On JUN 11, 2018 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing and commercializing immune activating oncology therapies to target, primarily, treatment resistant solid tumors, reported an update to its clinical development strategy (Press release, Targovax, JUN 11, 2018, View Source [SID1234527412]).
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Targovax has previously reported encouraging proof-of-concept data from clinical trials with both of its immune activator platforms technologies; ONCOS, which uses genetically armed oncolytic adenoviruses, and TG, a neo-antigen vaccine that targets mutant RAS cancers. However, based on recent external clinical data and market dynamics, Targovax has decided to prioritize and strengthen the development focus on the ONCOS program.
Over the past 12 months, there has been clinical data released from multiple external studies corroborating the potential of oncolytic viruses as an important class of immune activating agents that can boost the effect of other treatments, such as checkpoint inhibitors. This notion is further strengthened by increased partnering and M&A activity by major global pharmaceutical companies, underscored by the acquisitions earlier this year of Viralytics and Benevir by Merck and Johnson & Johnson, respectively.
Furthermore, data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 1-5 has fundamentally changed the development preconditions for the TG program. Data from independent trials testing the chemotherapy cocktail Folfirinox in resected pancreas cancer, the lead indication for TG01, has demonstrated an improvement in median overall survival of up to 2 years compared to the current standard of care (gemcitabine and capecitabine). These results are great news for patients suffering from this difficult-to-treat cancer. It is expected that the Folfirinox treatment regimen will be quickly adopted as a new standard of care in resected pancreatic cancer, and it is already clear that that the design of Targovax’s planned randomized phase II trial of TG01 in combination with gemcitabine and capecitabine is inadequate and that the trial will not start. Although we are confident that TG01 will be active in combination with any standard of care therapy, the new Folfirinox median survival benchmark of close to 5 years means that such a combination trial is not practically feasible for Targovax.
Targovax strongly believes in the potential of the TG platform to treat mutant RAS cancers, and is encouraged by the signal of efficacy seen in the recent phase I/II trial in resected pancreas cancer. In addition, the company already has a phase I trial underway in colorectal cancer with TG02, the second-generation product from the TG program, combining with pembrolizumab. This trial is expected to read out in 2019. In light of the new Folfirinox data, the Company will together with its clinical advisors reevaluate and reshape the development plans for TG, and devise a strategy for how to best create value for both patients and shareholders. A revised development strategy for the TG program will be presented during the autumn.
The resources freed up by this decision will be allocated to strengthen and speed up ONCOS development. In particular, Targovax is currently looking into options to expand the ongoing trial in mesothelioma, the target launch indication for ONCOS-102.
Øystein Soug, CEO of Targovax said "It is fortunate for us that the emerging Folfirinox data in resected pancreatic cancer was presented at ASCO (Free ASCO Whitepaper) already this year, as it gave us the opportunity to reassess our trial design before committing to an inadequate combination treatment. We are confident that our TG vaccine has potential to benefit patients with mutant RAS cancers, and will now reassess the TG development plan. ONCOS continues to be our lead program, and we will further sharpen our focus to drive ONCOS-102 forward with full force, and remain in the forefront of oncolytic virus development"