMINATE-206 Trial for the Treatment of Previously Treated Patients with Immunotherapy-Naïve Micro-Satellite Stable Colorectal Cancer (MSS-CRC)
Preliminary data from the second 10 patients dosed in the safety cohort of ILLUMINATE-206, which involves tilsotolimod in combination with ipilimumab and nivolumab, showed a safety profile consistent with the first 10 patients in ILLUMINATE-206 and with prior studies. Eight patients had a post-baseline disease assessment evaluated per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Of those, one patient experienced Stable Disease (SD) with disease control for more than six months; the remaining patients experienced Progressive Disease (PD). However, one of the RECIST v1.1 PD patients was determined to have experienced pseudo-progression, meaning that the initial increase from baseline in overall tumor burden was followed by a decrease from baseline in overall tumor burden. At the most recent disease assessment, the total decrease from baseline was 46.2%, which is considered an Immune-Related Partial Response (irPR) by Immune-Related RECIST (irRECIST). Per protocol, the patient is continuing in active treatment. No further enrollment in ILLUMINATE-206 is planned at this time.
Collaboration with AbbVie for the Treatment of Head and Neck Squamous Cell Carcinoma
AbbVie Inc. ("AbbVie") is conducting a Phase 1b study for treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma with ABBV-368 plus tilsotolimod and other therapy combinations. AbbVie has discontinued further patient enrollment in the study; this decision was not related to safety concerns. Current patient treatment and follow-up is ongoing. AbbVie is solely responsible for the conduct of the study, with Idera contributing tilsotolimod supply.
Investigator-Sponsored Trial for the Intradermal Treatment of Melanoma
The VU University Medical Center (VUmc) Amsterdam, which is conducting a randomized, controlled trial of a single, intradermal injection of tilsotolimod at the primary melanoma excision site in 214 patients, recently shared with the Company early translational data supporting the mechanism of action of tilsotolimod. "As expected, immune activation, including elevated frequencies of key dendritic cells, was seen in early analysis by flow cytometry of sentinel lymph node biopsies collected seven days post-injection," said Dr. Tanja de Gruijl of VUMC. "These data are consistent with previously reported translational data relating to tilsotolimod in other pre-clinical and clinical settings. We are eager to see if this evidence of immune system stimulation will translate to clinical benefit in this patient population." Enrollment in this study is ongoing.
Investigator-Sponsored Trial for the Treatment of Advanced Cancers
The Gustave Roussy Cancer Campus in Paris is conducting an open-label, Phase 1b study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab in advanced cancers, including non-squamous cell lung cancer, refractory advanced melanoma, and MSS-CRC. Dosing in Part A of the study, which involved 24 patients across two different dose frequencies of ipilimumab and tilsotolimod, is complete; patient follow up is ongoing.
Out-Licensing Consideration
"While our clinical trials with tilsotolimod have not yet translated into a new treatment alternative for patients, data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of pre-clinical and clinical work to date, together with its intellectual property protection, are noteworthy," stated Vincent Milano, Idera’s Chief Executive Officer. "As a result, we will consider an out-licensing arrangement for tilsotolimod so that its full potential may continue to be explored on behalf of patients who do not respond to traditional immunotherapy. We also continue both to preserve cash and to identify and explore potential development or commercial-stage assets for Idera’s portfolio, and we are encouraged by the opportunities presented to us."
About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.
Tilsotolimod is being evaluated in multiple tumor types and in combination with multiple CPIs. For more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.