HONG KONG – Humanigen Inc. has executed its first licensing agreement in the Asia-Pacific region, in a deal worth up to $20 million that gives Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. the development and commercialization rights to lenzilumab for COVID-19 in South Korea and the Philippines.
Telcon is an affiliate of KPM Tech, and both companies are headquartered in South Korea. Both also recently invested in Humanigen’s June PIPE offering. The companies will be responsible for gaining regulatory approval and subsequent commercialization of lenzilumab in the licensed territories.
“KPM/Telcon will conduct the studies, with input from Humanigen,” Bob Atwill, head of Asia-Pacific region for Burlingame, Calif.-based Humanigen, told BioWorld. “The timing [of market approval] in Asia Pacific will depend on clinical development and local regulatory requirements.”
The licensing agreement provides Humanigen with $6 million as an up-front payment upon execution, with the balance of $14 million to be paid in two payments based on achievement by Humanigen for specified milestones in the U.S.
Humanigen also stands to earn double-digit royalties on net sales subsequent to commercialization.
Atwill stated that Humanigen’s expansion strategy in the Asia-Pacific region is well underway and this is the first of other anticipated licensing transactions for lenzilumab in hospitalized COVID-19 patients.
Humanigen’s lead drug candidate, lenzilumab is a Humaneered GM-CSF monoclonal antibody in development for preventing and treating hypercytokinemia, the immune hyperresponse also known as cytokine storm. Given that potential, it has also been tapped as a possible treatment for COVID-19.
“Lenzilumab is currently being evaluated in a phase III randomized, double-blind, multicenter, placebo-controlled clinical trial to determine if lenzilumab can help hospitalized patients with COVID-19 recover faster,” Cameron Durrant, the chairman and CEO of Humanigen, told BioWorld.
In late August, the company released the first case-control data of lenzilumab in severe COVID-19, demonstrating an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death compared to the matched control group. The results were shared in Mayo Clinic Proceedings.
The study involved a total of 39 patients, including 12 treated with lenzilumab and 27 contemporaneous matched control patients who received standard-of-care treatment.
“We believe these to be some of the most compelling data published to date of an investigational therapeutic with potential to substantially fight the COVID-19 pandemic and we look forward to validating these data with the results of our ongoing phase III study,” said Dale Chappell, the chief scientific officer of Humanigen.
“We also appreciate that the stakes are even higher after some other pathways being explored across the industry haven’t met their clinical endpoints, and rates of infection are increasing in many areas,” he added.
Concurrently, lenzilumab was selected by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. NIH, to take part in the ACTIV-5 Big Effect Trial (ACTIV-5/BET) designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19. That would merit the candidate’s advancement into larger clinical trials.
“ACTIV-5/BET, which will enroll as many as 40 sites in the United States, will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized patients with COVID-19, with approximately 100 patients assigned to each study arm. Humanigen is providing lenzilumab for the study, which is fully funded by NIH,” said Durrant.
Lenzilumab is one of the few treatment options in development for COVID-19 to reach phase III trials. Humanigen has said it believes that the drug’s mechanism of action as an immunomodulator could work very nicely with remdesivir and potentially enhance first-line standard-of-care therapy to prevent serious and potentially fatal outcomes.
Humanigen will continue exploring the potential of the candidate for other indications.
“We are assessing multiple opportunities in COVID-19 and other indications and we will update accordingly,” said Atwill.
“CAR T, treatment/prevention of acute [graft-vs.-host disease and chronic myelomonocytic leukemia] are all indications with high unmet clinical needs that lenzilumab could offer great long-term potential to, and most importantly significant benefit for patients and their families,” said Durrant.
Durrant added that lenzilumab is also used in a collaboration trial called ZUMA-19 with Los Angeles-based Kite Pharma, a Gilead Co., to evaluate it in combination with axicabtagene ciloleucel (Yescarta) in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for phase II.