Hummingbird Bioscience Announces US FDA Clearance of IND for First-in-Human Phase 1 Trial of HMBD-002 in Patients with Advanced Solid Tumors

HOUSTON and SINGAPORE,Sept. 13,2021 -- Hummingbird Bioscience,an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets,today announced that the U.S. Food and Drug Administration (FDA) has approved the initiation of a Phase 1 clinical trial of HMBD-002,Hummingbird's anti-VISTA neutralizing antibody. HMBD-002 is being developed for the treatment of cancers with VISTA-mediated immune suppression,including triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC).

HMBD-002 is an IgG4 monoclonal antibody,rationally engineered with high affinity and specificity to bind and block the activation of VISTA,a protein that enables tumors to suppress and escape the immune system. HMBD-002 accomplishes this without depleting VISTA expressing immune cells that play important roles in the immune response. In pre-clinical cancer models,treatment with HMBD-002 could counteract immune suppression,as indicated by the decreased infiltration of immune-suppressing myeloid cells into the local tumor environment and the increased activity of T cells. Pre-clinical studies also show that HMBD-002 as a monotherapy,and in combination with pembrolizumab (an immune checkpoint inhibitor),significantly inhibited tumor growth,with no observed toxicity.

The Phase 1,multi-center,open-label trial will evaluate HMBD-002,as a monotherapy and in combination with pembrolizumab. Safety and tolerability will initially be assessed in a dose escalation study in patients with advanced solid malignancies,where the maximum tolerated or tested dose (MTD) and recommended Phase 2 dose (RP2D) will be identified. The anti-cancer activity of HMBD-002 will then be evaluated in a dose expansion study examining HMBD-002 as a monotherapy in patients with previously treated TNBC and NSCLC,or in combination with pembrolizumab in patients with TNBC,NSCLC,and other VISTA-expressing malignancies.

Correlative studies will assess pre- and post-treatment markers of immune activity in the periphery and the tumor microenvironment. The development of HMBD-002 into the clinic is supported by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

"VISTA is an exciting but complex new immune checkpoint protein. With Hummingbird's proprietary Rational Antibody Discovery platform,we used machine learning and computational biology to predict the optimal drug binding site on VISTA in order to develop an antibody therapy that could effectively block and neutralize its activity. As such,HMBD-002's mechanism of action is highly differentiated from other anti-VISTA drug candidates. We look forward to advancing the clinical development of HMBD-002 for cancer patients where VISTA is involved in suppressing immune response," said Jerome Boyd-Kirkup,Chief Scientific Officer and co-founder of Hummingbird Bioscience.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody,and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function,thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system.

Pre-clinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival,with no observed toxicity. It has also shown synergy when used in combination with anti-PD-1 therapy.

HMBD-002 is being developed for the treatment of multiple cancers that have strong evidence of VISTA mediated suppression,both as a monotherapy and in combination with PD-1 inhibitor.

HMBD-002 advanced to clinical trials with a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

About Hummingbird Bioscience

Hummingbird Bioscience is a clinical-stage biotechnology company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes. We harness the latest advances in systems biology and data science to better understand and solve the underlying causes of disease and guide development of our therapeutics.

Enabled by our proprietary Rational Antibody Discovery platform,we discover antibodies against optimal yet elusive epitopes on important targets that have not been successfully drugged,unlocking novel mechanisms of action. We are advancing a pipeline of first- and best-in-class precision therapies in oncology and autoimmunity,in collaboration with global partners in academia and industry.

Our highly experienced teams in the US and Singapore span antibody discovery,pharmacology,production and clinical development. Together we aim to accelerate the journey of new drugs from concept to clinical care. For more information,please visit www.hummingbirdbioscience.com,and follow Hummingbird on LinkedInand Twitter (@hummingbirdbio).