Hummingbird Bioscience announces collaboration with Tempus to harness AI-driven precision medicine to accelerate clinical development of HMBD-001 in HER3 driven cancers including NRG1-fusions

SINGAPORE, December 14, 2020 – Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing revolutionary therapies for hard-to-drug targets, today announced a collaboration with Tempus, a leader in artificial intelligence and precision medicine, to drive the development of Hummingbird’s lead clinical program, HMBD-001, as it advances into clinical trials in HER3-driven cancers, including those that harbor neuregulin 1 (NRG1) fusions. As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining  its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

NRG1 fusions are a rare genetic mutation that are increasingly recognized as a driver of multiple tumor malignancies, and an actionable target for HER3 targeted therapy. NRG1 fusions cause the overproduction of NRG1 ligands, resulting in increased HER3 activation and tumor growth. Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them.[1]

HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform. HMBD-001 has been immune-engineered to bind with high affinity to the HER3 dimerization interface and block HER3 growth signals to the cancer. Most importantly, HMBD-001 uniquely blocks HER3 in both open and closed conformations, and in the presence or absence of high concentrations of NRG1.[2] Pre-clinical studies have shown that these differentiated properties of HMBD-001 lead to robust and sustained tumor growth inhibition in multiple HER3 cancer models, including those with NRG1-fusions.

“We are excited to collaborate with Tempus to leverage their just-in-time clinical trial program and apply Hummingbird’s deep knowledge of disease driving protein mechanisms in order to identify patients with actionable genetic abnormalities,” said Dr Piers Ingram, Co-founder and CEO of Hummingbird.

“We look forward to Hummingbird joining our TIME Trial Network, providing patients across the country access to its HMBD-001 clinical trial,” said Amy Franzen, Vice President of Operations, Therapies, Tempus. “This collaboration is an opportunity to identify those patients who could benefit from this investigational therapy, and if they are eligible, rapidly open the trial just for them.”

 

About NRG1 fusions
A subset of patients with cancer have recently been identified who possess abnormal NRG1 gene fusions, that is the hybridization of their NRG1 gene with any one of a number of genes to produce NRG1 proteins that overexpress the HER3-binding domains.[3] This results in increased HER3 binding and dimerization, which consequently leads to increased tumor growth. Less than 1% of all solid tumors harbor NRG1 fusions, and there are currently no approved therapies to treat this patient population.1 Moreover, studies suggest that NRG1 fusions are mutually exclusive with other known molecular drivers of cancer, such as ALK, ROS, and RET gene fusions, meaning that NRG1 fusions are likely to be a distinct orphan indication in a discrete patient population.1

About HMBD-001
HMBD-001 represents a unique, highly-specific, anti-HER3 neutralizing antibody with a novel mechanism of action that offers significant potential for broad clinical benefit. Previous attempts to block the HER3 receptor, a key player in the signaling pathway that promotes cell division and tumor growth in cancer, have not proven to be efficacious. HER3 is activated by the binding of NRG1, which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Pre-clinical models have shown that HMBD-001 is able to effectively and uniquely bind to a difficult-to-target region on HER3, blocking the heterodimerization of HER3 with HER2/EGFR independent of NRG1 binding. This potently inhibits the activation of the signaling pathway – and consequently, stops tumor growth. Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer.

About Hummingbird Bioscience
Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing revolutionary therapies against hard-to-drug targets for improved 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 rich pipeline of first- and best-in-class drug candidates in oncology, autoimmune and infectious diseases, in collaboration with global partners in academia and industry.

Our highly experienced teams in Singapore and the US 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 LinkedIn and Twitter (@hummingbirdbio).

About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

[1] Jonna S, Feldman RA, Swensen J, Gatalica Z, Korn WM, Borghaei H, Ma PC, Nieva JJ, Spira AI, Vanderwalde AM, Wozniak AJ, Kim ES, Liu SV.. Detection of NRG1 Gene Fusions in Solid Tumors. Clin Cancer Res. 2019; 25: 4966–4972. https://doi.org/10.1158/1078-0432.CCR-19-0160

[2] Thakkar D, Sancenon V, Taguiam MM, Guan S, Wu Z, Ng E, Paszkiewicz KH, Ingram PJ, Boyd-Kirkup JD. 10D1F, an Anti-HER3 Antibody that Uniquely Blocks the Receptor Heterodimerization Interface, Potently Inhibits Tumor Growth Across a Broad Panel of Tumor Models. Mol Cancer Ther. 2020; 19: 490–501.

[3] Ruiz-Saenz A, Dreyer C, Campbell MR, Steri V, Gulizia N, Moasser MM. HER2 Amplification in Tumors Activates PI3K/Akt Signaling Independent of HER3. Cancer Res. 2018; 78: 3645–3658.

Hummingbird Bioscience Announces Agreement with Mycenax Biotech for Production of Anti-VISTA Antibody HMBD-002 for Cancer Clinical Trial

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 [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 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).

[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 tumor microenvironment. Journal for ImmunoTherapy of Cancer. 2018; 6(Suppl 1):
P447.
[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. Proceedings of the AACR Annual Meeting
2018; AACR; Cancer Res 2018, 78(Suppl): Abstract 1729.

About HMBD-002

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: www.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

Hummingbird Bioscience closes US$25M investment with Series B extension

Hummingbird Bioscience, an innovative biotherapeutics company focused on the discovery and development of new breakthrough therapies, has closed an extended Series B funding round of US$25 million. This brings the total capital raised through financing activities and strategic partnerships to more than US$65 million to date.

Leading the Series B extension is new investor SK Holdings, with participation from existing shareholders including Heritas Capital and SEEDS Capital, the investment arm of Enterprise Singapore.

The Series B round was extended to US$25 million due to significant over-subscription, with the addition of select quality and value-add investors. Hummingbird will use the new funds to accelerate development of new candidates into clinical trials and strengthen its scientific and research and development capabilities.

“We are delighted to have SK Holdings join our investor base. Hummingbird is building a strong portfolio of promising new therapies that we believe can deliver very meaningful benefit for patients across a broad spectrum of disease. These new funds give us further resources to develop our early stage pipeline, and support the clinical development of our lead programs,” said Dr Piers Ingram, Chief Executive Officer and co-founder, Hummingbird Bioscience.

“Heritas Capital is pleased to continue our backing of the Hummingbird team since leading its Series A extended round,” commented Chik Wai Chiew, Executive Director and Chief Executive Officer, Heritas Capital Management. “Even as the COVID-19 pandemic has resulted in a slow-down in investing, we are mindful that backing leading innovative biotech companies, especially players such as Hummingbird, to develop cures for addressing patients’ needs remains our priority.”

Earlier this year Hummingbird announced publication of positive data on its lead candidate, HMBD-001, a first-in-class HER3 antibody; and manufacturing of HMBD-002, a first-in-class VISTA antibody. Regulatory submissions to initiate Phase I studies for these two candidates are expected in the second half of 2020.

About Hummingbird Bioscience

Hummingbird Bioscience is on a mission to unravel the complexities of human disease and revolutionize treatment outcomes. Using systems biology to develop unparalleled insights into disease biology, Hummingbird applies computationally guided platforms to discover and engineer breakthrough biotherapeutics. This is a bold, new way of finding the right drugs for the right people.

Hummingbird is pursuing a broad pipeline of first and best-in-class drug candidates across multiple challenging targets with strong biological validation and disease association, including lead assets: HMBD-001, an anti-HER3 antibody, and HMBD-002, an anti-VISTA antibody, for the treatment of cancer. Hummingbird 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: www.hummingbirdbioscience.com or follow the company on LinkedIn and Twitter at @Hummingbirdbio.

About SK Holdings

As the integrated holding company of SK Group, SK Holdings continues to enhance its portfolio value by executing long-term strategic investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life sciences, energy and chemicals, information and telecommunications, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit http://hc.sk.co.kr/en/

About Heritas Capital Management

Heritas is a Capital Markets Services (“CMS”) licensed A/I (Accredited / Institutional) fund management company managing private equity, venture capital and fund-of-funds investments into healthcare, education, and technology globally. We are also proud to be a co-investment partner of SPRING SEEDS Capital, under the Startup SG Equity Scheme into leading healthcare start-ups in Singapore.

About SEEDS Capital

As the investment arm of Enterprise Singapore, SEEDS Capital catalyses smart investments into innovative Singapore-based startups with strong intellectual content and global market potential. We co-invest with independent investors in innovative startups. We help our startups commercialize and expand globally through leveraging on the expertise and strategic networks of our co-investment partners in areas such as technology translation, commercialization and market expansion. Through co-investments, SEEDS Capital aims to catalyse investments into nascent and strategic sectors. These include Advanced Manufacturing & Engineering, Health & Biomedical Sciences, Urban Sustainability & Solutions, and Services & Digital Economy.

About Enterprise Singapore

Enterprise Singapore is the government agency championing enterprise development. We work with committed companies to build capabilities, innovate and internationalist. We also support the growth of Singapore as a hub for global trading and startups, and build trust in Singapore’s products and services through quality and standards. Visit www.enterprisesg.gov.sg for more information.

Media contact:

Stephanie Tan
APCO Worldwide
Tel: +65 9107 5559
Email: stan@apcoworldwide.com

Hummingbird Bioscience Publishes Preclinical Data Demonstrating Efficacy of HMBD-001 in HER3 Driven Cancers

Hummingbird Bioscience, an innovative biotherapeutics company pioneering the discovery and development of new breakthrough precision antibody therapeutics for difficult-to-treat conditions, today announced the publication of preclinical data for its lead candidate, HMBD-001, an anti-HER3 antibody, in Molecular Cancer Therapeutics, a peer-reviewed American Association of Cancer Research journal.

HMBD-001 is a unique anti-HER3 antibody with a novel mechanism of action and favorable safety profile. HER3 is a member of the EGFR tyrosine kinase receptor family, which is responsible for driving cancer cell division and growth, and is expressed in over half of colorectal and gastric cancers, at least a third of breast cancers, as well as significant sub-populations of many other indications [1]. HER3 activation is implicated in cancer progression as well as in acquired resistance to drugs against other tyrosine kinase receptor family members such as EGFR (e.g. cetuximab or Erbitux) and HER2 (e.g. trastuzumab or Herceptin). HMBD-001 was developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery Platform to specifically bind to and inhibit a difficult-to-access region of the HER3 protein that is essential for activation.

The published findings show that HMBD-001 (also known as 10D1F) is superior at tumor growth inhibition, regardless of how HER3 is activated, compared to previous anti-HER3 drugs with different binding sites and mechanisms of action. HMBD-001 demonstrated potent efficacy in a broad panel of in vitro and in vivo tumor models that had high HER3 activity and oncogenic downstream signaling.

“Previous attempts to target HER3 with other drugs failed as they could not inhibit activation of HER3 effectively. The highly specific binding of HMBD-001 to a difficult-to-target region on HER3 allows us to completely shut-off activation of this important cancer-associated protein,” said Dr Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder, Hummingbird Bioscience. “This preclinical data provides proof-of-concept and represents exciting therapeutic opportunities for us as we look to develop HMBD-001 in hard-to-treat conditions such as gastric, colorectal, lung and pancreatic cancers.”

Hummingbird Bioscience, in partnership with Cancer Research UK, will be advancing HMBD-001 into clinical trials for the treatment of HER3 driven cancers. HMBD-001 is expected to enter Phase I trial following regulatory submission approvals in the second half of 2020.

The paper titled 10D1F, An Anti-HER3 Antibody that Uniquely Blocks the Receptor Dimerization Interface, Potently Inhibits Tumor Growth Across a Broad Panel of Tumor Models” can also be accessed online.

[1] Li Q., Zhang R., Yan H., Zhao P., Wu L., Wang H., Li T., Cao B. Prognostic significance of HER3 in patients with malignant solid tumors. Oncotarget. 2017; 8: 67140-67151.

About HMBD-001

HMBD-001 represents a unique, highly-specific, anti-HER3 neutralizing antibody with a novel mechanism of action that offers significant potential for broad clinical benefit. Previous attempts to block the HER3 receptor, a key player in the signaling pathway that promotes cell division and tumor growth in cancer, have not proven to be efficacious. HER3 is activated by the binding of neuregulin (NRG1), which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Preclinical models have shown that HMBD-001 is able to effectively and uniquely bind to a difficult-to-target region on HER3, blocking the heterodimerization of HER3 with HER2/EGFR independent of NRG1 binding. This potently inhibits the activation of the signaling pathway – and consequently, stops tumor growth.

Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer. 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: www.hummingbirdbioscience.com or follow the company on LinkedIn and Twitter at @Hummingbirdbio.

Media contact:

Stephanie Tan
APCO Worldwide
Tel: +65 9107 5559
Email: stan@apcoworldwide.com