Humanigen Australia Proprietary Limited Established to Facilitate Asia-Pacific Growth Plans
Burlingame, Calif., United States:
- New Humanigen entity in Australia creates focused opportunity for partnering, regional clinical trials and market access
- Structure allows for attractive financial incentives supported by the Australian government
Humanigen, Inc. (NASDAQ: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced the establishment of Humanigen Australia Proprietary Limited (“Humanigen Australia Pty Ltd”), through which Humanigen intends to assess potential partnering opportunities, facilitate clinical development programs, and conduct other corporate and business development activities in the Asia-Pacific region. The first of these was announced on November 3, with the execution of a licensing agreement for lenzilumab for South Korea and the Philippines.
The clinical trials that are ongoing, or in advanced planning in Australia are:
Lenzilumab in cancer patients who are COVID-19 positive and have pneumonia as part of the C-SMART (COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomized Trial)
The C-SMART study is led by the National Centre for Infections in Cancer at Peter MacCallum Cancer Centre and will be conducted at five Australian sites in Melbourne and Sydney. This study will include over 1,000 cancer patients at risk of, or known positive for, COVID-19 infection, with a subset of patients in the lenzilumab arm. The study is supported by a grant from the Australian Government’s Medical Research Future Fund.
Lenzilumab in refractory chronic myelomonocytic leukemia (CMML) as part of the PREcision Approach to CHronic Myelomonocytic Leukaemia (PREACH-M) trial
Humanigen is in advanced planning for a Phase 2 study of lenzilumab in combination with azacitidine in newly-diagnosed CMML patients who express NRAS/KRAS/CBL mutations, which are known to be hypersensitive to granulocyte macrophage-colony stimulating factor (GM-CSF) and therefore may lend themselves to responsiveness to lenzilumab treatment. CMML is a rare form of hematologic cancer with no FDA-approved treatment options and a three-year overall survival rate of 20% and median overall survival of 20 months.1,2 The study is funded by grant from the Australian Government’s Medical Research Future Fund and is expected to commence in 2021.
Ifabotuzumab in glioblastoma multiforme (GBM)
This Phase 1 trial has enrolled 11 of the 12 patients targeted for full enrollment. Results are expected to be available in the first half of 2021.
Professor Andrew Scott, Head, Tumour Targeting Laboratory, Olivia Newton-John Cancer Research Institute, and Professor, School of Cancer Medicine, La Trobe University, who has been instrumental in the research and development of both lenzilumab and ifabotuzumab, said, “The establishment of Humanigen Australia Pty Ltd speaks to the importance and culmination of 20 years of research for these two novel antibodies, which we helped discover and develop in Australia. We hope that lenzilumab will have a major impact in the treatment of COVID-19 patients. Ifabotuzumab holds promise as a novel approach to target the tumour microenvironment in a range of solid tumors.”
Bob Atwill, Head of Asia-Pacific Region at Humanigen said, “Humanigen’s expansion strategy in COVID-19 includes conducting regional clinical trials, local manufacturing, partnering and potential early market entry. Some of these opportunities may allow Humanigen Australia Pty Ltd to benefit from certain financial and tax incentives offered by the Australian government, including a potential 43.5% rebate on eligible research and development expenditures. This is a critical moment for important advancements in biotechnology and healthcare, and I look forward to progressing lenzilumab and the rest of the Company’s pipeline in the Asia-Pacific region as we grow Humanigen Australia Pty Ltd.”
Disclaimer: This content is distributed by Business Wire India.
