First up, GlycoMimetics Inc (NASDAQ:GLYC). GlycoMimetics just kicked off a phase 2 trial in patient with relapsed/refractory acute myeloid leukemia. The trial is the second part of a phase 1/2 in its lead oncology candidate, GMI1271, investigating the drug in combination with induction chemotherapy. The drug is what’s called a novel e-selectin antagonist, which means it inhibits the standard moa of e-selectin (which is a cell adhesion molecule) to – in theory – improve the efficacy of the chemotherapy being used to tackle the cancer as first line.
The first part of the trial identified the maximum tolerable dose, and this second part will attempt to establish efficacy at this dose. Sample size comes in at circa 25 individuals, and the trial should complete early next year.
GlycoMimetics is up more than 40% year to date, and trades at a market cap of $155 million, for a forward P/E of 19.15.
This one’s not quite as straightforward as the above, but let’s have a go at unraveling the fundamentals that underpin its volatility. Cara Therapeutics Inc (NASDAQ:CARA) lead pain management candidate is a kappa agonist called CR845. It’s designed as an alternative pain treatment that doesn’t affect the central nervous system (and in turn, doesn’t produce the addictive and abuse associated side effects associated with such). Instead, the drug plays on what’s called the peripheral system.
Anyway, Cara kicked off a pivotal phase 3 in CR845 in postoperative abdominal pain in September last year, In February, however, the FDA placed a clinical hold on the trial while it investigated some of the efficacy signals put forward as part of the trial application, as well as looked into some safety related issues. Cara tanked on the delay, but in April 2016, the agency released the hold. Just this week, the company announced it will be recommencing the study, with enrollment continuing this month.
Cara is up 32% on its February lows, for a market capitalization of $170 million.
Finally, Advaxis, Inc. (NASDAQ:ADXS). The company just released data from a phase 2 trial in its lead oncology candidate, and announced its intentions to present this data in more detail at ASCO this month. The drug in question is called Axalimogene, and is a cervical cancer target. The data, albeit light as things stand, looks indicative of efficacy, and it looks as though we will see a phase 3 announcement sometime during the third quarter of this year. As a kicker, the company concurrently announced the name of the upcoming phase 3 – AIM2CERV – which fuels expectations of a quick move into pivotal.
Advaxis is up 35% on last month’s lows, and trades for a market capitalization of a little over $325 million at last count.
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