Blinatumomab

iStock, Veronika Oliinyk Novartis is licensing an mRNA-based therapy designed to produce a CD3xCD19 T cell engager inside the body. Abogen Biosciences says the in vivo approach could reduce the likelihood of dangerous cytokine release. Novartis is putting up to $7.8 billion on the line to work with Suzhou, China-based Abogen Biosciences on an mRNA-based approach that could mitigate a key safety concern of T cell engagers. The agreement, announced early on Friday , will involve an upfront payment of $575 million, plus up to around $7.2 billion in potential development, regulatory and commercial milestones. Abogen could also receive royalties on any future sales. The centerpiece of the deal is ABO2203, an mRNA drug candidate designed to deplete disease-causing B cells by giving the patient’s body the genetic code to produce a potentially therapeutic CD3xCD19 T cell engager. This in vivo approach could lower the risk of cytokine release syndrome (CRS), a common and often severe safety issue with T cell engagers, Abogen claimed in a separate press release in April. Indeed, many FDA-approved T cell engagers carry boxed warnings for CRS. These include Roche’s Columvi , J&J’s Tecvayli and Amgen’s Blincyto . ABO2203 has the “potential to transform the treatment landscape for patients with autoimmune diseases,” the companies announced on Friday, though the partners did not explicitly say they would focus their development efforts in this space. A spokesperson for Novartis declined in an email to disclose specific target indications for the deal. First-in-human data for ABO2203 presented in April showed “exceptional” safety among nine patients with relapsed or refractory B cell non-Hodgkin lymphoma, Abogen claimed at the time. Specifically, the Chinese biotech reported no cases of CRS, dose-limiting toxicities or neurological complications typically linked to immunotherapies. Abogen also touted dose-dependent objective response rates, reaching 100% at the highest dose level. Aside from ABO2203, Novartis will also have the exclusive option to license a certain number of therapies developed through Abogen’s proprietary platform. The biotech takes an AI-centric approach to mRNA design, drug formulation and manufacturing, according to the Friday release. “Novartis was attracted to Abogen because of its differentiated proprietary RNA platform and pioneering work in mRNA-encoded T-cell engagers and other RNA-encoded therapeutic modalities,” the spokesperson said. Novartis has taken several trips to China this year. Just last month, the pharma licensed a radioligand asset from Suzhou’s BoomRay Pharmaceuticals for up to $900 million—a deal that could further entrench Novartis’ leadership position in the radiopharma space. And in January, the pharma fronted $150 million to partner with Shanghai- and Maryland-based SciNeuro Pharmaceuticals on an anti-amyloid therapy for Alzheimer’s disease. That deal involved up to $1.5 billion in milestones. During the pharma’s Q2 call in July, CEO Vas Narasimhan said that Novartis is “geography-agnostic” when it comes to dealmaking, adding, “Our strategy is to just go wherever the leading science is in a given therapeutic area or in a given technology area.” The Abogen deal also comes amid a series of setbacks for Novartis , including three deaths linked to its CAR T therapy rapcabtagene autoleucel. As a result, the pharma suspended several studies of the asset. Earnings Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma’s second quarter earnings call—though major pickups aren’t completely off the table. July 21, 2026 · 2 min read · Tristan Manalac Read more Clinical research Novartis drags peers down with triple asset stumble Novartis’ shares fell 13% this week after the report of three separate late-stage asset setbacks. The impact went beyond the Swiss drugmaker, dragging peers down across the market. September 11, 2026 · 1 min read · Annalee Armstrong Read more

Australia has cleared ATG-201, Antengene Corporation Limited's (HKEX: 6996.HK) CD19 × CD3 bispecific T-cell engager (TCE), to enter first-in-human testing, with the country's Human Research Ethics Committee (HREC) approving the Phase I ATTRACT study and the Therapeutic Goods Administration (TGA) completing its Clinical Trial Notification process. The approval follows China's NMPA IND clearance in June 2026, opening a two-jurisdiction first-in-human program for the molecule. ATG-201 is built on Antengene's proprietary AnTenGager platform, which uses a "2+1" format — two CD19-binding arms and one CD3-binding arm — combined with steric hindrance masking technology that restricts T-cell activation to the presence of CD19-expressing target cells. The design is intended to deplete pathogenic B cells while reducing cytokine release syndrome (CRS), a known toxicity that has constrained earlier CD19/CD3 bispecific approaches. The ATTRACT study is a dose-escalation and dose-expansion Phase I trial evaluating ATG-201 monotherapy in adult patients with B cell-related autoimmune diseases. Primary endpoints are safety, tolerability, and determination of the recommended Phase II dose (RP2D); secondary endpoints include pharmacokinetic and pharmacodynamic profiling, immunogenicity, and preliminary efficacy. Antengene will conduct the first-in-human studies in both China and Australia before transferring further clinical development to UCB, which holds worldwide exclusive rights to develop, manufacture, and commercialize ATG-201 under a deal signed in March 2026. The UCB agreement provided Antengene with USD 60 million upfront — confirmed received in July 2026 — plus up to USD 20 million in near-term milestones and eligibility for more than USD 1.1 billion in success-based payments and tiered royalties. Preclinical data presented at ACR 2025 showed that ATG-201 achieved complete and sustained B cell depletion in humanized mouse models and demonstrated a favorable safety profile in non-human primates at doses of 1–6 mg/kg, with only mild, transient cytokine elevation. Cryo-electron microscopy confirmed that the CD3 binding site remains sterically masked in the absence of CD19 cross-linking, supporting the conditional activation mechanism. No human data exist yet. CAR-T programs from Kyverna Therapeutics, AstraZeneca, Merck, and others have generated clinical proof-of-concept, while Amgen's blinatumomab — the first-in-class CD19/CD3 bispecific immunotherapy approved for B-cell acute lymphoblastic leukemia — is also under investigation in autoimmune settings. ATG-201's differentiated claim rests on the steric masking mechanism reducing CRS relative to first-generation TCEs, a hypothesis that the ATTRACT study will now begin to test in patients. Spot something wrong? Report an issue with this article