Karolinska portfolio biotech says PhII lung cancer drug on promising track

An early snapshot of preliminary data from a midstage study of an experimental lung cancer drug at a Karolinska Development ($KDEV) portfolio company offered an encouraging outline of its initial direction, persuading investigators to wrap enrollment earlier than initially planned as they complete the last leg of the trial.

Axelar AB says that its drug, AXL1717, is so far on a positive track in a Phase II study for non-small cell lung cancer (NSCLC), which compares its effect against docetaxel. "Preliminary analysis suggests that AXL1717 has similar rate of PFS [progression free survival] after 12 weeks as docetaxel," says the company. "The most frequent serious adverse events in the study were cases with neutropenia, which occurred in both treatment regimes." And as a result the investigators say they can stop enrolling patients once they hit the 100 mark instead of the planned recruitment of 140 patients, confident they'll have the data they will need.

NSCLC is a tough target, with an extremely poor 5-year prognosis for diagnosed patients. If Axelar can prove they have a good shot at noninferiority, then the biotech and Karolinska Development, which is advancing therapies identified by researchers at the prestigious Karolinska Institute, should have a good shot at finding a marquee partner to take it forward.  

"Firstly, this is preliminary data on rate of PFS after 12 weeks," cautions Benjamin Nordin, the investor relations officer at Karolinska, in an email to FierceBiotech. "Secondary parameters such as overall survival is of course also very important and it is too early to draw the final conclusions on the results." 

But the trend is encouraging and Karolinska Development's shares bounced higher on the news.

"This is an aggressive study where we compare AXL1717 vs docetaxel in second line treatment and we have said already from start that if AXL1717 shows similar or better effect than docetaxel, it is a successful outcome. The reason we think this is the case is the large number of patients that are resistant to docetaxel and as many as 90-95% of all NSCLC patients do not respond to second line treatment. There is an obvious need for new treatment options for these patients and with the data that has been generated so far with AXL1717, including the Phase I/II-data, we believe that AXL1717 has the potential to play an important role in future treatments of NSCLC."

- here's the press release
- read the Bloomberg report


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