ONC-841 / OncoC4 - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability. and Pharmacokinetics of ONC-841 Injection in Healthy Participants (ChiCTR) - P1 | N=32 | Recruiting | Sponsor: Xuanwu Hospital Capital Medical University; AcroImmune Biotech Co., Ltd (Beijing)

New P1 trial • Alzheimer's Disease • CNS Disorders

The neuroimmune network in Alzheimer's and Parkinson's diseases: from mechanistic insights to biomarker-guided immunotherapies and clinical translation. (PubMed, Inflammopharmacology) - "This review critically examines investigational immunotherapies aimed at this network: the CNS‑penetrant NLRP3 inhibitor NT-0796 (Phase 1b/2a) demonstrated preliminary biomarker reductions in axonal damage and T-cell activation in PD but remains unapproved and necessitates further confirmatory trials; the anti‑SIGLEC10 antibody ONC-841 improved microglial phagocytosis of Aβ and tau in preclinical studies but has yet to commence human trials; and CAR‑based platforms (CAR-T/NK) remain in the nascent preclinical phase, facing significant delivery and toxicity challenges. Effective immunotherapy may ultimately necessitate multi-node, network-aware combinations (e.g., inflammasome inhibition coupled with Treg augmentation) rather than single-target suppression. Embracing this complexity offers a roadmap for future disease-modifying therapies, though rigorous clinical validation remains essential."

Biomarker • IO biomarker • Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation • Movement Disorders • Parkinson's Disease • CD8 • IL1B • NEFL • NLRP3 • SIGLEC10

ONC-841-002: Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: OncoC4, Inc. | N=30 ➔ 72 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Enrollment change • Trial primary completion date • Oncology • Solid Tumor

OncoC4 Inc…announced first participant's dosing following the clearance of the Investigational New Drug (IND) application for a Phase 1/2 clinical trial of ONC-841, the company's investigational Alzheimer's disease therapy by the National Medical Product Administration (NMPA). (PRNewswire)

Trial status • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - "In two AD mouse models, anti-SIGLEC10 cleared the amyloid plaques or reduced the plasma p-Tau biomarkers. The clinical stage anti-SIGLEC10 antibody, ONC-841, promotes phagocytosis of protein aggregates. ONC-841 protects against AD pathogenic process in the mice by rejuvenating microglia functions. These studies provided the scientific foundation for further clinical development with ONC-841 as potential microglia targeting immunotherapy agent for AD."

IO biomarker • Journal • Alzheimer's Disease • CNS Disorders • Plasma T-Tau • p-tau181 • SIGLEC10

OncoC4 Selected to Present at the 2025 AACR Meeting's Showcase Session (GlobeNewswire) - "Oral presentation will feature AI-081, a potentially best-in-class PD-1/VEGF bispecific antibody and ONC-841, a first-in-class anti-Siglec-10 antibody....Initial clinical data for both AI-081 and ONC-841 in solid tumors expected 2H 2025."

Clinical data • Oncology • Solid Tumor

ONC-841-002: Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: OncoC4, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2027 ➔ Sep 2027 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

OncoC4 Announces First Patient Dosed in Phase 1 Trial for Novel SIGLEC10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors (GlobeNewswire) - "OncoC4, Inc...announced the first patient has been dosed in the first-in-human Phase 1 ONC-841-002 trial (NCT06352359) evaluating ONC-841, a potential first-in-class SIGLEC10 blocking antibody for the treatment of solid tumors....Initial data on the safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in 2025."

P1 data • Trial status • Oncology • Solid Tumor

OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors (GlobeNewswire) - "OncoC4...announced that the United States Food and Drug Administration ('FDA') has cleared the investigational new drug ('IND') application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors....'ONC-841 is designed to block this immune checkpoint to rejuvenate immune cell activity for tumor destruction within the TME. We are excited to begin clinical development of ONC-841 in advanced solid tumors'....Preliminary Phase 1 data on safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in the second half of 2025."

IND • Solid Tumor

Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: OncoC4, Inc.

Metastases • New P1 trial • Oncology • Solid Tumor

Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841 (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: OncoC4, Inc. | N=40 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology • Solid Tumor

A First in Human Study of the Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841 (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: OncoC4, Inc.

New P1 trial • Oncology • Solid Tumor