Jazz Pharmaceuticals and ImmunoGen Sign Development and Commercialization Agreement

Jazz Pharmaceuticals, an international biopharmaceutical company focusing on address unmet medical needs and ImmunoGen, a clinical-stage biotechnology company developing targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology, 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 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, a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a CD123-targeted ADC for hematological malignancies expected to enter clinical testing before the end of the year.


“This strategic partnership … significantly advances our goal of accelerating the development of our early-stage novel ADC assets… ”


IMGN779 is a novel, investigational ADC that combines a high-affinity, 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 [1][2]  IMGN779 is in Phase I clinical testing for the treatment of AML.

Lonza
ADC Bio
MabPlex
 

The second agent included in the agreement, IMGN632, is a preclinical stage humanized anti-CD123 antibody-based ADC that is a potential treatment for AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN), myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive malignancies. IMGN632 uses a novel payload, linker, and antibody technology and in AML xenograft models has demonstrated a large therapeutic index [3]

Researchers at ImmunoGen expect to file an investigational new drug application (IND) for IMGN632 this quarter and enroll the first patient in a Phase I study before the end of the year.

Multiple ADC programs
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.

Development funding
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 (U.S.) 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.

“We are pleased to enter into this collaboration with ImmunoGen, a well-known leader in the field of ADC technology, with demonstrated success in creating ADC molecules, including the only FDA-approved ADC product to treat metastatic breast cancer. This investment supports our long-term commitment to expand our hematology/oncology portfolio with the potential addition of multiple innovative antibody drug conjugates,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.

“We look forward to the advancement of these ADC programs and the potential synergy of these compounds with our current products and pipeline, as new therapeutic options for cancer patients are urgently needed,”Cozadd added.

Accelerating development
“This strategic partnership with Jazz significantly advances our goal of accelerating the development of our early-stage novel ADC assets. This deal joins us with a global partner, provides us with substantial funding to support these programs, and preserves the right to co-commercialize one of these assets,” said Mark Enyedy, president and chief executive officer of ImmunoGen.

“Jazz has demonstrated the ability to bring innovative compounds to patients and will make an ideal partner to help develop and commercialize our novel ADC assets targeting AML, and more broadly, in the area of hematology/oncology. In addition, this partnership significantly strengthens our financial position and moves us closer to delivering upon our mission of bringing ADC therapies to patients,” Enyedy noted.

To date, ImmunoGen’s ADC technology is used in ado-trastuzumab emtansine, also know as T-DM1 (Kadcyla®; Genentech/Roche), a human epidermal growth factor receptor 2 (HER2) antibody-drug conjugate that comprises the humanized anti-HER2 IgG1 (antibody) trastuzumab linked to the anti-mitotic agent mertansine (a maytansine derivative; also known as the maytansinoid DM1).  The company’s technology is also part of other clinical-stage product candidates, and in programs in development by a number of (bio) pharmaceutical companies.