Imugene provides Guidance for KEY-Vaxx Cancer Immunotherapy

Imugene Limited (ASX: IMU) is an ASX listed biotechnology company based in Sydney, Australia. The company’s primary focus is on the cancer immunotherapy by developing a range of new and novel immunotherapies that can activate the immune system of cancer patients to treat and eradicate tumours. The company’s platform generates antibodies against tumours for harnessing the body’s immune system. The company has multiple immunotherapy B-cell vaccine candidates in its product pipeline, which are targeted at curing a variety of cancers. A team of international cancer experts are supporting the company, who have vast experience in developing new cancer therapies with many approved for global sales and marketing.

On 20th March 2019, the company announced that it had received and accepted the minutes of its Pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) for its KEY-Vaxx cancer immunotherapy, conducted on 8th February 2019.

The meeting was held between the company’s team and a seven-member panel of the FDA Division of Regulatory Project Management Office of Tissues and Advanced Therapies in Washington DC. The meeting was aimed at seeking regulatory guidance on the studies required for Phase 1 clinical development of KEY-Vaxx and agreement of the preclinical, chemistry, manufacturing and controls and clinical development plan, which is to be included in an IND for Imugene’s PD-1 targeting KEY-Vaxx immunotherapy. Topics discussed in the meeting included the anticipated clinical indication and the treatment of cancers that overexpress PD-L1, including but not limited to, non-small cell lung cancer.

Leslie Chong, the Chief Executive Officer and Managing Director of Imugene stated, ‘’the outcome of the meeting was productive.’’ It was fruitful in providing the company with a clear direction for a successful IND submission and subsequent clinical development of KEY-Vaxx.

On 14th March 2019, the company reported that it had dosed the first patient with its HER-Vaxx (IMU-131) cancer vaccine in 68 patients randomised multi-centre Phase 2 study. The vaccine is targeted towards the treatment of HER-2 positive gastric cancer patients.

On 4th March 2019, the company disseminated information regarding its upcoming presentation on its KEY-Vaxx and B-Vaxx cancer vaccine. It stated that the presentation on these two vaccines would be presented by Dr. Tanios Bekaii-Saab from the Mayo Clinic at the American Association for Cancer Research (AACR) 2019 Annual Meeting, which is scheduled for March 29 to April 3, 2019.

On 28th February 2019, the company released its 1H FY19 results. The company reported a loss of $3.44 million in 1H FY19 compared to the previously reported loss of $1.63 million a year ago in 1H FY18. The increased loss was primarily due to a significant increase in clinical trial and research activities. After successfully raising capital of $20.1 million in July 2018, the group’s net assets increased to $31.18 million compared to $15.47 million at 30th June 2018. The company had a cash reserve of $24.05 million as at 31st December 2018.

On the technical front, the stock price rose by more than 10% and closed the day at A$0.021 as of 20th March 2019, compared to the previous day’s closing of A$0.019. The stock has given a negative return of 9.52% in the last six months, while YTD return stands at 5.56%.


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