Imugene (ASX:IMU) has received firm commitments to raise $3 million through a placement of shares priced at $0.0075 each to sophisticated investors.
This includes one free attaching option exercisable at $0.015 and expiring on 31st March 2017 for every two shares subscribed.
The company also plans to issue 2 bonus options for every 15 shares held in the company to shareholders. These have the same terms as the placement options.
The capital raising includes a subscription by non-executive director Otto Buttula for shares amounting to $225,000 and non-executive director Charles Walker for $11,250 worth of shares.
Proceeds will be used to initiate the company’s Phase 1b/2 clinical trial for its HER-Vaxx gastric cancer treatment and additional preclinical work on HER-Vaxx drug combinations.
The company has already appointed global contract research organisation (CRO) Simbec-Orion to conduct the trial and is targeting late this year or early 2016 to commence the Phase 1b trial.
Shareholder approval will be sought at company’s upcoming annual general meeting for the share placement.
Paul Hopper, executive chairman, commented:
“We are delighted to welcome new and existing shareholders to Imugene in this placement. The funds raised from this placement, subject to shareholder approval, in addition to our existing cash position, places us in a strong position to move ahead with our program.
“With our newly appointed COO, Ms. Leslie Chong, commencing her role shortly and the start of clinical trials, we look forward to an exciting time ahead for Imugene.”
Imugene is in the later stages of planning to conduct a new preclinical study of HER-Vaxx in an additional disease model of gastric cancer.
This could improve the company’s case to achieve orphan drug designation from the United States Food and Drug Administration as well as steering development of follow up clinical candidates using the HER-Vaxx technology.
Chief Scientific Officer Professor Ursula Wiedermann is also conducting additional work at the Medical University of Vienna on the final chosen formulation of HER-Vaxx.
This work is looking to further establish additional evidence of the enhanced efficacy from the new formulation of HER-Vaxx.
HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.
HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.
HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.
Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.
Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.
The $3 million to be raised will allow Imugene to start the HER-Vaxx gastric cancer human clinical trial, which is a key inflection point.
Pre-clinical data had previously showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.
It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.
Imugene had $1.96 million in cash as at 30th June 2015.
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