While the comeback plan for its lead drug is still up in the air, ImmunoGen says it has a second shot at an antibody-drug conjugate breakthrough.

The FDA has granted breakthrough therapy designation to IMGN632, which targets CD123, in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm. The aggressive cancer primarily affects the skin, bone marrow and lymph nodes.

Having presented initial data on the first-in-human study at ASH 2019, the biotech said it will report updates from the dose expansion cohort in December.

We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies, CEO Mark Enyedy said in a statement.

IMGN632 was one of three programs that Jazz Pharma paid $175 million in cash to collaborate on, in an R&D pact stretching out to 2024.

A longtime player in the ADC game, ImmunoGens tech platform had a significant role in developing Roches Kadcyla. But its had less luck with its own programs, getting slapped down by the FDA after the lead drug, mirvetuximab soravtansine, failed a Phase III study for ovarian cancer.

Having initially sought accelerated approval based on a secondary endpoint, the company is now counting on a new, single-arm trial to support the OK. The SORAYA study zeroes in on women with folate receptor alpha (FR)-high platinum-resistant ovarian cancer who have been previously treated with Avastin.

Amid the twists and turns Enyedy who slashed the headcount by a few months after he took the job in 2016 reached again for the axe to conserve cash. In addition to laying off 220 staffers, he also shelved IMGN779, the program for adults with relapsed/refractory CD33-positive AML, and subleased the extra empty space.

ImmunoGen reported $219.5 million in cash and cash equivalents as of June 30, 2020, compared with $176.2 million at the end of 2019.

The big idea around ADCs is that by attaching a cancer-killing toxin to a specific antibody, drugmakers can direct the payloads precisely to where they want them. While ImmunoGen boasts of expertise in all aspects targets, antibodies, payloads and linkers the key component of IMGN632 is the in-house novel indolino-benzodiazepine payloads, which they promise to be more potent than traditional chemotherapy to cancer cells but less toxic to normal marrow progenitors.

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After weathering failure, rejection and layoffs, ImmunoGen touts a new 'breakthrough' drug in its comeback plan - Endpoints News