(Press release, Apotex, OCT 28, 2013, View Source [SID:1234504500])

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(Press release, Regulus, OCT 28, 2013, View Source [SID:1234503635])

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Merck Provides Update on Investigational 9-valent HPV Vaccine V503 to U.S. Advisory Committee on Immunization Practices

On October 24, 2013 Merck & Co provided an overview of the clinical trial program for V503, the company’s investigational 9-valent human papillomavirus (HPV) vaccine, to the Advisory Committee on Immunization Practices in the United States (Press release Merck & Co, OCT 24, 2013, View Source [SID:1234500312]). Merck said that the pivotal efficacy trial is complete, the primary endpoints have been met and the company expects to submit a Biologics License Application for V503 to the U.S. Food and Drug Administration in 2013.
The study evaluated the efficacy, immunogenicity and safety of V503 in females 16-26 years of age. Merck plans to present results from this study, as well as other results from the Phase III clinical program for V503, at the EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) congress in November.

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(Filing, 10-Q, Epizyme, OCT 23, 2013, View Source [SID:1234503840])

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Imugene to Acquire Biolife Science Qld Limited

On October 23, 2013 Australian drug development and pharmaceutical company Imugene (ASX:IMU) was pleased to advise that, consistent with its strategy to diversify through acquisition, it has executed a Sale and Purchase Agreement to acquire 100% of Biolife Science Qld Limited (Biolife), a company incorporated in Australia (Press release, Imugene, OCT 23, 2013, View Source [SID:1234509845]).

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Biolife has the rights to a novel cancer immunotherapy platform that has been developed by scientists at the University Medical School in Austria. The scientists have developed a peptide-based immunotherapy that induces a polyclonal antibody response against HER-2/neu associated tumours, including breast cancer and gastric cancer ("HER-Vaxx").

HER-2/neu is a known and validated receptor that is over-expressed on various cancerous tumours, including gastric, breast, ovarian and pancreatic cancers. Having already successfully completed a Phase I human study in breast cancer, a Phase II study in gastric cancer is planned to potentially commence in calendar 2015, subject to FDA approval.

Forrest Capital coordinated the acquisition and will be lead manager for the capital raise.

Key information on the Biolife technology, intellectual property, market potential and previous studies are included in a presentation and Q&A placed on the ASX website at:
View Source

Imugene will, subject to Shareholder approval:

Issue 300 million shares to purchase 100% of Biolife Science Qld Ltd.
Raise an additional A$2.5 million via the placement of 250 million shares at $0.01. The placement will be managed by Forrest Capital, 85 million shares issued within current capacity with the balance subject to shareholder approval.
Dr Axel Hoos current vice president, Oncology R&D at GlaxoSmithKline is expected to join the board as Non-Executive Director.