ImaginAb and Roche have entered a clinical trial supply agreement for provision of atezolizumab (Tecentriq®)1 to Non-Small Cell Lung Cancer Patients Enrolled in ImaginAb's iPREDICT Phase IIb Study

LOS ANGELES, June 8, 2022 /PRNewswire/ -- ImaginAb Inc., a market leading global biotechnology company focused on developing next generation ImmunoPET imaging agents and therapeutic radiopharmaceuticals (RPT), is pleased to announce that Roche has agreed to provide US approved atezolizumab (Tecentriq^®)^1, to Non-Small Cell Lung Cancer (NSCLC) patients who are enrolled in ImaginAb's new Phase IIb iPREDICT study.

ImaginAb announced the launch of its Phase IIb "iPREDICT" trial in January this year, as it continues to develop clinical data to support marketing approval of its investigational CD8 ImmunoPET agent (zirconium Zr 89 crefmirlimab berdoxam). The Phase IIb trial, called 'iPREDICT' (NCT05013099), aims to assess 'predictive' performance. Its primary objective is to evaluate the performance of zirconium Zr 89 crefmirlimab berdoxam positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy. The study builds on the data from the company's Phase IIa 'BOT' (Baseline On/Treatment) Trial which completed enrolment in November 2021.

Cancer types targeted in the Phase IIb study include Melanoma, Merkel Cell, Renal Cell Carcinoma, NSCLC and other selected solid tumors.

Roche, which has licensed ImaginAb's CD8 tracer for use in ongoing clinical trials including [NCT03533283], is providing atezolizumab (Tecentriq®) as a monotherapy treatment for patients with NSCLC. The drug is provided for the duration of the patient's treatment within the study or until a decision is made to remove the drug from the patient's treatment path by the treating physician.

ImaginAb will be attending the SNMMI Annual Meeting, 11-14 June in Vancouver, Canada. Please use the contact details provided below if you would like to meet with the ImaginAb team.

Commenting on the announcement, William Le, VP Operations at ImaginAb, said:

"We are delighted that Roche is supporting our iPREDICT trial by providing atezolizumab (Tecentriq®) for patients with NSCLC who are enrolled in our study.

"There is growing scientific evidence² to suggest CD8+ tumor infiltrating lymphocytes (TILs) are an important biomarker in predicting response to immunotherapies. This has informed how we have designed the 'iPREDICT' trial, with ImaginAb setting "response prediction" at the heart of the trial.

"We would like to thank Roche for providing atezolizumab (Tecentriq®). Our goal is to gain regulatory approval for our CD8 ImmunoPET agent in multiple geographies, allowing for its use in assisting the management and treatment of cancer patients."

Notes

1. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

2. (www.pubmed.ncbi.nlm.nih.gov/8608507) and www.nature.com/articles/nature13954)

About ImaginAb

ImaginAb Inc. is a biotechnology company focused on developing radiopharmaceutical imaging and therapy agents. ImaginAb engineers antibody fragments called minibodies that maintain the exquisite specificity of full-length antibodies while remaining biologically inert in the body. Used with widely available PET Imaging technology and therapeutic isotopes, these novel minibodies bind specifically to cell surface targets, providing physicians with a whole-body picture of immune activity and the potential to treat cancer.

ImaginAb is advancing a pipeline of minibodies against both oncology and immunology targets. The company is backed by top tier venture capital firms and strategic corporate firms including, Adage Capital, The Cycad Group, Norgine Ventures, TRC, Jim Pallotta of the Raptor Group, The Parker Institute for Cancer Immunotherapy, and Merck (MSD) Pharma. For more information, please visit www.imaginab.com.

About CD8 ImmunoPET

The 89Zr CD8 ImmunoPET technology (zirconium Zr 89 crefmirlimab berdoxam) is a [89Zr]-labelled minibody that has been designed to bind to the CD8 receptor on human T cells and is used for quantitative, non-invasive PET imaging of CD8 T cells in patients. CD8 T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases. As such, quantitative imaging of CD8 T cells may be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes.