Radionuclide therapies for cancer is a hot area that has been noticed through clinical advances, approved drugs and completed licensing deals. First North-listed Spago Nanomedical is in the process of entering clinical phase with its drug candidate 177Lu-SN201 which is expected to have wide use in this particular area.
Radiation therapy is one of the most effective methods for treating cancer. With today’s radiopharmaceuticals, a targeted radiation treatment with very high precision can be achieved with the help of tumour-directed particles or molecules. These so-called radionuclide therapies have, with recent clinical advances, resulted in approved drugs and several high-profile licensing deals.
It is in this landscape that Spago Nanomedical operates. Within its cancer treatment project Tumorad, the company is preparing the drug candidate 177LU-SN201 for the first studies in humans. The company aims to submit the trial application for a phase I/IIa study around the turn of the year. In the first part of the study, the company will test the candidate’s safety and tolerability. The company also expects to be able to see images of the distribution of the drug candidate in the body to establish that it reaches the tumour cells as intended.
Several of the newly approved treatments in the area are based on biological targeting of the tumours, i.e. that the drug binds to a specific protein that is expressed in the tumour. Spago Nanomedical’s method is based on functional nanoparticles accumulating in the tumour via a clinically validated mechanism – enhanced permeability retention. Learn more. Due to this so-called EPR effect, Tumorad is not dependent on the specific biology of the cancer cell, which means that it potentially has a wide range of uses in solid tumours and difficult-to-treat cancers.
Towards phase I/IIa
The company has found support for the treatment method in preclinical tumour models for breast and colorectal cancer. Data from these studies show significantly reduced tumour growth and prolonged survival with Spago’s drug candidate.
The company is also awaiting data from a preclinical model for ovarian cancer, which is a potential focus for the second part of the clinical study. If the outcome is favourable, the company may choose to apply for orphan drug designation for the candidate within this indication. Learn more.
License deals and capital rounds in hot area
The major pharmaceutical companies have realised the potential of the new cancer treatments and have positioned themselves in the field.
Swiss Novartis is one of them – in 2017 it acquired French Advanced Accelerator Applications for USD 3.9 billion. The deal gave Novartis access to a platform technology for radionuclide therapies and the drug Lutathera, which in 2021 had a turnover of USD 475 million. The following year, Novartis acquired the Lu-PSMA-617 program from Endocyte for USD 2.1 billion, which in the spring of 2022 was approved by the FDA under the name Pluvicto.
Other big pharma companies are also competing for space in the market. In June 2021, German Bayer acquired the companies Noria and PSMA Therapies for undisclosed amounts to expand its portfolio and to complement its radionuclide treatment Xofigo, which in 2021 had sales of EUR 261 million.
In April last year, German ITM raised a convertible loan of USD 109 million to, among other things, run its phase III project in gastrointestinal neuroendocrine tumours.
American Aktis has Novartis and Bristol Myers Squibb among the financiers. Recently, Aktis received support also from Merck’s venture company which participated in a capital raise of USD 84 million to continue developing its biological radionuclide platform that targets several tumour types.
Also of note are the Belgian company Precirix, which earlier this year raised EUR 80 million, and the American company Curie Therapeutics, which in December 2021 raised USD 75 million, both in issues aimed at specialist investors.
In conclusion, there is a significant interest in the area from the pharmaceutical industry and the market is following the ongoing development work in Spago Nanomedical. Currently, the company’s potential is priced at approximately SEK 84 million according to the market value at First North.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.