September 27, 2023 Source: drugdu 179
By Tristan Manalac
Pictured: AbbVie headquarters in California/iStock, Michael Vi
AbbVie has terminated its license and collaboration agreement with I-Mab, the Maryland- and Shanghai-based biotech announced in an SEC filing posted Friday.
As a result, I-Mab will regain the global rights to develop and commercialize all CD47 compounds covered by the deal, including the monoclonal antibody lemzoparlimab. The termination will take effect on Nov. 20, 2023 and will not affect the $200 million in upfront and milestone payments that I-Mab had already received from AbbVie.
According to I-Mab’s SEC document, AbbVie is pulling away from the partnership as a “strategic decision,” though a prior program discontinuation also factored into its decision.
AbbVie and I-Mab first entered into their global agreement in September 2020. For an upfront payment of $180 million and the promise of up to $1.74 billion in success-based milestones, AbbVie earned exclusive rights—outside of the greater China area—to develop and commercialize lemzoparlimab. The deal also allowed for potential future targets using I-Mab’s CD47 molecules.
In August 2022, however, AbbVie ended two Phase Ib trials of lemzoparlimab, one in myelodysplastic syndrome (MDS) and another in acute myeloid leukemia. The partners gave no specific reason for discontinuing these studies, though I-Mab said that it was not triggered by “specific or unexpected safety concerns.”
At the time, the companies were studying lemzoparlimab in combination with azacytidine and AbbVie’s chronic lymphocytic leukemia drug Venclexta (venetoclax tablets). The partners also amended their collaboration then, which still had the potential for up to nearly $1.3 billion in development, regulatory and sales milestones for I-Mab.
Despite losing a powerhouse partner, I-Mab will continue its development of lemzoparlimab. According to the company’s SEC filing, the investigational antibody is in a Phase III registrational study in combination with azacytidine for high-risk MDS in China. The company will also continue analyzing data from the candidate’s development program to assess future opportunities for it.
If approved, lemzoparlimab could become a first-in-class CD47 antibody for hematologic malignancies in China, I-Mab said.
For AbbVie, dropping the I-Mab partnership comes just days after it chose not to exercise its exclusive licensing option for Harpoon Therapeutics’ TriTAC candidate HPN217, which is in a Phase I trial for multiple myeloma.
Last month, AbbVie also cut two early-stage oncology assets from its developmental pipeline. The first, ABBV-011, was an anti-SEZ6 antibody-drug conjugate (ADC) being trialed for relapsed or refractory lung cancer. The second dropped asset was ABBV-647, a Pfizer-partnered ADC targeting the PTK7 protein for the potential treatment of solid tumors.
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