On February 20, 2020 Hummingbird Bioscience, an innovative biotherapeutics company pioneering the discovery of new breakthrough antibody therapeutics for difficult-to-treat conditions, reported 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 (Press release, Hummingbird Bioscience, FEB 20, 2020, View Source [SID1234554586]).
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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, thus 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.[1],[2]
"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, Hummingbird Bioscience.
"We think HMBD-002 has great therapeutic potential and we are 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 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).
[1]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 immunosuppressive tumor microenvironment. Journal for ImmunoTherapy of Cancer 2018, 6(Suppl 1):P477.
[2]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. In: Proceedings of the AACR (Free AACR Whitepaper) Annual Meeting 2018; AACR (Free AACR Whitepaper); Cancer Res 2018, 78(Suppl): Abstract 1729.
About HMBD-002
HMBD-002 represents a unique first-in-class anti-VISTA neutralising 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 critical role in the formation of tumors and resistance to immunotherapy in cancer.
HMBD-002 binds to VISTA at a specific site predicted to be essential for ligand-binding and function thus blocking VISTA activation.
Preclinical models have shown that a 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 tumours that are unresponsive to existing therapies and have their anti-tumour 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.