Alteogen's technology for switching to a subcutaneous (SC) formulation has been applied to Sanofi's blockbuster therapy "Dupixent."
According to the industry on the 16th, Sanofi has begun a phase 1 trial to develop an SC formulation of Dupixent by applying Alteogen's hyaluronidase platform "ALT-B4."
Dupixent is an autoimmune disease treatment jointly developed by Sanofi and U.S.-based Regeneron. It recorded about 27 trillion won in sales last year, ranking fourth in global pharmaceutical sales. After receiving U.S. Food and Drug Administration (FDA) approval in 2017 as a treatment for atopic dermatitis, it expanded its approved indications to asthma and chronic obstructive pulmonary disease.
Following the SC formulation of the immuno-oncology drug "Keytruda" from U.S.-based Merck (MSD), which has already been commercialized, observers say the odds have grown that another global blockbuster medicine using Alteogen's technology will emerge.
According to the U.S. clinical trial registry ClinicalTrials, Sanofi is conducting a phase 1 trial of the Dupixent SC formulation in 40 healthy adults. The study compares the new formulation with the existing product to evaluate pharmacokinetic (PK) characteristics, safety and tolerability.
In April this year, Sanofi revealed plans to develop a high-dose formulation of Dupixent and said it would seek to extend the current dosing interval from every two weeks to as long as every four weeks. The industry views this trial as an extension of that high-dose, long-acting formulation strategy. Sanofi is expected to complete the trial in September and move into phase 3 within the year.
The trial is also meaningful in that it is the first time the details have been confirmed of the $1.373 billion (about 2 trillion won) technology licensing deal for switching to an SC formulation that Alteogen signed in 2019 with an undisclosed global pharmaceutical company. Although the counterparty and the product were not disclosed at the time, the market has consistently suggested Dupixent as the likely target. This is the first time Sanofi has officially revealed the application of Alteogen's technology.
Until now, Alteogen's SC conversion technology has been applied mainly to cancer drugs, including Keytruda and the antibody-drug conjugate (ADC) "Enhertu" from Japan's Daiichi Sankyo and the United Kingdom's AstraZeneca. Dupixent is the first case of applying it to an autoimmune disease treatment, which is meaningful in that the technology's use has expanded beyond oncology into immune and inflammatory diseases.
Alteogen's technology has also been applied or is being pursued for application to Enhertu, AstraZeneca's immuno-oncology drug "Imfinzi," and GSK plc's immuno-oncology drug "Jemperli," in addition to Dupixent.
An industry official said, "If these products are commercialized sequentially by 2030, Alteogen is expected to secure more than 1 trillion won in annual royalties."