HSV vaccine (GEN-003) / Genocea, Shionogi - LARVOL DELTA

Toward the Eradication of Herpes Simplex Virus: Vaccination and Beyond. (PubMed, Viruses) - "Notably, several vaccines-SL-V20, HF10, VC2, and mRNA-1608-have shown promising preclinical results, suggesting that an effective HSV vaccine may be within reach. However, GEN-003 and HerpV have not advanced further despite promising results. Continued progress with these candidates brings us closer to a significant breakthrough in preventing and treating HSV infections."

Journal • Review • Herpes Simplex • Infectious Disease

A Long-Term Follow-Up Study of Participants Exposed to REACT (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: Prokidney | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Long-Term Follow-Up Study of Participants Exposed to REACT (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: Prokidney

Trial completion date • Trial initiation date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

A Long-Term Follow-Up Study of Participants Exposed to REACT (clinicaltrials.gov) - P=N/A | N=80 | Not yet recruiting | Sponsor: Prokidney

New trial • Chronic Kidney Disease • Nephrology • Renal Disease

A Study of Autologous Renal Autologous Cell Therapy (REACT™) in Patients With Diabetic Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Prokidney | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A phase 1 study of safety and tolerability of AutoSynVax™ vaccine in patients with advanced cancer. (SITC 2018) - P1; "Trial Registrationl NCT02992977 ; Background Agenus AutoSynVax™ (ASV™), AGEN2003, is an individualized, fully synthetic neoantigen vaccine comprised of computationally defined peptide immunogens complexed to recombinant heat shock protein (HSP) and administered with QS-21 Stimulon® adjuvant. In animal models and clinical trials, vaccines employing HSP-peptide complexes mixed with QS-21 elicit antigen-specific CD8+ and CD4+ T-cell responses. Methods After signing an informed"

Clinical • P1 data • Oncology

A Study of Autologous Renal Autologous Cell Therapy™ (REACT) in Patients With Diabetic Chronic Kidney Disease (clinicaltrials.gov) - P2; N=10; Active, not recruiting; Sponsor: Prokidney; Trial completion date: Mar 2022 ➔ Dec 2022; Trial primary completion date: May 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

"$GNCA rocket thru EOY: •#ASCO21: GEN-009 part A (monotherapy) and part B (GEN-009 + ICI) data update •Shionogi GEN-003 deal pending •May 19, 2020, license option agreement agreement made w/ Shionogi⏱ •EOY’21: GEN-011 initial trial data •$IOVA is worried;)" (@RedditRocker)

Monotherapy

Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. (PubMed, Vaccine) - P2 | "GEN-003 vaccine manufactured with a scalable process gave results similar to those observed in prior clinical trials. GEN-003 had an acceptable safety profile and stimulated both humoral and cellular immune responses. The 60 µg antigen/50 µg M2 provided the maximal effect on virologic and clinical measures and warrants further development. (Funded by Genocea; ClinicalTrials.gov number NCT02515175)."

Journal • Fatigue • Herpes Simplex • Pain

A Study of Autologous Neo-Kidney Augment™ (NKA) in Patients With Diabetic Chronic Kidney Disease (clinicaltrials.gov) - P2; N=10; Active, not recruiting; Sponsor: inRegen; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection (clinicaltrials.gov) - P2; N=33; Completed; Sponsor: Genocea Biosciences, Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar

Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Genocea Biosciences, Inc.

New P2 trial • Biosimilar • Immunology

A Study of Autologous Neo-Kidney Augment™ (NKA) in Patients With Diabetic Chronic Kidney Disease (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: inRegen; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Renal Disease

Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine (clinicaltrials.gov) - P2; N=315; Active, not recruiting; Sponsor: Genocea Biosciences, Inc.; Trial primary completion date: Jun 2015 ➔ Mar 2016

Trial primary completion date • Biosimilar

Neo-Kidney AugmentTM (NKA): Phase II study of percutaneous injection of autologous homologous NKA in Type 2 Diabetes with Pre-Stage 5 Chronic Kidney Disease (NKF-CSM 2020) - P2; " REGEN-003 is a multi-center, non-randomized prospective, open-label, single-arm study recruiting 10 patients (NCT03270956). This active Phase 2 trial of pre-stage 5 DKD using novel imaged guided percutaneous targeted autologous homologous cell injection into the kidney offers potential for preservation of renal function and delay of renal replacement therapy."

P2 data

Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital HSV-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-controlled Trial. (PubMed, J Infect Dis) - P2; "No serious adverse events occurred with vaccination. The most efficacious vaccine combinations for GEN-003 were the 60 µg/50 µg and 60 µg /75 µg doses."

Clinical • Journal

A Study of Autologous Neo-Kidney Augment™ (NKA) in Patients With Diabetic Chronic Kidney Disease (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: inRegen; Trial completion date: Dec 2021 ➔ Mar 2022

Clinical • Trial completion date

Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection (clinicaltrials.gov) - P2; N=33; Terminated; Sponsor: Genocea Biosciences, Inc.; Completed ➔ Terminated; 2017 business decision to cease GEN-003 spending.

Clinical • Trial termination