Primmune Therapeutics to Present PRTX007 Phase 1 Pharmacology and Phase 2 INFLECTION-003 Study Design at the SITC 41st Annual Meeting
SAN DIEGO, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Primmune Therapeutics, a clinical-stage biotech company harnessing the
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SAN DIEGO, Nov. 03, 2026 (GLOBE NEWSWIRE) — Primmune Therapeutics, a clinical-stage biotech company harnessing the power of the innate and adaptive immune systems, today announced that two abstracts on polvitolimod HCl (also known as PRTX007), a novel orally administered, systemically acting toll-like receptor 7 (TLR7) agonist, will be presented at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting, taking place November 4-8, 2026, in Phoenix, AZ.
The presentations will cover the design of INFLECTION-003, a Phase 2 study of neoadjuvant polvitolimod HCL in combination with pembrolizumab in resectable Stage III melanoma, and the differentiated pharmacology of polvitolimod HCL characterized in its second Phase 1 clinical study.
Presentation details:
Title: INFLECTION-003: A Phase 2 study investigating the activity of neoadjuvant PRTX007, a novel orally administered TLR7 agonist prodrug, combined with pembrolizumab in participants with stage III melanoma
Presenting Author: Andrew Sharabi, MD, PhD
Abstract #: 573
Presentation Date and Time: Friday, November 6 at 12:15–1:45 PM and 5:30–7 PM MT
Location: North Building Lower Level, Exhibit Halls 4-5-6
Title: Prospective Phase 1 clinical development and optimization of the interferon-biased TLR7 agonist prodrug PRTX007
Presenting Author: James Appleman, PhD
Abstract #: 138
Presentation Date and Time: Saturday, November 7 at 12:15–1:45 PM and 6:40–8:10 PM MT
Location: North Building Lower Level, Exhibit Halls 4-5-6
Both posters will be available on the Primmune website on November 7, 2026.
About INFLECTION-003
INFLECTION-003 is a Phase 2, multi-center, single-arm study evaluating the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma. Participants will receive oral PRTX007 together with intravenous pembrolizumab for 9 weeks prior to surgical resection. The primary objective is to determine the major pathologic response rate following neoadjuvant therapy. Secondary objectives include evaluation of safety, pathologic complete response, event-free survival, overall survival, pharmacokinetics, and immune-related biomarkers. Additional details are available on ClinicalTrials.gov (NCT07565285).
About Polvitolimod HCl (PRTX007)
Polvitolimod HCl (PRTX007) is a novel orally administered, systemically acting toll-like receptor 7 (TLR7) agonist prodrug designed in house at Primmune to functionally tune immune signaling toward an IRF7-driven poly-interferon response and away from the NF-B-mediated pro-inflammatory cytokine signaling that has limited the utility of other systemically acting TLR7, TLR7/8, and TLR8 agonists. To date, PRTX007 has been administered to 118 healthy volunteers in two Phase 1 clinical studies (PRTX007-001 and PRTX007-002) in which it produced the intended systemic IRF7-driven poly-interferon response without an undesired NF-B-driven pro-inflammatory response. PRTX007 was generally well tolerated in both studies with no serious adverse events reported.
About Primmune Therapeutics
Primmune Therapeutics is a clinical-stage company dedicated to the design and development of novel, orally administered, systemically acting, small molecule toll-like receptor 7 (TLR7) agonists as immunotherapies for cancer and other immunotherapy-responsive diseases. For more information, please visit: www.primmunerx.com
Media Contact:
Cammy Duong
LifeSci Communications
cduong@lifescicomms.com
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