Clinical plan revealed 9 months after technology transfer in January
Target: 380 people... After selecting the SC dose, direct comparison with the existing IV formulation
The development of GSK's immuno-anticancer drug 'Zemperi (ingredient name: dostalimab)' SC using Alteogen's (196170) subcutaneous injection (SC) formulation modification platform 'ALT-B4' is moving to the clinical stage. A detailed clinical plan was released about nine months after the technology transfer agreement was signed last January.
According to the US clinical information site ClinicalTrials.gov and GSK clinical trial registration data on the 7th, GSK registered the ‘SAPPHIRE’ clinical plan to evaluate the Zemperi SC formulation for patients with advanced or recurrent endometrial cancer.
The clinical trial will proceed to a randomized phase 3 phase after selecting the appropriate dose of Zemperi SC in phase 1b. A total of 380 people are expected to participate, and it is currently in the pre-patient recruitment stage. In phase 3, the selected SC formulation will be directly compared with the existing intravenous (IV) formulation.
Find capacity in phase 1b and move to phase 3… SC·IV direct comparison
Unlike the typical phase 1, 2, and 3 order of new drug development, this clinical trial selects the dose in phase 1b and then moves on to phase 3. This is a formulation change development that changes the administration method of the already approved dostalimab from IV to SC. In phase 1b, the appropriate SC dose is found based on pharmacokinetic indicators such as blood drug concentration and exposure amount.
[Source: ClinicalTrials.gov, Semperi SC ‘SAPPHIRE’ clinical design registered by GSK]
Phase 1b also includes a control group using existing IV regimens. This is to select a dose that can ensure appropriate drug exposure after administering multiple SC doses compared to conventional IV administration.
In the following phase 3, SC and IV administration groups will be randomly divided and pharmacokinetics, efficacy, and safety will be compared. Both treatment groups use carboplatin and paclitaxel together. Anticancer efficacy indicators such as objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) are also evaluated.
Unlike clinical trials that first confirm the efficacy of a new anti-cancer substance, this is a development that changes the administration route of an already approved drug, so it is interpreted that it is designed to determine the appropriate SC dose and then directly compare it with the existing IV formulation.
Signed a contract with GSK in January... Clinical plan materialized in 9 months
The development of Semperi SC follows the technology transfer agreement that Alteogen signed with GSK subsidiary Tesaro in January. GSK secured exclusive rights to develop and commercialize the dostalimab SC formulation using ALT-B4.
The contract size is up to $285 million, including a down payment of $20 million and up to $265 million in milestones related to development, licensing, and sales. After commercialization of the product, royalties are paid separately based on net sales. Alteogen will also be responsible for supplying ALT-B4 needed for clinical trials and commercialization.
ALT-B4 is a human hyaluronidase-based technology that is used to develop biopharmaceuticals administered intravenously into subcutaneous injection formulations. Currently, Zemperi is administered by intravenous injection, and the administration time according to the European Medicines Agency (EMA) is about 30 minutes.
Zemperi is a PD-1 immune checkpoint inhibitor, an anticancer drug sold by GSK focusing on endometrial cancer. Sales in the first quarter of this year were 232 million pounds, up 40% from the same period last year. GSK is expanding the indications while also pursuing the development of SC formulations.
Following the commercialization of MSD’s ‘Keytruda SC’ using ALT-B4, Alteogen is continuing to develop products from other partner companies. If Zemperi SC passes phase 1b and enters phase 3 as planned, the scope of ALT-B4-applied products will expand from commercialized products to the late-stage clinical pipeline.
