On July 26, 2024, in Shanghai, Shanghai Escugen Biotechnology Co., Ltd. ("Escugen") and Innolake Pharma Co., Ltd. ("Innolake") jointly announced that they have entered into a global exclusive licensing agreement for the application of Escugen's novel ADC technology platform, EZWi-Fit®, in the development of ADC products targeting specific antigens by Innolake. Innolake will utilize Escugen's EZWi-Fit® in its innovative ADC products, be responsible for the preclinical, clinical development, manufacturing, and commercial sales of these products worldwide, and make upfront payments, R&D and regulatory milestone payments to Escugen, as well as tiered royalties on global sales after commercialization.
In addition, Innolake's first-in-class bispecific ADC product ILB-3103, which is designed from scratch using Escugen's EZWi-Fit® technology platform, has successfully completed the pharmacological validation of its PCC (preclinical candidate). This product targets two highly promising tumor-associated antigens, DLL-3 and B7H3. Its primary clinical positioning is for the treatment of neuroendocrine-derived malignant tumors, represented by small cell lung cancer, where there is still a significant unmet medical need. Moreover, based on the broad-spectrum tumor antigen B7H3, ILB-3103 can also cover a wider range of other malignant tumors. Excitingly, in animal pharmacological trials, this product can achieve long-term tumor suppression to undetectable or near-undetectable levels with a single dose, and it has demonstrated an absolute advantage over two single-target ADCs (with the same linker-payload) in head-to-head comparisons, as well as significantly better efficacy than the combination of the two single-target ADCs (with the same linker-payload), indicating that the bispecific ADC design has fully leveraged the synergistic killing effect of the two targets.
About Escugen Biotechnology
Established in 2017 in the Zhangjiang Hi-Tech Park, Pudong New District, Shanghai, Escugen Biotechnology focuses on the development of ADC new drugs. The company was founded by veteran returnees with decades of R&D experience in both international and domestic biopharmaceutical companies. The founding team has accumulated rich and successful R&D experience in leading biopharmaceutical companies both domestically and internationally, with capabilities covering antibody discovery, bioconjugation, process development and quality research, preclinical and clinical studies. Escugen's lead clinical pipeline, ESG401, is a Trop2-targeted ADC that uses an innovative stable and degradable linker to significantly reduce off-target toxicity. Clinical data suggest that ESG401 has a higher tolerable dose than other ADCs targeting the same antigen, with lower incidence and severity of off-target and on-target toxicities, demonstrating a clear safety advantage. The increased ADC dose and in-body exposure have led to encouraging efficacy in patients with advanced, heavily pretreated breast cancer, with significant antitumor effects on both visceral and intracranial metastases. Currently, ESG401 has initiated a pivotal Phase III clinical trial.
About Escugen's EZWi-Fit® ADC Technology Platform
EZWi-Fit® is Escugen's proprietary next-generation ADC technology platform, which has successfully filed for patent priority and obtained a registered trademark.
The EZWi-Fit® technology platform employs a stable degradable linker and a topoisomerase I (TopI) inhibitor payload. ADCs generated by this platform targeting multiple antigens have shown significantly higher in vivo activity compared to other ADCs with TopI inhibitors as payloads; they still demonstrate robust antitumor activity in various resistance models with MMAE, Dxd, and other payload molecules; they stably exhibit tumor suppression and elimination in multiple PDX models with low target expression and high heterogeneity; and they possess favorable pharmacokinetic characteristics and safety. Escugen has systematically completed mechanistic studies of the platform technology, elucidating the mechanisms at the molecular, cellular, and in vivo levels regarding resistance to drug resistance, bystander effect, and in vivo activity in low-expression target tumor models, providing convincing objective evidence for the platform's competitive advantages over international benchmark technologies. Escugen has conducted in vitro and in vivo studies on ADCs targeting multiple antigens using this platform technology, obtaining evidence of superiority, and has also achieved excellent safety data in non-human primate safety evaluations for several ADCs.
EZWi-Fit® surpasses international benchmark ADC technologies in multiple dimensions. Based on this platform, Escugen has co-developed the "First-in-Class" ADC FS001/ESG408 with Foreseen Bio, which has been successfully licensed to Ipsen Pharma SAS in France. Meanwhile, Escugen has licensed this platform technology to several companies both domestically and internationally, empowering more ADC products.
About Innolake Pharma
Innolake Pharma Co., Ltd. is a clinical-stage biotechnology company focused on the field of oncology and autoimmune diseases, having established a lean and efficient self-research system and preclinical/clinical development expert team for ADCs and small/large molecule innovative drugs. Focusing on truly unmet clinical needs, the company's R&D pipeline is concentrated on first-in-class or best-in-class candidate drug projects with differentiated innovative advantages in niche disease areas, possessing unique international competitive advantages.
Innolake Pharma has established, accumulated, and well demonstrated its capabilities and reliable experience in ADC-related platform technologies and product development. In line with its development strategy, the company will continue to make in-depth deployments in the ADC field, including the improvement of related technology platforms and the launch of more first-in-class bispecific ADC products with unique positioning and design.
