March 30, 2017 8:27 PM ET

Biotechnology

Company Overview of Valor Biotherapeutics, LLC

Company Overview

Valor Biotherapeutics, LLC engages in the clinical development and commercialization of monoclonal antibody-based therapeutics to treat cancer. Its products include IGN002 that includes an anti-CD20 monoclonal antibody attached to IFN through stable peptide linker system; IGN001 that comprises an anti-Her2 monoclonal antibody attached to IFN through stable peptide linker system; and IGN003 that includes a monoclonal antibody directed towards a validated multiple myeloma target attached to IFN through stable peptide linker system. The company was founded in 2012 and is based in Bryan, Texas.

8800 HSC Parkway

Bryan, TX 77807

United States

Founded in 2012

Phone:

877-777-9233

Fax:

877-777-9233

Key Executives for Valor Biotherapeutics, LLC

Valor Biotherapeutics, LLC does not have any Key Executives recorded.

Valor Biotherapeutics, LLC Key Developments

Valor Biotherapeutics, LLC Announces First Patient Treated in Phase 1 Study of IGN002

Valor Biotherapeutics, LLC announced that the first patient was dosed in a phase 1 clinical study of its lead product candidate, IGN002, a novel investigational treatment for non-Hodgkin lymphoma (NHL). The study is designed to assess the safety and tolerability of IGN002 administered weekly for up to 26 weeks, evaluate the pharmacokinetic profile of escalating doses of IGN002, and assess the anti-tumor activity, objective response rate, and duration of responses. The phase 1, multicenter, open-label, dose escalation clinical study of IGN002 is a two-stage study. In the first stage, patients will be treated with increasing doses of IGN002 in order to identify the maximum tolerated dose (MTD). In the second part of the study, known as the expansion stage, patients will receive up to 24 doses of IGN002 at the MTD. The study is expected to enroll about 60 patients who have NHL that returns within six months of treatment or does not respond to treatment (refractory NHL).

Valor Biotherapeutics Receives Approval for Investigational New Drug Application for IGN002

Valor Biotherapeutics has received approval for an investigational new drug application for its lead product candidate, IGN002, a new class of biotherapeutics, from the US Food and Drug Administration. The product is genetically engineered by fusing an antibody with interferon, a protein that plays a major role in regulating the immune system. The approved investigational new drug application will allow the company, via a joint venture with ImmunGene and Caliber Biotherapeutics, to start a Phase I clinical trial of IGN002 in patients with non-Hodgkin lymphoma. The Leukemia & Lymphoma Society has collaborated with the company and committed USD 6 million to advance this therapy into a Phase I trial.

Valor Biotherapeutics, LLC to Begin Phase 1 Clinical Study of Novel Lymphoma Therapy

Valor Biotherapeutics, LLC, (Valor) and The Leukemia & Lymphoma Society (LLS) announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for Valor's lead product candidate, IGN002. The approved IND is a key step in allowing Valor joint venture between ImmunGene and Caliber Biotherapeutics to begin a phase 1 clinical study of IGN002 in patients with non-Hodgkin lymphoma (NHL). Through its Therapy Acceleration Program (TAP), a strategic initiative to partner with biotechnology companies and speed the development of new therapies, LLS previously committed approximately $6 million to co-fund the pre-clinical development, manufacturing, and a Phase 1 clinical study of IGN002. IGN002 is a new class of biotherapeutics genetically engineered by fusing an antibody with interferon, a protein that plays a critical role in regulating the immune system. Together, they form a potent agent that is designed to be safer and less toxic while maximizing its targeted anti-tumor effects. IGN002 has the potential to improve treatment outcomes for indolent non-Hodgkin lymphoma (NHL) patients, for whom there are currently few effective therapies.

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