Noxopharm Ltd (ASX:NOX) traded higher after revealing that a CEP-2 study will begin shortly for the US Food and Drug Administration (FDA) approved Investigational New Drug (IND) application for Veyonda® in first-line sarcoma treatment.
The study, which is part of the company’s Chemotherapy Enhancement Program (CEP), is set to proceed with a contract research organisation appointed.
IND was granted by FDA earlier this year on evidence that Veyonda may increase generally poor response rates of sarcoma cancers to chemotherapy.
Shares higher
The contract research organisation will oversee the study designed to provide proof-of-principle of the ability of Veyonda to enhance chemotherapy and Noxopharm's appointment marks the company’s commitment to act on this valuable opportunity.
Shares were as much as 20.6% higher today to A$0.585 while the company's market cap is approximately A$135.3 million.
"CEP program a key part"
Chief executive officer Dr Graham Kelly said: “Soft tissue sarcomas are in that basket of cancers where there has been remarkably little advance in survival statistics over the past few decades, and the horizon looks to hold little change.
“What we have seen to date with Veyonda gives us confidence that a combination of Veyonda and doxorubicin has the capacity to make that change.
“We want to see Veyonda eventually used as a standard companion drug in cancer therapy - that is behind the company’s four-pillars oncology strategy of which the CEP program is a key part.”
Proof-of-principal indication
The company has selected soft tissue sarcomas as its proof-of-principle indication for demonstrating chemotherapy enhancement by Veyonda, following the US FDA approval of the IND application for Veyonda in combination with common chemotherapy drug, doxorubicin, for patients with soft tissue sarcomas.
Sarcomas have very limited treatment options with only an estimated 14% of soft tissue sarcomas responding to chemotherapy. It is a rare cancer, with an estimated 13,400 new cases to be diagnosed in the US in 2021.
Noxopharm is confident that Veyonda, with its unique mix of immunotherapy actions, has the means to change soft tissue sarcomas responding to chemotherapy and that the majority of chemotherapy drugs in use today would benefit from being combined with Veyonda, thereby creating a multi-billion dollar drug opportunity in its own right.
Establishing Veyonda as standard booster
The aim is to establish Veyonda as a standard booster of all four major forms of cancer therapy – chemotherapy, external radiotherapy, internal radiotherapy and checkpoint inhibitor therapy.
Each of those four sectors represents a major commercial opportunity, but collective success in two or more sectors stands to raise the potential industry value of Veyonda immeasurably.
The CEP-2 study is a key plank in that strategy because after 50 years, chemotherapy still remains the backbone of cancer therapy, a position anticipated to continue for the foreseeable future with the global chemotherapy market widely predicted to reach US$50+ billion by 2024.
CEP-2
CEP-2 builds on the encouraging outcomes of the CEP-1 pilot study where the chemo-enhancing effect of Veyonda was used to lower dosages of chemotherapy (carboplatin) in patients with advanced solid cancers (breast, ovarian, lung, prostate).
Further study details:
- CEP-2 builds on that positive experience by using higher dosages of Veyonda (expected to provide a greater chemo-enhancing effect) and patients undergoing first-line treatment (tumours expected to respond better to combination treatment);
- CEP-2 is a Phase I study where approximately 40 patients with a range of soft tissue sarcomas will receive the Veyonda/doxorubicin combination as a first-line treatment;
- Global clinical research organisation, Parexel® Biotech, has been engaged to oversee the study and site selection is underway in the US and Australia. The clinical protocol has been established and the study will start enrolling patients following site selection and ethics approvals; and
- The company’s strong cash position around a successful $23 million capital raise in December 2020 means it can proceed with this study, although the company continues to seek global sources of non-dilutive funding.
More details on the CEP-2 study will be shared as the project progresses.
This study is dedicated to the memory of Jennie Young, the second patient to receive Veyonda.
Jennie had metastatic leiomyosarcoma that was considered by her doctors to have successfully responded to a Veyonda/doxorubicin combination when given on compassionate use grounds.
That experience, backed by considerable positive pre-clinical data, forms the rationale for conducting this study.