This week, a Nature Biotechnology news article reported the recent significant impact of targeted radiotherapy / theranostics in the pharmaceutical industry. This is showcased by recent acquisitions of several small to medium sized biotech entities by companies such as Novartis and AstraZeneca. For example, Endocyte [$2.1 billion valuation], RayzeBio, PointPharma and Aktis.
Radiopharmaceuticals increase efficiency and lower risk of drug development.
Former Endocyte CEO Mike Sherman states in the article “Endocyte’s quick turnaround was made possible by a virtue of radiotherapeutic drug development. You can de-risk these programs pretty early.”
Drug developers can collect in-human pharmacokinetic data by clinical nuclear and fluorescent molecular imaging, using weakly radioactive molecules or near-infrared fluorescent dyes tagged to their therapeutic compound of interest directed at the same cancer target as the therapeutic agent alone. Subsequently, treatment protocols can be designed based on the knowledge of the precise amounts of drug absorbed by both tumor and normal tissue based on the imaging data. Any resulting toxicities are thus more predictable and manageable than with most other drug platforms. “A lot of that work can be done before you ever treat a patient with the more radioactive therapeutic agent,” said Sherman, “so it’s a faster path to development.”
First in-human data.
The same method of work is used in Proof of Concept (PoC) studies. Otherwise referred to as first in-human studies. In these studies, fast in-human data is obtained by applying advanced nuclear and/or fluorescent molecular imaging technologies. It is based on using the FDA/EMA approved microdosing concept in the development of targeted radiotherapies, among other targeted therapies. The imaging approach de-risks drug development programs and increases the speed of obtaining relevant clinical data in early clinical phases. Simultaneously, it creates the possibility of making a quantum leap into relevant and successful phase 3 registration trials.
At TRACER we believe that the R&D sweet spot can be found in the early stages of drug development. This sweet spot can be optimized by using nuclear and fluorescent molecular imaging techniques. Consequently, it boosts efficiency, cost-reduction and early go/no-go decision making for (precision) drug development. The push into radiopharmaceuticals, as described in the Nature article, confirms that the pharmaceutical industry is adopting this view more and more in a very successful pace.