Tox prompts Janssen to drop MacroGenics' cancer antibody

J&J is still on board for another program due to start clinical testing next year.

Janssen is ending a license deal with MacroGenics for duvortuxizumab, a CD19- and CD3-targeting drug for B-cell malignancies it paid $125 million upfront for in 2014, but isn’t severing ties with the biotech entirely.

Johnson & Johnson's pharma division is still on board with MGD-015, a second antibody which combines anti-CD3 activity with an undisclosed second target and is due to start clinical testing in 2018. J&J paid $75 million upfront for the rights to that last year, with up to $665 million in additional payments pending.

Shares in MacroGenics closed up nearly 5% yesterday but started to slide after hours as news of the rejection started to spread, reversing the earlier gain with a 9.5% decline.


How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

The demise of duvortuxizumab (MGD011) has come about because of safety concerns, and specifically treatment-related neurotoxicity. Despite seeing a number of responses to the therapy, the partners have decided that "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 specializes in drugs that can bind two or more targets in a single molecule, with an emphasis on stimulating immune responses to cancer. It has picked up a series of other big pharma partners, including Takeda, Servier, Pfizer and Boehringer Ingelheim, on the premise that its drugs could provide an alternative to CAR-T therapies.

It may be no coincidence that J&J's decision comes just after Novartis bagged approval for Kymria (tisagenlecleucel), a CAR-T for acute lymphoblastic leukemia (ALL), one of duvortuxizumab's target indications.

This isn't the first time that MacroGenics has lost a big name partner. Two years ago French drugmaker Servier walked away from a $450 million licensing deal for enoblituzumab, A B7-H3-targeting antibody for solid tumors, saying that the program was no longer in its core focus. Servier kept rights to two other early-stage cancer candidates however.

Enoblituzumab remains unpartnered, but is still in early clinical development and is being tested both as a monotherapy and in combination with immuno-oncology drugs, namely Merck & Co's PD-1 inhibitor Keytruda (pembrolizumab) and Bristol-Myers Squibb's CTLA4-targeting Yervoy (ipilimumab).

Right now, MacroGenics' most advanced therapy is the monoclonal antibody margetuximab, a HER2-targeting drug in phase 3 for breast cancer and phase 2 for stomach cancer, and it also has PD-1 and {D-1/LAG-3 antibodies in early stage development.

MacroGenics was named a Fierce 15 company in 2013 and went public in the fall of that year in a well-subscribed IPO. It was trading at under $19 at the time of writing, under its debut price of $26 and well below its peak of more than $40 in early 2014.

Suggested Articles

All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab for a rare, autoimmune eye disease.

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients.

OR-focused AI provider Caresyntax has garnered $45.6 million in new funding and picked up a data analytics firm to broaden its footprint.