Alpine Immune Sciences and Merck Collaborate to Evaluate ALPN-202 in Combination with Keytruda in Immuno-Oncology Study

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Recently, clinical-stage immunotherapy company Alpine Immune Sciences has entered into a collaboration agreement with MSD to evaluate the efficacy and safety of Alpine’s checkpoint inhibitor in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of cancer.

Under a new clinical trial collaboration and supply agreement, the efficacy of Alpine’s first-in-class conditional CD28 costimulatory and dual checkpoint inhibitor ALPN-202, in combination with Merck’s anti-PD-1 therapy Keytruda, will be evaluated in the NEON-2 trial. Following the NEON-1 study, the dosing phase will commence in June.

Alpine’s ALPN-202 has also demonstrated the ability to overcome T-cell suppression and improve the durability of anti-tumor responses in engineered T cells. The latest data presented at the 2021 ASCO Virtual Annual Meeting show that many cancer patients refractory to immunotherapy derived clinical benefit from ALPN-202.

MSD recently announced that the European Commission (EC) has approved Keytruda in combination with platinum and fluorouracil-based chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic esophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma with PD-L1-expressing tumors (Combined Positive Score [CPS] ≥10). [Related Reading: PD-1 Inhibitors Opdivo and Keytruda Approved for New Indications in the EU]

The Phase III KEYNOTE-590 trial demonstrated that the combination therapy significantly improved survival in these patients, forming the basis for the European Commission (EC) approval of KEYTRUDA. This approval now permits the KEYTRUDA combination to be marketed in all 27 EU member states, excluding Liechtenstein, Iceland, Norway, and Northern Ireland.

Alpine is not only focused on cancer; this Seattle-based company has also been dedicated to lupus research. Last week, the company announced that it had dosed the first patient in its Phase II clinical trial of ALPN-101, a study primarily targeting patients with systemic lupus erythematosus (SLE).

In its ALPN-101 announcement, Alpine stated that the company has also achieved a $45 million pre-option exercise development milestone, which is part of an option and license agreement entered into with AbbVie in 2020. The two companies signed an $865 million agreement in June 2020 to license a therapeutic for the treatment of lupus and other inflammatory diseases. Under the terms of the transaction with AbbVie, Alpine received a $60 million upfront payment and is eligible to receive $805 million in milestone payments upon option exercise, as well as for research and development, regulatory, and commercial milestones. Upon approval, the company is also eligible to receive tiered royalties on net sales of the lupus drug.

Reference: Alpine and Merck Study Checkpoint, Anti-PD-1 Cancer Combo in Collab Study