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Amplia Achieves Additional Partial Response as Data Begins to Mature

Data from Amplia Therapeutics' (ATX: $0.16) Phase Ib/IIa study in pancreatic cancer with its drug candidate narmafotinib is beginning to mature. The company has recruited 55 patients with advanced (metastatic) pancreatic cancer into the study. So far, 17 patients have achieved a partial response and one patient a complete response, giving an overall response rate (ORR) of 33%. This includes one additional partial response from when the data was last reported at the beginning of August. The aim for the company has been to achieve at least 15 responses, which has now been achieved. This benchmark indicates an improvement on chemotherapy treatment alone.

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Another five patients have an unconfirmed response and are awaiting confirmation at the next scan. This means the final figure for ORR will be between 33% - 42%. This is an improvement on chemotherapy alone, where the historical data from the MPACT study reported in 2013 in 413 patients achieved an ORR of 23%. The Amplia data also betters the MPACT study data on the measure of Days on Treatment, which is currently averaging 219 days (up from 201 days at the start of August). The MPACT study reported average days on treatment of 117 days. The longer patients stay on treatment equates to improved patient outcomes.

On the measure of Progression-Free Survival, the Amplia study is tracking at 7.6 months, compared to 5.5 months in the MPACT study, and 6.4 months with the FOLFIRINOX treatment, which comes with more significant side effects. The next measure the company will be reporting on is overall survival, which can be expected early next year, according to CEO Chris Burns. The overall survival in the MPACT study was 8.5 months, and 11.1 months with FOLFIRINOX from historical data (Prodige study).

Currently, there are nine patients remaining on treatment (down from 17 at the beginning of August), with seven patients alive for more than one year and two patients having received treatment for over one and a half years. The tolerability of narmafotinib has been excellent according to the company.

Registration Study Next
Full data from the current Phase Ib/IIa study is expected in the second half of next year. At that point, the company expects to have finalised planning for the Phase IIb/III registration study. Burns is hopeful that the registration trial will not need to be as large as the MPACT study.

Amplia has also commenced a study with narmafotinib with the FOLFIRINOX treatment, where a slightly higher dose could be explored, although good target (FAK) inhibition has been achieved at the current dose.

Amplia is capitalized at $62 million with around $35 million in cash following a $27.5 million capital raising last quarter at $0.23 per share.

Bioshares recommendation: Speculative Buy Class A.

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