Valor Biotherapeutics (Valor) has started a Phase I clinical trial of its lead product candidate, IGN002, to treat patients with refractory and relapsed non-Hodgkin lymphoma (NHL).
IGN002 is fusion of anti-CD20 antibody and interferon alpha, a protein that plays a major role in regulating the immune system.
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The combination forms a new agent that is designed to be safe while maximising targeted anti-tumour effects.
The trial will be carried out in two stages, and will enrol about 60 patients who have relapsed NHL (returns within six months of treatment), or refractory NHL (does not respond to treatment).
It is designed to evaluate the safety and tolerability of IGN002 being administered weekly for up to 26 weeks.
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It will also assess the pharmacokinetic profile of escalating doses of IGN002, as well as anti-tumour activity, objective response rate, and the duration of responses.
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By GlobalDataValor has partnered with the Leukemia & Lymphoma Society (LLS) for the pre-clinical development, manufacturing and initial proof-of-concept clinical trial of IGN002.
In the trial’s first stage, patients will be treated with increasing doses of IGN002 in order to identify the maximum tolerated dose (MTD). In the second (expansion) stage patients will be given up to 24 doses of IGN002 at the MTD.
Valor founding board member and ImmunGene president and CEO Sanjay Khare said: "This is a first step in the clinical development process of IGN002, and will allow us to determine a dose of IGN002 suitable for refractory and relapsed NHL patients.
"In this study, we will monitor drug safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of IGN002."
The trial is being conducted at the University of California, Los Angeles (UCLA), and the University of Florida. A third site is under consideration.
LLS chief scientific officer Lee Greenberger said: "LLS is very pleased to see our TAP partner, Valor, meet this very significant milestone in their effort to advance a therapy for refractory and relapsed non-Hodgkin lymphoma patients.
"We are hopeful that IGN002 will prove to be effective in improving outcomes for patients who currently have very few other options."
The company noted that IGN002 has the potential to improve treatment outcomes for NHL patients, for whom there are currently few effective therapies.
Source: Press Release
http://www.prnewswire.com/news-releases/valor-biotherapeutics-announces-first-patient-treated-in-phase-1-study-of-ign002-300201565.html
Valor Biotherapeutics Announces First Patient Treated in Phase 1 Study of IGN002
Phase 1 Clinical Study designed to assess IGN002 in patients with refractory and relapsed non-Hodgkin lymphoma
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BRYAN, Texas, Jan. 8, 2016 /PRNewswire/ — Valor Biotherapeutics, LLC (Valor) today 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. Valor, a joint venture between ImmunGene and Caliber Biotherapeutics, has partnered with The Leukemia & Lymphoma Society (LLS) on the pre-clinical development, manufacturing, and initial proof-of-concept clinical study of IGN002. Data from pre-clinical studies of IGN002 were presented at the American Society of Hematology annual meeting in December.
"This is a first step in the clinical development process of IGN002, and will allow us to determine a dose of IGN002 suitable for refractory and relapsed NHL patients," said Sanjay D. Khare, PhD, a founding board member of Valor and president and CEO of ImmunGene. "In this study, we will monitor drug safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of IGN002."
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). The study is being conducted at UCLA, University of Florida, and a third site under consideration. For more information, refer to www.clinicaltrials.gov (NCI# NCT02519270).
"LLS is very pleased to see our TAP partner, Valor, meet this very significant milestone in their effort to advance a therapy for refractory and relapsed non-Hodgkin lymphoma patients. We are hopeful that IGN002 will prove to be effective in improving outcomes for patients who currently have very few other options," said Lee Greenberger, PhD, LLS chief scientific officer.
About IGN002
IGN002 is a new class of biotherapeutics genetically engineered by fusing two clinically validated anti-cancer drugs — an anti-CD20 antibody and interferon alpha, a protein that plays a critical role in regulating the immune system. Together, they form a novel agent that is designed to be safe while maximizing targeted anti-tumor effects. IGN002 has the potential to improve treatment outcomes for NHL patients, for whom there are currently few effective therapies. NHL is a diverse group of blood cancers that impact the lymphatic system, part of the body’s immune system. In the U.S., indolent subtypes of NHL make up about 30 percent of the approximately 585,000 people living with or in remission from NHL.
About Valor Biotherapeutics, LLC
Valor Biotherapeutics, a joint venture between ImmunGene, Inc. and Caliber Biotherapeutics, is focused on the clinical development and commercialization of the next generation of monoclonal antibody-based therapeutics to treat cancer. For more information, please visit: www.valorbio.com.
About ImmunGene, Inc.
ImmunGene is a privately held biotechnology company focused on the development of proprietary antibody-cytokine fusion technology and monoclonal antibody-based therapies to treat cancer, autoimmune disorders, and other diseases. ImmunGene has several programs at various stages of development. ImmunGene is funded by federal government grants including the NIH-SBIR and by private investors including several biotechnology executives. More information can be found at: www.immungene.com.
About Caliber Biotherapeutics, LLC
Caliber Biotherapeutics is a biotechnology company focused on developing and commercializing novel therapies that improve outcomes for patients with cancer and other diseases.
