Hummingbird Bioscience Announces Collaboration with Tempus to Harness AI-driven Precision Medicine to Accelerate Clinical Development of HMBD-001 In HER3 Driven Cancers

SINGAPORE,Dec. 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 itsTIME 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 visitwww.hummingbirdbioscience.com,and follow Hummingbird on LinkedInand 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.