Radiopharm Theranostics Ltd (ASX:RAD) continues to see accelerated patient recruitment for clinical development of AVβ6-Integrin, currently under compassionate use in Europe, in patients with pancreatic cancer and head and neck disease.
The company has now dosed 31 patients, up from 18 patients dosed less than two months ago.
RAD managing director and CEO Riccardo Canevari said: “We are excited by the possibility to bring new imaging and therapeutic solutions to patients suffering from these devastating diseases.
“This is [in] line with the ambition of Radiopharm Theranostics to play a critical role in fighting cancer, through innovative radiopharmaceutical therapies, in areas of high unmet medical need.”
Plans brought forward
Based on the accelerated recruitment, RAD is bringing forward plans to start AVβ6-Integrin clinical development in the US.
Preliminary investigational new drug (IND) talks with the US Food and Drug Administration (FDA) are slated to start in the next few weeks.
AVβ6-Integrin is a strong selective ligand for a cell surface protein called αvβ6-integrin and can accumulate in tissue areas characterised by high αvβ6-integrin level.
There is compelling evidence that αvβ6-integrin is over-expressed in many of the most challenging cancers. AVβ6 offers noteworthy performance for radiolabelling with 68Ga and is a promising candidate for early detection of the targeted conditions by PET imaging.
Deadly disease with unmet need
The two diseases being treated have a high unmet medical need and require new imaging and therapeutic solutions.
Based on available US data, although pancreatic cancer is a relatively rare cancer, it is so deadly it is now on track to become the second leading cause of cancer-related deaths by 2040, accounting for about 3% of all cancers, but 7% of cancer deaths.
Overall, only one person in 10 diagnosed with pancreatic cancer survives five years.
TerraPower deal
RAD has also provided an update on the terms of its agreement with TerraPower for the supply of Actinium-225.
Under the agreement, TerraPower’s subsidiary, TerraPower Isotopes LLC, will supply Actinium-225 to RAD, with the initial order expected to be filled between April and July of this year.
RAD will deploy Actinium-225 in drug trials involving targeted alpha therapy in multiple disease areas.
In particular, the company plans to use the isotope in a Phase 1 trial of its asset RAD402 in prostate cancer patients.
Terms of the agreement
The costs associated with the purchase of Actinium-225 will be met from existing funds and are not material to RAD’s annual budgeted expenditure.
The supply agreement is for an initial period of three years and may be extended for a further two successive one-year periods unless agreed otherwise by either party. Cancellation provisions are at industry standard rates.
The rights to all data generated and all inventions and discoveries made or conceived from the clinical trials will be retained by RAD as a client of TerraPower.
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