Hummingbird Bioscience, an innovative biotherapeutics company pioneering the discovery of new breakthrough antibody therapeutics for difficult-to-treat conditions, today announced it has signed an agreement with Mycenax Biotech for the production of material for the Phase 1 clinical trial of its HMBD-002 program which is anticipated to commence in the second half of 2020.
HMBD-002 is an anti-VISTA antibody developed for solid tumors that are unresponsive to existing treatments. VISTA is a new and important target for cancer as it strongly suppresses the activation of the body's anti-tumor immune response. The presence of VISTA cells is frequently associated with the emergence of tumors and resistance to current cancer immunotherapies.
HMBD-002 uniquely blocks VISTA's activation, turning off the signal that keeps immune cells dormant. Critically, unlike other investigational anti-VISTA agents, HMBD-002 does not remove VISTA expressing cells from the body, this allowing many of these cells to become active tumor-killing cells. Pre-clinical studies have shown that HMBD-002 can strongly inhibit tumor growth, both as a monotherapy and even more potently when combined with anti-PD(L)1 treatment .
We are very pleased to be working with Mycenax, a pioneering provider of high-quality biologics for the production of our anti-VISTA antibody, HMBD-002. This contract takes us one step closer to realizing the goal of more effective immunotherapies for a broader population of individuals with cancer." said Dr Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder of Hummingbird Bioscience.
"We think HMBD-002 has great therapeutic potential and we honored and excited to work with Hummingbird Bioscience on this project. We are committed to providing professional and customized service to facilitate the progress of the project. We are optimistic that, with our expertise and capability in CMC and production, HMBD-002 will be able to enter clinical trials and show therapeutic benefits soon." said Dr Pei-Jiun Chen, CEO and President of Mycenax.
Further terms of the agreement were not disclosed. Following completion of manufacturing in Texas, an Investigational New Drug application will be submitted to the FDA to commence the clinical trial. The development of HMBD-002 into the clinic is supported by a grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
 Boyd-Kirkup, J. et al. HMBD-002-V4: A novel anti-VISTA antibody that uniquely binds murine and human VISTA and potently inhibits tumor growth by remodeling the tumor microenvironment. Journal for ImmunoTherapy of Cancer. 2018; 6(Suppl 1): P447.
 Boyd-Kirkup, J. et al. Integrative immune profiling of syngeneic tumor models provides predictive immune signatures for treatment response with HMBD002, a novel anti-VISTA neutralizing antibody. Proceedings of the AACR Annual Meeting 2018; AACR; Cancer Res 2018, 78(Suppl): Abstract 1729.
HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody. VISTA is a co-inhibitory immune checkpoint receptor of the B7 family that suppresses T-cell activity and has been shown to play a crucial role in the formation of tumors and resistance to immunotherapy in cancer.
HMBD-002 binds to VISTA and a specific site predicted to be essential for ligand-binding and function thus blocking VISTA activation.
Preclinical models have shown that HMBD-002 as a monotherapy significantly reduces tumor growth and prolongs progression-free survival with no observed toxicity. In combination with antibodies against PD(L)-1 efficacy more than doubled.
The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded Hummingbird Bioscience a US$13.1 million product development grant to advance this first-in-class anti-VISTA therapeutic antibody into clinical trials for the treatment of solid tumors that are unresponsive to existing therapies and have their anti-tumor immunity suppressed by VISTA-mediated activity. The clinical trial of this investigational candidate is expected to commence following regulatory submission approvals in the second half of 2020.
About Hummingbird Bioscience
Hummingbird Bioscience is an innovative biotherapeutics company pioneering the discovery and development of new breakthrough precision antibody therapies for difficult-to-treat conditions. Leveraging its proprietary rational antibody discovery platform and deep experience in systems biology, Hummingbird Bioscience is able to accurately identify novel disease targets enabling it to engineer and generate antibodies to precisely hit these difficult targets. The company is developing a broad pipeline of first and best-in-class drug candidates across multiple indications, including: HMBD-001, an anti-HER3 antibody, and HMBD-002, an anti-VISTA antibody, for the treatment of cancer. Hummingbird Bioscience has established strategic collaborations
with Cancer Research UK and Amgen, and has been awarded a product development grant from the Cancer Prevention and Research Institute of Texas.
Hummingbird Bioscience is located in Singapore, Houston, Texas and South San Francisco, California. To learn more about its science, pipeline assets, and team, please visit: hummingbirdbioscience.com or follow the company on LinkedIn and Twitter at @Hummingbirdbio.
About Mycenax Biotech Inc:
MYCENAX BIOTECH INC. is a contract development and manufacturing organization (CDMO) devoted to providing a one-stop solution for biologics development for customers around the globe. Mycenax is specialized in the development of cell-line, process, formulation and analytical methods. In addition, Mycenax has a PIC/S GMP certified factory with mammalian production of up to 2000L, microbial production up to 200L, and an aseptic fill-finish line. With extensive experience of peptides, recombinant proteins, Fc-fusion proteins and monoclonal antibodies for both novel and biosimilars, Mycenax can help clients bring candidate molecules through clinical trials, and eventually to market in the most economic and efficient way. Over the past 10 years, Mycenax has served customers from Japan, Korea, Germany, Netherlands and the US. Mycenax is dedicated to being the best partner for pharmaceutical, biotech and startup companies.
Mycenax is located in Taiwan. For more information, please visit: www.mycenax.com.tw