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April 19, 2017

Failed CF Drug Firm Nivalis to Merge with Immunotherapeutics Specialist Alpine

  • Seattle-based immunotherapeutics firm Alpine Immune Sciences has agreed to a merger with Nivalis Therapeutics, which has been evaluating potential strategic alternatives since January this year, after its lead cystic fibrosis (CF) drug cavosonstat failed Phase II evaluation. 

    The stock-based transaction to combine the firms will see Alpine merged with a wholly owned Nivalis subsidiary. The joint entity will retain the Alpine Immune Sciences name and will be owned 74% by Alpine shareholders, with Nivalis stockholders owning the remaining 26%, based on a Nivalis valuation of $50 million, which includes the latter’s projected cash pot of $44 million.

    The merged Alpine Immune Sciences business is expected to start out with approximately $90 million in cash and cash equivalents and will focus on exploiting Alpine’s vIgD™ (variant immunoglobulin domain) platform to develop engineered immune system proteins against inflammatory and autoimmune disorders and cancer.

    Alpine’s current executive chairman and CEO Mitchell H. Gold, M.D., will head the merged company as chairman and CEO, and an expanded board of directors will seat two Nivalis representatives.

    Dr. Gold described the merger as a unique opportunity to accelerate the development of its immunotherapy platform. “We look forward to building on our early success by taking multiple novel programs into the clinic to help patients with significant medical needs,” he said in a statement.

    Alpine was founded in 2015 to develop a pipeline of vIgD-engineered immunotherapeutics that target the immune synapse. The firm is also leveraging the vIgD technology through its TIP™ (transmembrane immunomodulatory protein) program, which aims to enhance engineered cellular therapies (ECTs), including chimeric antigen receptor (CAR) T-cell, T-cell receptor (TCR), and tumor infiltrating lymphocyte (TIL) therapeutics. In October 2015, the firm inked a potentially $535 million deal with Kite Pharma to develop two Transmembrane Immunomodulatory Protein (TIPTM) programs into CAR and TCR product candidates.

    Nivalis confirmed in November 2016 that the S-nitrosoglutathione reductase (GSNOR) inhibitor cavosonstat had failed in its first Phase II study, and at the start of January the Colorado-based firm announced that it was reviewing potential strategic alternatives. The firm’s then president and CEO Jon Congleton and CMO David Rodman, M.D., stepped down later in January as part of a cost-cutting restructuring exercise through which the firm said it would lose 25 of its 30-strong workforce, including the two executives. Six weeks after the restructuring announcement, Nivalis reported that cavosonstat had failed in a second Phase II CF study. 

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