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Alpine Begins Dosing in Phase I Study for Advanced Malignancies

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Alpine Immune Sciences, Inc. ALPN announced that it has dosed the first patient in an early-stage study evaluating its cancer candidate, ALPN-202 for the treatment of patients with advanced malignancies.

The phase I NEON-1 study is currently enrolling patients with advanced malignancies. The company plans to recruit subjects throughout 2020 and into 2021.

ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor have demonstrated superior efficacy in tumor models compared with checkpoint inhibition alone, in preclinical studies.

Per the press release, the NEON-1 study consists of two parts namely, dose escalation and expansion cohort in patients with advanced malignancies. The safety endpoints of the study include the dose-limiting toxicities, adverse events, and circulating cytokines.

Shares of Alpine have skyrocketed 160.4% so far this year against the industry’s decline of 3.6%.

We remind investors that, Alpine is an immunotherapy company which is engaged in leading a new wave of immune therapeutics. Apart from ALPN-202, the company has another candidate ALPN-10, a candidate which is being developed for autoimmune/inflammatory diseases.

Last week, Alpine signed an agreement with Humira’s developer, AbbVie ABBV, granting the latter an exclusive option to license worldwide rights to its autoimmune candidate, ALPN-101. Share of Alpine surged significantly back then.

Alpine is developing ALPN-101 in a phase Ib/II study as a treatment for acute graft versus host disease ("GVHD"). It is an autoimmune disorder, which occurs following allogeneic hematopoietic stem cell transplant where immune cells react against donor cells.

With no approved products in its commercial portfolio, Alpine lacks a source of generating regular income. Successful development of the two pipeline candidates are key to the company’s growth in the long run as it might become a revenue driver upon potential approval.

However, the candidates are in early-stage development and are still far from commercialization.  Hence any delay or failure on obtaining a regulatory nod to commence the study for the same will be a major disappointment for the company, leaving an adverse impact on its shares.

Zacks Rank & Other Stocks To Consider

Alpine currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the same sector include Avenue Therapeutics, Inc. ATXI and Aldeyra Therapeutics, Inc. ALDX, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Avenue Therapeutics’ loss per share estimates have narrowed 21.3% for 2020 and 5.5% for 2021 over the past 60 days. The stock has rallied 16.1% year to date.

Aldeyra Therapeutics’ loss per share estimates have narrowed 23.9% for 2020 and 24.2% for 2021 over the past 60 days.

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