Inglewood, California and Istanbul, Turkey – June 9, 2022 - ImaginAb, Inc., a market leading global biotechnology company focused on developing next generation immuno-oncology imaging agents and radioligand therapy (RLT), is delighted to announce that it has reached an agreement, in principle with Turkey-based Radiopharmaceuticals company, Monrol, for the supply of radioisotopes, Zirconium-89 (Zr-89) and Lutetium-177 nca (Lu-177), in diagnostic imaging and radiopharmaceutical therapy, respectively.
In addition, Monrol will manufacture and distribute ImaginAb’s proprietary investigational CD8 ImmunoPET agent, Zirconium 89Zr-crefmirlimab berdoxam, initially providing support on ImaginAb’s Phase IIb iPREDICT clinical study and additional partner pharmaceutical company studies and investigator-initiated trials. The agreement allows for the manufacture and distribution of the agent to continue post regulatory approval.
Lu-177 will initially be supplied to support ImaginAb’s IND-enabling studies and subsequent clinical trials for the Company’s emerging RPT pipeline.
Monrol General Manager Aydın Küçük, said: “We are delighted to be working with ImaginAb to supply, manufacture and distribute innovative radiopharmaceutical products for the Company’s proprietary CD8 ImmunoPET imaging technology as we continue our mission to improve quality of life for cancer patients and transform patient care for the future.”
Dr Gareth Smith, General Manager for Europe at ImaginAb, added: “ImaginAb is thrilled to be partnering with Monrol, a company with a broad set of offerings to support our development programs and pipeline. We look forward to rolling out the supply of high quality radioisotopes to our clinical trial patients in Europe and to those in Australia in the near future”.
Monrol is one of the world’s largest radiopharmaceuticals companies leading innovation for the development and manufacturing of GMP grade radioisotopes and radiopharmaceuticals having headquarters in Istanbul. Monrol is distributing its world-class radiopharmaceutical products portfolio with excellence in global markets. Monrol is a CDMO, providing early development support to its customers as well as offering fully integrated services for today’s nimble, lean, virtual companies effectively taking new product concepts into clinical trials, demonstrating proof of concept and going into first-in-human studies. Monrol is committed to transform and improve patient journey in cancer treatment with its radiopharmaceutical products portfolio distributing to more than 50 countries around the globe. To learn more, visit www.monrol.com and LinkedIn.
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 diagnostic and therapeutic 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 Zr 89 CD8 ImmunoPET agent (zirconium Zr 89 crefmirlimab berdoxam) is a Zr 89 -labelled Minibody that binds 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 can be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes.
Lutetium-177 n.c.a is a radioisotope of choice for targeted radionuclide therapy. Lu-177 n.c.a production process enables treatment options that have the potential to improve treatment outcomes for certain cancer patients today and more potential treatment options in future under clinical development. The unique properties of Lu-177 n.c.a make it a theranostically desirable radioisotope for peptide receptor radionuclide therapy (PRRT) to treat certain cancers like Neuro Endocrine Tumors (NET) and Prostate cancer. Lutetium-177 is registered at the FDA.
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