On January 3, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Codiak BioSciences, Inc. reported that the companies have entered into a strategic collaboration agreement focused on the research, development and commercialization of exosome therapeutics to treat cancer (Press release, Jazz Pharmaceuticals, JAN 3, 2019, View Source [SID1234532428]). Codiak granted Jazz an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize therapeutic candidates directed at five targets to be developed using Codiak’s engEx precision engineering platform for exosome therapeutics. The targets focus on oncogenes that have been well validated in hematological malignancies and solid tumors but have been undruggable with current modalities, including NRAS and STAT3.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Under the terms of the agreement, Codiak is responsible for the execution of pre-clinical and early clinical development of therapeutic candidates directed at all five targets through Phase 1/2 proof of concept studies. Following the conclusion of the applicable Phase 1/2 study, Jazz will be responsible for future development, potential regulatory submissions and commercialization for each product. Codiak has the option to participate in co-commercialization and cost/profit-sharing in the U.S. and Canada on up to two products.
As part of the agreement, Jazz will pay Codiak an upfront payment of $56 million. Codiak is eligible to receive up to $20 million in preclinical development milestone payments across all five programs. Codiak is also eligible to receive milestone payments totaling up to $200 million per target based on Investigational New Drug application acceptance, clinical and regulatory milestones, including approvals in the U.S., European Union and Japan, and sales milestones. Codiak is also eligible to receive tiered royalties on net sales of each approved product, with percentages ranging from mid-single digits in the lowest tier to high teens in the highest tier.
"We are looking forward to partnering with Codiak and their world-class management and R&D team. Their innovative exosome platform offers the opportunity to address targets that have been frequently implicated in hematological malignancies and solid tumors, including targets recognized as undruggable with current approaches," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "The exosome approach is differentiated and represents the ideal complement to our CombiPlex platform and other collaboration programs. The ability to develop multiple new therapies through these technologies is an important advance as we seek to add long-term value for patients and shareholders."
"We are excited to be working with the team at Jazz to bring a new class of medicines into clinical testing to treat patients with cancer," said Douglas E. Williams, PhD, president and chief executive officer of Codiak. "We believe that the Codiak engEx platform, along with Jazz’s insights into relevant but intractable targets, creates a unique opportunity to improve patient outcomes in various cancers. Codiak’s proprietary engEx platform allows us to deliver potent therapeutics in a precise, targeted and tunable way. This collaboration allows Codiak to accelerate the potential of our engEx platform as we advance our lead candidates and core pipeline."
Exosomes are naturally occurring, nanometer-sized vesicles that are released and received by nearly all cells in the body. They serve as an efficient system of intercellular communication. In the tumor microenvironment, exosomes have been shown to carry molecular messages between tumor and immune cells. Codiak has co-opted this process and, through its engEx platform, engineers potent drug molecules into the exosome to create bespoke therapeutic candidates which have shown potent preclinical antitumor activity.
With the engEx platform, Codiak has the ability to incorporate a range of therapeutic drug classes—including small molecules, proteins, peptides, cytokines and nucleic acids—onto the surface or in the lumen of its therapeutic exosomes. engEx also enables precise modifications of the engineered exosomes to optimize potency and to alter or enhance tropism for directed delivery to desired cell types. These flexible design features allow Codiak to create an optimized exosome therapeutic for the drug target and desired site of action.
Jazz Pharmaceuticals Conference Call Details
Jazz Pharmaceuticals and Codiak will host an investor conference call and live audio webcast on Friday, January 4, 2019 at 8:30 a.m. EST (1:30 p.m. GMT) to discuss the collaboration. The live webcast may be accessed from the Investors section of Jazz Pharmaceuticals’ website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 9698918.
A replay of the conference call will be available through January 11, 2019 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 9698918. An archived version of the webcast will be available for at least one week in the Investors section of Jazz Pharmaceuticals’ website at www.jazzpharmaceuticals.com