Over the last two months, there have been some strong price movements in several major and minor biotech stocks. Following a downturn that has lasted almost two years, has the Australian sector finally bottomed?
We reviewed Clinuvel Pharmaceuticals, Dimerix, Imugene, and Neuren.
Imugene (IMU) – Up 127% (up $373 million)
Imugene's market value has rebounded strongly by 373 million since its low point in October. After having been sold down considerably from $0.625 high two years ago, the stock experienced a strong resurgence last month following the early encouraging first results from its oncolytic virus CF33 trial.
Thirty-four patients with a range of solid tumours have been treated so far with the novel oncolytic virus drug candidate, CF33-hNIS, with initial results released from the first 25 patients. The strongest treatment effect was seen in patients with gastrointestinal tumours, where stable disease was achieved in seven of the eight patients, with one patient achieving a complete response. All patients enrolled in the study had previously undergone extensive treatment with other therapies that had either failed to control their cancer or provided only limited benefit.
Imugene will now expand the study with an additional 10 patients for the notoriously difficult-to-treat bile duct cancer which is considered 'immunologically cold,' meaning that it does not respond well to checkpoint inhibitor therapies.
The company has been granted Fast Track Designation from the FDA for the bile duct cancer treatment program. This designation may expedite the approval process (on smaller studies with a surrogate endpoint rather than for instance a survival benefit which can take longer to establish) and grant the study Priority Review (six months for FDA assessment of the NDA or BLA).
Imugene also stated that it has received a high level of interest from clinicians following the early bile duct cancer treatment results.
Bioshares recommendation: Speculative Hold Class A
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