Navigator Medicines Secures $100M Series A Financing and $900M Collaboration Deal for Autoimmune Therapy NAV-240

On August 27 local time, Navigator Medicines (“Navigator”), a company dedicated to developing novel therapies for patients with complex, heterogeneous autoimmune diseases, announced the completion of a $100 million (approximately RMB 713 million) Series A financing round, co-led by RA Capital Management and Forbion.

Furthermore, Navigator announced that it has obtained licensing rights from IMBiologics (hereinafter referred to as “IMB”) for NAV-240 (formerly known as IMB101) and its OX40L-targeted development pipeline, and appointed Dr. Dana McClintock as Chief Medical Officer. Reportedly, the funds raised in this financing round will also be used for the development of NAV-240 and other monoclonal and bispecific antibodies targeting OX40L.

In fact, according to news on the IMB website, Navigator had already obtained the license for the NAV-240 and 0X401 targeted R&D pipelines from IMB as early as June this year.

Under the licensing agreement, Navigator will obtain global R&D rights for NAV-240 outside of Asia. IMB will receive a $20 million upfront payment and is eligible for up to $925 million in development and commercial milestone payments (with a total transaction value of approximately RMB 6.7 billion). In addition, IMB will receive tiered royalties of up to double-digit percentages based on annual net sales.

In August this year, IMB entered into a collaboration with Zhongmei Huadong, a wholly-owned subsidiary of Huadong Medicine, covering two autoimmune pipeline assets, including IMB101 (also known as NAV-240). Under the agreement, Zhongmei Huadong will obtain exclusive rights to develop, register, manufacture, and commercialize IMB’s two global innovative autoimmune products, IMB-101 and IMB-102, in 37 Asian countries including China (excluding Japan, South Korea, North Korea, and others).

Under the terms of the agreement, Huadong Medicine will pay IMB a $6 million upfront payment, a $2 million technology transfer milestone payment, development, regulatory, and commercial milestone payments of up to $307.5 million (approximately RMB 2.2 billion), as well as tiered net sales royalties in the high single-digit to low double-digit percentages.

Within two months, IMB secured successive collaborations with Navigator Medicines and Huadong Medicine regarding its IMB101 pipeline, with a total value exceeding RMB 8.9 billion, underscoring its remarkable capital-raising prowess.

NAV-240 is a bispecific antibody targeting OX40L and TNFα, involved in regulating inflammatory cytokines, promoting T cell and plasma cell differentiation as well as autoantibody production, and maintaining immune homeostasis.

This drug was first discovered in 2016 through a joint research effort by Ybiologics and HK Innoen, two South Korean companies. Y Biologics contributed to the discovery of OX40L candidate antibodies, while HK Innoen developed bispecific antibody candidates targeting OX40L and TNF. Subsequently, core antibody researchers from HK Innoen founded IMB in 2020, which obtained licenses for further non-clinical and clinical development of the drug.

In 2023, IMB submitted an Investigational New Drug (IND) application for IMB-101 to the U.S. FDA and obtained approval. Preclinical data demonstrated favorable efficacy and safety in animal models. Currently, IMB-101 is undergoing Phase I clinical trials in the United States for the treatment of rheumatoid arthritis. Navigator Medicines indicated that the single-ascending-dose Phase Ia trial of NAV-240 is expected to be completed soon, with the multiple-ascending-dose Phase Ib trial scheduled to commence in the second half of this year.

Currently, there are only two investigational dual-targeting bispecific antibodies against the same target disclosed in global public information. The other one is Sanofi’s SAR442970, which is in Phase II clinical trials and is intended for the treatment of hidradenitis suppurativa, minimal change nephrotic syndrome, and focal segmental glomerulosclerosis. IMB stated that this therapy has the potential to become a “best-in-class” drug for treating various autoimmune diseases.

In addition to the IMB101 pipeline, which has gradually drawn attention due to a series of major collaborations, the two companies behind this transaction are also worth examining.

IMB, one of the transacting parties, is a biotechnology company headquartered in Suwon, Gyeonggi Province, South Korea. Established in August 2020, the company leverages its next-generation IgM platform technology, ePENDY, to develop innovative immuno-oncology products and is committed to creating new therapeutic solutions for autoimmune diseases and cancer. IMB secured KRW 4 billion in seed funding in 2020, successfully raised KRW 13 billion in Series A financing in August 2021, and completed a KRW 20 billion Series B funding round in July 2023. IMBiologics will focus on developing the novel bispecific antibody IMB-101 and expanding its immuno-oncology product pipeline using the next-generation IgM platform technology, ePENDY.

The IMB management team possesses deep expertise in biopharmaceuticals and extensive commercialization experience. Gyongsik Ha, Founder and CEO, has over 20 years of experience in the biopharmaceutical industry, having overseen the development of multiple biologics through IND and NDA stages, with a composite background in R&D, clinical development, and commercialization. Prior to joining IMB, Gyongsik Ha served as Head of the Bio Research Center at HK inno.N and as a Senior Researcher at CJ CheilJedang.

Notably, the other party to the transaction is Navigator. Founded in 2024, Navigator is a subsidiary of Sera Medicines. While Sera Medicines focuses on the development of pregnancy-related biomarkers, Navigator aims to evolve into a company specializing in OX40–OX40L signaling inhibitors by licensing in NAV-240 and its OX40L-targeted pipeline.

In addition to being backed by its parent company, Sera Medicines, Navigator is supported by two major investors: RA Capital Management and Forbion. As part of the financing round, Wouter Joustra, General Partner at Forbion, and Andrew Levin, M.D., Partner and Managing Director at RA Capital Management, will join Navigator’s Board of Directors.

This model, in which capital partners collaborate with pharmaceutical companies to establish subsidiaries and provide management and support to rapidly advance acquired pipelines to milestone achievements or commercialization, is precisely the NewCo model currently gaining traction in the innovative drug sector. In China, the NewCo model is emerging as a new trend for Chinese innovative drugs going global. Since the beginning of this year, numerous Chinese pharmaceutical companies have successfully expanded overseas through this approach, including Genor Biopharma, Hengrui Medicine, and Keymed Biosciences, all of which are actively exploring this development strategy.

Regarding this collaboration, Kyung-Sik Ha, CEO of IMB, stated, “We believe in Navigator Medicines’ capabilities and experience in the field of autoimmune diseases. We will work closely with them to successfully bring IMB-101 and IMB-102 to market, becoming a company that can help improve patients’ lives.”

Stefan Thomas, CEO of Navigator Medicines, stated, “We are delighted to commence our collaboration with IMBiologics, which is developing a best-in-class OX40L-targeting antibody drug based on its outstanding development expertise and capabilities. Navigator Medicines also plans to continue the development of IMB-101 and IMB-102 and rapidly make them available to patients in need.”