Noxopharm set for busy six months ahead with strong news flow expected from drug pipeline

Noxopharm Ltd (ASX:NOX) is set for a very busy six months ahead with news flow expected from its Veyonda® immune-oncology drug that works with the body’s defence mechanisms to fight cancer cells.  The clinical-stage drug development company is targeting Veyonda® to become a standard go-to drug to boost the effectiveness of a range of anti-cancer therapies such as radiation treatment and chemotherapy.  It has an exciting pipeline of drugs under development and believes that its novel technology platform is “one of the most exciting and valuable platforms” in the pharmaceutical industry.  News flow ahead Noxopharm chief executive officer Graham Kelly said the company was into some of the latest and most active areas of interest by the pharmaceutical industry - areas spanning cancer, chronic inflammatory diseases and autoimmune disorders. “The result is an exciting pipeline of drugs now under development within Noxopharm that you will be hearing more about over coming months.” Currently, Noxopharm remains focused on its 4-pillars oncology program. In the next six months, the company is looking forward to the start of patient recruitment for its IONIC-1 (checkpoint inhibitor therapy), DARRT-2 (radiotherapy) and CEP-2 (chemotherapy) programs for its Veyonda® anti-cancer drug candidate. Describing the drug as a cancer treatment enhancement, Veyonda has multiple mechanisms of action that boost the effectiveness of other standard anti-cancer therapies. It is also targeting the completion of the COVID-19 clinical trial and progressing its novel drug pipeline in the coming six months. Pharmorage, a wholly-owned subsidiary in partnership with the Hudson Institute of Medical Research and in collaboration with The Australian National University, is also progressing novel drug development for chronic inflammation and autoimmunity. Significantly de-risked The company highlighted how it is significantly de-risked as it is targeting areas of major medical need and industry interest. It has multiple shots at the goal-post and is not limited to a single therapeutic field. Noxopharm’s aim is to assist in existing therapies and not rely on the test drug carrying the full load. 4-pillars oncology program The 4-pillars oncology program is Noxopharm’s signature clinical program, aiming to prove that Veyonda® can make other common forms of anti-cancer therapy work better. It is testing Veyonda® in the following combinations: Noxopharm has said this was a completely new concept in cancer therapy, made possible only because of a unique collection of anti-cancer functions possessed by idronoxil, the active ingredient in Veyonda®. Where almost all other anti-cancer drugs operate through a single or very limited specific mechanisms, idronoxil targets a range of tricks employed by cancer cells to resist treatments ranging from the old standards, chemotherapy to radiotherapy, to the new checkpoint inhibitor drug therapies. From stopping cancer cells dividing, to blocking cellular repair mechanisms, to increasing immune cell trafficking, to killing cancer cells outright, idronoxil is a unique multi-purpose, cancer-fighting molecule. Key European patent allowance In late June 2021, the company secured a crucial European patent allowance for Veyonda®. The European Patent Office issued a formal Notice of Allowance of claims for patent application number 17778482.4, indicating an intention to move to the patent grant stage. Noxopharm believes the patent allowance bodes well for related Veyonda® patent applications in Europe and other important territories such as the US. CEO Graham Kelly said: “This allowance is very pleasing validation of our strategy of building a strong IP position around Veyonda® based on a series of inter-connected patents. “The interconnection is between method of administration and clinical use and removes the reliance on the strength of any single patent. “A granted patent also will help underpin our commercial aim of Veyonda® becoming a standard of care drug in combination with other major forms of cancer therapy.” The patent will run through to April 2037. It is also not limited to a particular cancer type, should cover the treatment of any cancer and can be administered to patients who have received or are receiving chemotherapy or radiotherapy. Phase 2 trial for DARRT-2 study The company is also moving ahead for the Phase Two trial of Veyonda® for its upcoming DARRT-2 study. This week NOX secured Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its DARRT-2 multi-national clinical study, paving the way for the trial to kick off in the United States. The green light marks the second IND classification granted to cover the administration of Noxopharm’s anti-cancer drug candidate, Veyonda®, in US cancer patients. So far, two prominent US cancer centres have volunteered to participate in the DARRT-2 study, which will take place over as many as 15 trial sites across Australia, France, Hungary and the United States and involve around 100 patients. Specifically, the US’ largest and top-ranked comprehensive oncology institution, the Texas-based MD Anderson Cancer Center, and Los Angeles’ Beverly Hills Cancer Center sought to participate in the clinical trial and will serve as the study’s US sites. DARRT-2 will involve around 100 patients with progressive, metastatic prostate, breast or lung cancers that have failed standard treatment options and are eligible for low-dose, palliative external beam radiotherapy (RT) to a single lesion. The clinical-stage drug development company will utilise a higher dose of its Veyonda® drug candidate to generate the phenomenon of the abscopal response in cancer patients.  Building on the successful results of DARRT-1, DARRT-2 will be a much bigger study and will explore a more intensive treatment with Veyonda®. Noxopharm chief medical officer Dr Gisela Mautner  “To increase the value of the study, we have added a second trial arm to include a small number of breast and lung cancer patients. “This will ensure that, apart from the main focus of the study in prostate cancer, we also will generate results in two additional cancer types.” COVID-19 beneficiary Noxopharm has produced not only a drug capable of restoring cancer-fighting immune function in a cancer patient, but the same drug could also potentially block an inappropriately excessive immune system in a patient infected with SARS-C0V-2 virus. The STING signalling pathway is a forward scout that detects the presence of damage in the body and triggers an immune response. COVID-19 patients who fall into septic shock mostly do so because their STING response has gone into overdrive. Veyonda® blocks the STING response and Noxopharm is now testing the ability of Veyonda® to prevent the acute consequences of septic shock in COVID-19. LuPIN program The LuPIN program is the first of the 4-pillars program to reach Phase-2 level. Noxopharm is set to benefit from Novartis’ VISION study featuring its experimental drug, 177Lutetium-PSMA-617 (Lu-PSMA-617), which looks set to become an important new treatment for late-stage prostate cancer, based on the Phase 3 clinical trial data. The study reported a median overall survival (mOS) of 15.3 months for Lu-PSMA-617 + standard of care versus 11.3 months for standard of care alone. This compares with 19.7 months from the LuPIN trial that tested the combination of Lu-PSMA-617 and Veyonda® in men with end-stage mCRPC, who had progressed on at least three previous lines of therapy. This is strong encouragement for Noxopharm, given its recent LuPIN trial data showing even stronger survival outcome when the experimental radioligand Lu-PSMA-617 is combined with Veyonda®. Dr Kelly said the news confirms that Veyonda® in combination with Lu-PSMA-617 provides a considerable survival advantage over Lu-PSMA-617 alone. “The LuPIN mOS outcome of 19.7 months still remains the best survival outcome of any drug approved for use in men with end-stage prostate cancer including enzalutamide, abiraterone, docetaxel, cabazitaxel and now Lu-PSMA-617. He said having Lu-PSMA-617 likely to come to market as a third-line therapy provides a clear development pathway now for Veyonda® to come to market itself, with a distinct opportunity to make the Veyonda®/Lu-PSMA-617 combination a new standard of care for end-stage prostate cancer.” Commercial end-point for Veyonda® Noxopharm prepared to take Veyonda all the way to market but given that it is a general booster of most forms of cancer therapy, a partnership is potentially more likely. A commercial transaction is seen as potentially likely in the current Phase 2 trialling.