Noxopharm receives FDA investigational new drug approval for Veyonda

Noxopharm investigational new drug IND FDA Veyonda ASX NOX approval
Noxopharm is on course to conduct a phase 1b study involving a combination of Veyonda and doxorubicin in adults with soft tissue sarcomas.

Oncology drug development company Noxopharm (ASX: NOX) has received FDA investigational new drug (IND) approval for using its Veyonda in combination with doxorubicin to treat patients with soft tissue sarcomas.

IND allows Noxopharm to  go ahead with a phase 1b study involving a combination of Veyonda and doxorubicin in adults.

Importantly, the news provides a significant boost for Noxopharm’s aspirations to develop Veyonda into a major new drug used in the treatment of late-stage cancers, with the company selecting prostate cancer as its most viable initial target of research.

Taking Veyonda to market for late-stage prostate cancer remains the company’s “commercial imperative” with IND approval opening the door for Noxopharm to offer Veyonda to US patients in further trials.

“This IND grant for a less common cancer type contributes to that overall commercial objective in several ways,” Noxopharm chief executive officer Dr Graham Kelly said.

Dr Kelly explained that the IND approval process allowed the FDA to familiarise itself with Veyonda ahead of IND applications for more advanced DARRT and LuPIN study submissions.

Furthermore, approval means Veyonda can now be provided to selected US patients thereby helping to appease the growing number of enquiries being made by people seeking cancer treatment.

This time last week, Noxopharm reported positive interim results from its LuPIN phase I/II clinical trial into end-stage prostate cancer that 47% of patients were well enough to receive all six cycles of therapy, indicating a durable response.

Moreover, the interim trial data indicated Veyonda was able to deliver a meaningful anti-cancer response for at least 50% of patients with stage 4 of any form of cancer, a feat which Dr Kelly hailed as “remarkable”.

Veyonda as a treatment option

Veyonda has been designed to treat patients with late-stage, progressive and metastatic cancer that have limited survival prospects.

According to Noxopharm, the clinical objectives are not to halt or regress cancer progression but rather to attain greater pain relief, generate a better quality of life and extend survivability in patients where palliative care is the only treatment option.

As a drug, Veyonda is on course to deliver on these clinical objectives with today’s FDA approval serving as validation of the clinical potential of Veyonda, according to Noxopharm’s chief medical officer Gisela Mautner.

Ms Mautner also reaffirmed that Veyonda has met the very high standard set by the FDA for being a safe and well-tolerated drug.

Veyonda is a suppository dosage form of idronoxil, a first-in-class inhibitor of sphingosine-1-phosphate (S1P) – a key secondary messenger in cells, with dual roles of activating major pro-survival signalling pathways and regulating immune cell trafficking in tissues.

Research has shown that many solid cancers over-express S1P, thereby supporting unregulated tumour growth and suppressing immune cell populations in tumours.

Noxopharm believes that by inhibiting the over-expression of S1P driven pro-survival pathways, idronoxil could sensitise cancer cells to the anti-cancer effects of drugs such as doxorubicin, as well as to radiation.

By inhibiting the over-expression of S1P-driven exclusion of immune cells from tissues, idronoxil could potentially restore normal trafficking of immune cells.

“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 research and development and merger and acquisition activities,” said Dr Kelly.

Noxopharm shares were up 34% to $0.315 in morning trade.