Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, today announced a strategic partnership with Asian genomic sequencing and bioinformatics company, Novogene Co., Ltd.. The partnership will leverage Novogene's strong molecular diagnostics capabilities to expand patient identification through Next Generation Sequencing, NGS, testing in China to support the development of Hummingbird Bioscience's investigational drug candidate HMBD-001, an anti-HER3 antibody that will be evaluated for treatment of multiple tumor types, including NRG1-fusion driven cancers. HMBD-001 is expected to enter phase 1 clinical trials later this year.

While rare, occurring in less than 0.5% of all solid tumors[1], NRG1-fusions are increasingly recognized as an actionable oncogenic driver that may potentially be addressed through effective HER3 inhibition. The partnership will focus on validation and expansion of clinical-grade testing for NRG1 fusions in key patient populations with selected solid tumors.

"Biomarker-driven, precision clinical trials are critical to successful drug development, increasing both the probability of technical success, and ensuring that patients who enroll in trials are likely to benefit. The collaboration with Novogene will allow us to create testing options for patients with NRG1-fusions, as well as providing greater awareness as we expand our clinical program into China," said Piers Ingram, Chief Executive Officer and co-founder of Hummingbird Bioscience. "We look forward to building on our collaboration with Novogene to expand diagnostic options beyond NRG1-fusions into other molecular biomarkers."

"'Finding the right drug for the right patient' is the essense of precision medicine. Hummingbird Bioscience's HMBD-001 is a perfect example of such efforts and we are excited to commence this collaboration," said Dr. Jeff Cheng, Chief Scientific Officer of Novogene. "With our solid technical capabilities, rich experience of developing molecular diagnostics and strong presence in the domestic clinical testing sector, we believe we can help significantly accelerate clinical development of this potential best-in-class molecule in China."

[1] Laskin J, Liu SV, Tolba K, Heining C, Schlenk RF, Cheema P, Cadranel J, Jones MR, Drilon A, Cseh A, Gyorffy S, Solca F, Duruisseaux M. NRG1 fusion-driven tumors: biology, detection, and the therapeutic role of afatinib and other ErbB-targeting agents. Ann Oncol. 2020 Dec;31(12):1693-1703. doi: 10.1016/j.annonc.2020.08.2335. Epub 2020 Sep 9. PMID: 32916265.

About HMBD-001

HMBD-001 is a unique anti-HER3 neutralizing antibody, with a novel mechanism of action that offers significant potential for clinical benefit. Previous attempts to block the HER3 receptor, a key player in the PI3K/MAPK signaling pathways 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 studies have shown that HMBD-001 potently inhibits the formation of these heterodimers, blocking activation of the signaling pathway – and consequently, prevents tumor growth. Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel drug candidate into clinical trials for the treatment of HER3-driven cancers.

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 fusion proteins that express the HER3-binding domains. This results in increased HER3 binding and HER3 pathway activation, which consequently leads to tumor growth. Less than 0.5% of all solid tumors harbor NRG1 fusions, however their presence is significantly higher in certain types of cancer including pancreatic and lung cancers. Moreover, studies suggest that NRG1 fusions are mutually exclusive with other known molecular drivers of cancer, such as ALK, ROS, and RET gene fusions, and represent a distinct patient population. There are currently no approved therapies to treat this patient population.

About Hummingbird Bioscience

Hummingbird Bioscience is an innovative clinical-stage biotech 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 rich 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.

About Novogene

Founded in March 2011 in Beijing Zhonguangcun Life Science Park, Novogene specializes in the application of cutting-edge molecular biology technologies and high-performance computing in life science research and human health. Currently providing services to clients in more 60 countries and 6 continents, Novogene has become a global leader in the field of genomic sequencing and bioinformatics services.

With a deep understanding of the drug R&D process, rich project management experience and a strong commitment to data quality, Novogene provides fully integrated services for preclinical, translational, clinical and diagnostic R&D needs from pharmaceutical companies across the world in our strategically located CAP-accredited and CLIA-certified labs across the globe.