VV169 / Vyriad - LARVOL DELTA

Vyriad…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial of VV169, an off-the-shelf, in vivo CAR T cell therapy targeting BCMA in patients with relapsed/refractory multiple myeloma (Businesswire) - "The Phase 1 trial will evaluate the safety and initial efficacy signals of VV169 in up to 40 patients with relapsed/refractory multiple myeloma. The trial, conducted at Mayo Clinic by principal investigator Yi Lin, M.D., Ph.D... will have key primary objectives to assess overall safety, identify dose-limiting toxicities, and determine the recommended Phase 2 dose."

IND • Trial status • Multiple Myeloma

A Phase 1 Dose-escalation and Expansion Study of In Vivo BCMA-CAR T Cell Therapy (VV169) in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Vyriad, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase 1 Dose-escalation and Expansion Study of In Vivo BCMA-CAR T Cell Therapy (VV169) in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Vyriad, Inc.

First-in-human • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Vyriad…announced the closing of the $25M final tranche to its Series B financing, bringing the total Series B round to $85M (Businesswire) - "This additional funding supports the imminent first-in-human testing of VV169, Vyriad’s in vivo CAR-T candidate, in patients with relapsed or treatment-refractory multiple myeloma....'We are optimistic about the potential of our wholly owned in vivo CAR T therapy, which will enter the clinic in 2026'."

Financing • First-in-human • New trial • Multiple Myeloma

Lead in vivo CAR T candidate VV169 (Businesswire) - "100% of mice treated with a single intravenous injection of therapy cleared OPM-2 tumors completely within 28 days. This response held true for all dose levels, including the lowest dose tested. The mice remained tumor-free 84 days post-treatment and successfully resisted tumor re-challenge; The treatment was well tolerated. Analysis of cytokines confirmed the absence of a severe cytokine storm. While IFNγ was elevated during T-cell expansion, inflammatory markers, such as IL-6, TNFα and GM-CSF, were barely detectable....Vyriad is continuing preclinical work for the development of VV169 and plans to begin a clinical trial in the U.S. in 2026."

New trial • Preclinical • Multiple Myeloma