Biotech Stock Mailbag: YM Bio, Infinity, Delcath and Galena
BOSTON ( TheStreet) -- @atrini opens this week's Biotech Stock Mailbag by asking: "Are you expecting any news on CYT387 at ASH in December?"
YM BioSciences (YMI) will release final nine-month results from the 166-patient phase II study of CYT387 in myelofibrosis, plus additional data from the extension study. The oral presentation at the American Society of Hematology (ASH) annual meeting is scheduled for Sunday at 5:15 pm.
What we already know about the new CYT387 data comes from the study abstract released in November. For the first 60 patients with the longest followup (median 21.5 months), the anemia and spleen response rates were 59% and 48%, respectively.
Among 33 patients who were dependent on red blood cell transfusions, 70% achieved transfusion independence for at least 12 weeks. Some of these patients were transfusion-independent for more than two years.
These are fantastic data and suggest CYT387 could be a superior myelofibrosis drug stacked next to Incyte's (INCY) Jakafi. Unfortunately, relatively few investors believe CYT387's anemia benefit is real. YM Bio's share price has barely budged since interim results from the CYT387 phase II study were presented at the ASH meeting last December.
YM Bio has done nothing to bolster the credibility of CYT387 by dragging its feet on moving the drug into phase III studies. Investor hopes that a Big Pharma partner would come aboard and bless CYT387's potential haven't materialized.
Final phase II data on Sunday that continues to show CYT387 demonstrating robust anemia response and transfusion independence will be welcome news. But unless YM Bio pairs the data with a boffo partner deal, I suspect investors will leave the ASH meeting disappointed.
Sticking with this weekend's ASH meeting, there are two additional drugs that will garner much attention from health-care investors.
Pharmacyclics (PCYC) and partner Johnson & Johnson (JNJ) will be presenting updates from ongoing, mid-stage trials of their Bruton's tyrosine kinase (BTK) inhibitor ibrutinib. Investors will be paying particularly close attention to data from trials in relapsed/refractory chronic lymphocytic leukemia (CLL) and elderly treatment-naive CLL. Results from a separate study in mantle cell lymphoma (MCL) will also be presented.
Investors will get the first detailed look at Infinity Pharmaceuticals' (INFI) PI13K inhibitor IPI-145 from a phase I study enrolling patients with various blood cancers, including CLL and MCL. A first peek at IPI-145 data from the abstract released in November caused Infinity's stock price to rise from $18 to $26 per share.
Ibrutinib and IPI-145 are considered competing drugs because they're being developed in many of the same blood-cancer indications. Their respective cancer-killing mechanisms -- BTK and PI13K inhibition -- are also closely related.
Investors are keen to compare ibrutinib and IPI-145 because the former has been the spark for an astonishing increase in Pharmacyclics' market value, which now stands at $3.7 billion. (And that's with Pharmacyclics sharing economic rights to ibrutinib with J&J.)