Imugene Limited (ASX: IMU), an Australian-headquartered clinical-stage immuno-oncology company, focusses on the development of emerging immunotherapies to enhance the efficacy of cancer treatments. The company utilises its unique platform technology to harness the patient’s immune system against tumours. Imugene aims to enhance and transform the lives of the cancer patients who require effective treatments.
A Glance at Imugene’s Product Pipeline
Imugene’s product pipeline comprises of numerous immunotherapy B-cell vaccine candidates and CF33 (an oncolytic virotherapy) targeted at the treatment of a range of cancers in combination with standard of care medications and novel immunotherapies.
Let us take a quick look at its pipeline products below:
Oncolytic virus, CF33
Imugene has recently announced its intention to acquire an exclusive licence to a promising oncolytic virus technology, CF33 from the City of Hope Cancer Centre. CF33 is a chimeric poxvirus that has shown compelling tumour inhibition in multiple cancers. CF33 with anti-PD-L1 has shown better cancer growth inhibition in pre-clinical studies relative to Genelux or Amgen oncolytic virus. Currently, CF33 is in the pre-clinical phase of development with the company planning to begin the Phase I trials in the first half of 2020.
HER Vaxx (anti-HER-2)
HER-Vaxx has the potential to improve on the efficacy of existing commercialised monoclonal antibodies used to treat cancer that overexpress the HER-2 protein. The company has successfully completed the Phase 1b trials of HER-Vaxx, which depicted an increased antibody response in all patients with no safety or toxicity issues. Imugene has already commenced Phase II study of HER-Vaxx, whose results are due to be completed in 2020. The company expects that Phase II study results will provide greater insight to the efficacy of HER-Vaxx in cancer treatments.
Imugene’s well advanced B cell peptide cancer vaccine, B-Vaxx stimulates a polyclonal antibody response to HER-2/neu. The vaccine has provided positive results in Phase I trial and is currently in Phase II development phase.
PD1-Vaxx is a B cell peptide cancer vaccine that induces a patient’s body to generate polyclonal antibodies that inhibit PD-1 signalling proteins, thus producing a similar anti-cancer effect as generated by other monoclonal antibodies like Opdivo and Keytruda. The pre-clinical studies of PD1-Vaxx have demonstrated strong tumour growth inhibition in mouse models of colorectal cancer. The company is planning to advance the PD1-Vaxx to a Phase I trial in 2020.
Combination of B-Vaxx & PD1-Vaxx
The company had detected better inhibition of tumour growth when PD1-Vaxx was combined with the B-Vaxx agent. The combination delivered 90 per cent inhibition of cancer growth in pre-clinical studies in colorectal cancer model, which was far greater than the outcomes from PD-1 Vaxx alone.
The below table summarises the cost estimates provided by the company for the progress of the clinical trials of its pipeline products:
Imugene’s Strong Management Team
Imugene’s considerable progress in the development of novel immunotherapies was backed by a strong and efficient management team that provides confidence in the ability of the company to identify and manage the development and sales process for the company’s products. Its Board and Management team holds extensive experience in developing oncology therapies and selling/licensing therapies to big pharma.
The company possess an international leadership team with extensive commercialisation expertise in the sector, which includes the following members:
Paul Hopper, Executive Chairman
Mr Paul Hopper is the founder of Imugene and Polynoma LLC with extensive experience in biotech capital markets both domestically and internationally. He specialises in immuno-oncology and vaccines. He was formerly the Chairman of Viralytics Limited which was sold to Merck & Co in 2018. Previously, he also served as the Director of Somnomed, pSivida and Fibrocell Science.
Currently, he is the Founder and Director of Prescient Therapeutics Limited (ASX: PTX) and Chairman of Suda Pharmaceuticals Ltd (ASX: SUD). He is also a major shareholder of Vaxinia Pty Ltd. Recently, Imugene informed about its intention to acquire 100 per cent of the shares of Vaxinia.
Leslie Chong – MD and CEO
Ms Leslie Chong has more than 20 years of experience in oncology clinical development programs. She was previously the Senior Clinical Program Lead at Genentech, a significant player in the global biotech market which sold the bestselling breast cancer drug Herceptin. Ms Chong has also worked at the global pharmaceutical companies GSK and Exelixis.
Dr Axel Hoos – Non-Executive Director
Dr Axel Hoos is Head of Oncology and Senior Vice President at GSK. He is also currently the Co-Chairman of the Think-Tank, Cancer Immunotherapy Consortium and Chairman of the Sabin Vaccine Institute. Dr Hoos was previously the Medical Lead for Yervoy, the first survival-improving immuno-oncology treatment approved in 2011.
Mr Charles Walker – Non-Executive Director
Mr Charles Walker has extensive financial markets experience having executed over 50 cross border transactions. He has held senior executive positions at Alchemcia Limited (ASX: ACL) and Imugene. Mr Walker’s clinical experience incorporates handling a pipeline of drugs in every stage of discovery through to Phase III to product launch.
Dr Lesley Russell – Non-Executive Director
Dr Russell has over 25 years of senior international operational and leadership experience having worked at Amgen, Eli Lilly, Teva, TetraLogic, Innocoll Holdings Plc, and Cephalon. She has extensive knowledge and experience with novel early drug development. Currently, she is also a Non-executive Director of AMAG Pharmaceuticals, Sojournix and Enanta Pharmaceuticals. Previously, she was also a Non-executive director of Endocyte Pharmaceuticals Inc.
Dr Jens Eckstein – Non-Executive Director
Dr Eckstein is the Managing Partner of Apollo Ventures and Former president of SR One Ltd., the VC arm of GSK. He holds over 15 years of experience in venture capital funding early to clinical stage biopharmaceutical firms. He has extensive experience as chairman, the board of director and founder of several biotechnology and venture capital companies. He is also a inventor of the world’s largest life science accelerator, OneStart.
Imugene’s management team also includes Dr Mark Marino, Dr Nick Ede and Dr Anthony Good with extensive experience in drug and clinical development.
Dr Mark Marino – Chief Medical Officer
Dr Marino has over 28 years of experience in drug development. He was formerly the Chief Medical Officer of Cytori, Head of Research and Development at Mannkind, Head of Clinical Pharmacology at Eisai and Roche and Vice President of Clinical Development at Daiichi.
Dr Nick Ede – Chief Technology Officer
Dr Ede has more than 25 years of experience with peptide vaccines and drug development. Dr Ede was formerly Vice President of Chemistry Chiron (now Novartis) and Research Fellow CRC Vaccine Technology.
Dr Anthony Good – Vice President of Clinical Research
Dr Good holds over 20 years’ experience in clinical development. He has been integral to the development of several medicines including Viagra, Revatio, Lipitor and Somavert. Dr Good previously worked with Covance Clinical Services and Pfizer Global Research and Development.
Imugene’s sound management team is backed by well qualified and highly experienced Scientific Advisory Board members which include:
Imugene’s management team holds considerable experience in biotechnology and pharmaceutical industry, particularly in oncology drug development. The company’s sound and efficient management team has proven to be a substantial contributory factor in its swift progress.
Imugene’s stock is trading at AUD 0.023 on 13th August 2019 (as at 3:39 PM AEST), with 3.1 million shares in rotation. The stock has delivered a return of 27.78 per cent on a YTD basis.
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