AG019 / Precigen - LARVOL DELTA

A first-in-human, open-label Phase 1b and a randomised, double-blind Phase 2a clinical trial in recent-onset type 1 diabetes with AG019 as monotherapy and in combination with teplizumab. (PubMed, Diabetologia) - P1b/2a | "Oral delivery of AG019 was well tolerated and safe as monotherapy and in combination with teplizumab. AG019 was not shown to interfere with the safety profile of teplizumab and may have additional biological effects, including changes in preproinsulin-specific T cells. These preliminary data support continuing studies with this agent alone and in combination with teplizumab or other systemic immunotherapies in type 1 diabetes."

Combination therapy • IO biomarker • Journal • Monotherapy • P1 data • P2a data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8 • IL10

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1b/2a; N=42; Completed; Sponsor: Precigen Actobio T1D, LLC; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CCR6 • CD4 • IL10

[VIRTUAL] Ag019 ActoBiotics as monotherapy or in association with teplizumab in recent-onset type 1 diabetes was safe and demonstrated encouraging metabolic and immunological effects (EASD 2021) - P1b/2a | "AG019 was safe and well tolerated, and may favorably modulate autoimmune T-cell responses. The metabolic and immunological data suggest that AG019, alone or associated with teplizumab, may have the potential to be effective in preserving insulin-production in recent-onset T1D. AG019 has the convenience of oral administration and data suggests an opportunity for an improved effect with prolonged treatment duration."

Monotherapy • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • CD8 • IL10

"$PGEN @Precigen AG019 #diabetes update on 10/01 at #EASD2021" (@Biotech2050)

Diabetes • Metabolic Disorders

"Congrats. $PGEN has harnessed Tregs…”Administration of AG019 is designed to induce specific regulatory T cells (Tregs)…” opening up opportunities in autoimmune diseases including #multiplesclerosis @ScienceAtBMS @AlbertBourla @ScottGottliebMD @SangamoTx @sanofi @NovartisScience" (@Biotech2050)

CNS Disorders • Immunology • Multiple Sclerosis

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1b/2a; N=41; Active, not recruiting; Sponsor: Precigen Actobio T1D, LLC; Recruiting ➔ Active, not recruiting; Trial completion date: May 2021 ➔ Oct 2021; Trial primary completion date: Oct 2020 ➔ Oct 2021

Clinical • Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • CD4 • IL10

Precigen Provides Latest Clinical Developments at Virtual R&D Update Event (PRNewswire) - "The event showcased data from several of Precigen's most advanced clinical programs—PRGN-3005 UltraCAR-T®, PRGN-3006 UltraCAR-T® and AG019 ActoBioticsTM with presentations and discussions from Precigen executives and key opinion leaders, including Dr. Helen Sabzevari, President and CEO of Precigen, Dr. Pieter Rottiers, CEO of Precigen ActoBio, Dr. Mary L. (Nora) Disis, faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 clinical study, and Dr. Kevan Herold, Professor of Immunobiology and of Medicine (Endocrinology) at Yale School of Medicine and one of the lead investigators for the AG019 clinical study."

Clinical data • Acute Myelogenous Leukemia • Fallopian Tube Cancer • Gynecologic Cancers • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Ovarian Cancer • Peritoneal Cancer

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1b/2a; N=48; Recruiting; Sponsor: Precigen Actobio T1D, LLC; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1b/2a; N=48; Active, not recruiting; Sponsor: Precigen Actobio T1D, LLC; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed

A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recently Diagnosed Type 1 Diabetes Mellitus (T1D) (clinicaltrials.gov) - P1b/2a; N=48; Recruiting; Sponsor: Precigen Actobio T1D, LLC; Trial completion date: Jun 2020 ➔ May 2021; Trial primary completion date: Dec 2019 ➔ Oct 2020

Clinical • Combination therapy • Trial completion date • Trial primary completion date

"#AG2019 ⁦@ClusterGIPSO⁩ #Technopole #Martillac Président Luc GRISLAIN reçoit Françoise JEANSON conseillère régionale #Sante @NvelleAquitaine⁩ Charlyne QUERCIA DG ⁦@fondationbxuniv⁩ Interventions adhérents ⁦@Merck⁩ ⁦@novartis_france⁩ ⁦@SanofiFR⁩" (@DuboscqPaco)

Quadrisphaera oryzae sp. nov., an endophytic actinomycete isolated from leaves of rice plant (Oryza sativa L.). (PubMed, J Antibiot (Tokyo)) - "...Phylogenetic analyses base on the 16S rRNA gene sequences showed that strain RL12-1S belonged to the genus Quadrisphaera and was closely related to Quadrisphaera granulorum AG019 (99.0%)...is proposed. The type strain is RL12-1S ( = TBRC 8486 = NBRC 113447)."

Journal