UCB SA

UCB Chief Scientific Officer Alistair Henry said T-cell engagers are “emerging as an exciting and potentially disruptive therapeutic modality for immunological diseases.”\n UCB has entered the red-hot T-cell engager (TCE) space by paying $80 million for the rights to a Chinese biotech’s preclinical autoimmune candidate.At the center of the deal is ATG-201, a CD19/CD3 bispecific TCE that Shanghai-based Antengene has been lining up to enter phase 1 trials on both its home turf of China as well as in Australia before the end of the month. Under yesterday’s deal, Antengene will complete these first-in-human phase 1 studies before transferring ATG-201 across to UCB to take forward.In return, Antengene will receive $80 million in upfront cash and near-term milestones, while being eligible for up to $1.1 billion in development and commercial milestones, as well as tiered royalties on sales should ATG-201 make it to market.The licensing deal marks UCB’s first foray into TCEs, which activate a patient’s own T cells. The modality continues to be a hot area for dealmaking, with Astellas penning a $1.7 billion collaboration with Vir Biotechnology only last week for a prostate cancer TCE.While many TCEs are being developed for cancer, some companies have been exploring their use against autoimmune conditions, including Harbour BioMed and Cullinan Therapeutics.ATG-201 has been produced by Antengene’s AnTenGager platform, which the biotech has touted as offering a “differentiated TCE approach” of “2+1” bivalent binding for low-expressing targets. The company has already showcased preclinical data for ATG-201 that Antengene said demonstrated the potential for the asset’s bispecific interaction with T and B cells through CD3 and CD19 to treat B-cell-driven diseases.UCB Chief Scientific Officer Alistair Henry said TCEs are “emerging as an exciting and potentially disruptive therapeutic modality for immunological diseases.”“Access to Antengene’s cutting-edge T-cell engager platform technology enhances our ambition to lead in immunology,” Henry added. “It complements our expertise in monoclonal antibodies and novel biologics, demonstrates our inorganic innovation strategy in action, and brings transformational new capabilities that take UCB into the advancing field of bispecific T-cell engagers.” The Belgian drugmaker has tasted success with Bimzelx, a dual IL-17F/IL-17A inhibitor that scored five approvals in just two years and has gone on to become an immunology blockbuster. UCB is currently putting Bimzelx’s potential to the test with a head-to-head study against AbbVie’s Skyrizi in psoriatic arthritis.As UCB attempts to live up to its newfound reputation as a fledgling immunology powerhouse, the company is pouring $5 billion into a manufacturing expansion while scaling up partnerships with U.S.-based contract manufacturers to ensure the continued supply of its growth drivers. Alongside this move, the Brussels-based company will soon launch its first ultrarare disease drug in the U.S. in the form of Kygevvi, a treatment for genetic mitochondrial disease thymidine kinase 2 deficiency that was approved last November. 

Sanofi has paid $135 million upfront to license a potential therapy to tamp down transplant rejection from the Hong Kong-based company Sino Biopharmaceutical. The French pharma will get exclusive worldwide rights to develop, make and sell rovadicitinib, in a deal made via Sino’s subsidiary Chia Tai Tianqing Pharmaceutical. Sanofi is on the hook for up to $1.4 billion in milestone payments, plus possible double-digit tiered royalties, according to a Wednesday securities filing . Sino described rovadicitinib as its “breakout star” in the field of rare diseases. It is a first-in-class inhibitor of both JAK, through which it exerts anti-inflammatory effects, and another enzyme called ROCK. ROCK blockade suppresses overactivated T helper cells and boosts regulatory T cells, helping the patient achieve immune homeostasis. In a statement, Sino called the deal a rare instance of a Chinese pharma ceding worldwide rights to a late-stage clinical asset to a Western company; usually, China-based drugmakers hang on to the rights for their home market. The deal offers Sanofi a potential backup asset to its transplant drug Rezurock. That product was approved as a third-line therapy for chronic graft-versus-host disease (cGVHD) in June 2021, when it was still owned by its originator, Kadmon. Sanofi bought Kadmon for $1.9 billion three months later. But Rezurock has never made it onto the European market, having been rejected by the Committee for Medicinal Products for Human Use last fall. Meanwhile, rovadicitinib is already approved in China under the brand name Anxu, though not for cGVHD. Last month, it got the nod as a first-line treatment for various forms of the bone marrow cancer myelofibrosis. Sino is working on mid-stage trials for cGVHD in China. According to data from a Phase 1b/2 study in cGVHD presented at last year’s American Society of Hematology meeting, about 60% of patients given the drug had a significant improvement in rejection symptoms, and the best overall response rate was 86%. At one year, the failure-free survival rate was 85%, which Sino said was “significantly superior” to approved products. Phase 3 trials in this indication are underway in China, and Sino said Sanofi would collaborate in running these. In the US, the FDA has given the go-ahead for mid-stage trials. Sino has other Western partnerships, including a deal struck in January in which another of its subsidiaries, Jiangsu Chia Tai Feng Hai Pharmaceutical, licensed a small molecule aimed at miR-124 to Formation Bio for an as-yet-undisclosed indication. (For this deal, Sino kept the China rights.) It also has a 2024 pact, which saw Boehringer Ingelheim out-license China rights to a handful of clinical-stage cancer programs to Sino. Western pharma companies continue to seek assets in China, with UCB also announcing a licensing deal Tuesday evening.

UCB has turned to the east to bolster its immunology pipeline with a T-cell engager (TCE), licensing China-based Antengene Corporation’s ATG-201— a novel CD19/CD3 bispecific designed for B cell-driven autoimmune diseases — in a deal worth up to $1.18 billion.ATG-201 is developed using Antengene’s proprietary AnTenGager platform, which applies steric hindrance-based masking to enable disease antigen-dependent CD3 engagement. It combines bivalent CD19 binding with a proprietary fast-on/fast-off CD3 binder, aiming to achieve potent B-cell depletion while minimising cytokine release syndrome risk and T-cell exhaustion."Access to Antengene's cutting-edge [TCE] platform technology enhances our ambition to lead in immunology," said Alistair Henry, chief scientific officer at UCB.Under terms of the agreement announced Tuesday, UCB secures an exclusive licence to develop, manufacture and commercialise ATG-201 globally, alongside access to associated manufacturing technology. Antengene will pocket $60 million upfront, with eligibility for an additional $20 million in near-term milestones, followed by over $1.1 billion in success-based milestone payments, plus tiered sales royalties.Antengene will complete Phase I studies of ATG-201— planned in China and Australia — before transferring further development responsibilities to UCB. The former noted it retains nine additional disclosed programmes in its pipeline, spanning autoimmune diseases, solid tumours and haematological malignancies. The latest pact adds to a rising wave of licensing activity around TCEs. Earlier this year, AbbVie signed a $1.2-billion deal with Suzhou Zelgen Biopharmaceuticals for ex-China rights to the trispecific alveltamig. More recently, Astellas committed $1.7 billion to partner with Vir Biotechnology on a dual-masked CD3 TCE.