TGN-S11 / Toragen - LARVOL DELTA

Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer (clinicaltrials.gov) - P1 | N=55 | Active, not recruiting | Sponsor: Toragen, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: Oct 2024 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Oncology

Toragen, Inc. Provides Update on Phase 1 Clinical Trial of TGN-S11 as Monotherapy and in Combination with Keytruda in Patients with Stage 4 HPV-Associated Cancers (Businesswire) - P1 | N=55 | NCT05826275 | Sponsor: Toragen, Inc. | "Today, Toragen, Inc...announced positive safety data from its Phase 1 trial of TGN-S11, a small molecule inhibitor of the human papillomavirus (HPV) E5 oncogene protein, in patients with cancers associated with HPV....One-third of the patients who received TGN-S11 monotherapy showed drug activity with decreases in tumor size and decreases in Tumor Tissue Modified Viral (TTMV) HPV DNA as measured by the NavDx test. In addition, 10 patients were treated in Part 2 in 3 dose levels evaluating TGN-S11 in combination with Keytruda with no safety issues. Half of these patients in this portion of the study showed drug activity with decreases in tumor size and/or decreases in TTMV-HPV DNA score."

P1 data • Oncology

Toragen, Inc. Provides Update on Data from Ongoing Phase 1 Clinical Trial of TGN-S11 as Monotherapy and in Combination with Keytruda (pembrolizumab) in Patients with Stage 4 Human Papillomavirus-Associated Cancers (GlobeNewswire) - P1 | N=55 | NCT05826275 | Sponsor: Toragen, Inc. | "In Part 1, 9 patients were treated with TGN-S11 as monotherapy in the first 3 dose cohorts with no safety issues identified. One-third of the patients in this portion of the study showed drug activity with decreases in tumor size and decreases in circulating tumor HPV DNA (ctHPV DNA). In addition, three patients have been treated in Part 2 Level 1 evaluating TGN-S11 in combination with Keytruda with no safety issues. Two of these 3 patients in this portion of the study showed drug activity with decreases in tumor size and decreases in circulating tumor HPV DNA. One of these 3 patients continues to receive combination therapy and has a 93% reduction in ctHPV DNA. The study is ongoing with patients currently being dosed in Part 1 Cohort 4 and Part 2 Level 2....'Based on the current progress, we believe both parts of the study will be completed by the end of 2024.'"

P1 data • Trial status • Oncology • Solid Tumor

Toragen, Inc. Announced Positive Safety Data Update from Cohort 2 and the Initiation of its Dose Expansion of its Phase 1 Trial in Patients with Human Papillomavirus-Induced Cancer (Businesswire) - P1 | N=55 | NCT05826275 | Sponsor: Toragen, Inc. | "No safety issues identified in Cohort 2...This Phase 1 trial is an open-label, non-randomized study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The study is being conducted in two parts: a dose escalation part and dose expansion part. The dose escalation consists of five Cohorts of three to six patients. The dose expansion will now begin in parallel with Cohort 3 of the dose escalation. Level 1 of the dose expansion part of the Phase 1 trial will be in combination with a PD-1 checkpoint inhibitor."

P1 data • Trial status • Oncology

Toragen, Inc. Announced Positive Safety Update from Cohort 1 of its Phase 1 Trial in Patients with Human Papillomavirus-Induced Cancer (Businesswire) - P1 | N=55 | NCT05826275 | Sponsor: Toragen, Inc. | "Today, Toragen Inc...announced positive safety data from Cohort 1 of its Phase 1 trial of TGN-S11, its first drug candidate, in patients with HPV-associated cancers....The study is being conducted in two parts: a dose escalation part and dose expansion part. The dose escalation consists of five Cohorts of three to six patients. The dose expansion will begin in parallel, if Cohorts 1 and 2 of the escalation part are observed to be safe and well-tolerated and will be one dose level lower than the highest dose observed to be safe and well-tolerated in the dose escalation in combination with a PD-1 checkpoint inhibitor."

P1 data • Oncology

Toragen, Inc. Announced Full Enrollment of Cohort 1 of its Phase 1 Trial in Patients with Human Papillomavirus-Induced Cancer (Businesswire) - "...Toragen Inc...announced that it has fully enrolled patients in Cohort 1 of its Phase 1 clinical study to evaluate TGN-S11, its first drug candidate, in patients with HPV-associated cancers...This Phase 1 trial is an open-label, non-randomized study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers....'Once the patients are treated for 28-days with TGN-S11, we intend to begin to enroll Cohort 2. Cohort 1 enrolled quickly, using just one clinical trial site, but we expect recruitment for Cohort 2 to be even more accelerated because we now have three clinical trial sites actively screening patients. Upon successfully completing Cohort 2, we will be able to move to the expansion phase in combination with a PD-1 checkpoint inhibitor.'"

Trial status • Oncology

Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Toragen, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

Toragen, Inc. Announces Initiation of Phase 1 Trial of TGN-S11 in Patients with Human Papillomavirus-Induced Cancer (Businesswire) - "Toragen, Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, today announced that it has initiated a Phase 1 clinical trial to evaluate its first drug candidate (TGN-S11). It is believed that HPV survives within the cells and can eventually cause cancer by blocking immune responses and going undetected by the immune system. Toragen’s drug candidate, TGN-S11, inhibits the E5 oncogene of HPV in pre-clinical studies."

Trial status • Oncology