Humanigen Inc (OTCMKTS:HGEN) said Friday that it has forged a clinical collaboration with Kite, a company belonging to Gilead Sciences Inc (Nasdaq:GILD), to study its flagship therapy lenzilumab, with Yescarta in patients with relapsed diffuse large B-cell lymphoma (DLBCL).
An aggressive tumor develops in the first signs of DLBCL when a type of white blood cell starts to divide in an uncontrolled way. DLBCL is the most common type of non-Hodgkin lymphoma.
Burlingame, California-based Humanigen's key drug candidate lenzilumab, is a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells. Lenzilumab improves the effectiveness of CAR-T, a new approach to cancer therapy involving altered T cells.
Yescarta, developed by California-based Kite was the first CAR-T cell therapy to be approved by the US Food and Drug Administration for the treatment of adult patients with relapsed large B-cell lymphoma after two or more lines of systemic therapy.
The objective of the Phase 1/2 study is to determine the effect of lenzilumab on the safety of Yescarta (axicabtagene ciloleucel) in patients with relapsed diffuse large B-cell lymphoma (DLBCL).
Kite will act as the sponsor of the study
“CAR T therapy represents a significant advance in the way relapsed or refractory large B-cell lymphoma is treated,” said John McHutchison, chief scientific officer, at Gilead. “As leaders in cell therapy, we are committed to pursuing clinical and preclinical strategies aimed at improving the efficacy and safety of CAR-T therapy. We look forward to this clinical collaboration with Humanigen and to evaluating the combination of lenzilumab and Yescarta in our clinical trial.”
Pre-clinical work involving mice shows lenzilumab is effective in preventing side effects associated with cancer therapies involving altered T cells.
“Humanigen has pioneered the approach to neutralizing GM-CSF to improve CAR-T,” said Humanigen CEO Cameron Durrant. “This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR-T cell treatment outcomes.”
Contact Uttara Choudhury at [email protected]