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IMUGENE LIMITED — Investor Presentation 2014
Jun 10, 2014
65124_rns_2014-06-10_12e16d29-128f-4139-b233-b0ed0b26c7b1.pdf
Investor Presentation
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----- Start of picture text ----- HER2+ gastric and breast cancer immunotherapy----- End of picture text -----
Imugene (ASX; IMU) is an immuno-‐oncology biopharmaceutical company developing HER2+ gastric and breast cancer immunotherapies
Investor
Update Issue 2
Investor
Update Issue 2
Dear
shareholders
Welcome to issue 2 of the Imugene Investor Update newsletter. Since our previous newsletter we have continued to make considerable progress on many fronts related to our goal of dosing cancer patients within 12 months. Once again, your support of our company is crucially important as we continue to advance our HER-‐Vaxx program to help patients with gastric cancer.
In order to meet our goal of dosing patients within 12 months, the focus over the past three months has been the appointment of specialist companies to commence manufacture of HER-‐Vaxx. In May we announced the appointment of Bachem to undertake clinical-‐grade manufacture of the peptide component of HER-‐Vaxx. The peptide component is the payload that stimulates cancer-‐ fighting antibodies by the immune system; hence locking this contract in has been an important milestone passed.
Over my 25 years involved in the global peptide community from both the scientific and business perspective, Bachem has been a constant in quality and experience. Given its experience in supplying peptides in the form suitable for incorporation into our chosen vaccine delivery platform, Bachem is the logical choice to manufacture our clinical grade peptide.
Looking ahead, June is going to be an exciting month of building awareness of our program, both locally and in the United States.
Professor Ursula Wiedermann from our Scientific Advisory Board will be presenting to a multitude of interested parties during the week 16-‐20 June in Sydney and Melbourne, including special twilight shareholder briefings. I urge you to attend either of these briefings if you can.
Ursula was the Principal Investigator for the preclinical development of HER-‐Vaxx Message from and together with Prof Zielinski´s team in Imugene’s Executive Vienna, the Phase I clinical trial of HER-‐ Director Vaxx in metastatic breast cancer patients was performed. Furthermore she has led Dr Nick Ede the design of the Phase II study for gastric cancer due to commence in 2015.
Executive Chairman Paul Hopper has been invited to speak at the Australian Life Science Investment Showcase in San Francisco on 20 June where he will highlight HER-‐Vaxx. This trip is partially supported by the Victorian Government which awarded Imugene a TRIP (Technology Trade and International Partnering Program) Grant to assist Imugene promote itself.
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ASX: IMU
Investor Update Issue 2
HER2+ gastric and breast cancer immunotherapy
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**Meet
Professor Wiedermann – Scientific Advisory Board**
Professor Ursula Wiedermann is Professor of Vaccinology and Head of the Institute of Specific Prophylaxis and Tropical Medicine of the Medical University Vienna. She is also currently Visiting Professor at the University of Gothenburg, Sweden. She has authored more than 100 peer-‐reviewed publications and is frequently performing presentations at national and international conferences.
Professor Wiedermann was the Principal Investigator for the preclinical development of HER-‐Vaxx and together with Prof Zielinski´s team in Vienna, the Phase I clinical trial of HER-‐ Vaxx in metastatic breast cancer patients was performed. Furthermore she has led the design of the Phase II study for gastric cancer due to commence in 2015.
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Professor Wiedermann studied Medicine in Vienna, Austria. Over 1990-‐1995 she entered a PhD program in Sweden at the Institute of Clinical Immunology at the University of Gothenburg focusing her research on mucosal immunity and vaccination. Back in Vienna she continued her research career at the University of Vienna concentrating on mucosal vaccination against allergic diseases. After her habilitation (venia docendi) in 1999 she founded the research group “Mucosal Immunity and Vaccination”.
In 2001 she finished her medical training as specialist for “Immunology” and “Specific Prophylaxis and Tropical Hygiene”. At the Institute of Specific Prophylaxis and Tropical Medicine she enlarged her research areas to vaccine development against infectious diseases and tumours and focused on clinical vaccine trials to study immune responsiveness and immune failures upon vaccination.
In 2004 she became Head of the Institute of Specific Prophylaxis and Tropical Medicine of the Medical University Vienna and in 2006 she was assigned Professor for Vaccinology at the Medical University Vienna. She is a member of the Supreme Board of Health and the Chairman of the National Committee of Immunization Practice of the Austrian Ministry of Health. Since 2009 she is Speaker of the newly founded Centre for Geographic Medicine at the Medical University Vienna.
**ALL
SHAREHOLDERS ARE INVITED**
**TWILIGHT
BRIEFINGS FROM INVENTOR PROF URSULA WIEDERMANN**
Imugene scientific advisory board member and principal investigator for the preclinical development of HER-‐Vaxx Professor Ursula Wiedermann will be in Australia in June for a series of company briefings.
Shareholders along with any interested parties in Melbourne or Sydney are encouraged to attend:
Sydney twilight briefing – 4:30pm Monday 16 June– Occidental Hotel, level 2, 43 York St, Sydney Melbourne twilight briefing – 4:15pm Wednesday 18 June – Auditorium at level 12, 15 William St, Melbourne
RSVPs – Matthew Wright – Monsoon Communications – 03 9620 3333 or [email protected]
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ASX: IMU
Investor Update Issue 2
HER2+ gastric and breast cancer immunotherapy
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**Meet
Dr Neil Segal – Scientific Advisory Board**
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Dr Segal is a medical oncologist at the Memorial Sloan Kettering Cancer Center, the oldest and largest private cancer centre in the US. His research interests focus on the development of new therapies and more specifically, ways to use the immune system to treat cancer.
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Currently Dr Segal is a Lead Investigator on three clinical trials that aim to modulate the patient’s immune system to fight cancer.
This parallels the approach taken with Imugene’s HER-‐Vaxx immunotherapy, which aims to activate the patient’s immune system to produce its own antibodies.
Dr Segal has further clinical expertise in colorectal, pancreatic, bile duct and other gastrointestinal cancers. His work has been published in some of the world’s most prestigious peer-‐reviewed medical journals. He holds a Doctorate of Medicine and Philosophy from University of the Witwatersrand in South Africa.
**An
update on HER-‐Vaxx manufacturing and preparation for the clinical trial**
HER-‐Vaxx is a cancer immunotherapeutic comprised of two critical components, (1) a fusion peptide containing three B-‐ cell epitopes and (2) a delivery/adjuvant platform known as the influenza virosome. Both components are assembled separately and are made by industry leading world-‐class contract research organisations in Switzerland.
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Last month we announced the appointment of Bachem AG to undertake clinical-‐grade manufacture of the peptide component of HER-‐Vaxx.
Bachem has extensive experience in synthesising clinical grade peptides suitable for incorporation and assembly into the immunotherapy delivery platform to be used in HER-‐Vaxx, and has previously manufactured the peptides (three individual peptide B-‐cell epitopes) used in the completed Phase I breast cancer trial. For the peptide used in HER-‐Vaxx, all three peptides are being combined into a single (longer) version of peptide, which potentially presented manufacturing challenges. Bachem has now completed a highly successful feasibility trial for this longer peptide, and hence manufacture of the immunotherapy has now commenced.
**News
flow and what’s to come**
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----- Start of picture text ----- Complete! HER@Vaxx! Clinical!trial! Clinical!trial!acquisi/on!of!Biolife! manufacture! prepara/on! commences!• Secure!IP! ✔ • Appoint!US!FDA! • US!FDA!IND! • Recruit!&!run!!posi/on! Regulatory! ✔ granted! lead!in!trial!• Appoint!SAB! Consultant! • Appoint!CRO!to! • Report!!trial!• Commence! ✔ • Appoint! ✔ run!clinical!trial! result!extensive! manufacturer!of! • Finalise!trial! • Ini/ate!Phase!II!awareness! ✔ pep/de!an/gen!! protocol! double!blind,!campaign! • Appoint! • Appoint!Principal! randomised!manufacturer!of! Inves/gator! placebo@HER@Vaxx! ✔ • Announce!final! controlled!study!vaccine! preclinical! • Publish!results!• Expand!SAB! ✔ results!----- End of picture text -----
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ASX: IMU
Investor Update Issue 2
HER2+ gastric and breast cancer immunotherapy
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**Imugene
Facts**
Listings Australian Securities Exchange (ASX) Stock code ASX: IMU Issued capital Ordinary shares 940 million Market capitalisation (1 June 2014) $10 Million
**Board
and Management**
Mr Paul Hopper Executive Chairman Dr Nick Ede Executive Director Dr Axel Hoos Non-‐executive Director Mr Phillip Hains Joint company secretary and Financial Controller
**For
further information please contact:**
Dr Nick Ede (Australia) Executive Director Imugene Limited Ph: +61 400 642 254 E: [email protected] W: www.imugene.com A: Suite 1, 1233 High Street Armadale, VIC 3143 Australia
Mr Paul Hopper (USA) Executive Chairman Imugene Limited Ph: +1 858 334 5820 E : [email protected]
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**Forward
looking statement**
Any forward looking statements in this newsletter have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors many of which are outside Imugene Limited's control. Important factors that could cause actual results to differ materially from any assumptions or expectations expressed or implied in this newsletter include known and unknown risks. As actual results may differ materially to any assumptions made in this newsletter, you are urged to view any forward looking statements contained in this newsletter with caution. This newsletter should not be relied on as a recommendation or forecast by Imugene Limited, and should not be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
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ASX: IMU