Humanigen Aligns with FDA on Potential Registration Phase 3 Study for Lenzilumab with CAR-T

Rhea-AI Summary

Humanigen, Inc. (Nasdaq: HGEN) has received FDA alignment on the registration pathway for the Phase 3 SHIELD clinical trial of lenzilumab. This trial aims to prevent CAR-T therapy-related toxicities such as ICANS and CRS in patients with relapsed or refractory Non-Hodgkin lymphoma. The randomized, double-blind trial is set to begin recruitment in H1 2022. It intends to demonstrate significant improvements in neurotoxicity and healthcare resource utilization. The SHIELD study follows positive results from the ZUMA-19 study, reflecting the potential for lenzilumab to address critical unmet needs in CAR-T therapy.

Positive

• FDA alignment on registration pathway for lenzilumab's Phase 3 SHIELD trial.
• Trial designed to improve management of CAR-T therapy toxicities (ICANS, CRS).
• SHIELD study recruitment set to begin in H1 2022.
• Aims to demonstrate significant improvement in neurotoxicity and potential economic benefits.

Negative

• None.

• 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)

BURLINGAME, Calif.--(BUSINESS WIRE)-- 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.

About Humanigen

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as aGvHD in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are 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," “alignment”, and similar expressions identify forward-looking statements, including, without limitation, statements regarding: the timeline for recruitment in the SHIELD study and the potential sharing of preliminary date from it; the status and timing of other ongoing and planned studies relating to lenzilumab; Humanigen’s beliefs as to the potential benefits of lenzilumab as a treatment for hospitalized COVID-19 patients; and its other plans to initiate or participate in planned clinical trials and otherwise explore the effectiveness of lenzilumab and other candidates in its development portfolio as therapies for other inflammation and immune-oncology indications.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company’s lack of profitability and need for additional capital to conduct its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; challenges associated with manufacturing and commercializing a biologic such as lenzilumab; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen'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 rely upon any forward-looking statements as predictions of future events. The Company undertakes 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. Emma C. Morris et al, Cytokine release syndrome and associated neurotoxicity in cancer immunotherapy, Nature Reviews Immunology https://doi.org/10.1038/s41577-021-00547-6

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Humanigen Investor Relations Contact

Timothy E. Morris

COO/CFO

tmorris@humanigen.com

650-400-6874

Source: Humanigen, Inc.

FAQ

What is the purpose of the SHIELD trial for lenzilumab (HGEN)?

The SHIELD trial aims to evaluate lenzilumab's effectiveness in preventing CAR-T therapy-related toxicities, including ICANS and CRS.

When will the SHIELD trial for lenzilumab (HGEN) begin?

Recruitment for the SHIELD trial is expected to commence in H1 2022.

What are the expected outcomes of the SHIELD trial for lenzilumab (HGEN)?

The trial aims to demonstrate significant improvements in neurotoxicity and assess healthcare resource utilization.

How does the SHIELD trial relate to previous studies like ZUMA-19?

The SHIELD trial builds on positive results from the ZUMA-19 study, aiming to enhance the management of CAR-T therapy toxicities.

What is the potential market impact of lenzilumab (HGEN) based on the SHIELD trial?

If successful, lenzilumab could improve patient outcomes and healthcare efficiency, potentially leading to broader adoption of CAR-T therapies.