• 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

BURLINGAME, Calif.–(BUSINESS WIRE)–Nov. 24, 2020

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.”

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations surrounding our operational, research, development or commercialization activities in the Asia Pacific region, and our ability to mitigate the impact of COVID-19, to develop CAR-T or solid cancer therapies or to prevent or treat GvHD via any of the technologies in our current pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

1. Patnaik MM, Tefferi A. Chronic Myelomonocytic leukemia: 2020 update on diagnosis, risk stratification and management. Am J Hematol. Jan 2020;95(1):97-115. doi:10.1002/ajh.25684

2. Coston T, Pophali P, Vallapureddy R, et al. Suboptimal response rates to hypomethylating agent therapy in chronic myelomonocytic leukemia; a single institutional study of 121 patients. Am J Hematol. Jul 2019;94(7):767-779. doi:10.1002/ajh.25488

View source version on businesswire.com: https://www.businesswire.com/news/home/20201123006238/en/

Cammy Duong
Westwicke, an ICR company

Alan Lada
Solebury Trout