AbbVie calls off PhI trial for I-Mab’s CD47 days after Zai Lab shelves its own program
The CD47 field ran into another hurdle Tuesday as I-Mab quietly disclosed in an SEC filing that AbbVie is saying goodbye to a Phase I study of the biotech’s drug.
Weeks after ending an exploratory trial of I-Mab’s CD47 antibody, AbbVie has now called it quits on another early-stage trial. The Phase I was testing the drug, lemzoparlimab, in combination with azacitidine and venetoclax in patients with acute myeloid leukemia and myelodysplastic syndrome.
“This decision was not based on any specific or unexpected safety concerns,” I-Mab disclosed in the paperwork filed with the SEC.
The study arose from the pact AbbVie and I-Mab inked in autumn 2020 with $200 million upfront and more than a billion dollars in back-end payments.
The partnership will continue with “certain new anti-CD47 antibodies” or “other licensed products,” I-Mab disclosed. I-Mab stands to receive up to $1.295 billion in payments and tiered royalties under the amended deal, the company said.
The move comes days after Zai Lab shelved a Phase I program of its CD47 inhibitor ZL-1201 after scoping out the competitive landscape.
Multiple setbacks have occurred to the CD47 space since Gilead’s magrolimab, formerly of the biotech Forty Seven and one of the lead programs in the industry, was placed on partial clinical holds last year. All study pauses have since been lifted, and the California biopharma has reiterated its “unwavering” confidence in the program, which aims to block the “don’t eat me” signal loved by some cancer cells.
I-Mab once touted lemzoparlimab as one of the “global front-runners after magrolimab,” the drug that Gilead picked up in its $4.9 billion Forty Seven acquisition two years ago.
But the China-Maryland biotech is also aware of the difficulties with CD47.
“As one of the most promising drug classes in immuno-oncology, the development of CD47 antibodies is primarily hampered by their on-target binding to red blood cells (RBCs). Therefore, various CD47 antibodies in their clinical development are found to be susceptible to severe anemia and other hematologic side effects. As a result, many CD47 antibody programs have been either terminated in early clinical trials or faced drug safety challenges in clinical trials,” I-Mab disclosed in an SEC filing earlier this year.
I-Mab is also testing the drug’s potential at treating MDS, other hematological malignancies and various solid tumors.