Noxopharm Limited (ASX: NOX) has released July 2019 edition of its Newsletter called ‘Versatility’.
The clinical-stage drug development company, Noxopharm reports on the progress of its lead anti-cancer drug candidate Veyonda® achieved over the past six months. The drug candidate, recognised for its apparent versatility (for use with both radiotherapy and chemotherapy) is currently being investigated for its potential in the treatment of prostate cancer and is also planned to be tested in sarcoma for better treatment outcomes.
Veyonda® has been established as an innovative dosage formulation of the experimental anti-cancer drug, idronoxil, and is being tested for its use across chemotherapy, radiotherapy and could be for potential use with some forms of immuno-oncology, where all the three treatments are viewed as the three pillars of cancer therapy for the foreseeable future.
STING- A looming new force in cancer therapy that NOX aims to ride
Noxopharm’s pre-clinical and clinical research is now looking at the potential use of the so-called STING mechanism that has created a lot of excitement in the global pharma world. There currently is a lot of activity among pharmaceutical and biotech companies to develop a drug that re-activates the STING process in tumours throughout the body to fight cancer, but preferably in a well-tolerated way.
STING stands for Stimulating Interferon Genes. It is a mechanism that triggers the body to make interferon (a signalling protein that the human body uses to alert immune cells). The aim is to get a tumour to make interferon which then goes on to pull immune cells into the tumour and activates them, with the result that you now have a ‘HOT’ tumour. A drug that activates STING in order to convert tumours into a “HOT” state, and then hopefully become responsive to an immuno-oncology drug, is known as a “STING agonist”. A drug’s ability to cause this change is the latest goal among some pharma and biotech companies.
Noxopharm believes that idronoxil (Veyonda®’s active compound) has the potential to activate this STING mechanism and Veyonda®may be a drug candidate that could do so in a well-tolerated way. Working with a number of Australian and overseas researchers in this emerging field, NOX has confirmed that idronoxil (IDX) is a potent activator of the innate immune system involving natural killer (NK) cells and monocytes and certain lymphocytes.
Idronoxil Impact as unique Immuno-Activator (Source: Company’s July Newsletter)
The encouraging results in ongoing clinical trials has been further showing the possibility of Veyonda® to become a potential blockbuster drug in the cancer world. Noxopharm believes that to the best of its knowledge, besides Mavupharma’s pre-clinical drug candidate MAVU-104, (now newly acquired by AbbVie) Veyonda® is the only other STING agonist under development, that intends to deliver a STING effect on a general basis throughout the body, but limited only to cancer cells.
This could potentially solve the big problem in the biotech industry where most of the compounds under drug development do not distinguish between cancer cells and healthy cells, thus causing often severe well-known side-effects during treatment. In such a scenario, Noxopharm’s Veyonda®, aiming to deliver a STING effect limited only to cancer cells, may potentially open the doors for the company for the future use of Veyonda® in the immuno-oncology market. The sales of immuno-oncology drugs are expected to be about US$15 billion in 2019, rising to US$34 billion in 2024, as per the company’s Newsletter information.
In this edition of the Newsletter, Noxopharm also further highlighted the progress of its ongoing LuPIN trial and the promise coming from combining Veyonda® with a radiopharmaceutical treatment in late-stage prostate cancer.
Highlights of ongoing LuPIN Trial
Based on the interim LuPIN-1 trial data released recently, NOX has said that Veyonda® appears to increase the effectiveness of the experimental radioactive drug 177Lu-PSMA-617, which is administered by intravenous injections.
The recent read-out of the LuPIN-1 interim data showed that over half of the men (9/16) were being able to complete their full course of 6-cycles of treatment, all in a generally well-tolerated way. The treatment involved the combination of 177Lu-PSMA-617 (injected) with either 400 mg or 800 mg Veyonda® in the men with late-stage, progressive metastatic castration-resistant prostate cancer (mCRPC).
Noxopharm’s approach intends for the radioactive payload to destroy almost all the prostate cancer cells scattered throughout the body by delivering radiation in a highly targeted way. The method helped the trial to date, achieve an overall survival rate of 100% at 3 months; 93% at 6 months and at the time of reporting the data, 81% at 12 months and with a PSA response rate of 69% in the patients trialled so far, at a stage where some studies have shown that most of the patients under treatment with 177Lu-PSMA-617 alone, have relapsed before completing their full course of treatment.
The red bars show men who did not have a decrease in PSA while the blue bars show the men who did. This ‘waterfall’ graph represents the change in PSA level relative to starting levels. (Source: Company July Newsletter)
These interim results were presented recently by Principal Investigator of the study and Director of Theranostics and Nuclear Medicine at St Vincent’s Hospital, Associate Professor Louise Emmett, at the 2019 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Further, 177Lu-PSMA-617 technology (used with Veyonda® in this trial) is licensed by its German inventors to Endocyte Inc, a wholly-owned subsidiary of Novartis since being acquired in late-2018 for US$2.1 billion.
Noxopharm plans to investigate Veyonda® for the treatment of Sarcomas
Noxopharm also discussed in the July Newsletter the burgeoning need for new treatment options for sarcoma of all forms in both adult and children, including agents that improve the current therapies. Sarcomas are malignant cancers of the body’s connective tissue, which are broadly classified according to whether it arises in soft tissues or bone.
The company, therefore, is planning a trial for sarcomas, with the aim to broaden the clinical value of Veyonda® by improving outcomes in sarcoma. Although sarcoma is classified as a rare cancer, the unmet clinical need in these cancers is substantial, and regulators such as the FDA, through its Office of Orphan Products Development (OOPD), offer a range of incentives for sponsors to develop products for rare diseases. These incentives include grants, tax incentives, research design assistance, FDA fee waivers, extended patent life and 7-year market exclusivity. (NOX ASX announcement 29.1.19)
In the Newsletter, Noxopharm announced that the active component of Veyonda®, idronoxil, is proving to be active against a range of sarcoma types in the laboratory, including to make the standard chemotherapy agent, doxorubicin, far more effective at killing sarcoma cells. The optimism observed at laboratory level makes Noxopharm believe that Veyonda® could possibly bring some meaningful benefit to sarcoma patients.
The company’s confidence in Veyonda® as a treatment with some chemotherapies was further elevated after its CEP-1 clinical trial (completed) showed some meaningful anti-cancer effects in patients with late-stage breast, lung, ovarian or prostate cancer when using Veyonda® in combination with the chemotherapy, carboplatin.
As per the latest update, Noxopharm’s team is currently in the process of filing an IND (Investigational New Drug) application with the FDA to run a Phase I/II trial in the United States that the company expects to start early-2020. The study is reportedly designed to include 32 patients to evaluate the tolerability level of Veyonda® combined with doxorubicin, and to confirm the evidence of benefit that would justify taking this approach through to a registration study in people with advanced sarcoma.
NOX was trading at $0.460, up 1.1% by the end of trading session on 24 July 2019. The stock has registered a positive change of 10.98% in its year-to-date performance.
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