Despite $2B AML Deal, AbbVie Stops Early Cancer Combo Trial With I-Mab

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Courtesy of Abbvie Inc.

Chinese biotechnology firm I-Mab quietly announced that its partner, AbbVie, is halting a Phase IB trial on lemzoparlimab for two types of cancers, without giving a specific reason. 

AbbVie and I-Mab are studying a lemzoparlimab combination therapy with azacitidine and venetoclax in patients diagnosed with myelodysplastic syndrome (MDS) and acute myelocytic leukemia (AML). The endeavor was based on positive topline results from a Phase I study showing lemzoparlimab to be safe and generally well tolerated.

The two companies signed a collaboration deal in September 2020 to develop and commercialize lemzoparlimab, I-Mab's highly differentiated anti-CD47 monoclonal antibody, to address multiple types of cancers. The drug is one of the lead products in I-Mab's pipeline and is designed to minimize red blood cell binding without compromising its anti-tumor capability.

Under terms of the deal, AbbVie agreed to pay I-Mab $200 million in upfront and Phase I milestone payments, and I-Mab was eligible to receive up to $1.74 billion in success-based milestone payments for lemzoparlimab.

"Cancer is the second-leading cause of death globally and the need for novel cancer therapies has never been more acute. The addition of I-Mab's novel CD47 programs complements our global clinical strategy in hematology and immuno-oncology," Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer at AbbVie, said in an earlier statement.

I-Mab did not provide further information on its decision to terminate the Phase IB study but clarified that it was "not based on any specific or unexpected safety concerns." The company added that it has $671 million in cash, cash equivalents and short-term investments to help support ongoing and future development plans for lemzoparlimab and its other late-stage clinical assets.

On the upside, while the study for the mentioned combination therapy is no longer continuing, the companies will still move forward with other research and development activities involving lemzoparlimab, particularly the initiation of a Phase III clinical trial in patients with MDS in China. This specific trial is backed by positive efficacy and safety data from a Phase II trial on lemzoparlimab plus azacitidine in participants with a higher risk type of MDS. More details about this study will be shared in September at the European Society for Medical Oncology Congress.

"To date, Phase 1 and Phase 2 clinical studies of lemzoparlimab in the U.S. and China with nearly 200 patients enrolled have shown a good safety profile without the need for a priming dosing regimen," John Long, I-Mab's director and chief financial officer, noted in the SEC filing.

I-Mab, which has exclusive rights to develop and commercialize all licensed products under the agreement with AbbVie, remains eligible to receive as much as $1.295 billion in development, regulatory and sales milestone payments from the revised deal. This also covers tiered royalties on global net sales beyond Greater China and original milestone payments and royalties listed in I-Mab's Form 20-F for the fiscal year 2021.

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