PRV-3279 / MacroGenics, Huadong Medicine, Sanofi - LARVOL DELTA

PREVAIL-2: PRV-3279-2a Trial in Systemic Lupus (clinicaltrials.gov) - P2 | N=28 | Terminated | Sponsor: Provention Bio, a Sanofi Company | N=100 ➔ 28 | Trial completion date: Sep 2025 ➔ Jun 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ May 2024; termination for strategy reasons

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

PREVAIL-2: PRV-3279-2a Trial in Systemic Lupus (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Provention Bio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

PREVAIL-2: PRV-3279-2a Trial in Systemic Lupus (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Provention Bio, Inc. | Trial completion date: Mar 2024 ➔ Sep 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

PREVAIL-2: PRV-3279-2a Trial in Systemic Lupus (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Provention Bio, Inc. | Phase classification: P2a ➔ P2

Phase classification • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Identification of the common differentially expressed genes and pathogenesis between neuropathic pain and aging. (PubMed, Front Neurosci) - "Aldesleukin, Valziflocept, MGD-010, Cinryze, and Rhucin were the potential effective drugs in neuropathic pain and aging. This study identified co-DEGs, revealed molecular mechanisms, demonstrated the immune microenvironment, and predicted the possible TFs, miRNAs regulation networks and new drug targets for neuropathic pain and aging, providing novel insights into further research."

Journal • Neuralgia • Pain • CD4 • CD8 • MIR363 • NCAM1

Provention Bio Announces Initiation of the Phase 2a PREVAIL-2 Study of PRV-3279 (CD32B × CD79 Bispecific DART Molecule) in Systemic Lupus Erythematosus (SLE) (PRNewswire) - "Provention Bio...announced the initiation of the Phase 2a PREVAIL-2 study (PRV-3279 EVAluation In Lupus- Phase 2). PRV-3279 is an investigational humanized bispecific DART molecule targeting the B-cell surface proteins CD32B and CD79B, which has the potential to intercept the pathophysiology of systemic lupus erythematosus (SLE) and other B cell-mediated autoimmune diseases, as well as to prevent the immunogenicity of biotherapeutic products such as gene therapy....We look forward to reporting data from PREVAIL-2 in the first half of 2024."

P2 data • Trial status • Immunology • Lupus • Systemic Lupus Erythematosus

PREVAIL-2: PRV-3279-2a Trial in Systemic Lupus (clinicaltrials.gov) - P2a; N=100; Recruiting; Sponsor: Provention Bio, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Oct 2021 ➔ Jan 2022

Clinical • Enrollment open • Trial initiation date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Provention Bio Reports Third Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - "Provention Bio, Inc...today reported financial results for the third quarter ended September 30, 2021 and provided a business update....The Company remains on track to initiate a Phase 2a trial of PRV-3279...in the fourth quarter of 2021."

New P2a trial • Immunology • Lupus • Systemic Lupus Erythematosus

Huadong Medicine (000963.SZ) third quarterly report released: performance in line with expectations, medical beauty business growth exceeds expectations [Google translation] (jrj.com) - "....In the field of autoimmunity, the world’s first double-antibody new drug HDM3002 (PRV-3279) has submitted a pre-IND application and received feedback in China. China is about to join the Phase 2 international multi-center clinical study..."

Trial status • Immunology • Lupus • Systemic Lupus Erythematosus

PREVAIL-2: PRV-3279-2a Trial in Systemic Lupus (clinicaltrials.gov) - P2a; N=100; Not yet recruiting; Sponsor: Provention Bio, Inc.

Clinical • New P2a trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Provention Bio Reports Second Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - “PREVAIL Phase 2a Trial Evaluating PRV-3279 in Systemic Lupus Erythematosus: Provention Bio remains on track to initiate a Phase 2a trial of PRV-3279, an investigational DART® (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B in the fourth quarter of 2021.”

New P2a trial • Immunology • Lupus • Systemic Lupus Erythematosus

[VIRTUAL] An Anti-CD32B/CD79B Bispecific DART® Molecule Modulates B Cells, Inhibits Antibody Responses to rAAV9 Vector, and Improves GAA Vector Survival and Transgene Efficiency in a Mouse Model of Pompe Disease (ASGCT 2021) - "Taken together, these results suggest that PRV-3279 treatment, via modulation of antigen-specific B cell responses, can reduce the deleterious antibody response to AAV-transgene vectors, increasing their survival with consequent improvement in transgene delivery to target tissues. Importantly, inhibition of antibody mediated immunity should also ameliorate downstream immune-mediated toxicities. Combination with sirolimus may improve T cell dependent outcomes."

Preclinical • Gene Therapies • Immune Modulation • Inflammation • Pompe Disease • CD79B • FCGR2B

Provention Bio and Huadong Announce Strategic Collaboration to Develop and Commercialize PRV-3279 in Greater China (PRNewswire) - “Provention Bio, Inc….and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd…today announced that the companies have entered into a strategic collaboration to develop and commercialize PRV-3279...Provention Bio will retain all rights to PRV-3279 in the rest of the world…Provention Bio plans to begin a Phase 2a trial of PRV-3279 in systemic lupus erythematosus (SLE) in the second half of 2021 and expects a portion of such trial to be conducted in China….Under the terms of the agreement, Provention Bio will receive an upfront payment of $6 million, and up to $11.5 million in funding over the next three years…eligible to receive additional milestone payments of up to $172 million…Provention Bio is also eligible to receive low-to-mid double digit royalties as a percentage net sales of PRV-3279 by Huadong in Greater China."

Licensing / partnership • New P2a trial • Immunology • Lupus • Systemic Lupus Erythematosus

[VIRTUAL] PREVAIL 1: A Multiple Ascending Dose Study in Normal Healthy Volunteers of PRV-3279, a Novel Bispecific DART Molecule Targeting CD32B and CD79B on B Cells, with Potential for Treatment of SLE (ACR-ARHP 2020) - "PRV-3279 was well tolerated after repeat administration with no B cell depletion and dose-dependent PK and PD. Consistent with its mechanism of action, sustained IgM reduction was observed. In vitro studies demonstrated equivalent effects of PRV-3279 on B cells from SLE subjects."

Clinical • Immunology • Inflammatory Arthritis • Lupus • CD79B • FCGR2B

Provention Bio reports first quarter 2020 financial results and provides business update (PRNewswire) - "In March, Provention announced positive top-line results from the Phase 1b portion of the PREVAIL (PRV-3279 EVAluation In Lupus) study evaluating PRV-3279 in healthy volunteers....Based on the results, Provention plans to commence the Phase 2a portion of the PREVAIL study in lupus patients in the first half of 2021."

Enrollment status • Immunology • Lupus

Provention announces positive data from phase 1b PREVAIL study of PRV-3279 (PRNewswire) - P1, N=6; PREVAIL (NCT03955666); Sponsor: Provention Bio; "Provention Bio...today announced positive top-line results from the Phase 1b portion of the PREVAIL (PRV-3279 EVAluation In Lupus) study evaluating PRV-3279 in healthy volunteers....Based on the results, Provention plans to commence the Phase 2a portion of the PREVAIL study in lupus patients in the first half of 2021."

New P2a trial • P1 data

PREVAIL 1: A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects (clinicaltrials.gov) - P1b; N=16; Completed; Sponsor: Provention Bio, Inc.; Recruiting ➔ Completed

Clinical • Trial completion

Provention Bio initiates phase 1b/2a PREVAIL clinical trial evaluating PRV-3279 in lupus (BioSpace) - "Provention Bio...today announced that it has dosed the first patients in its PREVAIL (PRV-3279 EVAluation In Lupus) study, a Phase 1b/2a clinical trial evaluating PRV-3279....Upon successful completion of the Phase 1a study, Provention plans to initiate the Phase 2a portion of the study in lupus patients....We look forward to reporting data from Part 1 of the study in the first half of 2020."

P1/2 data • Trial status

PREVAIL 1: A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects (clinicaltrials.gov) - P1b; N=16; Recruiting; Sponsor: Provention Bio, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

"$PRVB $MGNX deal terms for teplizumab & PRV-3279" (@JacobPlieth)

PREVAIL 1: A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects (clinicaltrials.gov) - P1b; N=16; Not yet recruiting; Sponsor: Provention Bio, Inc.

Clinical • New P1 trial

PRV-3279: Expiry of patents between 2023 and 2034 (Provention Bio) - Annual Report 2018

Patent