PROVIDING SHELTER FROM CYTOKINE STORM

"Therapeutics with the best data reported in the past month are remdesivir, lenzilumab and dexamethasone."

-BioWorld, July 2nd 2020

Source:

Carey, Karen “Snowballing research preps avalanche to bury COVID-19” BioWorld, 2 Jul. 2020,

https://www.bioworld.com/articles/436226-snowballing-research-preps-avalanche-to-bury-covid-19

Humanigen is taking action on the novel coronavirus outbreak.

Stay informed with our COVID-19 resources page.

HUMANIGEN TO HOST INVESTOR CONFERENCE CALL TO DISCUSS NIH’S SELECTION OF LENZILUMAB FOR BIG EFFECT TRIAL

Conference call and webcast scheduled for today, August 3, 2020 at 4:30 pm EDT

TIMOTHY MORRIS JOINS HUMANIGEN AS CHIEF OPERATING OFFICER AND CHIEF FINANCIAL OFFICER

NATIONAL INSTITUTES OF HEALTH SELECTS HUMANIGEN’S LENZILUMAB FOR ITS COVID-19 BIG EFFECT TRIAL

  • Big Effect Trial (BET) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) to advance high priority therapeutic candidates for COVID-19

  • Lenzilumab will be evaluated in combination with remdesivir and compared to placebo and remdesivir

HUMANIGEN REPORTS ADDITIONAL ANALYSIS OF LENZILUMAB IN SEVERE AND CRITICAL COVID-19 PATIENTS

  • Lenzilumab median time to recovery of five days compares favorably to remdesivir’s 10 days in a similar patient group

  • Lenzilumab Phase 3 potential registration study ongoing in severe and critical COVID-19 patients

  • Humanigen hosted a webinar on June 16th, 2020 to discuss results of the initial cohort of patients treated with lenzilumab

MAYO CLINIC STUDY OF HUMANIGEN’S LENZILUMAB SHOWS RAPID RECOVERY AND DISCHARGE IN SEVERE AND CRITICAL COVID-19 PATIENTS

  • Median time to recovery and discharge of five days

  • All patients were at high risk of progression, including four patients who were in the ICU prior to receiving lenzilumab

  • No treatment emergent adverse events were attributable to lenzilumab

HUMANIGEN ANNOUNCES $71,800,000 EQUITY FINANCING

  • J.P. Morgan Securities LLC acting as placement agent

  • Financing syndicate includes Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), HealthCor, Valiant Capital Partners, First Light Asset Management and Ghost Tree Capital

FIRST PATIENT DOSED IN FDA-APPROVED PHASE III LENZILUMAB STUDY FOR COVID-19

First Phase III pivotal study for an anti-GM-CSF therapy in COVID-19 patients

  • First US randomized, double-blind, placebo-controlled, multi-center, Phase III study with an anti-GM-CSF monoclonal antibody which, if successful, may lead to lenzilumab product approval for COVID-19

  • Targeting prevention of serious outcomes in adult, hospitalized patients with COVID-19 pneumonia

HUMANIGEN PARTNERS WITH CTI, A LEADING CONTRACT RESEARCH ORGANIZATION, FOR PLANNED PHASE III STUDY FOR LENZILUMAB FOR CORONAVIRUS TREATMENT

FIRST PATIENT INFUSED IN JOINT HUMANIGEN/KITE, A GILEAD COMPANY CLINICAL STUDY

  • ZUMA-19 study being conducted as part of a clinical collaboration in the U.S.

  • Study evaluating the potential effects of lenzilumab (anti-human-GM-CSF monoclonal antibody) prior to Yescarta® (axicabtagene ciloleucel) in adults with relapsed or refractory large B-cell lymphoma

KITE AND HUMANIGEN ANNOUNCE CLINICAL COLLABORATION TO EVALUATE INVESTIGATIONAL COMBINATION OF YESCARTA® (AXICABTAGENE CILOLEUCEL) WITH LENZILUMAB IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

  • GM-CSF has been identified, through clinical correlative analysis and preclinical modeling, as a potential key signal in the inflammatory cascade triggering toxicities associated with chimeric antigen receptor T (CAR T) cell therapy

  • Emerging pre-clinical evidence suggests that lenzilumab inhibition of GM-CSF may have the potential to disrupt CAR T cell mediated inflammation without disrupting CAR T cell anti-tumor efficacy

  • Phase 1/2 Multi-Center Clinical Trial to Begin Enrolling in Q4 2019

“This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR T cell treatment outcomes.”

HUMANIGEN STUDY OF GM-CSF NEUTRALIZATION WITH CAR-T THERAPY SELECTED FOR FRONT COVER OF CURRENT EDITION OF ‘BLOOD’®, THE OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF HEMATOLOGY (ASH)

  • Enhanced anti-tumor activity, improved overall survival, and an exponential increase in CAR-T cell proliferation was observed with GM-CSF neutralization

  • Lenzilumab (an anti-GM-CSF antibody) used in combination with CAR-T significantly reduces neuro-inflammation, prevents cytokine release syndrome and improves durable control of leukemic disease

  • GM-CSF neutralization with lenzilumab is a next generation strategy to improve efficacy, safety and durability of CAR-T

“This work represents a significant advance in understanding and preventing toxicities after CAR-T cell therapy. Our results strongly suggest that modulating myeloid cell behavior through GM-CSF blockade helps control CAR-T cell mediated toxicities and reduce their immunosuppressive features to improve leukemic control.”

The link to the publication is available for review at:

https://doi.org/10.1182/blood-2018-10-881722

"The more original a discovery the more obvious it seems afterwards."

Arthur Koestler

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