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Executive Summary

Imugene Limited (ASX: IMU, Mcap $19.5m) is a clinical stage immuno-oncology company, developing HER-Vaxx, a B Cell peptide vaccine for the treatment of gastric cancer.

Gastric cancer is a leading cause of cancer death worldwide, representing 10.1% of male cases. Incidence of gastric cancer is substantially higher in Asia and there is difficulty in accessing current treatments.

Imugene has recently announced commencement of Phase 1b/2 clinical study of its HER-Vaxx therapy in gastric cancer patients at eight key cancer hospital sites in Asia, including Hong Kong, Thailand and Taiwan.

HER-Vaxx works by targeting the same receptor (and additional receptors) as Herceptin and Perjeta, two of the leading antibody drugs on market, with annual sales of US$8.2 billion. Current immunotherapies are predicted to generate sales of US$36 billion by 2025 but cost remains prohibitive for patients. The mechanism of action for HER-Vaxx may help generate improved efficacy over existing treatments and at a lower cost.

In January 2016 Imugene announced a new partnership with the Medical University of Vienna to discover and develop mimotope-based immunotherapies against validated and new oncology targets. This partnership has the potential to create game-changing B Cell peptide vaccines that would replace or augment conventional monoclonal antibodies.

Since completion of Phase 1, Imugene has optimised the formulation of HER-Vaxx, enhancing the vaccine’s potency ten-fold, enabling a faster immune response and lowering the cost of goods.

It has been shown in pre-clinical studies and in one Phase 1 study to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.

Given HER-Vaxx targets the immune system and not the cancer directly, it should be possible to get early signs of efficacy from patients by monitoring their immune systems; Through this process it may be possible to tell at an early stage that a patient’s immune system is being “turned on” by HER-Vaxx and that the appropriate cancer-fighting antibodies are being produced by the patient to target the cancer.

Competitive Advantage

Investment Highlights

  • Promising science with impeccable provenance in the hottest area of cancer today - cancer immunotherapy
  • Pipeline/Franchise – HER-Vaxx & Mimotopes
  • Breast Cancer clinical trial complete & on the cusp of starting our second Phase 1b/2 clinical trial in gastric cancer
  • Tight share register with leading Funds Manager, Platinum, as our largest shareholder
  • Frequent, rich, quality news flow ahead
  • Axel Hoos head of immuno – oncology at GSK, plus team with successful track record in drug development & strong dedication & commitment
  • Low market cap - undervalued against ASX peers

Newsflow:

  • Patients dosed in the Phase 1b/2 trial in gastric cancer (2H, 2016)
  • Publication in BMC cancer journal
  • Patent filings on mimotopes (1H, 2017)
  • Recruitment progress and interim Phase 1b/2 data
  • First mimotope drug candidate identified
  • Preclinical in vivo/vitro results (2H, 2017)
  • Final Phase 1b/2 trial readout  (2H, 2017)

Board & Management

Paul Hopper

Executive Chairman

International & ASX biotech capital markets experience particularly in immuno-oncology & vaccines  Chairman of Viralytics, Director of Prescient, Founder of Polynoma LLC, former Director pSivida, Somnomed & Fibrocell Science Head of Life Sciences Desk & Australia Desk at Los Angeles-based investment bank, Cappello Group

Axel Hoos, MD, PhD

Non-Executive Director

Currently Vice President Oncology R&D at GlaxoSmithKline Previously Clinical Lead on Ipilumimab at Bristol-Myers Squibb Co-Director of the think-tank Cancer Immunotherapy Consortium; Imugene is his only Board seat worldwide

Ursula Wiedermann, MD, PhD

Chief Scientific Officer

Co-inventor of Her-Vaxx; inventor of mimotope platform technology Professor of Vaccinology at Medical University of Vienna

Nick Ede, PhD

Chief Technology Officer

Former CTO Consegna, CEO Adistem Ltd, CEO Mimotopes P/L, COO EQiTX Ltd (ZingoTX & VacTX) VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology