Amplia Therapeutics (ATX: $0.295) is developing a small molecule drug for the treatment of pancreatic cancer. It is initially trialing the treatment in patients with advanced form of the disease, metastatic prostate cancer.
The company is currently conducting a Phase I/II study with 55 patients (50 evaluable) having been treated. In May the company reported that its target of a partial response in at least 15 patients had been met. The compound is being given to patients with standard‑of‑care chemotherapy. At that point 21 patients remained on the study, which meant that further responses were possible.
In mid June the company reported that the therapy had achieved a pathological complete response in both the primary and secondary tumours in one patient, which CEO Chris Burns said was extremely unusual. The response was termed ‘pathological’ because the tumours were excised as a result of the response allowing surgical treatment. However what was of particular interest is that the tumours excised were necrotic with ‘no live tumour tissue’.
According to Burns, this had not been seen before by clinicians, with Burns able to cite one paper where a complete response had been achieved from chemotherapy alone in both the primary and secondary tumours. In that study, one patient of 431 achieved a complete response from chemotherapy.
In patients less advanced with non‑metastatic disease, around 5% of patients achieve a pathological complete response.
A few days later, the company announced that a second complete response had been achieved from one of the previous partial responders.
Since then another partial response has been achieved (greater than 30% tumour shrinkage) bringing the total responses (partial and complete) to 16 from 55 (29%). The outcomes from a further 20 patients continuing therapy awaits.
Amplia is now capitalized at $114 million. It places the company in a much stronger position to progress its drug candidate.
Bioshares recommendation: Speculative Buy Class A
CEO Chris Burns will be presenting at next month’s Bioshares Biotech Summit in Hobart.
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