AstraZeneca Initiates Phase 1 Clinical Trial for Subcutaneous Formulation of Rilvegostomig, a PD-1/TIGIT Bispecific Antibody
AstraZeneca has commenced a Phase 1 clinical trial (ARTEMIDE-subQ) to evaluate the pharmacokinetic profile of the subcutaneous (SC) formulation of rilvegostomig (AZD2936), a bispecific antibody targeting both PD-1 and TIGIT. The current intravenous (IV) administration method presents challenges for both patients and healthcare providers due to its longer administration time. The SC formulation aims to significantly reduce administration time to just a few minutes. This trial will involve patients with advanced solid tumors who have completed standard treatment and will focus on enhancing drug absorption and bioavailability in subcutaneous tissue through co-administration with recombinant human hyaluronidase (rHu).
The development of SC formulations is a key lifecycle management strategy in the oncology market, allowing companies to extend patent exclusivity and defend market share in response to patent expiration. Several major immune checkpoint inhibitors, such as Roche's Tecentriq, have already received approval for SC formulations, enhancing convenience and raising the barrier to market entry. Rilvegostomig is currently in Phase 3 clinical trials for biliary tract cancer and non-small cell lung cancer (NSCLC), making the proactive development of an SC formulation a potentially significant differentiator in the future commercialization phase.
Rilvegostomig is based on COM902, a TIGIT-targeting monoclonal antibody originally developed by Compugen, an Israeli biotechnology company, through a $200 million licensing agreement with AstraZeneca in 2018. The drug simultaneously blocks the PD-1 and TIGIT pathways, which suppress immune cells, thereby maximizing the activation of T cells in their anti-cancer activity. Notably, the Fc region of the antibody is precisely engineered with a triple mutation to minimize Fc-effector function, which can induce side effects such as immune cell depletion.
The global market for PD-1 and TIGIT-targeting therapies is highly competitive, with an estimated annual value of $21 billion to $45 billion, primarily driven by the NSCLC market. Roche's tiragolumab, Merck's vibostolimab, and Gilead/Arcus's domvanalimab are among the leading candidates in clinical development. AstraZeneca plans to secure clinical data from Phase 3 trials of the IV formulation of rilvegostomig while simultaneously advancing the Phase 1 trial of the SC formulation to establish a clear advantage in terms of ease of administration.
AstraZeneca is accelerating the Phase 1 trial of the SC formulation of rilvegostomig in parallel with the Phase 3 trial of the IV formulation to maximize its competitiveness in the $21 billion to $45 billion NSCLC and biliary tract cancer markets. From an industry perspective, this is a strategic move to proactively gain a competitive edge in terms of ease of administration in response to the market entry of strong competing candidates such as Roche's tiragolumab and Merck's vibostolimab. From a researcher's perspective, a key short-term objective is to demonstrate comparable pharmacokinetic and safety profiles to the existing IV formulation by applying recombinant human hyaluronidase co-administration technology. From an investor's perspective, the successful progression of this trial will activate milestone payments under the $200 million licensing agreement with Compugen, which provided the original patent, and diversify long-term royalty revenue streams after commercialization.
Source: ClinicalTrials.gov (api_ct)