- Submission of high-profile imaging and radiopharmaceutical therapy to major US universities, Case Western Reserve University (CWRU), Ohio
- PTPµ (PTPmu) is the only biomarker found in tumor cells, but not in healthy cells.
- The radionuclide carried by the PTPµ-targeting agent has potential first in class therapy in different types of tumors
- Phase 1 Approximate study of brain tumor images. 12 months
- Attractive trading conditions with low monetary obligations and low single-digit rights
MELBOURNE, Australia, June 9, 2022 / PRNewswire / – Radiopharm Theranostics (ASX: RAD, “Radiopharm” or “Company”), a global developer of leading radiopharmaceuticals for both diagnostic and therapeutic use, is pleased to announce that it has signed an exclusive. A sub-licensing agreement with NeoIndicate, LLC (“NeoIndicate”) for a radiopharmaceutical targeting PTPµ, developed at CWRU. Ohio, USA.
The sub-licensing agreement gives Radiopharm the right to develop a PTPµ agent as part of its clinical development channel as a diagnostic imaging and radiopharmaceutical target.
The future of precision medicine is a very specific and targeted agent for the detection, imaging and treatment of tumors. Combined with low-level radiation, the PTPµ-targeting agent functions as a highly specific positron emission tomography (PET) imaging agent. Combined with high-energy radiation, the PTPµ-targeting agent acts as a radiopharmaceutical to destroy tumors.
The targeting agent is labeled with invasive tumor cells far from the main tumor mass to detect the full extent of an invasive tumor. This part is also recognized in many types of tumors, including brain tumors and gynecological cancers.
The technology has shown encouraging preclinical data in human glioblastoma (GBM) tumor models¹ˉ⁶, the focus of Radiopharm’s initial research and the most common and destructive form of brain cancer, with a median one-year survival from diagnosis. The current standard of care is surgery, followed by nonspecific radiation and chemotherapy. Due to limited treatment options and poor prognosis, there is an immediate need for targeted therapies with high sensitivity and specificity.
Manufacturing of PTPµ is scheduled to begin next year December 2022.
Dr. Susann Brady-Kalnay, a professor in the Department of Molecular Biology and Microbiology at the CWRU School of Medicine, created an agent for PTPµ. His work spans 30 years of research into the cell molecules that regulate cancer cell progression and metastasis. The development of agents to improve the detection, image and treatment of tumors Dr. Brady-Kalnay founded NeoIndicate, a woman-owned and operated biotechnology company. Wellington, Ohio, United States of America.
General Manager and Director of Radiopharm Riccardo Canevari he said:
“We are committed to bringing PTPµ to a highly sensitive, tumor-specific agent for our clinical development, and we plan to enter Phase 1 studies in approximately 12 months. radiopharmaceutical therapy portfolio With this new PTPµ-targeted agent, many types of tumors can be detected.When limited treatment options and immediate therapies are needed, we focus on detecting and treating aggressive brain tumors with PTPµ-targeted agents.
“From a monetary point of view, the trading conditions are very attractive and can be absorbed in the forecasts of our existing cash flows.”
A research agreement will give Radiopharm the inventor and access to NeoIndicate.
The technology is backed by a wide, long patent portfolio until 2037.
Essential conditions of the sublicense agreement
Under the sub-license agreement, Radiopharm guarantees the right to use the agent that is the target of PTPµ combined with radiotherapy for the detection and treatment of human diseases. The sublicense agreement will start on the effective date June 9, 2022 and extends to the expiration or termination of the applicable patent rights.
The agreement sets a number of development milestones from the approval of the IND.
The cost of the sublease agreement and the payment of milestones are not significant to the Company in the initial period and are supported by the Company’s existing research budget. No additional or new funding is required to start the sublicense agreement. The sublease agreement may be terminated by agreement, or in accordance with the provisions of ordinary commercial resources.
The agreement includes industry standards, a single-digit percentage, and royalties on future sales of products developed under the agreement.
Agreements for the development of products using PTPµ under the Radiopharm sub-license; however, the CWRU retains ownership of the PTPµ targeting agent.
Authorized by the Executive Chairman on behalf of the Board of Directors of Radiopharm Theranostics Paul Hopper.
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1. Burden-Gulley SM, Gates TJ, Burgoyne AM, Cutter JL, Lodowski DT, Robinson S, Sloan AE, Miller RH, Basilion JP, Brady-Kalnay SM. A new molecular diagnosis of glioblastoma: detection of an extracellular part of the protein tyrosine phosphatase mucosa. Neoplasia. 2010; 12 (4): 305-16. PubMed PMID: 20360941; PMCID: PMC2847738.
2. Burden-Gulley SM, Qutaish MQ, Sullivant KE, Tan M, Craig SE, Basilion JP, Lu ZR, Wilson DL, Brady-Kalnay SM. Recognition of a single-cell molecule that migrates and invades tumor cells using a fluorescent probe aimed at the PTPmu receptor. Int J Cancer. 2013; 132 (7): 1624-32. doi: 10.1002 / ijc.27838. PubMed PMID: 22987116; PMCID: PMC3558593.
3. Covarrubias G, Johansen ML, Vincent J, Erokwu BO, Craig SEL, Rahmy A, Cha A, Lorkowski M, MacAskill C, Scott B, Gargesha M, Roy D, Flask CA, Karathanasis E, Brady-Kalnay SM. Nanoparticles targeting PTPmu label pediatric and adult invasive glioblastoma. Nanomedicine. 2020; 28: 102216. 2020/05/16 epub. doi: 10.1016 / j.nano.2020.102216. PubMed PMID: 32413511; PMCID: PMC7573884.
4. Herrmann K, Johansen ML, Craig SE, Vincent J, Howell M, Gao Y, Lu L, Erokwu B, Agnes RS, Lu ZR, Pokorski JK, Basilion J, Gulani V, Griswold M, Flask C, Brady-Kalnay SM. Tumor Molecular Imaging Using T1 Quantitative Mapping Technique Using Magnetic Resonance Imaging. Diagnostics (Basel). 2015; 5 (3): 318-32. doi: 10.3390 / diagnostics5030318. PubMed PMID: 26435847; PMCID: PMC4589153.
5. Johansen ML, Gao Y, Hutnick MA, Craig SEL, Pokorski JK, Flask CA, Brady-Kalnay SM. Quantitative molecular imaging with a single Gd-based contrast agent reveals specific tumor binding and retention in vivo. Anal Chem. 2017; 89 (11): 5932-9. doi: 10.1021 / acs.analchem.7b00384. PubMed PMID: 28481080.
6. Johansen ML, Perera R, Abinojar E, Wang X, Vincent J, Exner AA, Brady-Kalnay SM. Molecular imaging based on tumor ultrasound with Nanobubble Contrasting Agents for PTPmu Biomarkers. Int J Mol Sci. 2021; 22 (4). 2021/03/07 epub. doi: 10.3390 / ijms22041983. PubMed PMID: 33671448; PMCID: PMC7922223.
SOURCE Radiopharm Theranostics