Clinical-stage biotech player Imugene Limited (ASX: IMU) soared ~27 per cent on the ASX today, settling the day’s trade at $0.033 on 11th November 2019. The stock has delivered a substantial return of ~53 per cent in the last six months, driven by significant developments in its product portfolio.
The stock has moved ~ 13 per cent up in the last five trading days during which the company notified about the receipt of an R&D tax refund of $4.13 million, released an Investor presentation and announced results of its Annual General Meeting.
Novel technology is one of the most sought-after areas of cancer immunotherapy today. Given this backdrop, the immuno-oncology player, Imugene develops a range of novel immunotherapies to trigger the patients’ immune system to treat and suppress tumours. The company has a broad and robust product pipeline that includes a range of B-cell immunotherapies and a proposed oncolytic virotherapy (CF33), which is poised to enter Phase 1 clinical trials in 2020.
Imugene has made speedy progress so far, observing several significant developments in the year 2018-2019, which include:
Successful Integration of Ohio State University B Cell Immunotherapies
The company licensed an extensive B-cell immuno-oncology portfolio from the Ohio State University (OSU) Wexner Medical Center & Mayo Clinic in June 2018. The company signed an exclusive, worldwide licence to the entire body of cancer vaccine work and intellectual property developed by Professor Pravin Kaumaya of the OSU Wexner Medical Center, the Comprehensive Cancer Center - the Richard J. Solove Research Institute and Arthur G. James Cancer Hospital and Mayo Clinic.
The substantial intellectual property estate licensed included a broad patent portfolio with 6 patent families containing 16 issued patents or pending applications for compositions of matter and/or methods of use of a large range of B-cell peptide and cancer vaccines comprising HER-1, HER-2, HER-3, PD-1, VEGF, IGF-1R, CD28 peptides and combinations thereof.
Commencement of PD-1 Manufacturing
Imugene commenced cGMP manufacture of the clinical batch of a PD-1-Vaxx cancer immunotherapy for the proposed Phase 1 PD-1 clinical trial in September 2018, after successful completion of pilot studies. The company appointed cGMP peptide manufacturer AmbioPharm Inc. in South Carolina USA to supply clinical grade PD-1 cancer vaccine.
Successful Pre-IND FDA Meeting for Guidance for PD1-Vaxx Clinical Development Plan
Imugene received and accepted the minutes of its Pre-IND meeting with the US FDA for its PD1-Vaxx immunotherapy on 8 February 2019. The meeting presented the company with an apparent roadmap for a successful submission of the IND application and following clinical development of B cell immunotherapy, PD1-Vaxx.
The panel members of the FDA encouraged the company to carry out the scheduled submission of the IND application and subsequent clinical studies.
Met Endpoints in Phase 1B HER-Vaxx Gastric Study
Imugene met all endpoints from the Phase Ib study of HER-Vaxx gastric cancer immunotherapy in December 2018. The positive top-line results demonstrated that of the 10 patients evaluable for tumour growth assessment during the study, 5 patients showed partial response and 4 patients showed stable disease for their best overall response.
First Patient Dosed in HER-Vaxx Phase 2 Study
In March 2019, the company announced dosing of the first patient in an open-label Phase 2 study with its HER-Vaxx (IMU-131) cancer immunotherapy for the treatment of HER-2+ gastric cancer patients. The first patient of the 68-patients study was dosed with IMU-131 at Chisinau’s Oncological Institute in Eastern Europe.
Leading International Life Science Experts Joined the IMU Board: Dr Russell and Dr Eckstein
A leading global pharmaceutical executive, Dr Lesley Russell and a leading biotechnology executive and entrepreneur, Dr Jens Eckstein joined IMU board as Non-executive Directors in April and May 2019, respectively. These international life science experts enhanced the Board’s skill mix.
Scientific Advisory Board Enhanced with Hiring of Professors Kaumaya, Saab, & Caligiuri
The company strengthened its Scientific Advisory Board (SAB) during the year with appointments of Professor Tanios Bekaii-Saab of the Mayo Clinic, Professor Pravin Kaumaya of OSU Comprehensive Cancer Centre and Professor Michael Caligiuri, President of the City of Hope (COH) National Medical Center in Los Angeles.
Proposed Acquisition of City of Hope CF33 Oncolytic Virus
Imuegne announced in July 2019 that it would acquire Vaxinia Pty Ltd as well as a worldwide exclusive license to the highly-potential oncolytic virus technology, known as CF33, invented at COH by Professor Yuman Fong.
The acquisition is subject to shareholder approval at the EGM scheduled to be held next week on 18th November 2019.
The company has planned to conduct two distinct Phase 1 clinical trials for CF33 in 2020 to review a Vaxinia and a CheckVacc construct. COH researchers have recently received a grant of ~USD 564k from the US Department of Defense to examine CF33 in gastric cancer.
Proposed new OV SAB to be Chaired by Prof Yuman Fong
The company appointed Dr Fong to chair its newly formed oncolytic virotherapy SAB in October 2019. Dr Fong is an internationally recognized surgeon, a researcher, a scholar, a true renaissance man. Moreover, the company mentioned that the formation of OV SAB is subject to CF33’s proposed licensing transaction.
It is worth noting that Imugene has made considerable progress and attained several milestones in 2018-2019, backed by its robust product pipeline and efficient management team. The company is further eyeing key developments in near future.
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