MedicalResearch.com Interview with:
Graham Kelly, BSc (Vet) (Hons, BVSc (Hons), PhD
Managing Director and Chief Executive Officer
MedicalResearch.com: What is the background for this announcement? What are the main findings?
Response: Veyonda is an experimental drug being developed as a means of enhancing the anti-cancer effect of radiotherapy. The Phase 1b DARRT-1 study is assessing the ability of Veyonda to boost a palliative dose of external beam radiotherapy (EBRT) applied to a single lesion, to result in a systemic response in non-irradiated lesions (known as an abscopal response) in men with metastatic, end-stage prostate cancer. The aim is to provide at the least better palliation, and at best a survival advantage. The reported data concerns the study’s initial dose-finding arm involving three different dosages of Veyonda. This arm involves 12 subjects and the report concerns their clinical status at 12-weeks post-irradiation. The data provide clinical evidence of an abscopal effect in at least half of the eight subjects receiving the two highest Veyonda dosages and demonstrate that the combination of Veyonda and palliative radiotherapy was well-tolerated. The 1200 mg dosage was confirmed as the therapeutic dose.
MedicalResearch.com: How does Veyonda differ from other treatments for prostate cancer?
Response: Current standard anti-cancer treatments for metastatic prostate cancer are radiotherapy, cytotoxic chemotherapy and anti-androgen therapy. Each of these treatments is intended to delay disease progression; none is curative. Veyonda is attempting to shift the spectrum of response to a more curative outcome by activating the innate immune system. A locally active innate immune system is now known to be critical to the response of cancerous lesions to both radiotherapy and checkpoint inhibitors. Veyonda is believed to work by boosting the damage inflicted by radiotherapy, which triggers activation of the immune cells within the irradiated tumor, which then extends out to activate the innate immune cells within distant non-irradiated tumors, leading to their destruction.
MedicalResearch.com: What should readers take away from your announcement?
Response: The two key take-aways are that:
(i) We saw evidence of an anti-cancer response in off-target lesions (abscopal response) in patients, and
(ii) That this was achieved in a well-tolerated way. In the 8 patients who received the two highest dosages of Veyonda, 4/8 showed significant (>50%) declines in prostate-specific antigen (PSA) levels, 5/8 reported significant (>30%) declines in pain levels and 6/8 were classified by RECIST as having stable disease or better. Given that all patients came into the study with rapidly, progressive disease, multiple tumors and high pain levels, achieving these outcomes by irradiating just one lesion, is noteworthy. It also is noteworthy that PSA levels in a number of subjects are continuing to decline at 12-weeks, raising the prospect of an ongoing anti-cancer effect.
MedicalResearch.com: What future research is planned?
Response: Stage 2 of this study is proceeding with an additional 12 men receiving 1200 mg Veyonda + radiotherapy. The 24-week data of these 12 subjects, plus the current 8 subjects, should provide a clearer picture of the potential benefit of this therapeutic approach. This data will become available in October 2019.
Veyonda also is being evaluated in a study known as LuPIN-1. This is testing Veyonda with an alternative form of radiotherapy, known as brachytherapy, where the radiation is given intravenously with a radiopharmaceutical drug. The drug is 177lutetium-PSMA-617, an experimental radiopharmaceutical, and is being tested in men with late-stage prostate cancer. By combining 177lutetium-PSMA-617 with Veyonda, Noxopharm aims to increase the response rate and provide a greater depth and duration of response to the radiopharmaceutical treatment. The study is fully recruited and the last patient is expected to complete treatment in August 2019.
With both the DARRT and LuPIN programs, Noxopharm aims to substantiate Veyonda’s potential as a transformative treatment in radiotherapy, whether the radiation is delivered externally or intravenously. We look forward to providing an update on both programs in the near future as we are confident that results will demonstrate clinically meaningful benefit and improved survival for men with late-stage prostate cancer.
Noxopharm is also in the process of extending its clinical program into earlier-stage prostate cancer and other indications, including lung cancer and sarcoma.
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