USFDA approves Veyonda + doxorubicin: Noxopharm

USFDA approves Noxopharm’s Veyonda in combo with doxorubicin to treat soft tissue sarcomas

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Noxopharm, a clinical-stage Australian oncology drug development company, announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Veyonda for combination treatment with doxorubicin in patients with soft tissue sarcomas.

“Based on preclinical and clinical data, the FDA’s approval of this IND is validation of the clinical potential of Veyonda,” said Noxopharm CMO Gisela Mautner, M.D., Ph.D. “Further, it means that Veyonda has met stringent FDA standards for safety and tolerability.”

“While the Company’s resources and energies are primarily focused on bringing a treatment for late-stage prostate cancer to market, this IND grant for a less common cancer type advances that commercial objective,” said Noxopharm CEO Graham Kelly, Ph.D.

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“The recent IND approval process has familiarized the FDA with Veyonda ahead of IND applications for more advanced DARRT and LuPIN study submissions. It also opens the door to Veyonda’s use in the US, where patient demand has been growing.”

DARRT and LuPIN are ongoing investigations in which combination therapies with Veyonda are exhibiting promising interim results for the treatment of late-stage, progressive prostate cancer resistant to other treatments.

“This IND grant is an important step toward achieving a strategic partnering arrangement,” Kelly said.

“With the emerging clinical data and growing evidence that Veyonda is a uniquely acting immuno-oncology drug candidate designed to restore immune function to cold tumors, we are confident that the industry will recognize the considerable opportunities in the adjunctive benefits of Veyonda.”

Veyonda is a suppository dosage form of idronoxil, a first-in-class inhibitor of sphingosine-1-phosphate (S1P). By inhibiting the overexpression of S1P-driven pro-survival pathways in solid tumors, idronoxil is designed to sensitize cancer cells to the anti-cancer effects of drugs such as doxorubicin, as well as to radiation.