THERAGNOSTICS SIGNS AGREEMENT WITH ASTRAZENECA
LONDON, UK, 05 September 2019 – Theragnostics, which is developing molecular radiotherapy for imaging and treating a broad range of cancers, announces a licence agreement with AstraZeneca (LSE/STO/NYSE: AZN) for intellectual property (IP) that enables Theragnostics’ freedom to operate globally in the diagnostic field of certain selected radionuclide-labelled PARPi (Poly (ADP-Ribose) Polymerase inhibitors) with an option to an exclusive licence for freedom to operate globally in the therapeutic field of certain selected radionuclide-labelled PARPi.
PARP inhibitors are a novel class of oncology drugs that block an enzyme, Poly (ADP-Ribose) Polymerase, that cancer cells use in response to DNA damage, both endogenous and as caused by treatments such as chemotherapy.
Theragnostics’ technology platform enables the development of molecular radiotherapy based on a PARPi for imaging and treating cancer. Theragnostics modifies a PARPi drug molecule with a radioactive atom to create a radionuclide PARPi (rPARPi). This can either be used to image PARP in a cancer patient for diagnostic use or the radioactive isotope can be used to deliver a therapeutic dose of radiation into tumour cells, which offers the potential to molecularly target the radiation in order to hit and kill tumour cells whilst avoiding damage to healthy cells and associated side effects.
The potential market for PARP inhibitors is large. There are at least four approved conventional pharmaceutical PARPi on the market with new and expanded indications being approved in several markets in recent months, opening up a multibillion-dollar opportunity. Analysts estimate that peak sales for the PARPi class could reach $4.8 billion by 2023 (source, Evaluate Pharma), a figure which only includes indications in ovarian, breast and prostate cancer. Analyst PARPi peak sales forecasts could rise as newer indications and label expansions are included within estimates. PARPi is a therapeutic class that could be applicable in up to 40% of tumours with varying DNA Damage Response associated mutations or dependencies and may have additional efficacy in combination with chemotherapy or radiotherapy.
Gareth Smith, Chief Operating Officer of Theragnostics, said:
“We believe that a radionuclide PARPi therapy will work independently of DNA mutations associated with heightened PARPi activity, such as BRCA1/BRCA2 and will avoid development of treatment resistance. Therefore, the number of patients benefiting from PARPi therapy could significantly expand.”
Greg Mullen, Chief Executive Officer of Theragnostics, said:
“Theragnostics’ strategy is to develop novel diagnostic imaging agents and targeted radionuclide therapies to improve treatment of a range of cancers. This agreement with AstraZeneca strengthens our IP estate and enables us to accelerate the development of our rPARPi therapy and diagnostic portfolio which has the potential to offer new and expanded treatment options to patients in a number of cancers.”
The agreement follows Theragnostics’ global licensing agreement for rPARPi with Memorial Sloan Kettering Cancer Center (MSK), USA, a world leading facility in oncology research and cancer treatment in February 2019. Together these agreements give Theragnostics flexibility and expanded capabilities to design and develop a broad range of both diagnostic and therapeutic molecular radiotherapies.
Theragnostics is a private clinical-stage pharmaceutical company developing precision oncology products for diagnostic medical imaging and targeted radionuclide therapy. The Company has completed a number of proof-of-concept phase I and II clinical trials for several radionuclide diagnostics and targeted therapies.
For more information, please visit www.theragnostics.com.
rPARPi was invented and developed within the lab of Thomas Reiner, PhD, at Memorial Sloan Kettering Cancer Center, New York, where the positron emission tomography (PET) agent [18F]PARPi is currently recruiting patients in a Phase I clinical trial in head and neck cancers. The core structure of the developed rPARPi agents allow for their application as theragnostic agents – they can be labelled with diagnostic isotopes as well as with isotopes to enable cancer therapy.
Poly (ADP-ribose) polymerase (PARP) enzymes are involved in normal cellular processes including DNA damage response. PARP activity and expression are up-regulated in tumour cells and through the inhibition of PARP it is possible to render cancer cells unable to respond effectively to DNA damage, such as DNA single-strand break. Currently approved PARP inhibitors also actively trap PARP onto DNA resulting in the generation of DNA double-strand breaks that can result in cancer cell death. PARP inhibitors are a rapidly emerging drug class showing promise as anti-cancer agents in a range of tumour types.