Biotech company Noxopharm’s (ASX: NOX) came out of a trading halt this morning with positive interim results from its LuPIN phase I/II clinical trial into end-stage prostate cancer.
The LuPIN study is currently being conducted by St Vincent’s Hospital in Sydney, where researchers are evaluating Noxopharm’s lead drug candidate, Veyonda, in combination with Lu-PSMA-617, a radiopharmaceutical therapy.
The trial involves 56 patients with late-stage metastatic castration-resistant prostate cancer, with interim results now available for the first 32 patients.
All patients had received and failed two prior lines of therapy in the form of chemotherapy and androgen-signalling inhibitors while most patients had failed a third line of therapy prior to entering the trial.
According to Noxopharm, the combination treatment of Veyonda and Lu-PSMA-617 delivered a clinically meaningful and strong anti-cancer effect in a high proportion of men and continues to exhibit an excellent safety profile.
Further efficacy findings showed that 47% of patients were well enough to receive all six cycles of therapy, indicating a durable response and enabling them to continue to receive treatment until the end of the study.
In addition, 87% of patients had a fall in PSA, which is a marker for anti-cancer activity, while 62.5% had a strong PSA response of over 50%.
Half of the patients with severe pain at the start of the study reported a significant reduction in pain from secondary tumours, yet again supporting Veyonda’s efficacy and increasing the probability that the drug will move onto a phase 3 trial.
The interim results were presented at the ASCO Genitourinary Cancers Symposium in San Francisco today.
In the first 32 patients, Noxopharm declared an unprecedented median overall survival of 17.1 months in a patient group that normally would have a much shorter survival expectation.
Boosting the effect of radiopharmaceuticals
The biotech company also stated that Lu-PSMA-617 is an encouraging new treatment option for late-stage prostate cancer, wielding significant commercial potential following a series of acquisitions worth $6 billion by Novartis in 2018.
This morning’s results could potentially serve as an early indicator that Veyonda could become a major new drug in the treatment of late-stage cancers, starting with prostate cancer.
Given the positive results obtained so far, Noxopharm said it expects Veyonda to work in a way that will provide a worthwhile lift to all radiopharmaceuticals, not just Lu-PSMA-617.
“The data boosts our confidence that Veyonda will prove to be of major benefit for a high proportion of patients with late-stage prostate cancer,” Noxopharm chief medical officer Dr Gisela Mautner said.
“Being able to deliver a meaningful anti-cancer response for at least 50% of patients with stage 4 of any form of cancer would be a remarkable outcome,” Noxopharm executive chairman and chief executive officer Dr Graham Kelly added.
“It is even more noteworthy to do so in late-stage prostate cancer where the disease typically involves a substantial number of secondary tumours in the skeleton, presenting a large and poorly accessible tumour load,” he noted.
Noxopharm said it hopes to publish further interim data later this year, covering the remaining 24 patients receiving Veyonda while a final read-out is forecast for mid-2021.
Cashed-up to advance cancer drug trials
The company also surprised the market by announcing an $8.1 million capital raising, consisting of a $3.1 million equity placement and a $5 million loan.
According to Noxopharm, the capital raising delivers crucial funding to progress current initiatives including preparation for the upcoming multi-national DARRT-2 study and to retire convertible notes held by significant shareholders The Lind Partners and CST Investment Funds.