Noxopharm (NOX:ASX) has announced the US FDA has approved the Investigational New Drug (IND) application for Veyonda for combination treatment with doxorubicin in patients with soft tissue sarcomas.
According to Gisela Mautner, MD, PhD, Noxopharm chief medical officer, “The IND approval, based on pre-clinical and clinical data presented to the FDA, is validation of the clinical potential of Veyonda. In addition, Veyonda has met the very high standard set by the FDA for being a safe and well-tolerated drug.”
The IND approves a Phase 1b study involving a combination of Veyonda and doxorubicin in adults with soft tissue sarcomas.
CEO Graham Kelly PhD said, “Bringing Veyonda to market for late-stage prostate cancer remains our commercial imperative. This IND grant for a less common cancer type contributes to that overall commercial objective in several ways.
"First, because the IND approval process has familiarised the FDA with Veyonda ahead of IND applications for more advanced DARRT and LuPIN study submissions, and second because it opens the door to the use of Veyonda in patients in the US from where the Company increasingly is receiving patient enquiry.”
“This IND grant is just one step in our objective of achieving a strategic partnering arrangement. Immuno-oncology therapies are the current dominant area of development in the cancer field, with the particular need for therapies that restore immune function to tumours emerging as a prime area of global R&D and M&A activities. This follows the recent awareness of many human tumours being so-called cold, or devoid of immune function, limiting the effectiveness of current immuno-oncology drugs,” continued Kelly.
“Our growing pre-clinical and clinical data points to Veyonda® as a uniquely acting immuno-oncology drug candidate capable of meeting this need. The Company is actively positioning itself to take advantage of this opportunity.”