Humanigen Inc (HGENQ)

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Humanigen announces preparation of Phase 1b study of ifabotuzumab in solid tumors following presentation of Phase 1 study results at EANM‘21

https://ir.humanigen.com/English/news/news-details/2021/Humanigen-announces-preparation-of-Phase-1b-study-of-ifabotuzumab-in-solid-tumors-following-presentation-of-Phase-1-study-results-at-EANM21/default.aspx


-An abstract showing tumor specific targeting at all known tumor sites in glioblastoma patients, with no normal tissue uptake of ifabotuzumab, from a Phase 1 study will be presented at EANM‘21

-A Phase 1b study of ifabotuzumab in non-CNS solid tumors (such as breast, colorectal, lung, and pancreatic cancer) is planned to start in early 2022

BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company, today announced its research partners will present Phase 1 results from a study of ifabotuzumab in glioblastoma multiforme (GBM) at the Annual Congress of the European Association of Nuclear Medicine (EANM’21) and plan to initiate a follow-on Phase 1b study in non-CNS solid tumors in early 2022. EANM is the largest organization dedicated to nuclear medicine in Europe and represents more than 9,000 specialists from 41 different countries.

The abstract will be presented virtually by Principal Investigator Prof. Andrew Scott, Head, Tumor Targeting Laboratory, Olivia Newton-John Cancer Research Institute; Director of the Department of Molecular Imaging and Therapy, Austin Health; and Professor, School of Cancer Medicine, La Trobe University. The abstract (OP-0854) entitled: “Phase I safety and bioimaging trial of ifabotuzumab in patients with glioblastoma” has been published in the EANM‘21 abstract book and was chosen to be included in a TOP 3 trials session at EANM’21 that will take place from 3:05-4:35pm Central European Standard Time on October 22, 2021.1

“The biodistribution characteristics demonstrated in the Phase 1 GBM study indicate ifabotuzumab has ideal characteristics for a range of therapeutic options including the creation of an antibody-drug conjugate,” said Prof. Scott. “Our preclinical studies with antibody-drug conjugate forms of ifabotuzumab have shown promising results. We hope to take this payload delivery approach into the clinic in the next 1-2 years.”

The Olivia Newton-John Cancer Research Institute plans to conduct a Phase 1b dose-escalation and imaging study in non-CNS solid tumors that is scheduled to begin in early 2022. This will be led by Prof. Andrew Scott and Prof. Hui Gan, Clinical Research Lead, Olivia Newton-John Cancer Research Institute and Director, Cancer Clinical Trials Center, Austin Health.

“We are excited by the potential ifabotuzumab holds to create a novel cancer therapeutic that delivers cytotoxic agents to tumor cells while minimizing toxicity to normal tissue,” said Cameron Durrant, Chairman and CEO of Humanigen. “We look forward to supporting our valued partners in Australia as they advance research of ifabotuzumab into solid tumors.”

About Ifabotuzumab
Ifabotuzumab is a proprietary Humaneered® monoclonal antibody that binds the EphA3 receptor, which plays an important role during fetal development but is not thought to be expressed nor play a significant role in healthy adults. EphA3 is a tyrosine kinase receptor, aberrantly expressed on the tumor vasculature and tumor stroma in many solid tumors including melanoma, breast cancer, lung cancer, colorectal cancer, GBM and prostate cancer, making it an attractive target for a range of cancers.

Humanigen has completed a Phase 1 study in multiple hematologic malignancies that suggest it is well tolerated with mild-to-moderate infusion reactions that can be managed by stopping infusion, or using medications to treat reactions (chills, fever, nausea, hypertension, and rapid heart rate).

In 2021, a Phase 1 safety and bioimaging study of ifabotuzumab, supported by Cure Brain Cancer Foundation, and Humanigen, showed specific and reproducible targeting of the tumor and its microenvironment, with no normal tissue uptake, in all patients. Future development plans, in conjunction with our research partners in Australia, are intended to confirm highly specific tumor uptake in non-CNS solid tumors with the intention of creating an antibody-drug conjugate by linking ifabotuzumab to a cytotoxic (cell-killing) agent.