After popping 14% on Friday follow earnings that didn't justify the increase, shares of ImmunoGen (IMGN) are down 12.6% at 2:49 p.m. EDT on Monday, also for no apparent reason. The biotech reported second-quarter earnings on Friday, but without any revenue-generating drugs on the market, the focus is on the biotech's pipeline rather than the earnings number.
ImmunoGen results: The only number that really matters
|
Metric |
Q2 2017 |
Q4 2016 |
Year-Over-Year Change |
|---|---|---|---|
|
Cash and equivalents |
$150.3 million |
$160.0 million |
(6%) |
Data source: ImmunoGen.
What happened with ImmunoGen this quarter?
- The phase 3 trial called Forward I testing mirvetuximab soravtansine in patients with ovarian cancer now has more than 60 sites open in North America and Europe and is on track for at least 100 sites before the end of the year. The faster the enrollment, the quicker the data, and hopefully the faster mirvetuximab soravtansine could be approved.
- ImmunoGen announced two deals that brought in much-needed cash: A deal to exchange future royalties on drugs partnered with Sanofi for $30 million upfront and a separate deal that sent IMGN529 to Debiopharm in exchange for $25 million upfront, $5 million after the transfer of technologies related to the asset, which is expected before year end, and the potential for another $25 million if the drug enters phase 3 development.
- The biotech presented plenty of promising data this quarter, including phase 1 data on IMGN779 in patients with acute myeloid leukemia (AML) and phase 1b data from Forward II, a trial testing mirvetuximab soravtansine in combination with other drugs.
Image source: Getty Images.
What management had to say
Based on the aforementioned Forward II trial, ImmunoGen's chief medical officer, Anna Berkenblit, hinted during the earnings call at future plans for testing mirvetuximab soravtansine in combination with other drugs: "So we are considering options to move mirvetuximab as a doublet with carboplatin, or potentially as a triplet with Avastin or even Keytruda into earlier lines of therapy. We're currently assessing the options, and we'll keep you posted as we solidify our development plan."
Berkenblit also provided an update on plans for IMGN779, which have changed after Seattle Genetics (SGEN) stopped phase 3 development of vadastuximab talirine in patients with AML and a regulatory decision by the FDA's Oncology Drug Advisory Committee (ODAC) for Pfizer's Mylotarg:
Our prior plan had been to develop 779 around them, assuming success [of Seattle Genetics ' vadastuximab talirine]. Since they are no longer developing it, that provides additional opportunities for our agent, which alkylates DNA and does not cause double-stranded DNA damage. The other event that occurred is the positive ODAC for Mylotarg. ... What that means for us is it may open up the potential for event-free survival being the primary endpoint for a first-line AML trial for approval, which could allow us to develop the drug with a smaller and shorter phase 3 trial. So we're taking these two events into consideration as we're thinking about moving 779 up into earlier lines of therapy.
Looking forward
Data from Forward I is the most important event for ImmunoGen, but it's still a few years away, although there will be a futility analysis in the first half of next year to ensure the trial is worth continuing.
In the meantime, investors can look forward to additional data from the phase 1 trial for IMGN779 later this year and more data from Forward II for patients treated with mirvetuximab soravtansine and Merck's Keytruda in the first half of next year.
The company is also continuing to develop new drugs with plans to file an application in the third quarter to start clinical trials for IMGN632, which targets blood cancers expressing CD 123.
And hopefully ImmunoGen will do more cash-generating deals with its pipeline drugs, because its current stockpile will only fund operations into the second half of 2018.
