WuXi Biologics Licenses Preclinical Trispecific TCE Antibody to Candid Therapeutics in $925M Deal

On January 7, 2025, WuXi Biologics (2269.HK), a globally leading contract research, development and manufacturing organization (CRDMO), announced that it had entered into a research services collaboration agreement with Candid Therapeutics (“Candid”). Candid is a clinical-stage biotechnology company dedicated to becoming a leader in T-cell engager (TCE) therapies for autoimmune and inflammatory diseases.

Under the agreement, Candid will hold global rights to a tri-specific antibody currently in preclinical development. The antibody was discovered using WuXi Biologics’ proprietary WuXiBody™ platform for universal multi-specific antibodies. WuXi Biologics will receive an upfront payment and is eligible to receive development and sales milestone payments totaling up to $925 million (approximately RMB 6.776 billion), as well as tiered royalties on net sales of the product following its commercial launch.

Candid again.

A more formal description characterizes it as a clinical-stage biotechnology company dedicated to becoming a leader in advancing T-cell engager (TCE) therapies for B-cell depletion in the treatment of autoimmune diseases. Candid is advancing two leading B-cell depletion TCE antibody candidates, aiming to broadly explore the therapeutic potential of TCEs across various autoimmune diseases by targeting different B-cell protein targets and evaluating varying depths of B-cell depletion.

Candid, founded in 2024 and headquartered in San Diego, California, is led by a team of entrepreneurs with distinguished track records in project advancement and development, and is backed by numerous prominent investors in the life sciences sector.

The mysterious trader behind this buying spree of Chinese TCEs only made a high-profile debut in the pharmaceutical market about 20 days ago.

On December 16, 2024, Candid Therapeutics, a company focused on the development of T-cell engager (TCE) molecules for autoimmune diseases, announced three R&D collaboration deals regarding TCEs in one go. The counterparties were Harbin No. 59 Pharmaceutical’s wholly-owned subsidiary Nona Bioscience, as well as Y-mAbs Therapeutics and Genor Biopharma/Ab Studio. The total potential transaction value exceeded $1.32 billion, equivalent to nearly RMB 10 billion. This figure does not even include the undisclosed amount from Ab Studio.

Three months earlier, on September 9, 2024 (U.S. time), Candid officially announced its establishment and secured $370 million in initial financing, stating that the funds would be used for clinical evaluations of autoimmune therapies, including products such as the CD20/CD3 bispecific antibody developed by Genor Biopharma. In retrospect, Candid has been advancing various transactions at a breakneck pace.

Among them, the NewCo entity for EMBRACE Bio is Vignette Bio, organized by the renowned biopharmaceutical venture capital firm Foresite Capital; the NewCo entity for Genor Biopharma is directly named TRC 2004, formed by shareholders Two River and Third Rock Ventures. Notably, a close comparison of Candid Therapeutics’ investor roster reveals that, in addition to the lead investors Venrock Healthcare Capital Partners, venBio Partners, TCGX, and Fairmount, both Foresite Capital and Third Rock Ventures are prominently listed among the participating investors.

In other words, Candid was essentially established from the outset as a platform designated by the aforementioned investors to acquire assets divested by domestic biotech companies.

Candid’s founding team comprises several seasoned entrepreneurs. Dr. Ken Song, Chairman, President, and Chief Executive Officer, has successfully led multiple life sciences companies, generating over $5.5 billion in shareholder value, and has become a prominent serial entrepreneur in the U.S. biopharmaceutical industry. Previously, he guided RayzeBio, a radiopharmaceutical company, from an innovative concept to Phase 3 clinical trials in just over three years. In early 2024, he successfully completed the sale of RayzeBio to Bristol Myers Squibb for $4.1 billion.

Additionally, Timothy Lu, M.D., Chief Medical and Scientific Officer, previously led the clinical development of a novel oral IL-17 drug for autoimmune diseases during his tenure at DICE Therapeutics, which was acquired by Eli Lilly and Company in 2023. Dr. Bernie Huyghe, Chief Technology Officer, brings over 30 years of experience in the manufacturing of biologics and other complex therapeutic products. Prior to joining Candid, he oversaw two Phase III antibody programs at Viridian Therapeutics. Arvind Kush, Chief Financial and Business Officer, formerly served as a Managing Director in Healthcare Investment Banking at Bank of America before transitioning to RayzeBio as Chief Financial Officer, where he successfully guided the company through an oversubscribed initial public offering (IPO) in September 2023.

One perspective holds that the team led by Dr. Ken Song approaches biopharmaceuticals with an investment mindset. In 2018, Novartis’ Pluvicto received regulatory approval and achieved strong sales volume, reigniting enthusiasm for therapeutic radiopharmaceuticals. Within two years, RayzeBio was established; as global multinational corporations (MNCs) scrambled to build their radioligand drug conjugate (RDC) pipelines, it was smoothly acquired by Bristol Myers Squibb (BMS). This strategy exemplifies entering the market early during its nascent stage and exiting when industry hype reaches its peak.

Candid remains focused on TCE.

T Cell Engagers (TCEs) are a type of T-cell engager and a specialized class of bispecific antibodies. One end binds to the CD3 epitope on T cells, while the other binds to tumor-associated antigens (TAAs) to target tumor cells, thereby activating T cells to exert their cytotoxic effects against tumors. Haitong International noted in its research report that, as TCE bispecific antibody therapy essentially works by activating T cells, it has lower requirements for target expression levels compared to antibody-drug conjugates (ADCs), but demands higher tumor specificity. Furthermore, compared with CAR-T therapy, “off-the-shelf” TCE bispecific antibodies offer greater advantages in terms of convenience, accessibility, and production costs.

Furthermore, TCE is also considered poised to succeed ADCs as the next major investment hotspot in innovative drugs.

Notably, NewCo’s capital operation model is gaining increasing popularity in the TCE field. According to incomplete statistics from VBInsight, five out of six NewCo transactions in 2024 involved TCE pipelines.

TCEs have broad application scenarios in hematologic malignancies, solid tumors, and autoimmune diseases. In the field of hematologic malignancies, seven TCE bispecific antibodies have been approved globally, primarily from Amgen, Roche, and AbbVie, targeting BCMA, GPRC5D, CD20, and CD19, among others. These approvals cover multiple indications in hematologic malignancies, including multiple myeloma and diffuse large B-cell lymphoma.

The autoimmune disease sector represents a major domain where T-cell engager (TCE) therapeutics are poised for potentially revolutionary R&D breakthroughs. Consequently, companies both in China and abroad have already established strategic footholds in this area, with indications spanning neuroimmunology, rheumatology, and nephrology. However, as research on TCE bispecific antibodies remains largely in its early stages, significant advancements and improvements are still required in both technology platforms and indication expansion, despite the current surge of interest. This underscores why innovative pharmaceutical companies possessing proprietary TCE technology platforms are increasingly favored by investors and industry stakeholders.

Industry experts have pointed out that the key challenge in developing T-cell engager (TCE) bispecific antibodies lies in optimizing the affinity of the CD3 and tumor antigen-binding arms to achieve a balance between efficacy and safety.

This is also the direction Candid is exploring. Previously, Candid initiated three large-scale transactions in a single day, engaging Nonacore Biopharma, E-Mab Therapeutics, and Ab Studio as CROs to leverage their respective bispecific antibody platforms for the development of next-generation T-cell engagers (TCEs), with indications expanding from oncology to autoimmune diseases. The current collaboration with WuXi Biologics follows the same pattern.

At the heart of this collaboration is the WuXiBody™ platform, an innovative and proprietary technology platform developed by WuXi Biologics to expand the application scope of bispecific antibodies. This platform overcomes technical bottlenecks in bispecific antibody CMC (Chemistry, Manufacturing, and Controls) and effectively addresses challenges encountered during development. It offers advantages such as high expression levels, high stability, good solubility, and ease of purification. Furthermore, it can save 6 to 18 months of R&D time for each project while significantly reducing the production costs of multispecific antibodies, thereby enabling more cost-effective and environmentally sustainable drug development.

Leveraging the extensive application of the WuXiBody™ platform in bispecific antibody discovery, WuXi Biologics has technologically upgraded the platform to enable the customized discovery of innovative multispecific antibodies, thereby meeting the growing global demand for research services on these complex molecules. The WuXiBody™ platform can utilize nearly all antibody sequences to construct multispecific antibodies, with the potential to reduce immunogenicity risks and extend in vivo half-life. Additionally, the WuXiBody™ platform offers unique flexibility, allowing for the construction of various valencies (e.g., 1+1, 2+2, 1+1+2) to satisfy the biological requirements of different projects.

On January 17, 2024, the WuXiBody™ platform was granted a patent by the United States Patent and Trademark Office, marking its patent authorization in the United States, Japan, and China.

Dr. Chen Zhisheng, CEO of WuXi Biologics, stated that this collaboration not only validates the exceptional capability of the technology platform in discovering trispecific antibodies but also solidifies WuXi Biologics’ position as the partner of choice in the field of next-generation biologic drug development collaborations. Dr. Chen further pointed out that, with this collaboration included, WuXi Biologics’ research technology platforms enabled seven global molecular discovery service projects in 2024, securing near-term payments totaling approximately $140 million, with potential total transaction values exceeding $2.3 billion.

As previously mentioned, the team led by Dr. Ken Song—now the core team at Candid Therapeutics—approaches biopharmaceutical development from an investment perspective. Previously, certain bispecific antibody assets targeting T cells were shelved due to intense competition within the sector and significant uncertainties surrounding commercialization.

Today, T-cell engagers (TCEs) are experiencing a renaissance in the autoimmune disease field. These once-overlooked assets have regained their luster, with Roche, Amgen, and AstraZeneca all restarting their clinical programs in autoimmunity. Naturally, Chinese biotech companies developing TCEs have also landed on the acquisition radar.

TCE officially gained momentum in 2024. Since its establishment in September 2024, Candid Therapeutics has rapidly built a portfolio of five TCE pipelines within less than three months, transitioning from a shell company to a substantive player—a clear testament to the arrival of this strategic window. Some observers note that Ken Song has demonstrated even greater efficiency in this venture compared to his tenure at RayzeBio.

However, unlike the radiopharmaceutical sector where RayzeBio operates, the supply of TCEs is more abundant. Coupled with the unfreezing of various previously stalled assets, competition in this therapeutic area is expected to intensify gradually. Whether biotech companies can ultimately achieve optimal product launches will depend on continued monitoring of their pipeline progress.