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HONG KONG – Humanigen Inc. signed its first license agreement in the Asia-Pacific region, in an agreement of up to $ 20 million provided by Telcon RF Pharmaceutical Inc. and KPM Tech Co. Ltd. -19 in South Korea and the Philippines.
Telcon is a subsidiary of KPM Tech, and both corporations are headquartered in South Korea. Both have also recently invested in Humanigen’s June PIPE offer. Companies will be destined to obtain regulatory approval and the forthcoming marketing of lenzilumab in legal territories.
“KPM/Telcon will conduct the studies, with the input of Humanigen,” Bob Atwill, manager of Humanigen’s Asia-Pacific region, told BioWorld in Burlingame, California. “The timing [of market approval] in Asia-Pacific will feature clinical progression and local regulatory requirements. “
The license agreement provides Humanigen with $6 million as a prepayment at the time of execution, with the balance of $14 million to be paid on two bills based on Humanigen’s final touch for specific milestones in the United States.
Humanigen is also expected to collect double-digit royalties on post-marketing sales.
Atwill stated that Humanigen’s expansion strategy in the Asia-Pacific region is underway and that this is the first of the other license transactions planned for lenzilumab in patients hospitalized with COVID-19.
Humanigen’s main drug candidate, lenzilumab, is a gm-CSF Humaneered monoclonal antibody in progression to save and treat hypercytopenemia, the immune hyperresposed also known as cytokine storm. Given this potential, it has also been used as a imaginable remedy for COVID -19.
“Lenzilumab has been evaluated lately in a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial to determine whether lenzilumab can help patients hospitalized with COVID-19 more quickly,” said Cameron Durrant, President and CEO of Humanigen. Bioworld.
Last August, the company published the first case-knowledge of lenzilumab in severe COVID-19, demonstrating 80% relief in the relative threat of invasive mechanical ventilation (VMI) and/or death compared to the paired group. were shared in the minutes of the Mayo Clinic.
The study involved a total of 39 patients, adding 12 treated with lenzilumab and 27 new patients who obtained a popular treatment.
“We believe this is one of the most compelling knowledge published to date about an experimental remedy with the prospect of substantially combating the COVID-19 pandemic and we look forward to validating this knowledge with the effects of our ongoing Phase III study,” said Dale Chappell, Humanigen’s Chief Scientific Officer.
“We also appreciate that what is at stake is even higher after other avenues explored in the industry have met their clinical goals and infection rates are expanding in many areas,” he added.
At the same time, lenzilumab was decided through the National Institute of Allergy and Infectious Diseases (NIAID), a component of US NIHs. USA, to take part in the ACTIV-5 Big Effect (ACTIV-5/ BET) trial designed to determine whether approved treatments or experimental complex clinical progression drugs oppose COVID-19, which would warrant the candidate’s advancement in larger clinical trials.
“ACTIV-5 /BET, which will recruit up to 40 sites in the United States, will compare remdesivir-related lenzilumab, compared to placebo and remdesivir, in patients hospitalized with COVID-19, with approximately one hundred patients assigned to examine Arm. Humanigen supplies lenzilumab for the test, which is fully funded by NIH,” Durrant said.
Lenzilumab is one of the few remedies in progression for COVID-19 to succeed in Phase III trials. Humanigen said he believed that the mechanism of action of the drug as an immunomodulator could work very well with remdesivir and potentially improve the popular first-line remedy to avoid serious and life-threatening results.
Humanigen will continue to explore the candidate for additional guidance.
“We are comparing opportunities in COVID-19 and other indications and will update accordingly,” Atwill said.
“CAR T, the treatment/prevention of [host graft disease and chronic myelomonític leukemia] are all indications with the main unsatisfied clinical desires to those who lenzilumab may be offering wonderful long-term potential, and especially a significant advantage for patients and their families. Durrant said.
Durrant added that lenzilumab is also being used in a collaborative essay called ZUMA-19 with Kite Pharma, a Gilead Co. Company. based in Los Angeles, to compare it in mixture with axicabtagene ciloleucel (Yescarta) in the participants. has giant B mobile lymphoma in relapse or refractory. and identify the appropriate maximum dose of lenzilumab for phase II.
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