Earendil Labs has announced a strategic collaboration with Sanofi to apply Earendil’s discovery platform to multiple autoimmune and inflammatory disease programmes.
Sanofi will lead the development and worldwide commercialization of bispecific candidates arising from the collaboration. This transaction is subject to customary closing conditions.
As part of the agreement, Earendil Labs will receive up to $160m in upfront and near-term payments tied to early programme achievements. The total potential value of the collaboration, including upfront, development, and commercial milestones, is up to $2.56bn. Earendil Labs will also receive tiered royalties on net product sales up to low double-digit percent.
Jian Peng, CEO of Earendil Labs, said: “Partnering with Sanofi allows us to apply Earendil’s discovery platform to a broader set of autoimmune disease targets than ever before. By combining advanced predictive protein modelling with high-throughput experimental validation, we can identify and optimize bispecific antibody candidates more efficiently and precisely. This collaboration underscores our commitment to advancing next-generation therapeutics that have the potential to set new standards of care.”
Zhenping Zhu, president and co-CEO of Earendil Labs, said: “Autoimmune diseases impose a heavy burden on patients and healthcare systems alike, with many conditions requiring lifelong management and often yielding incomplete responses to existing therapies. By leveraging Sanofi’s deep expertise in clinical development and global commercialization, we aim to accelerate the translation of our platform-enabled bispecific antibody candidates into potentially transformative medicines, bringing new treatment options to patients in need.”
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GenEditBio receives FDA clearance for TGFBI corneal dystrophy genome-editing programme
GenEditBio Limited has announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate phase 1/2 CLARITY trial activities for its lead in vivo genome-editing programme GEB-101 for TGFBI corneal dystrophy.
The trial will collect initial data on the safety, tolerability and efficacy of GEB-101 in corneal dystrophy patients with TGFBI mutation. The study has a seamless, adaptive, multicentre, sequential design. Trial participants will receive a single intrastromal injection of GEB-101. Patient enrolment is expected to commence in the second quarter of this year after site activation in the US.
“This regulatory IND clearance for our lead clinical asset, GEB-101, marks a momentous milestone in our commitment towards bringing transformative ribonucleoprotein (RNP)-based, ready-to-act and rapid degradation editor for one-and-done in vivo genome-editing therapy to patients globally. This achievement reflects the concerted efforts of the entire company to advance preclinical assets into clinical stage with rigorousness, professionalism, and speed,” said Zongli Zheng, chairman and co-founder of GenEditBio.
“GEB-101 is a first-in-class investigational genome-editing therapy for TGFBI corneal dystrophy. Current treatment options are limited and do not address the underlying cause, highlighting a significant unmet need for a targeted genetic approach. This IND clearance validates our robust preclinical data on safety and efficacy. We look forward to trial site activation and plan to expand the CLARITY trial through regulatory clearance in other major markets,” said Tian Zhu, CEO and co-founder of GenEditBio.
GEB-101, a wholly owned programme of GenEditBio, is a first-in-class genome-editing drug candidate designed as a one-and-done treatment for TGFBI corneal dystrophy. GEB-101 is based on the CRISPR-Cas genome-editing technology that targets a particular locus in the mutated TGFBI gene. GEB-101 is encapsulated as ribonucleoprotein in engineered protein delivery vehicle (PDV), a proprietary in vivo delivery system developed by GenEditBio.
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