Back in the fall of 2014, a restless AbbVie stepped in with a $275 million upfront payment to partner with Infinity Pharmaceuticals on duvelisib, its oral PI3k-delta/gamma inhibitor for blood cancers. Today, after duvelisib failed to impress the pharma company in a mid-stage study, AbbVie is walking away from their partnership and Infinity is axing 100 staffers to conserve cash.
Infinity’s troubles hit after duvelisib hit its primary endpoint for indolent non-Hodgkin lymphoma in a Phase II with a 46% overall response rate. Zydelig and Rituxan both did better than that, though, spurring some big questions over what kind of future the drug could have on the market.
AbbVie immediately suspended a combination study with venetoclax, and now Infinity says the study is being terminated. The biotech is also closing BRAVURA, a Phase III study of duvelisib in patients with relapsed iNHL, and CONTEMPO, a Phase Ib/2 study of duvelisib in treatment-naïve patients with follicular lymphoma.
But the Cambridge, MA-based biotech is not giving up on duvelisib. Neither are the executives who are pursuing a questionable strategy in continuing to try and blaze a path to the FDA.
In an 8-K filed with the SEC, Infinity laid out a series of 6-figure retention bonuses for CEO Adelene Perkins, R&D chief Julian Adams along with the CFO and chief commercial officers. Perkins is in line for $334,750; Adams gets $249,000; Lawrence Bloch gets $209,000 and Sujay Kango gets $205,000. That’s half of their base pay.
The news kicked up a fuss on Twitter, though TheStreet’s Adam Feuerstein later reported all remaining staffers at the biotech are in line for a 50% retention bonus.
1/ An apology and correction is necessary. $INFI is paying retention bonuses to ALL employees who stay w/ company, not just top executives.
— Adam Feuerstein (@adamfeuerstein) June 28, 2016
A spokesperson for Infinity broke it down like this for Endpoints: “The number of people eligible for a retention bonus is 79 (65 remaining plus 14 of the 100 impacted who are staying past labor day but concluding work by 12/30). Each of those employees gets a bonus up to 50% but it’s on a pro-rated basis. The payment dates are 12/30/16 and 7/1/17.
“Example: If you make 100K, and work until December 30th, you get 25K. If you were to work until July 1, 2017, you would get another 25K. If you were to be terminated Sept 30th, you get $12,500K (pro-rated with start date of retention program being July 1 of this year).”
In a statement, Perkins says the company plans to pursue an approval with the FDA, mixing its Phase II data with results from an ongoing Phase III in search of an accelerated approval. Topline data is expected from the Phase III in the next few months. And if that flies with regulators they’ll turn to their FRESCO study to serve as a confirmatory study for full approval in follicular lymphoma.
“Data reported to date have demonstrated that duvelisib is clinically active with a manageable safety profile, and we believe that it could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients,” Perkins noted. We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib.”
Wedbush analyst David Nierengarten wasn’t surprised by AbbVie’s exit. But with Infinity also shifting focus to an early-stage drug in the pipeline, it’s going to face another uphill struggle to gain convincing data in a very competitive field.
“IPI-549 is a PI3K-gamma inhibitor currently in Ph 1 study as monotherapy and in combination with an anti-PD1 antibody,” he says. “INFI has shown preclinically that combination of IPI-549 with checkpoint inhibitors results in synergistic anti-tumor activity in mouse models. However, given the large number of ongoing checkpoint inhibitor combination trials, we would expect IPI-549 to have to demonstrate compelling activity to generate significant investor interest. With significant cost reductions not expected until 2017, we model for YE cash to be approximately $58M.”
This is Perkins’ third major crisis at Infinity, following the failure of two earlier lead programs in cancer. Whether it can survive this one, though, is still uncertain.
— j l (@bio_clouseau) June 28, 2016
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