Vicus Therapeutics Announces Safety and Survival Benefit of VT-122 in Combination with Anti-Cancer Therapies for Advanced Liver and Pancreatic Cancers

Initiation of Registrational Studies Planned for This Year

MORRISTOWN, N.J., January 16, 2015 – Vicus Therapeutics, an immuno-oncology company focused on bringing breakthrough immunotherapies to patients with solid-tumor cancers, today announced the presentation of two separate studies demonstrating a safety and survival benefit for VT-122, the company’s lead compound, when combined with standard-of-care therapy in patients with advanced liver and pancreatic cancers. Results from both studies were presented today at the 2015 Gastrointestinal Cancers Symposium in San Francisco, Calif.

VT-122 is a novel, chrono-modulated combination of the non-selective beta-adrenergic receptor blocker propranolol and the COX-2-selective non-steroidal anti-inflammatory drug (NSAID) etodolac. In one study, a Phase 2 trial in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, administration of VT-122 30 days after initiation of sorafenib therapy was generally well-tolerated and associated with an increase in 12-month survival and median overall survival (OS), compared to sorafenib alone. In the other study, the combination of VT-122 plus gemcitabine and a nanoparticle albumin-bound-paclitaxel (GemNab) was associated with increased median OS in patients with locally advanced and metastatic pancreatic cancer, compared to patients treated with GemNab alone. No treatment-associated serious adverse events were reported in either study.

“These data add to the growing body of evidence of a safety and survival benefit for VT-122 plus standard therapy in patients with advanced cancers,” commented G.S. Bhattacharyya, MD, study investigator and Head of the Department of Medical Oncology at Fortis Hospitals, India. “We continue to be encouraged by the data emerging from patients receiving VT-122-based combination therapy. In particular, we are most excited about the long-term survival shown in patients with liver and pancreatic cancers. The long-term survival is consistent with VT-122’s unique immune-targeting effects and ability to inhibit tumor-promoting inflammation and tumor evasion of the immune system.”

 

HCC Study Highlights

The HCC study was designed to evaluate the safety, tolerability, and efficacy of VT-122 in patients receiving sorafenib as standard-of-care, first-line therapy. The double-blind, multi-center study assessed 20 patients with advanced HCC who were randomly assigned to receive either VT-122 (n=11) or placebo (n=9) on a background of stable-dose sorafenib (initiated 30 days prior to randomization).

Among patients treated with VT-122 plus sorafenib, 12-month survival was greater than that in patients treated with sorafenib alone (5/11 [45.5%] vs. 3/9 [27.3%]). Additionally, median OS increased by 2.0 to 4.4 months (8.8 to 13.2 months, data still maturing) in the VT-122-treated patients, compared to patients receiving sorafenib alone. Three patients treated with VT-122 have demonstrated durable responses. No treatment-associated serious adverse events were reported in the study.

 

Pancreatic Cancer Study Highlights

In the second study, a single-center, open-label, investigator-led trial, 37 patients with advanced pancreatic cancer were randomly assigned to receive either VT-122 (n=20) or placebo (n=17) in addition to GemNab. The VT-122 regimen was initiated one week prior to starting GemNab and then administered in combination with GemNab chemotherapy. Although follow-on lines of chemotherapy after disease progression were not administered, VT-122 treatment was continued after discontinuation of GemNab upon disease progression.

The use of VT-122 was associated with an increase in median OS of 7.7 months (9.3 to 17 months; hazard ratio: 0.10; 95% confidence interval [CI]: 0.035, 0.282; P<0.001), compared to that observed with GemNab alone. Additionally, no treatment-associated serious adverse events were reported in the study.

“Both studies presented today support further development of VT-122 for HCC and pancreatic cancer,” noted John W. Maki, president and chief executive officer of Vicus Therapeutics. “We look forward to initiating approval-enabling Phase 2 and 3 studies this year.”

 

About Vicus Therapeutics

Vicus Therapeutics  (www.vicusrx.com) is an immuno-oncology company bringing breakthrough immunotherapies to patients with solid-tumor cancers. Vicus is focused on the development and commercialization of its lead product VT-122, a novel, chrono-modulated formulation of etodolac and propranolol. VT-122 targets onco-inflammation and is designed to synergistically damp tumor-promoting inflammation and restore a tumor-suppressing immune state. VT-122 is currently being investigated in combination with sorafenib in a Phase 2 clinical study of patients with advanced liver cancer (http://clinicaltrials.gov/show/NCT01265576) and in combination with standard-of-care anticancer therapies in investigator-initiated studies of pancreatic, gallbladder, and other solid-tumor cancers.