Loxo Oncology is seeing the kind of early clinical responses the biotech hoped to see in their Phase I study of an innovative new cancer therapy. And with their ongoing mid-stage study billed as a potential registration study, they really don’t want you to miss out on a single patient case.
The Stamford, CT-based operation ($LOXO) muscled their way into the spotlight at AACR over the weekend, touting tumor regressions seen in 6 patients with TRK (tropomyosin receptor kinases) fusion genetic mutations.
TRK genes play a role spurring the development of neurons during fetal development, but can go rogue later in life when fused with other genes--driving the spread of cancer. While they typically account for only a small sliver of any patient population in any cancer type, they add up when viewed in total. And Loxo’s investigators were happy to report that their drug LOXO-101 had an impact across a range of TRK fusion cancer types.
Five of six evaluable patients with TRK fusion cancers qualified as partial responders (30% or more regression), with evidence of regression in a 6th patient that hasn’t qualified yet as a PR. None of those patients has seen their cancer progress yet, indicating durability. And the 100 mg dose being used in the Phase II trial was doing well with a satisfactory safety profile.
A snapshot like this might go unreported at a Big Pharma operation, but a small public biotech looking to highlight positive catalysts isn’t about to let it pass without a public celebration. In part, that’s because it’s important to sustain your share price, especially in a bear market. More importantly, cancer drug development has changed dramatically in the last few years. It’s possible for a drug aimed at orphan populations to ring up the kind of efficacy data needed to win an accelerated approval after Phase II, making early evidence of efficacy more significant.
The stakes go up faster, with share prices more likely to gap up or down at each turn of the card. And investors are starting to gauge Loxo’s chances for a pivotal Phase II, so the stakes are rising faster than ever before on earlier and earlier data, long before anyone can get any kind of read on whether the drug can actually prolong someone’s life.
This morning, Loxo CEO Josh Bilenker reviewed individual responses in their studies, including a patient that is now on a 14th dosing cycle. Another patient is training for the Boston marathon.
Loxo is shooting for around 151 subjects for the Phase II, though execs said today that the exact number hasn’t been established yet, and once they do that later this year analysts can start to narrow down a date for a possible advance to the FDA.
Loxo is running a risky game with bets resting on individual responses at this stage. In premarket trading today the stock was up 8%. So far, so good.
- here's the release