Antisoma rethinks strategy after lung cancer drug fails pivotal trial

Lung cancer claims another victim. Antisoma announced today Novartis is ending a phase III trial for ASA404/AS1404 in previously untreated non small cell lung cancer (NSCLC), the seventh candidate that has suffered a phase III clinical setback in this hard-to-treat indication in recent months (Therapeutic focus - Shots on goal could be the key for lung cancer, February 10, 2010).

The announcement caused Antisoma’s share price to tumble 72% to a record low of just 9p in afternoon trading today as investors assumed the end is nigh for ASA404, eliminating an estimated $626m in net present value from the company. With the failure of the trial Antisoma is under extra pressure to partner phase III acute myeloid leukaemia (AML) candidate AS1413, as cash will start to get tight next year without the milestones and revenues from the lung cancer drug.

Futility rule

The UK company announced that it was ending the 1,200-patient Attract-1 trial in NSCLC after a data monitoring committee evaluating an interim analysis found that the study had met a stopping rule for futility. The rule indicated that ASA404 in combination with carboplatin and paclitaxel when compared with carboplatin and paclitaxel alone, had "little or no prospect" of demonstrating a survival benefit.

A second trial in NSCLC, Attract-2, is still underway, comparing ASA404 in combination with docetaxel to docetaxel alone. After speaking with their partners at Novartis, Antisoma executives said the Swiss company would be reviewing the entire clinical programme for ASA404 but added that the data monitoring board had found no safety issues that would preclude continuation of trials in other indications.

It would not be the first time ASA404 has run up against a commercialisation barrier. Antisoma and Roche had partnered the drug in 2002 for $37m upfront and $4m in share purchases as part of a multi-product deal, only to have Roche return the rights to the ASA404 in 2006.

On a conference call today, Glyn Edwards, Antisoma’s chief executive, said the company would be putting more of a focus on AS1413 and another AML candidate, AS1411, now in phase II.

Antisoma had licensed the rights for ASA404 to Novartis in 2007 for $75m upfront and was paid $25m upon initiation of the phase III clinical trials, with up to $330m in additional developmental and regulatory milestones, $325m in sales milestones, and $110m for follow-on indications. However, the chances of Antisoma receiving any more cash under the deal look slim indeed.

Cash runway

With £45.1m ($67.5m) in cash at the end of February, the company has a little cushion, but not much. Mr Edwards said it was sufficient to get the company through the end of 2011, which will allow trials of AS1413 to report at the end of 2010 or the beginning of 2011, and AS1411 early in 2011.

However, he acknowledged that the company will have to be more "pragmatic" in its partnering approach with both drugs, suggesting that Antisoma may have to surrender value in the lucrative US market in order to secure a deal. Asked if the company would be laying off employees, Mr Edwards said Antisoma will "look at headcount" but did not announce any job cuts today.

It is surely nervous times for Antisoma and its investors, as shown by the collapse in the share price today. Like most companies in this situation, they are betting on remaining pipeline candidates to come through with good results. The indication is that within a year, we will know whether Antisoma is flying high again or will be reviewing its strategic options.

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