Following Rova-T Failure, AbbVie Enters Immuno-Oncology Deal with Idera


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Shares of Idera Pharmaceuticals are climbing this morning after the company announced it entered into an immuno-oncology collaboration with AbbVie to evaluate a combination therapy aimed at stimulating the immune system to create an anti-tumor response.

The companies will pair AbbVie’s OX40 agonist ABBV-368 with Idera’s tilsotolimod in a Phase Ib trial in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial will include three separate treatment arms. In addition to the pairing of ABBV-368 and tilsotolimod, other arms will include the combination treatment plus chemotherapy and ABBV-368 plus tilsotolimod plus chemotherapy and a checkpoint inhibitor, ABBV-181.

For AbbVie, the partnership with Idera comes at a time the company is looking to course-correct following the utter failure of its $5.8 billion gamble on Rovalpituzumab Tesirine (Rova-T). Last week, the Illinois-based company announced it scrapped Rova-T development following several trial failures, including the most recent, a Phase III trial evaluating Rova-T as first-line maintenance therapy for advanced small-cell lung cancer. Prior to the most recent trial, in December 2018, AbbVie halted a Phase III study of Rova-T as a second-line treatment for advanced small-cell lung cancer. Following that 2018 failure, the company culled 178 employees from Bay Area-based Stemcentrix, the company AbbVie acquired in 2016 to gain Rova-T.

Financial terms of the collaboration were not disclosed but shareholders of the Pennsylvania-based company responded favorably. Share prices have climbed more than 3% in morning trading. Under terms of the collaboration that were made public, Idera will provide clinical trial supply of tilsotolimod to AbbVie and AbbVie will be responsible for the conduct of the study.

Elizabeth A. Tarka, chief medical officer of Idera, said the company is excited about the collaboration, which will continue to advance the company’s strategy of developing treatments for difficult to treat cancers, “which historically have not generated significant objective response rates through checkpoint inhibition alone.” Tarka added that the company is looking forward to advancing their understanding of the combination of ABBV-368 and tilsotolimod.

Idera’s tilsotolimod is involved in a number of trials, including the Phase III ILLUMINATE-301, which is aimed at patients with anti-PD-1 refractory metastatic melanoma. The ILLUMINATE-301 trial pairs tilsotolimod with an ipilimumab, an anti-CTLA4 antibody, like Bristol-Myers’ Yervoy. Tilsotolimod is also being paired with Merck’s Keytruda in anti-PD-1 refractory melanoma.

Tilsotolimod (IMO-2125) has been granted both Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration.

AbbVie has been looking to transform itself as it faces a patent cliff for its cash cow Humira, which generated about $20 billion in revenue for the company last year. Humira has already lost patent protection in Europe and will lose it in the United States in 2023. In addition to expanding its oncology focus with companies like Idera, in June, AbbVie announced it will acquire Ireland-based Allergan for $63 billion as part of a “transformational” deal. The combined companies are expected to have several strong franchises across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology.




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