September 1, 2017
By Alex Keown, BioSpace.com Breaking News Staff
ROCKVILLE, Md. – Shares of MacroGenics Inc. are down more than 9 percent this morning after Janssen Pharmaceuticals terminated a three-year-old collaboration agreement for MGD011, a CD19/CD3 DART molecule for B cell malignancies over concerns of neurotoxicity.
In December 2014 Janssen, a division of Johnson & Johnson, forged the deal worth up to $700 million for MGD011. But that came to an end today. In announcing the termination of the agreement, MacroGenics said a number of patients in the Phase I study of duvortuxizumab experienced treatment-related neurotoxicity similar to that seen in patients treated with other CD19-targeted T-cell therapies. Given the recent advances in the highly competitive field for the treatment of B cell malignancies, the opportunity for development and commercialization has become less attractive, the company said.
Those advances are likely referring to booming advances made in CAR-T treatments, including the recent approval of Novartis ’ acute lymphoblastic leukemia treatment earlier this week. When it was approved, the U.S. Food and Drug Administration hailed it as a new era in cancer treatment. At the time the deal between Janssen and MacroGenics was announced in 2014, Scott Koenig, president and chief executive officer of MacroGenics, touted MGD011 as a therapy that could rival CAR-T treatments, John Carroll noted in Endpoints News this morning. However, MGD011 has not gotten beyond Phase I.
This morning in announcing Janssen’s closure of the MGD011 agreement, MacroGenics said the Phase I dose-escalation study for the treatment has been discontinued. With Janssen walking away, Keonig pointed to MacroGenics’ “large portfolio of product candidates” and said it is unlikely the company will continue to pursue development of the drug on its own – signaling its likely demise.
“While this decision is disappointing, MacroGenics and its strategic partner, Janssen, continue to be fully committed to the DART platform and our ongoing collaboration on MGD015. Duvortuxizumab’s neurotoxicity profile is a CD19-targeting issue and has not been observed in our other DART clinical programs,” Koenig said in a statement.
Carroll noted this is the second time MGD011 has been scrapped. Citing Wedbush Securities Carroll said another study of MGD011 combined with Janssen’s ibrutinib (Imbruvica) was halted last year without any explanation.
While Janssen terminated its agreement for MGD011, MacroGenics said the Johnson & Johnson subsidiary reaffirmed its commitment to MGD0155, also known as JNJ-9383, a second DART molecule licensed from MacroGenics. The two companies forged a development agreement for this molecule last year. The deal for MGD015 is worth up to $755 million for MacroGenics.
MGD015 is a preclinical program that targets CD3 and a non-disclosed cancer antigen expressed in hematological malignancies and lung cancer. Janssen has indicated that it anticipates initiating a first-in-human study with this molecule in 2018, MacroGenics said.
