Date: 2017-08-29
Type of information: Development agreement
Compound: IMGN779, IMGN632 and an additional program to be designated
Company: Jazz Pharmaceuticals (Ireland) Immunogen (USA - MA)
Therapeutic area: Cancer - Oncology
Type agreement: development - commercialisation
Action mechanism:
- antibody drug conjugate. IMGN779 is a CD33-targeted antibody drug conjugate. It combines a humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen's novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells. IMGN779 is in Phase 1 clinical testing for the treatment of acute myeloid leukemia.
- IMGN632 is a preclinical stage humanized anti-CD123 antibody-based antibody drug conjugate that is a potential treatment for acute myeloid leukemia, blastic plasmacytoid dendritic cell neoplasm, myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive malignancies. ImmunoGen expects to file an investigational new drug application (IND) for IMGN632 this quarter and enroll the first patient in a Phase 1 study before the end of the year.
Disease: hematological cancers
Details:
- • On August 29, 2017, Jazz Pharmaceuticals and ImmunoGen announced that the companies have entered into a collaboration and option agreement granting Jazz Pharmaceuticals exclusive, worldwide rights to opt into development and commercialization of two early-stage, hematology-related antibody-drug conjugate (ADC) programs, as well as an additional program to be designated during the term of the agreement. The programs covered under the agreement include IMGN779 in Phase 1 testing, and IMGN632, expected to enter clinical testing before the end of the year.
- Under the terms of the agreement, ImmunoGen will be responsible for the development of the three ADC programs prior to any potential opt-in by Jazz. Following any opt-in, Jazz would be responsible for any further development as well as for potential regulatory submissions and commercialization.
Financial terms:
- As part of the agreement, Jazz will pay ImmunoGen an upfront payment of $75 million . Additionally, Jazz will pay ImmunoGen up to $100 million in development funding over seven years to support the three ADC programs. For each program, Jazz may exercise its opt-in right at any time prior to a pivotal study or any time prior to a biologics license application (BLA) upon payment of an option exercise fee of mid-double digit millions or low triple digit millions, respectively. For each program to which Jazz elects to opt-in, ImmunoGen would be eligible to receive milestone payments based on receiving regulatory approval of the applicable product, plus tiered royalties as a percentage of commercial sales by Jazz, which depending upon sales levels and the stage of development at the time of opt-in, range from mid- to high single digits in the lowest tier to low 10's to low 20's in the highest tier. After opt-in, Jazz and ImmunoGen would share costs associated with developing and obtaining regulatory approvals of the applicable product in the United States and the European Union . ImmunoGen has the right to co-commercialize in the U.S. one product (or two products, under certain limited circumstances) with U.S. profit sharing in lieu of Jazz's payment of the U.S. milestone and royalties to ImmunoGen.
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