BUSINESS DEVELOPMENT
At Humanigen, Inc. we are committed to working with strategic and commercial partners, medical and academic institutions to maximize product and technology portfolio. We are dedicated to working in partnerships and collaborations to add value and fill unmet medical needs in life threatening conditions such as COVID-19, CAR-T, GvHD, CMML, Eosinophilic Diseases, GBM and other solid tumors.
Humanigen’s portfolio is broad and currently, we are open to strategic partnership discussions in the areas of:
LENZ COVID-19 prevention / treatment of Hyper-inflammation / Cytokine Storm
Phase 3 & Launch
LENZ CAR-T increased efficacy and safety
Phase 3
LENZ Eosinophilic Asthma
Phase 2/3
Ifabotuzumab Solid tumors
Phase 2
HGEN005 Eosinophilic diseases
Phase 1/2
Early stage opportunities for innovative programs with our proprietary CARs
Key areas we are looking for in LENZ partners are:
Partners:
Multinational, Regional or Domestic Pharmaceutical or Biotechnology Company
Territories:
Global, Regional and Countries such as People’s Republic of China, Latin America, Russia, India and certain other Asia-Pacific countries are available for discussion
Product:
LENZ (currently 10mg/ml filled into a 10ml vial)
Indications:
Treatment of hypoxic hospitalized COVID-19 pneumonia patients; treatment and prevention of CAR-T CRS and neurotoxicity and improvement in CAR-T efficacy
Clinical development:
Partner to complete required clinical development suitable for registration in the Territory
Regulatory:
Partner to submit for approval in the territory for the Indication. Partner is free to reference EUA, BLA and any other approvals
Manufacturing:
Ideally partner will have experience in the manufacturing of mAbs and will complete the tech transfer of the process (to cGMP standard) from our current CMO’s. If no manufacturing capability exist, partner may find a suitable CMO to supply Product. Alternatively, Partner may be able to purchase Product from Humanigen.
Commercialization:
Partner will need to have existing commercial infrastructure to commercialize and distribute lenzilumab to hospitals and other relevant institutions.
If you have an interest in Humanigen, or any of its portfolio or technologies to work together and achieve great outcomes for patients and their families, then please get in contact with:
Bob Atwill at: batwill@humanigen.com
PARTNERS AND COLLABORATION
Humanigen, Inc. currently has a number of Partners and Collaboration.
National Institute of Allergy and Infectious Diseases (“NIAID”)
COVID-19
NIAID, a part of the National Institutes of Health (“NIH”), which is part of the United States Government Department of Health and Human Services (“HHS”) as represented by the Division of Microbiology and Infectious Diseases (“DMID”), and Humanigen have executed a clinical trial agreement for lenzilumab as an agent to be evaluated in the NIAID-sponsored Big Effect Trial (“BET”) in hospitalized patients with COVID-19.
BET will help advance NIAID’s strategic plan for COVID-19 research, which includes conducting studies to advance high-priority therapeutic candidates. Identification of agents with novel mechanisms of action for therapy is a strategic priority.
This trial builds on initial data from NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gilead’s investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19. BET will evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial was planned to enroll 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients had been enrolled in each arm.
With data from the BET and our ongoing Phase III study, we expect to have data from approximately 500 hospitalized COVID-19 patients.
ACTIV-5/BET clinicaltrials.gov Identifier: NCT04583969
IMPACT
GvHD
We are collaborating with IMPACT, a clinical trial partnership of 23 transplant centers in the United Kingdom, in planning a potential randomized, placebo controlled, Phase II/III study focused on early intervention with lenzilumab in patients at high risk or intermediate risk for steroid refractory acute GvHD based on specific biomarkers. The goal of the trial, as it is currently contemplated, would be to determine the efficacy and safety of lenzilumab in reducing non-relapse mortality at six months.
Humanigen, Inc. also has exclusive worldwide license agreements with the University of Zurich in GvHD and the Mayo Foundation for Medical Education and Research in CAR-T.
Humanigen Australia Pty Ltd has been established and the current Australian Trials and Partners are listed below:
C-SMART (COVID-19 Prevention and Treatment in Cancer; a Sequential Multiple Assignment Randomized Trial)
LENZ in cancer patients who are COVID-19 positive and have pneumonia
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.
C-SMART clinicaltrials.gov ID: NCT04534725
PREACH-M (PREcision Approach to CHronic Myelomonocytic Leukaemia)
LENZ in refractory chronic myelomonocytic leukemia (CMML)
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.
More information (via Leukaemia Foundation):
https://www.leukaemia.org.au/stories/aim-of-first-ever-cmml-study-to-improve-survival
[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
Ifabotuzumab in glioblastoma multiforme (GBM)
This 12 patient Phase 1 trial is now fully enrolled. 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."
Ifabotuzumab in GBM clinicaltrials.gov ID: NCT03374943