CEP Program

(Chemotherapy Enhancement Program)

Veyonda^® combined with chemotherapy

CEP-1

Phase-1 multi-centre study – complete

CEP-1 was a two-part study:

• In part 1 Veyonda (400 or 800 mg) was administered alone
• In part 2 Veyonda was administered in combination with carboplatin.

Of the 9 patients allocated to the higher dose (800 mg) of Veyonda, 5/9 (56%) showed stable disease (no significant tumour growth and no new tumours) or a partial response (significant shrinkage of measurable lesions) over the 8-month term of the study.

Findings from this study have been published in the independent peer-reviewed Journal Current Therapeutic Research in 2021.^[i]

CEP-2

Phase-1 multi-centre study - closed

CEP-2 was a Phase 1, open-label, study of Veyonda administered to cohorts of patients being treated with doxorubicin for the treatment of metastatic soft tissue sarcoma.

Patients in the United States with a range of soft tissue sarcomas were enrolled across six US sites to be treated with the Veyonda / doxorubicin combination as a first-line treatment.

Soft tissue sarcomas are generally very aggressive cancers. Up to 50% of high-grade sarcoma patients develop metastases and die within 12 months. They are defined as a rare cancer, with fewer than 20,000 new cases diagnosed in the US in 2021.

Veyonda was granted US FDA Orphan Drug Designation (ODD) for the treatment of sarcoma. This confers a period of market exclusivity and a number of financial and regulatory benefits.

ODD confers the following benefits:

• Seven years of market exclusivity
• Waiver of New Drug Application fees (value of approximately $2.9 million in 2021)
• Opportunities for grant funding from the Office of Orphan Products Development
• Regulatory guidance and assistance from the FDA with the drug development process

The CEP-2 Safety Steering Committee found that a dose of Veyonda up to 1200mg was safe.

The study is now closed.

^[i] Kiknavelidze K, Shavdia M, Chikhladze N, Abshilava L, Messina M, Mautner G, Kelly G. NOX66 as Monotherapy, and in Combination With Carboplatin, in Patients With Refractory Solid Tumors: Phase Ia/b Study. Curr Ther Res Clin Exp. 2021 Mar 28;94:100631. DOI: 10.1016/j.curtheres.2021.100631