Noxopharm Ltd (ASX:NOX) had a highly productive December quarter, making significant advances across its main activities, which include advancing its cancer drug R&D pipeline, trialling Veyonda® in both cancer and septic shock and progressing its Pharmorage platform.
The company recently moved from COVID-focused uses of its assets back to cancer. The basis for the refocus is the lower risk of lung-associated toxic shock in this phase of the pandemic, while on the cancer front, NOX is on the verge of major clinical breakthroughs, particularly in the realm of pancreatic cancer.
NOX was also active in the patent space during December, applying for and securing several patents to protect its assets.
The company’s cancer clinical trial program made solid progress this quarter with patients under treatment in the IONIC and DARRT trials, and the CEP trial ready to begin patient recruitment.
Financial update
NOX’s cash outlook is healthy, with the company sitting on A$16.7 million as the year closed. It received an additional boost shortly after, garnering an ATO research and development rebate of A$5.9 million on January 7.
A post-rebate cash position of around A$22.6 million will meet the company’s forecast funding needs for the next 12 months.
Expenses were also up, with net cash used for operating activities during the quarter totalling A$6.9 million, compared with A$4.4 million in the September quarter. The company made payments for R&D of A$5.5 million during the quarter, compared to A$2.9 million in the previous quarter.
The increased expenditure reflects the significant milestones being met in current clinical trials.
Pivot from COVID to cancer
Noxopharm is poised to reactivate its NOXCOVID strategy should the public health need arise, but for the moment has restored its pre-pandemic focus on developing Veyonda® as a highly promising anti-cancer drug candidate.
The company will also build on the discovery, announced last year, that the prime value of Veyonda® as a treatment for cytokine storm and septic shock in COVID-19 lies in the ability of idronoxil (IDX) to block the inflammatory marker, Tank-binding kinase 1 (TBK1).
This asset is already marked as a key player in the development of autoimmune disease, and now recently identified as a key moderator of the cytokine storm and septic shock in COVID-19 patients.
NOX will pursue this strategy via the Pharmorage TBK1 inhibiting drug program, an opportunity already recognised by a grant of $50,000 from the NSW Department of Health.
Advances in pancreatic cancer
The pancreatic cancer program made the most noteworthy progress this quarter and NOX regards it as potentially ground-breaking, with the strong prospect of a breakthrough in the treatment of pancreatic cancer, which for most patients is highly aggressive, has a poor response to chemotherapy and therefore poor survival outcomes.
NOX is targeting a drug that eliminates the cause of aggressive growth in pancreatic cancer, converting pancreatic adenocarcinoma into a slow-growing tumour better able to be managed on a long-term basis by chemotherapy.
The company is sponsoring an Australian university to discover how to grow human pancreatic cancer biopsies in the laboratory in a way that preserves all components of the cancer tissue, including stromal cells, a connective tissue which research indicates produces chemical signals that drive the aggressive growth of cancer cells and block access by chemotherapy drugs.
This world-first development, currently attracting global attention, gives scientists the ability to measure the effect of drugs on stromal cells. And NOX scientists have developed drugs that are able to block the action of these cancer-associated stromal cells.
This quarter saw this program take a major step with NOX drugs being added to cultured biopsies of pancreatic cancer collected during surgery and evaluated for their ability to both block the growth of cancer cells and to reduce the scarring effect.
Key to mRNA vaccines
In November, NOX announced the in-licence of a new RNA drug technology platform developed by Hudson. The result of more than 15 years of work, the technology is designed to block inflammation at its source by blocking the sensors in a cell that trigger inflammation, offering an entirely novel approach to the treatment of acute and chronic inflammation.
This licensed technology is already well advanced, with drug candidates ready to undergo in vivo preclinical studies. Pharmorage is focused on these drug candidates as treatments for autoimmune disorders such as lupus or psoriasis.
NOX believes that these novel molecules hold the key to making mRNA vaccines safer, more effective and cheaper to produce, placing Pharmorage at the forefront of the fast- growing market of RNA drugs and vaccines.
Studies underway
NOX’s current studies involve prestigious cancer centres in the US, Europe and Australia, with more sites coming online over the coming quarter.
Lockdowns and the emergence of the Omicron variant have had an impact on hospital workforces worldwide, affecting the availability of hospital resources to conduct clinical trials. The company is nevertheless confident it will meet its budgeted timelines for full patient recruitment across all its trials.
Ionic program
The Ionic program is currently in Phase 1, studying around 30 patients with a range of tumour types across several Australian sites. Treatment combines Veyonda® with the Bristol Myers Squibb checkpoint inhibitor, nivolumab (Opdivo®). The first site for this trial started enrolling and treating patients in December.
DARRT program
This Phase 2 clinical trial in around 100 patients across multiple sites in the US, Europe and Australia combines Veyonda® with low-dose radiotherapy for the treatment of prostate, breast and lung cancer. The first dose cohort has reached the end of the first treatment cycle.
In the December quarter two leading US cancer centres – MD Anderson Cancer Center and the Beverly Hills Cancer Center – began recruitment. The first Australian site for the trial, Macquarie Private Hospital, opened for patient recruitment, with further sites expected to follow soon.
CEP program
This is a Phase 1 study in approximately 30 patients with soft tissue sarcoma who are being treated with a combination of Veyonda® and the chemotherapy drug, doxorubicin.
During the December quarter the first of several major US sites – Los Angeles’s City of Hope Cancer Center – opened for enrolment, with additional US sites to be added shortly.
LuPIN program
This program is investigating Veyonda® to enhance the responsiveness of men with late-stage prostate cancer to PSMA radioligand (theranostic) therapy.
In the December quarter a compassionate-use program, now involving 100 Australian and overseas patients, continued to be offered in Australia as part of an effort to determine the optimal patient cohort to benefit from the use of Veyonda® in combination with 177LuPSMA in real-world conditions.
NOX has been approached by a European clinical group for access to Veyonda® for further clinical investigations and negotiations are ongoing.