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Cavatak data continue to impress

Update | Pharmaceutical & healthcare | 21 Nov 2016

Viralytics' Cavatak continues to impress, with a 100% disease control rate in 10 patients (seven objective responses) in combination with Keytruda in the CAPRA Phase Ib study. Furthermore, in the MITCI Phase Ib trial Cavatak, in combination with Yervoy, achieved a 50% response rate in the first 18 patients treated, which is an impressive response rate in a heavily pre-treated population. The encouraging results are a good sign for the ongoing trials of Cavatak and are likely to be of great interest to potential partners. We have increased our anticipated deal value assumptions for Viralytics following recent deals in oncolytic virotherapy, which lifts our valuation to A$385m or A$1.60/share.


Looking towards pivotal Cavatak combo studies

Outlook | Pharmaceutical & healthcare | 05 Dec 2017

Viralytics continues to report impressive preliminary data for Cavatak in combination with immune checkpoint inhibitors (ICIs), whether administered intravenously (iv) or by intra-tumoural injection. Viralytics is currently recruiting additional patients in expansion cohorts in melanoma, lung and bladder cancers in order to obtain more robust estimates of tumour response rates. It has announced plans to initiate four Phase I studies in additional indications and has commenced planning for a potential pivotal study of Cavatak plus Yervoy in melanoma patients who had failed prior single-agent, anti-PD1 ICI therapy, a serious unmet medical need. Updates on MITCI, CAPRA and Keynote 200 are expected in Q218. We increase our valuation to A$469m or A$1.95/share (vs A$408m and A$1.70/share).


Cavatak/Yervoy combo enters the spotlight

Outlook | Pharmaceutical & healthcare | 19 Apr 2017

Viralytics' presentations at AACR highlighted an impressive 36% response rate when melanoma patients refractory to the best available PD1/L1 checkpoint inhibitor therapy were treated with its Cavatak virotherapy plus Yervoy. It has expanded the Phase Ib MITCI trial to recruit an extra 44 patients who have failed prior PD1/L1 therapy, which could put it on track to a pivotal study or even provide a potential pathway to accelerated approval. The CAPRA study of Cavatak plus Keytruda in melanoma was expand to enrol up to 50 patients following a 60% response rate in the first 15 assessable patients. We increase success probability for Cavatak from 35% to 40% and lift our valuation to A$408m or A$1.70/share from A$385m.


Cavatak combo data at AACR next month

Update | Pharmaceutical & healthcare | 09 Mar 2017

Viralytics will present updates on three Phase Ib trials of Cavatak in combination with marketed immune checkpoint inhibitor (ICI) drugs at the AACR conference in the first week of April, including two prestigious podium presentations. The presentations will include preliminary data from the MITCI and CAPRA intralesional injection trials and an update on the Keynote 200 (STORM) IV Cavatak trial. We leave our valuation unchanged at A$385m or A$1.60/share as we await the updates.


Three Cavatak/checkpoint combination trials

Update | Pharmaceutical & healthcare | 10 Jun 2016

Additional data presented at ASCO confirm the potential for synergistic combinations of Cavatak with immune checkpoint inhibitor (ICI) drugs to improve the proportion of cancer patients who respond to ICI therapy. Three Phase Ib trials are underway testing Cavatak in combination with Yervoy or Keytruda in melanoma, lung and bladder cancers. Initial data in April showed an impressive 67% response rate in the first six patients in the MITCI study of Cavatak and Yervoy in melanoma. Further updates on MITCI and initial data from the CAPRA trial of Cavatak plus Keytruda could be potential catalysts for the stock in H216. We maintain our valuation of A$272m (A$1.15 per share) ahead of the anticipated newsflow.


Eye-catching MITCI data

Update | Pharmaceutical & healthcare | 05 May 2016

Impressive initial results from the MITCI Phase Ib trial suggest that Viralytics could push to the forefront of the crowded field of immune checkpoint inhibitor (ICI) combination therapies. The first six melanoma patients treated with Cavatak in combination with Yervoy (ipilimumab) experienced a higher response rate (67%) and lower serious adverse event rate (9%) than other prominent ICI combination therapies. These encouraging initial data bode well for the ongoing Phase Ib trials of Cavatak in combination with Merck's Keytruda in melanoma, lung and bladder cancer, and are likely to be of great interest to potential partners. We increase our valuation to A$272m (A$192m previously), or A$1.15 per share (was A$1.04).


Combination trials gather momentum

Update | Pharmaceutical & healthcare | 26 Nov 2015

Viralytics is escalating combination trials of its Cavatak oncolytic virotherapy with immune checkpoint inhibitors (ICI), adding a collaboration with Merck to study IV Cavatak combined with Keytruda in advanced lung and bladder cancers to its portfolio of ongoing trials combining intralesional Cavatak with Keytruda or Yervoy in melanoma patients. Cavatak has the potential to markedly improve the proportion of patients who respond to ICI therapy and we expect it to continue to attract attention from big pharma. We value Viralytics at A$192m or A$1.04 per share.


Clinical data package continues to build

Outlook | Pharmaceutical & healthcare | 13 Aug 2015

Clinical data from CALM, STORM and CANON trials presented at scientificconferences further highlight the potential efficacy of CAVATAK (oncolyticvirus) against a range of cancers using several delivery approaches. Whilethe evidence of CAVATAK's efficacy as a single agent continues to build, itis also likely to be attractive to big pharma companies seekingcomplementary therapies to boost immune responses to their checkpointinhibitors; a Phase Ib trial in combination with ipilimumab (Yervoy) isalready underway. We value Viralytics at A$189m or A$1.03 per share.


STORM shows promise at AACR

Update | Pharmaceutical & healthcare | 30 Apr 2015

Initial data from STORM presented at AACR highlight the potential for CAVATAK (oncolytic virus) to be delivered IV as well as by intratumoural injection, broadening the appeal to potential partners. CAVATAK could be attractive to big pharma companies seeking complementary therapies to boost immune responses to their checkpoint inhibitors. The FDA panel's vote in favour of Amgen's T-vec oncolytic virus is likely to increase interest in CAVATAK. We value Viralytics at A$147m or A$0.80 per share.


Building the clinical data package

Outlook | Pharmaceutical & healthcare | 08 Jan 2015

The potential combination of Cavatak (oncolytic virus) with checkpoint inhibitors represents a substantial commercial and partnering opportunity for Viralytics. The company is currently focused on building the clinical data package on Cavatak, which could prove attractive to big pharma companies seeking complementary therapies to boost immune responses to their checkpoint inhibitors. We see a potential deal for Cavatak in 2016 and value Viralytics at A$141m, or A$0.76 per share.


Keep CALM and carry on

Update | Pharmaceutical & healthcare | 05 Jun 2014

Updated key efficacy data from the open-label CALM Phase II study in metastatic melanoma, confirmation of Cavatak's benign safety profile and preclinical synergies, in combination with anti-PD-1 immunotherapy, were presented at ASCO. These features, coupled with the potential of further near-term data and wider interest in oncolytic virotherapy, suggest that the prospects for partnering remain promising. Cavatak's safety profile is a significant advantage for a potential combination regimen given the high side effect burden of existing melanoma therapies. The combination approach may form part of the design for a planned US multi-centre Phase II randomised advanced melanoma study due to start late in 2014.


STORMing start to a transformational year ahead

Update | Pharmaceutical & healthcare | 14 Apr 2014

Viralytics successfully raised A$27.1m, including the placement of A$23m with healthcare institutional investors. These funds will enable completion of key Cavatak clinical trials including the ongoing Phase II CALM trial; the Phase I/II STORM trial, which began recruiting in March 2014; and a Phase II randomised intratumoural trial planned to commence late 2014. Positive interim data from CALM presented at AACR, with more data expected at ASCO, coupled with a stronger balance sheet raise the prospects of negotiating partnering deals on more commercially attractive terms.