Noxopharm Ltd (ASX:NOX) has received strong validation of its science with an A$8.79 million grant from the Australian Government’s Medical Research Future Fund (MRFF) that represents one of the largest of its kind ever awarded by the fund to a biotechnology company for a single drug program.
The 3-year grant will fund the company’s CEP-2 study assessing the combination of Veyonda® and standard of care chemotherapy drug, doxorubicin, for the treatment of soft tissue sarcomas (STSs). The grant is intended to cover the cost of the trial, releasing the funds for other Noxopharm projects.
The company is now well funded to pursue its pipeline, following a successful A$24 million capital raise in December last year and an upcoming R&D rebate.
“External validation”
Noxopharm CEO Dr Graham Kelly said, “This grant not only provides substantial non-dilutive funding to Noxopharm, but it also lends external validation to our work. It also is testament to the extraordinary efforts and talents of our scientific and clinical teams.
“The MRFF awards a limited number of grants, funding only those projects that are highly rated against a series of strict criteria that are perceived to be capable of turning research findings into real health benefits.
“It is gratifying that this panel of experts saw the potential therapeutic benefit that the CEP-2 study has to cancer patients in Australia, and worldwide, and the potential financial benefit the opportunity has to Australian industry.
“It needs to be stressed that the Veyonda/doxorubicin/sarcoma combination is not something we see being limited to this one combination. We view the CEP-2 combination as providing proof-of-concept, potentially opening the way for Veyonda to be used more broadly in combination with many other chemotherapeutics in a wide range of cancers.
“With chemotherapy remaining the workhorse of cancer treatment, anything that boosts its effectiveness without sacrificing safety will be a major advancement in the fight against cancer.
“Fittingly, in this fight, we have dedicated this trial to Jennie Young, a lady who bravely fought sarcoma and, in the process, helped us better understand the potential benefit of Veyonda.”
Chemo-enhancing potential
Noxopharm is an Australian clinical-stage drug development company. The company is focused on new treatments for a broad range of solid tumour cancers and one for septic shock.
The aim of the current study 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” according to Noxopharm.
The CEP-2 study is foundational in that effort, with chemotherapy remaining the standard treatment of cancer therapy, a position considered likely to continue for the foreseeable future with the global chemotherapy market estimated at more than US$50 billion.
Noxopharm is confident that most chemotherapy drugs in use today would benefit from being combined with Veyonda, thereby creating a multi-billion-dollar drug opportunity.
The company also believes there is an additional commercial imperative in that the current market is dominated by drugs that either are off-patent or nearing the end of their patent life.
Combining drugs with Veyonda to achieve greater anti-cancer potency offers the potential for renewed patent life, a highly prized outcome in the pharmaceutical industry.
Noxopharm has a patent application relating to the use of idronoxil (Veyonda active component) in combination with certain chemotherapy drugs and cancer types, that has been granted in Europe, Japan and Australia as well as other territories.
Sarcoma
Noxopharm has selected soft tissue sarcomas as its proof-of-principle indication for demonstrating chemotherapy enhancement by Veyonda;
- In part, because sarcoma is a rare cancer (estimated 13,400 new cases to be diagnosed in the U.S. in 2021) and marketing approval for rare cancers offers important commercial incentives including potential Orphan Drug Designation carrying valuable funding benefits/regulatory review benefits/7-year market exclusivity;
- In part because there is little apparent competition; and
- In part because many sarcomas respond poorly to chemotherapy, including the standard of care, doxorubicin, and the Company has compelling pre-clinical data showing strong enhancement of doxorubicin by idronoxil.
CEP-2
CEP-2 builds on encouraging results from the CEP-1 pilot study with higher dosages (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 45 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 U.S. and Australia. The clinical protocol has been established and the study will start enrolling patients following site selection and ethics approvals.
Medical Research Future Fund
The MRFF is a A$20 billion investment fund supporting health and medical research and innovation to improve the health and wellbeing of Australians.
The Rapid Applied Research Translation Initiative forms part of the MRFF and is investing in research projects that turn research findings into real health benefits that help patients, by bringing together expert groups in health and medical research.
Trading halt
Noxopharm is now in a trading halt in respect of an update on the Australian Government grant.
Securities will remain halted until the earlier of the start of normal trading on Wednesday, November 17, 2021, or when the announcement is released to the market.