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Humanigen Aligns with FDA on Potential Registration Phase 3 Study for Lenzilumab with CAR-T
January 10 2022 - 05:55AM .. Business Wire

FDA Type C meeting and advice creates alignment on registration pathway for Phase 3 clinical development of lenzilumab for the prevention of CAR-T therapy related toxicities including Immune Effector Cell-Associated Neurotoxicity (ICANS) and Cytokine Release Syndrome (CRS)
Randomized, double-blind, placebo-controlled SHIELD trial to commence in H1 2022, designed to inform a potential label that reflects both the clinical benefit of lenzilumab and the economic benefit (measured by reduction in healthcare resource utilization)

Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ today outlined the next steps for the development of its lead candidate, lenzilumab, in the prevention of CAR-T therapy related toxicities including ICANS and CRS in patients with relapsed or refractory Non-Hodgkin lymphoma (rrNHL).

“Following recent constructive interaction with FDA on the design of the Phase 3 study, known as SHIELD (Study on How to Improve Efficacy and toxicity with Lenzilumab in DLBCL and other NHL patients treated with CAR-T therapy), we believe that we have collaboratively aligned on a potential registration study, recognizing the clinical and economic benefits for patients and healthcare systems,” stated Adrian Kilcoyne,
chief medical officer of Humanigen. “The SHIELD trial will
build on the positive results from the ZUMA-19 study. The primary endpoint of SHIELD will focus on demonstrating a significant improvement in neurotoxicity associated with
both YESCARTA® and TECARTUS®. In agreement with FDA, we will also seek to demonstrate the beneficial impact that lenzilumab may have on healthcare resource utilization.”

CAR-T therapies have resulted in significant advances for patients but the clinical benefit observed often comes at a
cost. In up to one-third of patients, significant toxicities of ICANS and CRS occur1. Currently, the widespread adoption
of CAR-T therapy is limited, in part, by the requirement for treatment in centers that are experienced in managing the common toxicities of ICANS and CRS and by the financial
and health burden that this creates.

“CRS and ICANS remain huge challenges for physicians
and patients treated with CAR-T therapy,” said Dr. Saad Kendarian, Consultant Hematologist at Mayo Clinic and the primary investigator for the SHIELD study. “They result in additional morbidity for patients, as well as significantly increased costs for healthcare providers. Treatments that
can prevent ICANS and CRS could address a critical unmet need.”

The SHIELD study will begin recruitment in H1 2022, with preliminary data potentially being shared at the American Society of Hematology congress in December 2022.

“We are very encouraged with the outcome of our meeting with FDA,” said Dr. Cameron Durrant, Chairman and CEO of Humanigen. “Defining a potential registration pathway across multiple indications is an important next step in our development of lenzilumab. The PREACH-M study in chronic myelomonocytic leukemia has begun dosing patients. Both the SHIELD study in CAR-T and the RATinG study in acute graft vs. host disease are planned to begin enrolling in the first half of 2022. The NIH-sponsored ACTIV-5/BET-B study has reached target recruitment and there are additional COVID studies being initiated in Korea and Australia. Further strengthening the Humanigen pipeline is our Phase 1 program focused on ifabotuzumab in solid tumors.”

Lenzilumab is an investigational product and is not authorized or approved in any country.