Friday, May 02, 2014

Agios Impresses With Leukemia Drug: Investor Beware

Agios Pharmaceuticals (AGIO-$43.35) moved substantially higher in price last month after reporting Phase 1 data demonstrating that its cancer metabolism drug AG-221, a first-in-class inhibitor of IDH2 mutations, generated promising clinical activity, including complete remissions in several patients whose blood cancers harbored the IDH2 mutation. 

What has investors excited is that in addition to being well-tolerated, a “substantial” reduction of plasma 2-HG was achieved: Called an “oncometabolite” for its role in cancer metabolism, the metabolite 2-hydroxygluturate (2HG) is a by-product of the mutated IDH2 gene. The initial findings support the theory that inhibiting mutant forms of IDH2 suppresses the growth of these 2HG-producing tumor cells.

Investors are making the quantum leap – based on a small safety/dosing trial – that curtailing 2-HG supply will normalize gene expression….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy. 

Biotech Losers of 2013: AVEO, INFI, AFFY, and ARIA -- Where Are They Now?

Despite having lost more than 90% of its market valuation in the last 21 months, AVEO Pharma’s (AVEO-$1.24)  management believes it can drive shareholder creation by moving forward with other early-stage, oncology assets, principally by securing partnerships after providing proof-of-concept data. Though attractive commercial opportunities do exist, even in highly competitive markets, for targeted cancer therapies, we question this management team’s ability to develop their putative “first-in-class clinical assets” following the debacle of the VEGF receptor tyrosine kinase inhibitor, tivozanib, last year.

Evolving Phase 1 data presented at the American Society of Hematology (ASH) meeting held in early December 2013 showed not only that earlier safety concerns on Infinity’s (INFI-$9.20) lead asset, IPI-145, had been overblown, but that the drug demonstrated impressive efficacy in patients with either relapsed or refractory CLL (81% of patients had been treated with three or more systemic therapies), too.

Unfortunately, we’ll never know the “would of, could of” commercial potential for Affymax’s (AFFY-$0.70) anemia treatment, brand-name Omontys. After posting sales of $34.6 million for the nine-month period ending December 31, 2012 – slightly below analyst forecasts, suggestive of the contract-grip Amgen held on dialysis centers – Omontys was recalled on February 23, 2013 following reports of severe hypersensitivity reactions including anaphylaxis in 0.2% (or about 50 patients) — including fatal reactions in 0.02% of the 25,000 patients –within 30 minutes of their first IV dose in the post-marketing phase. Almost a third of the reported cases required prompt medical intervention and in some cases hospitalization, according to an FDA safety alert issued at the time.

Though the stock price of Ariad Pharma (ARIA-$7.25) has rallied off its 52-week low of $2.15 per share (October 31, 2013) to the $7.00 level, it still trades significantly below its 52-week high of $23.00 (September 11, 2013). The relief rally has stalled for two reasons:
  • Iclusig competes in an already crowded market for just two rare cancers. According to National Cancer Institute statistics, approximately 5,200 new cases of CML and 1,800 new cases of Ph+ ALL are diagnosed each year in the United States; and,
  • Ariad has discontinued – after consulting with the FDA – its EPIC trial, which had been designed to investigate the use of Iclusig in the front-line settings.

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.