Infinity/ Bristol-Myers Adds TNBC Patients To Clinical Deal

Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) announced that it has expanded its existing clinical collaboration with Bristol-Myers Squibb (NYSE:BMY) for evaluating IPI-549 in combination with latter’s checkpoint inhibitor Opdivo. The collaboration will include patients with triple negative breast cancer (TNBC), who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy.

Very few patients with triple negative breast cancer respond to checkpoint inhibitors alone and so they are left with very limited therapeutic options. Thus expanding the collaboration to include patients with triple negative breast cancer (TNBC), who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy. This, in turn, will enable Infinity to test whether IPI-549 in combination with Opdivo can increase the number of patients who respond to checkpoint inhibition.

Markedly, IPI-549 is the lead pipeline candidate of Infinity Pharmaceuticals and is being evaluated in a phase I/Ib study for the treatment of patients with solid tumors. It is an orally administered treatment that selectively inhibits phosphoinositide-3 kinase (PI3K)-gamma.

In November 2016, Infinity entered into a clinical trial collaboration with Bristol-Myers to evaluate IPI-549 in combination with Opdivo in patients with advanced solid tumors.

Meanwhile, Opdivo is approved for varied indications in the EU and the United States. Also, it has received approvals for several indications including melanoma, head and neck, lung, kidney and blood cancer.

However, Infinity’s shares have underperformed the industry year to date. The stock has been down 10.4%, as against the industry’s gain of 2.1% in the same time frame.

It should be noted that the phase I/Ib study evaluates IPI-549 as a monotherapy and in combination with Opdivo in about 200 patients with advanced solid tumors. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and its expansion is expected to begin in the second half of 2017.

Markedly, the combination expansion component comprise multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer that include patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. Additionally, it will also have a cohort of patients with TNBC who have not been previously exposed to immune checkpoint blockade therapy.

Zacks Rank & Stocks to Consider

Infinity currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in health care sector include Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) . While Regeneron sports a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates have increased from $12.84 to $14.99 for 2017 and from $15.32 to $16.65 for 2018 over the last 60 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 19.3% year to date.

Alexion Pharmaceuticals’ earnings per share estimates have moved up from $5.57 to $5.60 for 2017 and from $6.90 to $7.06 for 2018 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 11.12%. The share price of the company has increased 17.7% year to date.

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