BioInvent scores unpleasant biotech triple

If bad luck happens in threes then BioInvent, whose monoclonal antibody project BI-204 has just flunked a phase II study in atherosclerosis, should now be able to look forward to some good fortune.

However, there is likely to be more bad news in store for the Swedish company. After the scrapping of a deal with Roche and now the failure of two drugs in phase II in the space of five weeks it is hard to see which way BioInvent can turn. The next move could see Roche hand back rights to BI-204 – like the earlier project this was partnered with the Swiss firm’s Genentech unit – followed by the expansion of an already announced cost-cutting programme.

Although BioInvent has tried to put a brave face on events investors do not share its optimism, and the stock crashed by more than 60% in early morning trade, valuing the business at barely SEK150m ($21m). The shares took their first hit early last month, losing 74% of their value after Roche pulled out of a deal for the oncology project TB-403, and TB-402 failed a phase II study in preventing venous thromboembolism in hip-replacement surgery patients.

Touching the void

In the phase II Glacier trial BI-204 failed to show any statistically significant reduction of inflammation in patients with stable atherosclerotic disease versus the control group. The company would not say whether there were any numerical differences either between active and control or between the single and multiple doses in the two active arms.

It is possible that all BioInvent has shown is that statins, which were included as part of standard of care in the control group, are very good in this setting. BI-204 was also well tolerated; in a sense, therefore, this looks better than last month’s result with TB-402, which as well as failing to show superiority over Bayer’s Xarelto threw up an unexpected significant risk of bleeding (Event - FDA adcom should provide clear vision of ThromboGenics's future, July 9, 2012).

But cash at the Swedish company is tight, and its current $20m or so is expected to last only around 12 months. After the failure of TB-402 BioInvent announced plans to cut 24% of its 89-strong workforce to save $2.2m a year, and further cost-cutting seems likely, albeit not before Glacier data are analysed in full.

Announcement of the full results, including biomarker measurements that might reflect drug effects, might also be the trigger for a decision by Roche on whether to continue with BI-204.

Weak hand

BioInvent insists that its remaining portfolio provides a strong platform for future growth. By far its most promising project now is BI-505, an anti-ICAM-1 antibody. Before BI-204’s failure analysts at Edison Investment Research said they believed that this was potentially the company’s most valuable asset, even though it is at a very early stage – phase I – and targets the highly competitive indication of multiple myeloma.

However, little will be possible without another cash injection, and Edison's Dr John Savin said BI-505 was worthwhile as long as investors put in more cash to fund it at least through phase IIb. "A deal on it now will deliver little, now or later," he told EP Vantage.

There had been hopes that BI-505 could be retained as an orphan product for in-house marketing. However, this is now looking highly unlikely, and BioInvent might have to find licensing partners at any stage of development and on any terms available. The company no longer has anything like a strong hand in negotiations.