• Results Reported in Melanoma, Lung, Prostate, and Bladder Cancers
9 November 2015, Sydney, Australia: Viralytics Limited (ASX: VLA, OTC: VRACY) today announced positive data from two clinical studies of its lead drug candidate, CAVATAKTM , at the 30th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) in National Harbor, Maryland, USA. These data included updated results from the Phase 1 STORM clinical trial of intravenous CAVATAK in advanced cancers and from the Phase 1 CANON clinical trial of intravesicular CAVATAK in non- muscle invasive bladder cancer.
CAVATAK is an investigational novel cancer immunotherapy based on a proprietary bioselected common cold virus that has been shown to preferentially infect and attack cancer cells.
Phase 1 STORM1 Clinical Trial Update
In the ongoing Phase 1 STORM clinical trial, multiple intravenous doses of CAVATAK are being administered to patients with late-stage non-small cell lung cancer (NSCLC), hormone refractory prostate cancer (HRPC), metastatic bladder cancer, and late stage melanoma. Initial results from the dose escalation phase in the first 12 patients, including six patients in the third cohort who have been administered the highest dose of CAVATAK, show that multiple infusions of CAVATAK are generally well tolerated with no Grade 3 or higher CAVATAK-related adverse events.
In addition, there is evidence of successful tumour targeting in two melanoma patients in Cohort 3 (i.e. highest dose), with CAVATAK replication and CAVATAK RNA evident in tumour biopsies. These biopsies also revealed the presence of immune cell infiltrates and notable levels of PD-L1 staining suggesting a potential benefit for CAVATAK with an immune checkpoint blockade agent such as KEYTRUDA®2 (pembrolizumab). Moreover, a number of patients have exhibited signs of possible tumour-specific secondary viral replication. Finally, several patients achieved a best overall response of stable disease, including one with a confirmed partial response.
Multi-dosing with single-agent CAVATAK in Cohort 3 of the STORM trial continues. The second stage of the trial, due to commence in 2016, will assess the intravenous delivery of CAVATAK in combination with KEYTRUDA in patients with advanced non- small cell lung or metastatic bladder cancer.
“The STORM study continues to generate very promising data. Tumour targeting, along with the potential immune activation mediated by CAVATAK, provides considerable encouragement for potential synergy from the combination of intravenous CAVATAK with checkpoint inhibitors such as KEYTRUDA,” stated Professor Hardev Pandha, Director of the Surrey Cancer Research Institute at The University of Surrey and Principal Investigator of the STORM study. “We look forward to the initiation of the second stage of the trial to assess the combination of these two novel immunotherapies.”
“These updated positive findings are very supportive of the potential benefits from combining CAVATAK with KEYTRUDA,” said Dr Malcolm McColl, Viralytics Chief Executive Officer. “We are very excited about initiating the STORM trial’s second stage to look at this potentially complementary approach in two of the most common types of cancer.”
The poster presentation discussing the STORM trial results can be found on the Viralytics website:
Phase 1 STORM Study: Intravenous Delivery of a Novel Oncolytic Immunotherapy Agent, CAVATAK, in Advanced Cancer Patients
Phase 1 CANON3 Clinical Trial Update
The Phase 1 CANON trial is assessing the administration of CAVATAK via catheter directly into the bladder (intravesicular treatment) in patients with non-muscle invasive bladder cancer (NMIBC), also known as superficial bladder cancer. Initial results demonstrate that CAVATAK has been generally well tolerated with no Grade 2 or higher CAVATAK-related adverse events.
Evidence of targeting of tumour tissue, with viral replication and tumour cell death, has been seen in patients following single or double administrations of CAVATAK. Also, clinical activity of CAVATAK was demonstrated, with signs of viral replication and viral-induced tumour inflammation and a complete tumour response in one out of the 3 patients in the highest dose cohort.
The first stage of the CANON trial assessing CAVATAK as a single agent is complete. The second stage, evaluating CAVATAK in combination with a sub-therapeutic dose of the standard chemotherapy, mitomycin C, prior to the surgical removal of the tumour, is underway.
“These positive results, in particular the complete tumour response in one patient, represent a very encouraging outcome in the first stage of the study,” said Professor Hardev Pandha, Principal Investigator of the CANON study. “We believe that the tumor targeting, viral replication and cancer cell death we are seeing in this trial can lead to both a strong local and systemic anti-tumour immune response. There is considerable potential for CAVATAK, either prior to surgical resection or in combination with the checkpoint inhibitors, as a new treatment approach to NMIBC, where there is a high unmet need for better therapies.”
1 Systemic Treatment of Resistant Metastatic disease
2 KEYTRUDA is a trademark of Merck and Co.
3 CAVATAK in Non-muscle invasive bladder cancer
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