PRTX007 / Primmune Therap - LARVOL DELTA

A Phase 1, Randomized Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intermittent Consecutive Day Dosing Regimen of PRTX007 in Healthy Adults (ANZCTR) - P1 | N=15 | Completed | Sponsor: United States Defense Threat Reduction Agency (DTRA) | Not yet recruiting ➔ Completed

Trial completion

A Phase 1, Randomized Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intermittent Consecutive Day Dosing Regimen of PRTX007 in Healthy Adults (ANZCTR) - P1 | N=15 | Not yet recruiting | Sponsor: United States Defense Threat Reduction Agency (DTRA)

New P1 trial

CLINICAL VALIDATION OF AN ORALLY-DELIVERED, SYSTEMICALLY ACTIVATED TLR7 AGONIST TO BOOST HOST IMMUNE RESPONSE TO CHRONIC VIRAL DISEASES, INCLUDING HEPATITIS B VIRUS (AASLD 2023) - "PRTX007 was well tolerated, with mostly mild AEs and no SAEs. Activation of the innate and adaptive immune responses were observed without systemic increases in proinflammatory factors. Sustained immune pressure and extended PD response was demonstrated with oral QOD doses."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • IL1R1 • IL6 • TNFA

A study to compare the pharmacokinetics and pharmacodynamics of the free base form of PRTX007, the hydrochloride salt form of PRTX007 and the hydrochloride salt form of PRTX007 in combination with probenecid in healthy adults (ANZCTR) - P1 | N=18 | Completed | Sponsor: Primmune Therapeutics Australia Pty Ltd | Initiation date: May 2000 ➔ May 2022

Combination therapy • Trial initiation date • Infectious Disease • Novel Coronavirus Disease • IFNA1 • IL1B • IL1R1 • IL6 • TNFA

A study to compare the pharmacokinetics and pharmacodynamics of the free base form of PRTX007, the hydrochloride salt form of PRTX007 and the hydrochloride salt form of PRTX007 in combination with probenecid in healthy adults (ANZCTR) - P1 | N=18 | Completed | Sponsor: Primmune Therapeutics Australia Pty Ltd

Combination therapy • New P1 trial • Infectious Disease • Novel Coronavirus Disease • IFNA1 • IL1B • IL1R1 • IL6 • TNFA

Primmune Therapeutics to Present at the 2023 STING & TLR-Targeting Therapies Summit (Businesswire) - "Primmune Therapeutics, announced that Primmune’s Senior Vice President & Chief Scientific Officer James Appleman, Ph.D., will present at the 4th STING & TLR-Targeting Therapies Summit being held in Boston, Massachusetts from May 9-11, 2023. The oral presentation will cover the recent clinical progress of PRTX007...small molecule toll-like receptor 7 (TLR7)-specific agonist and will evaluate how the unique pharmacology elicited by PRTX007 distinguishes Primmune’s lead candidate from other TLR7 agonists in human cellular models, in non-human primates, and in the clinical setting. The presentation at the Summit will also review how PRX034, the TLR7 agonist systemically delivered by PRTX007, has been shown to induce engagement of the innate and adaptive immune responses while avoiding systemic inflammation in healthy volunteers, and why PRTX007’s favorable profile is expected to correlate with efficacy in cancer therapy."

Preclinical • Infectious Disease • Novel Coronavirus Disease • Oncology

Activation of innate and adaptive immune response with a clinical stage TLR7 agonist prodrug PRTX007 (AACR 2023) - "PRTX007 demonstrated a favorable safety profile in all SAD and MAD cohorts. In the 750 mg MAD cohort, activation of the innate and adaptive immune response including important effector cell populations were observed without systemic increases in proinflammatory factors."

Clinical • IO biomarker • Oncology • CD8 • IL1R1 • IL6 • TNFA

Primmune Therapeutics Presents New Clinical Data from Phase 1 Study Evaluating PRTX007 in Healthy Volunteers at the 2023 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "PRTX007 demonstrated a favorable safety profile when administered orally to all 9 SAD and 4 MAD cohorts tested. Most AEs were mild and not dose-related, with no instances of dose modification or discontinuation due to treatment-related AEs throughout the study. The most common drug-related AE was headache, seen across both treated and placebo groups independent of dose. PRTX007 demonstrated well-controlled expression of interferon-stimulated genes (ISGs) independent of dose, without significant increases in circulating IFNs...CD8+ T cells and NK cell activation (CD38+ markers) increased markedly from pretreatment to end of dosing in all HVs. These data justify further exploration of PRTX007 as a potential cancer therapeutic. Primmune plans to conduct a future study evaluating PRTX007 in combination with a checkpoint inhibitor across the active doses identified in the Phase 1 study for the potential treatment of solid tumors."

P1 data • Infectious Disease • Oncology • Solid Tumor

Primmune Therapeutics to Present New Clinical Data from Phase 1 Study Evaluating PRTX007 at the 2023 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "Primmune Therapeutics...announced the upcoming presentation of new clinical data from its Phase 1 study of PRTX007, an orally administered prodrug of a novel, small molecule toll-like receptor 7 (TLR7)-specific agonist, at the 2023 American Association for Cancer Research (AACR) Annual Meeting. The AACR Annual Meeting will be held in Orlando, Florida from April 14-19."

P1 data • Oncology

Primmune Therapeutics (BIO 2022) - "Primmune is developing a novel orally administered small molecule TLR7 agonist (PRTX007) to treat cancer and HPV pre-cancerous lesions...These results in the clinic align with in vitro and extensive in vivo primate data and will lead to efficacy studies in patients with cancer and HPV pre-cancerous lesions. Primmune is a San Diego-based company founded in 2017."

Oncology • IL1B • IL6 • TNFA

PRTX007, an optimized TLR7 agonist for systemic immunotherapy of cancers: Interim analysis of phase I study in healthy volunteers (AACR 2022) - "At the interim analysis, PRTX007 demonstrated a favorable safety profile when administered orally to all tested SAD and MAD cohorts. Dose-dependent systemic exposure was observed, as well as activation of the innate immune response, without production of proinflammatory factors."

Clinical • IO biomarker • P1 data • Oncology • CD4 • CD8 • IL1B • IL1R1 • IL6 • TNFA

Primmune Therapeutics Presents Data from Phase 1 Study Evaluating PRTX007 in Healthy Volunteers at the 2022 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - P1 | N=NA | "Data show that PRTX007 was well-tolerated and expressed a favorable safety profile in the analyzed patient cohorts, with most adverse events (AEs) considered incidental and no instances of moderate, severe or serious AEs. In addition, every other day (QOD) dosing demonstrated stable systemic immune induction without evidence of counter-regulation. Both the clinical characteristics and unique pattern of immune induction by PRTX007 support its use in combination with immune checkpoint inhibitors...At the interim analysis, PRTX007 demonstrated a favorable safety profile when administered orally to all 9 SAD and 3 MAD cohorts tested. PRTX007 demonstrated induction of interferon-stimulated genes (ISGs) without significant increases in circulating interferons (IFNs). There was no increase in expression or circulating levels of proinflammatory cytokines (e.g., TNFα, IL-6, IL-1β)."

P1 data • Oncology

Primmune Therapeutics to Present Interim Clinical Data from Phase 1 Study Evaluating PRTX007 at the 2022 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "Primmune Therapeutics...announced that they will present interim Phase 1 clinical data for PRTX007, a novel, orally administered, small molecule toll-like receptor 7 (TLR7) specific agonist, at the 2022 American Association for Cancer Research (AACR) Annual Meeting. The AACR annual meeting will be held in New Orleans from April 8-13. An e-poster will be made available online Friday, April 8 at 1 p.m. ET."

P1 data • Oncology

INTERIM ANALYSIS OF A PHASE I STUDY OF PRTX007: SAFETY, PK, AND PD RESPONSE (CROI 2022) - "Exposure-dependent PD response measured by induction of interferon stimulated genes in the blood is observed at drug AUC > 4,300 hr*ng/ml (Panel B); duration of induction >24 hours (Panel C). Interim analysis of PRTX007 demonstrates a favorable safety profile with dose-dependent systemic exposure and demonstrated activation of innate immune response."

Clinical • P1 data • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections