Development

Radiopharma
Development

NorthStar Radiopharmaceutical Development Support
Radiopharmaceuticals are very different to traditional pharmaceutical products. Developing radiopharmaceuticals for imaging and therapeutic purposes requires specialized knowledge, skills and infrastructure. NorthStar is ideally positioned to help pharmaceutical companies develop molecules that will optimally bind with a range of radioisotopes, and to ensure the binding process is efficient, reliable and repeatable.

NorthStar has several development programs in place that demonstrate this capability.

FibroScint (Tc-99m F4A) is a fibrin-targeted, peptide compound labeled with the radioisotope technetium-99m (Tc-99m) for SPECT imaging of conditions such as Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT) and Acute Coronary Syndrome (ACS). NorthStar licensed the global commercial rights to this product, and made a minority investment in Capella Imaging, in 2020. The licensing agreement called on NorthStar to support the development of the product, and NorthStar Nuclear Pharmacists and Radiochemists have led work to make the compound usable in a commercial radiopharmacy by making the formulation and binding process much faster and more reliable, and with a high yield. NorthStar is also working with Capella to develop an eIND such that initial clinical studies can start in the near future.

NorthStar formed a 50:50 collaboration with Monopar Therapeutics in early 2020, with an initial vision to combine Monopar’s uPAR binding agent NMPR-101 with a therapeutic radioisotope such as Ac-225. Given that cells infected with COVID-19 expressed receptors with which MNPR-101 would bind strongly, these cells could be selectively destroyed by an alpha emitting radioisotope. NorthStar provided the expertise related to binding radioisotopes with pharmaceuticals as well as procuring and transporting the Radioisotopes. This work has led to two patents related to binding being published in 2022. Due to market and clinical trial dynamics, both companies agreed in early 2022 to also purse Oncology indications since uPAR is also expressed by multiple cancers. The program is expected to start Phase 0 imaging studies in a range of Cancer indications later this year, based on the strong results seen in images from multiple animal model cancers. Successful completion of the Phase 0 imaging studies during 2023 will provide a very compelling proof of concept since with Radiopharmaceuticals we know that “if you can see it, you can treat it”. Initial cancer target selection will occur once Phase 0 data is analyzed.

NorthStar entered into an agreement with Inhibrx to select a range of Inhibrx designed single domain antibodies that would both bind well with cancer cell receptors and with both therapeutic and diagnostic radioisotopes. The first four candidates are in the process of being selected. NorthStar will focus on the radiochemistry, radiopharmacy, patient dose manufacture and logistics while Inhibrx will focus on pharmaceutical development and clinical trial work. Both companies envisage continuously assessing candidate compounds to develop a steady flow of potential Radiopharmaceuticals that could be of interest to Pharmaceutical Companies.

Our Mission

PROVIDING PATIENTS GLOBAL ACCESS TO GAME-CHANGING RADIOPHARMACEUTICALS

NorthStar expects to add more agreements in the coming months and years. Companies interested in partnering with us should contact RPTinfo@northstarnm.com.