Rovadicitinib

Sanofi has licensed exclusive worldwide rights to KT501, a tri-specific T-cell engager developed by Kali Therapeutics, for the treatment of B cell-mediated autoimmune diseases. Kali Therapeutics, a clinical-stage biotechnology company based in San Mateo, California, will receive upfront and near-term payments totaling USD 180 million under the agreement. Paris-based Sanofi assumes full responsibility for development and commercialization of the asset globally. Kali Therapeutics is also eligible for up to USD 1.05 billion in development and commercial milestone payments. The deal includes tiered royalties on net product sales ranging from high-single digits to double digits. The total potential deal value, excluding royalties, reaches approximately USD 1.23 billion. KT501 is an IgG-like tri-specific T-cell engager (TCE) that simultaneously binds three targets: CD3 on T cells, and CD19 and BCMA on B-lineage cells. By engaging both CD19 and BCMA, the molecule is designed to deplete a broader range of B cell populations than agents targeting a single B cell marker. This includes long-lived plasma cells expressing BCMA, which may evade CD19- or CD20-directed therapies. The tri-specific format recruits T cells to kill the targeted B cells directly. A central feature of KT501 is Kali Therapeutics’ CD3 masking technology, which aims to decouple T-cell activation potency from cytokine release. In non-human primate studies, KT501 demonstrated B cell depletion in peripheral blood and tissues with reduced cytokine production relative to unmasked constructs, according to the company. KT501 is currently in a first-in-human Phase I trial evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in adults with moderately to severely active rheumatoid arthritis who have had inadequate responses to disease-modifying antirheumatic drugs. The trial (NCT07234773) began enrolling in March 2026 with an estimated completion date of August 2027. For Sanofi, the deal continues a spending spree focused on boosting its immunology portfolio, with recent deals including: a USD 1.53 billion tie up with Sino Biopharmaceutical for global rights to first-in-class oral JAK/ROCK inhibitor rovadicitinib signed earlier this month; the USD 9.5 billion acquisition of Blueprint Medicines signed in June 2025, focused on rare immunological diseases; and the USD 1.9 billion deal with Dren Bio signed in March 2025, focused on a CD20-directed bispecific antibody. The CD19 × BCMA × CD3 target combination used by KT501 is based on the rationale that dual B cell targeting depletes both CD19-positive B cells and BCMA-positive plasma cells, potentially leading to deeper and more durable responses than single-target approaches in autoimmune diseases where pathogenic antibody-secreting cells persist. Other companies pursuing TCEs for autoimmune indications with overlapping biology: • CMG1A46 — GSK/Chimagen Biosciences — dual CD19 and CD20-targeted T cell-engager (TCE) for systemic lupus erythematosus • LBL-051 — Oblenio Bio — CD19 × BCMA × CD3 engager for autoimmune diseases • REGN7257 — Regeneron — bispecific T-cell engager targeting CD20 × CD3 for autoimmune indications Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Kyowa Kirin's ill-fated OX40 autoimmune program, Sanofi and Sino Biopham's first-in-class licensing deal, and BioNTech and DualityBio's B7-H3 update made our news this week. Kyowa Kirin has decided to discontinue all clinical development of its OX40 drug after two new cancer cases emerged. Sanofi is committing up to $1.5 billion for global rights to Sino Biopharm's first-in-class JAK/ROCK inhibitor, which has potential in graft-versus-host disease. With strong early-stage data in prostate cancer, BioNTech is moving a DualityBio-licensed B7-H3 antibody-drug conjugate into phase 3. And more.1. New cancer cases prompt Kyowa to discontinue late-stage autoimmune disease programKyowa Kirin has decided to discontinue all clinical development of its anti-OX40 drug about a month after Amgen exited a partnership around the candidate, rocatinlimab. Two new cases of Kaposi’s sarcoma—one confirmed and one suspected—were reported on top of a previous case, drawing a “potential mechanistic link to OX40 pathway modulation,” according to the company.2. Sanofi strikes $1.5B global licensing deal for Sino Biopharm's first-in-class JAK/ROCK assetSanofi will pay $135 million upfront to obtain global rights to Sino Biopharm’s first-in-class JAK/ROCK inhibitor rovadicitinib, which was just approved in China in myelofibrosis. The drug’s “core value,” according to the seller, is in its potential in chronic graft-versus-host disease. The deal includes up to $1.395 billion in potential milestones. 3. BioNTech advances DualityBio ADC into phase 3 with half the patients of Merck-Daiichi rivalBioNTech’s DualityBio-partnered B7-H3 antibody-drug conjugate showed median radiographic progression-free survival of 11.3 months among heavily pretreated patients with metastatic castration-resistant prostate cancer, including some who had failed on Novartis’ Pluvicto. BioNTech is moving the drug, BNT324, into a phase 3 that’s half the size of a competing program from Merck & Co. and Daiichi Sankyo.4. Pfizer's oncology R&D strategy: Jeff Legos on speed, breadth and novel combinationsWith 3SBio’s PD-1xVEGF bispecific, partner Pfizer is aiming to beat the competition based on breadth of research, speed and novel combinations, the pharma’s oncology chief said. In less than a year since the agreement, Pfizer will have started 12 clinical trials of the drug, Pfizer’s Jeff Legos, Ph.D., told Fierce. Pfizer’s first phase 3 trials look similar to its competitors’, but the company is evaluating new combinations, including with its ADCs, he added.5. UCB enters TCE space with $1.1B deal for Chinese biotech's autoimmune candidateUCB is paying $80 million upfront for rights to a CD19xCD3 T-cell engager made by Antengene. The drug is slated to enter phase 1 testing in China and Australia by the end of March. Antengene is responsible for completing first-in-human studies before UCB takes over. The Chinese biotech is eligible to receive up to $1.1 billion in milestone payments.6. Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem'Roche signed a memorandum of understanding with the South Korean government for the Swiss pharma to spend about $484 million in South Korea’s biopharma industry. The partnership will strengthen the country’s competitiveness “by establishing an ecosystem for global clinical trials and enhancing R&D capabilities for innovative medicines,” a Roche spokesperson said.Other News of Note:7. Padcev-Keytruda combo aces another bladder cancer trial as MIBC landscape becomes more complex8. Ono's Deciphera drops early-stage solid tumor drug for strategic reasons9. Merck KGaA drops pipeline assets from SpringWorks buyout, Hengrui licensing deal10. BioDuro enters Taiwan joint venture, adding commercial API plant to production network11. TCE biotech Candid scores Nasdaq listing via reverse merger with rare-disease-focused Rallybio12. Earendil pens $885M pact to use WuXi XDC's linker tech for next-gen ADCs13. GLP-1 player QL Biopharm raises $73M in series C (Fundraising tracker)14. Daiichi Sankyo pens pact with Germany's Gaia to sell digital therapeutic for high cholesterol