Noxopharm White Paper

NOXOPHARM L IMITED White Paper 14 Veyonda® – CEP program continued CEP-1 Phase-1 multi-centre study investigating Veyonda alone, and in combination with carboplatin for patients with refractory solid tumours of the breast, head and neck, lung, prostate or ovaries. CEP-1was amulticenter, open-label, nonrandomized, 2-dose cohort study of NOX66 asmonotherapy (Phase 1a) and in combination with carboplatin (Phase 1b). Patients with refractory solid tumors who had stopped responding to standard treatments were eligible to participate. Twenty patients were screened and 19 enrolled in the study. They were divided into 2 groups: cohort 1 (n = 8) received 1 suppository daily (400 mg) and cohort 2 (n = 11) received 2 suppositories daily (800 mg) for 14 consecutive days followed by 7 days of rest. Patients who completed Phase 1a without significant toxicity continued to Phase 1b, where NOX66 (Veyonda) was combined with carboplatin for up to 6x 28-day treatment cycles, with low-dose carboplatin (600 mg) for cycles 1B through 3B and standard dose carboplatin (900 mg) for cycles 4B through 6B. The main outcomes assessed were safety (n = 18) and efficacy signals (n = 14). The findings of this study were published in peer-reviewed journal Current Therapeutic Research 2021, vol 4. https://doi.org/10.1016/j.curtheres.2021.100631 Tumour response was evaluated after 2 and 5 cycles of Veyonda/carboplatin combination therapy. The response data is summarized below. Dose Cohort Assessment time n PR SD PD COHORT 1 Cycle 3 5 0 4 1 Cycle 6 2 0 1 1 COHORT 2 Cycle 3 9 0 7 2 Cycle 6 6 1 4 1 CEP-2 Phase 1 multi-center study - dose escalation and dose expansion study of Veyonda with doxorubicin in patients with soft tissue sarcoma. CEP-2 has been granted approval from the United States FDA under the IND (Investigational New Drug) process. This approval was based upon evidence that Veyonda may improve the response rate of soft tissue sarcoma, a cancer type that generally responds poorly to standard chemotherapy. This study will use higher doses of Veyonda than were used in CEP-1. Patients with a range of soft tissue sarcomas will be recruited and will be treated with the Veyonda / doxorubicin combination as a first-line treatment. CEP-2 is in planning stage with an established clinical protocol and site selection is underway. The study will start following ethics review.