June 23, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Cambridge, Mass.-based biotech Epizyme has been on a roller coaster this week, after early stage trial data on its experimental cancer drug showed it improved symptoms in nine out of 15 patients with non-Hodgkin lymphoma—a sign some analysts are taking to mean the drug, tazemetostat, has what it takes to go the distance.
That news pushed Epizyme’s share price up more than 30 percent in Monday trading, before settling down a bit Tuesday to $24.15 in afternoon trade.
This newest data comes from a medical conference in Lugano, Switzerland, where Epizyme presented early markers that showed a lot of promise, said an analyst with Citigroup.
“Notably, seven patients deepened responses from the previous data cut (SD→PR; PR→CR),” wrote Citigroup analyst Kennen MacKay in a note to investors this week. “Interestingly, patients that showed responses at two months, tended to deepen these responses over time while other patients showed no treatment effect at all.”
Citigroup said its models predict EPZ-6438 potentially reaching the market in 2017, through accelerated approval, and sales of $700 million by 2025.
“We continue to hope that molecular profiling could suggest a biomarker that could guide EPZ-6438 development to the most responsive patients,” said MacKay.
Formerly dubbed EPZ6438, tazemetostat has been developed at Epizyme in partnership with Japanese drugmaker Eisai Company, Ltd., before Epizyme bought back all commercial rights to it for as much as $110 million. Now Wall Street is closely monitoring how the drug performs, as early-stage trials are often a make-or-break for even the most promising of candidates.
“Epizyme presented updated Phase I data from EPZ-6438 in NHL. EPZ- 6438 showed a 60 percent (9/15) overall response rate in evaluable NHL patients (up from 40 percent at last update),”said MacKay. “We note responses were durable with three responses lasting ≥ 1yr. EPZ-6438 continued to appear safe and well tolerated with one recorded DLT (thrombocytopenia) and one drug-related discontinuation.”
That has analysts wondering just how successful tazemetostat could be if it eventually comes to market as a go-to therapy. They are also keeping an eye on Epizyme’s management, after Chief Development Officer Peter Ho said on a conference call Monday that the dugs has shown a pattern of “gradual but prolonged reduction of tumor mass” across all the different subtypes of NHL.
“The Phase I trial enrolled all comers with retrospective EZH2 profiling. AT ICML, Epizyme reported a PR in their first EZH2 mutant DLBCL patient,” wrote MacKay. There are caveats to that data, however, said analysts.
“We are optimistic this patient responded, but note an N of 1 is difficult to interpret, and await further validation of prospectively defined EZH2 patients in the Phase II study,” said MacKay in his note. “Furthermore, this incidence (1/19) suggests EZH2 mutation may be less common than previously anticipated in rel/ref NHL patients.”
MacKay said Citi finds the combination of drugs used in the trial “intriguing” and is closely following a planned Phase II trial that began earlier this month.
“Following ICML, Epizyme presented preclinical data suggesting EPZ-6438 synergizes with the chemotherapeutic agents of R-CHOP,” said MacKay. “Given EPZ-6438’s clean safety profile and potential to induce long lasting responses, combo therapy presents an intriguing option. Epizyme noted plans to initiate combination trials with R-CHOP and B-cell signaling agents.”
As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be?
Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo.
Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo, a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK).
So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom?
