Halozyme and Incyte have signed a global licensing agreement to develop ENHANZE-enabled subcutaneous formulations of INCA033989 for mutant CALR-positive myeloproliferative neoplasms, with rights to expand the collaboration to two additional targets.
Written By: Disha Jadhao, BPharm
Reviewed By: Pharmacally Editorial Team
Halozyme Therapeutics has entered a global collaboration and license agreement with Incyte to develop additional subcutaneous formulations of INCA033989, an investigational mutant calreticulin (mutCALR)-targeted monoclonal antibody for patients with mutCALR-expressing myeloproliferative neoplasms (MPNs). The partnership will integrate Halozyme’s proprietary ENHANZE® drug delivery technology with Incyte’s hematology program, with the goal of improving treatment convenience through subcutaneous administration.
Under the agreement, Incyte gains rights to develop and commercialize ENHANZE-enabled formulations of INCA033989 and holds an option to nominate up to two additional therapeutic targets for the technology platform. Halozyme will receive an upfront payment, milestone-based development and commercial payments, and royalties on future net sales of products incorporating ENHANZE.
Expanding Subcutaneous Delivery for INCA033989
The collaboration centers on INCA033989, a first-in-class monoclonal antibody that selectively targets mutant calreticulin (mutCALR), a driver mutation found in a subset of myeloproliferative neoplasms. The investigational therapy is currently being developed for patients with mutCALR-positive MPNs, a group of chronic blood cancers characterized by uncontrolled production of blood cells and increased risks of thrombosis, bone marrow fibrosis, and progression to acute leukemia.
Halozyme’s ENHANZE platform uses recombinant human hyaluronidase PH20 (rHuPH20) to temporarily break down hyaluronan in the subcutaneous space. This allows larger volumes of biologic medicines to be administered under the skin, creating an alternative to intravenous infusion while potentially reducing treatment time and improving patient convenience.
The companies will evaluate whether ENHANZE can further strengthen the subcutaneous formulation already under development for INCA033989, with the potential to support more flexible dosing schedules and a better treatment experience.
Collaboration Broadens ENHANZE Development Portfolio
The agreement extends Halozyme’s strategy of licensing ENHANZE to biopharmaceutical partners developing biologics across oncology, immunology, hematology, and other therapeutic areas.
In addition to the INCA033989 program, Incyte has secured an option to nominate up to two additional development candidates for incorporation of ENHANZE technology. If exercised, the collaboration could expand beyond hematologic malignancies into additional therapeutic indications supported by Incyte’s research pipeline.
Financial terms include an undisclosed upfront payment to Halozyme, potential development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales of any commercialized ENHANZE-enabled medicines.
Leadership Highlights Strategic Value
Halozyme President and Chief Executive Officer Dr. Helen Torley said the collaboration reflects the expanding adoption of ENHANZE across high-value therapeutic areas. She noted that Incyte’s expertise in hematology and oncology makes it well positioned to advance convenient subcutaneous treatment options for patients with myeloproliferative neoplasms.
Torley added that the agreement further diversifies Halozyme’s partnered development portfolio and reinforces the broad applicability of the ENHANZE platform across multiple biologic therapies.
Path Forward
The collaboration marks another step in the industry’s broader shift toward subcutaneous delivery of complex biologic medicines. If successful, ENHANZE-enabled formulations of INCA033989 could provide a more convenient alternative to conventional administration while preserving the therapeutic activity of the investigational antibody.
The companies have not disclosed development timelines or the value of the financial agreement. Future progress will depend on ongoing clinical development of INCA033989 and Incyte’s decision on whether to nominate additional ENHANZE-enabled targets under the collaboration.
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About the Writer
Disha Sanjay Jadhao (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.