VAC85135 / J&J, Nouscom - LARVOL DELTA

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Jun 2025

Trial completion • Trial completion date • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A PHASE 1 STUDY OF VAC85135, A NEOANTIGEN VACCINE REGIMEN TARGETING CALRETICULIN AND JAK2 MUTATIONS, IN COMBINATION WITH IPILIMUMAB (IPI) IN PATIENTS (PTS) WITH MYELOPROLIFERATIVE NEOPLASMS (MPNS) (EHA 2025) - "The absence or delayed onset of immune response in most pts suggests the VAC85135 regimen was poorly immunogenic and unable to generate productive CALR or JAK2 neoantigen anti-tumor immunity. Combined with lack of disease-modifying efficacy in any pts in the study timeframe, further development of VAC85135 for tx of MPNs will not be pursued."

Clinical • Combination therapy • IO biomarker • P1 data • Tumor-specific neoantigens • Complement-mediated Rare Disorders • Essential Thrombocythemia • Fatigue • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Musculoskeletal Diseases • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombocytosis • CALR • IFNG • JAK2

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Feb 2025 ➔ Jun 2025

Trial primary completion date • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2027 ➔ Oct 2025 | Trial primary completion date: Jan 2026 ➔ Feb 2025

Trial completion date • Trial primary completion date • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=60 ➔ 14

Enrollment change • Enrollment closed • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2028 ➔ Nov 2027

Trial completion date • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2027 ➔ Jul 2028

Trial completion date • Essential Thrombocythemia • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2026 ➔ Jul 2027

Trial completion date • Essential Thrombocythemia • Myeloproliferative Neoplasm • Oncology • CALR • JAK2

ProBioGen’s Vaccine Production Cell Line AGE1.CR.pIX Used for Clinical Production (PharmiWeb) - "ProBioGen is announcing another important clinical milestone for its proprietary viral vector and vaccine production cell line AGE1.CRpIX^®. Our valued customer Nouscom recently proclaimed that their sub-licensee, has initiated phase 1 clinical trials for VAC85135, a viral vector-based cancer vaccine for an oncologic indication."

Trial status • Hematological Malignancies • Myeloproliferative Neoplasm • Oncology

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jan 2026 ➔ Jul 2026

Trial completion date • Myeloproliferative Neoplasm • Oncology • CALR • JAK2

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Myeloproliferative Neoplasm • Oncology • CALR • JAK2

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P1 trial • Myeloproliferative Neoplasm • Oncology • CALR • JAK2

Nouscom Announces Janssen Receives US FDA IND Clearance for VAC85135, an 'Off-The-Shelf' Cancer Immunotherapy Developed using Nouscom's Proprietary Viral Vector Platform (PRNewswire) - "Nouscom...announced that Janssen Research & Development, LLC (Janssen) received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) candidate VAC85135, an off-the-shelf, viral vector-based cancer vaccine for an oncologic indication. VAC85135 has been exclusively licensed to Janssen....Under the terms of the agreement, Janssen has sole responsibility for clinical development of VAC85135. Financial terms, including individual product-specific upfront payments, potential development and commercial milestones, and future tiered royalties remain confidential."

IND • Oncology