Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, today announced a Trials in Progress poster presentation outlining the Phase 1 clinical trial design for HMBD-002, a unique anti-VISTA antibody developed using Hummingbird's Rational Antibody Discovery platform to address VISTA-mediated suppression of anti-tumor immune responses, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The meeting will be held in Washington, D.C. and virtually from November 10 to 14, 2021.

HMBD-002 is designed to target the region where V-domain Ig suppressor of T cell activation (VISTA) interacts with binding partners that have been shown to play an important role in modulation of T cell activity, potentially unlocking the immune system to attack cancer cells. The Trials in Progress poster will summarize the Phase 1 clinical trial design for HMBD-002 (NCT05082610). The Phase 1, open-label, multi-center, first-in-human trial intends to evaluate HMBD-002 as a monotherapy and in combination with KEYTRUDA? (pembrolizumab) in order to determine the maximum tolerated dose and investigate the anti-cancer activity of HMBD-002. The pembrolizumab combination arm of the study will be conducted in collaboration with Merck (known as MSD outside the US and Canada).

The dose escalation portion of the study is expected to enroll patients with advanced solid malignancies, while the dose expansion portion of the study plans to evaluate HMBD-002 in disease-directed cohorts, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and other cancers where VISTA is present at high levels and may be suppressing immune responses. TNBC and NSCLC were identified as priority indications for clinical investigation based on their high VISTA expression and the unmet need for new treatment options in these tumor types.

"We are excited to present our Phase 1 clinical strategy for HMBD-002 at SITC and discuss our longer-term clinical development plans with the wider immuno-oncology community," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "HMBD-002 could represent a unique and innovative approach to benefit cancer patients who do not respond to current therapies. We look forward to continued collaboration with Merck to advance HMBD-002 through clinical trials."

Hummingbird Bioscience currently plans to dose the first patient in Q4 2021 and expects to have clinical data from the Phase 1 clinical trial in the second half of 2023.

Details of the poster presentation

Title: A Phase 1 First-in-Human Study of HMBD-002, an IgG4 Monoclonal Antibody Targeting VISTA, as a Monotherapy and Combined with Pembrolizumab in Patients with Advanced Solid Malignancies

Poster number: 469

Date and time: 12th November, 7:00 am – 8:30 pm ET

Location: Poster Hall, Hall E

KEYTRUDA? is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About HMBD-002

HMBD-002 is an investigational IgG4 anti-VISTA antagonist antibody discovered and rationally designed with our RAD platform to target the region where VISTA interacts with binding partners that have been shown to play an important role modulating T cell activity, potentially unlocking the immune system to attack cancer cells. We believe HMBD-002 is the first Fc-independent anti-VISTA antibody designed to bind a computationally predicted functional epitope distinct from the epitopes of other known anti-VISTA antibodies in development. In the Company's preclinical studies, HMBD-002 demonstrated potent anti-tumor activity both as monotherapy and in combination with pembrolizumab, in multiple syngeneic and humanized mouse models of cancers. HMBD-002 is being developed for various VISTA-expressing cancers, both as a monotherapy and in combination with pembrolizumab.

About Hummingbird Bioscience

Hummingbird Bioscience is a clinical-stage biotechnology company with a proprietary and differentiated Rational Antibody Discovery (RAD) platform, developing a broad pipeline of novel, precision therapeutics for the treatment of cancer and autoimmune disease. We are focused on targets with significant biological validation and disease association that have not been drugged, or are inadequately drugged to date, which we refer to as "hard targets".

Our RAD platform uses data-driven computational and systems biology with the goal of selecting promising protein targets that are associated with dysregulated biology and clinical disease, enabling us to develop antibodies that bind to specific epitopes and have the potential to be best-in-class against these targets.

Source: Hummingbird Bioscience