Cascadian $CASC changed its name (from Oncothyreon) and installed a new CEO in the hope of shedding the seeming curse that dogged almost every step at the biotech. And now it has a new, accelerated development program in place for its lead drug that puts it squarely in the pivotal phase.
The drug tucatinib — formerly known as ONT-380 in the pre-makeover days — is a HER2 inhibitor that has been matched up with Herceptin and Xeloda in combatting treatment-resistant breast cancer. It’s a pill, intended to get through the blood-brain barrier to help some desperately ill patients.
In new Phase Ib data, the triplet scored a median progression-free survival rate of 7.8 months, an overall response rate of 61% and a median duration of response of 10 months.
With that in mind, CEO Scott Myers, who stepped in last summer, went back to the FDA and asked for a makeover on the Phase II study. And Myers says that the FDA signed off, agreeing to let Cascadian increase enrollment in the mid-stage study to 480 and make it a registrational trial in the process. It’s already enrolling in the US and Canada, and Cascadian will now add sites in Europe, Australia and Israel.
Longtime biotech observers will recall that the company suffered through a series of setbacks. Its cancer vaccine Stimuvax helped establish the accepted view that the first wave of cancer vaccines has been a bust. Merck KGaA tried, twice, with big late-stage efforts on that and failed.
The FDA’s approval of the accelerated timeline for tucatinib fits in with its enthusiastic endorsement of finding ways to accelerate R&D in oncology. Of all the various disciplines at the FDA, the oncology group has been willing to sign off on some of the most dramatic ways to speed up development, carving years out of the process in some cases.
Cascadian still has a long way to go before it can claim a comeback. Its market cap is a small $138 million. But it does have a plan for changing the narrative.
Myers had this to say:
“We look forward to continuing a collaborative relationship with the agency and our clinical investigators as we advance the development of tucatinib in combination in the third-line metastatic breast cancer setting where there is no single standard-of-care and a need for more tolerable therapeutic options. The improvement in the updated data from our Phase 1b “triplet combination” study reinforces our strategy with tucatinib in this patient population.”
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