Blueprint Medicines Corporation BPMC along with China’s CStone Pharmaceuticals announced that it has dosed the first patient in a phase Ib/II study evaluating its FGFR4 inhibitor fisogatinib in combination with CStone’s PD-L1 inhibitor CS1001 for the treatment of locally advanced or metastatic hepatocellular carcinoma (HCC), a type of liver cancer. The objective of this program is to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of the combination regimen.
The above-mentioned study will assess the potential of two complementary treatment approaches, namely precision therapy and immuno-oncology therapy to enhance anti-tumor activity in the given patient population.
Blueprint Medicines has a collaboration agreement with CStone for developing and commercializing fisogatinib across Mainland China, Hong Kong, Macau and Taiwan, either as monotherapies or combo regimes.
Per the company, data from the ongoing phase I study, published on Oct 1, 2019, showed that treatment with fisogatinib monotherapy was well-tolerated in patients with heavily pretreated advanced HCC.
Notably, the FDA has granted an orphan drug designation to fisogatinib for the treatment of HCC.
Shares of Blueprint Medicines have surged 30% in the past year against the
industry’s decline of 2.5%.
We remind investors that Blueprint Medicines’ lead pipeline candidate avapritinib, an inhibitor of KIT and PDGFRA proteins, is being evaluated in several late-stage studies for cancer indications.
In August 2019, the FDA accepted the new drug application (NDA) for avapritinib to treat patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of any prior therapy, and the fourth-line GIST. The FDA has set an action date of Feb 14, 2020 for both indications.
Other than GIST, Blueprint Medicines is pursuing a broad clinical development program for avapritinib across the advanced, indolent and smoldering forms of systemic mastocytosis (SM).
Last month, the company announced encouraging initial data from the dose-finding part 1 of phase II PIONEER study on avapritinib for treating patients with indolent SM. The company plans to submit an NDA for avapritinib in the first quarter of 2020 to treat advanced SM indication.
Notably, Blueprint Medicines has no approved product in its portfolio. Revenues generated by the company are drawn from its partnerships with Roche
RHHBY and CStone Pharmaceuticals for the development of its pipeline candidates. Therefore, a potential nod to avapritinib will lower the company’s excessive dependence on its partners for revenues and help boost its growth prospects. Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Epizyme, Inc.
EPZM and Puma Biotechnology, Inc. ( PBYI Quick Quote PBYI - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Epizyme’s loss per share estimates have narrowed 1% north for 2020 over the past 60 days. The stock has skyrocketed 170.3% in the past year.
Puma Biotechnology’s loss per share estimates have narrowed 29.3% for 2020 over the past 60 days.
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