Serono-Ono co-co- for go/no-go on so-so onco Stimuvax
This article was originally published in Scrip
Merck Serono and Ono Pharmaceutical have signed a licence agreement providing Ono with co-development and co-marketing rights to Merck's investigational therapeutic cancer immunotherapy Stimuvax in Japan. Stimuvax (BLP25 liposome vaccine), which is designed to stimulate the body's immune system to target cancer cells that express the tumour antigen MUC-1, is in Phase III for the treatment of patients suffering from non-small cell lung cancer. Merck had originally obtained the exclusive worldwide licensing rights from Oncothyreon.
Under the terms of this agreement, Ono will receive a co-development and co-marketing licence for Stimuvax in Japan while Merck Serono will receive an upfront payment of €5 million. No further financial terms were disclosed.
A Phase II study for Stimuvax (EMR63325-009) is being conducted by a Japanese subsidiary of Merck, for the treatment of non-small cell lung cancer in Japan.
Merck is hoping to tap into Ono's experience in developing new treatments as well as Ono's understanding of Japanese regulatory requirements, it said. Merck would not elaborate further on what Ono can do over and above Merck's own Japanese unit. It told Scrip: "Like most pharmaceutical companies, we rely on a mixture of new drug candidates from our own research as well as from in-licensing and acquisitions."
Merck Serono has faced significant difficulties with the non-small cell lung cancer indication. In late March, the company announced that it was making a second attempt to get EU approval for its EGFR-targeted monoclonal antibody product Erbitux (cetuximab) for non-small cell lung cancer (NSCLC), but this time for use in a much narrower patient population. Prior to that, the CHMP had rejected the company's first submission for the use of the product in combination with standard first-line chemotherapy in advanced or metastatic patients expressing EGFR, but without any defined level of expression. The new filing was for the use of Erbitux in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic NSCLC who have high levels of epidermal growth factor receptor (EGRF) expression (scripintelligence.com, 30 March 2011).
Stimuvax studies
Merck suffered a setback with Stimuvax last year when it temporarily suspended Phase III trials in NSCLC and breast cancer due to an unexpected serious adverse event reaction of encephalitis in a patient enrolled in a Phase II trial of the vaccine in patients with multiple myeloma. The clinical hold was lifted by the US FDA in June 2010 for NSCLC (scripintelligence.com, 17 June 2010).However, the hold on the breast cancer trial remained in effect and Merck discontinued the Phase III breast cancer trial.
Merck Serono has two studies for Stimuvax ongoing. The first is the START study, a Phase III multi-centre, randomised, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,500 patients in approximately 30 countries. The primary endpoint of the START study is overall survival (OS). The company could not specify a completion date for this study.
The second Phase III trial, the INSPIRE study, began in December 2009. The multi-centre, randomised, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The design of the INSPIRE study is almost identical to the START study. INSPIRE will enrol approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.