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#双抗/多抗

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Oct 15Thu
  1. nature.com83

    Engineered TYK2 dependence enables myeloid-selective IL-10 receptor agonism

    IL-10's therapeutic use is limited because its myeloid-suppressive and T-cell-activating effects cannot be separated. Using the JAK1 inhibitor VVD-118313 in bone-marrow-derived macrophages, the authors show that JAK1-JAK1 transphosphorylation only partially reduces IL-10-induced STAT3 phosphorylation, with TYK2-mediated transphosphorylation compensating; in TYK2-deficient BMDMs, VVD-118313 fully abrogated STAT3 phosphorylation and IL-10 function. In human monocytes, the TYK2 inhibitor zasocitinib similarly partially reduced IL-10-driven STAT3 phosphorylation, revealing differential TYK2 dependence that may enable myeloid-selective IL-10 receptor agonism.

    Why it matters: It maps a signalling route that could separate IL-10's anti-inflammatory benefit from its toxic T-cell activation.

  2. biospace.com65

    Gilead snags equity stake in Vir with up to $1.87B deal for three T cell engagers

    Gilead Sciences has licensed three dual-masked T cell engagers for solid tumors from Vir Biotechnology in a deal worth up to $1.87 billion, including $135 million in upfront and near-term payments. The upfront portion comprises $65 million in cash and a $25 million equity stake, plus $45 million in near-term preclinical milestones, with $1.74 billion in additional milestones possible. Vir will run discovery before handing development of promising assets to Gilead; analysts at H.C. Wainwright await VIR-5818 Phase 1 data in HER2-targeted solid tumors by year-end.

Oct 14Wed
  1. jamanetwork.com73

    From Biological Insight to a New Class of Medicines for Hemophilia A

    The 2026 Lasker-DeBakey Clinical Medical Research Award recognizes researchers who developed a bispecific antibody mimicking blood coagulation factor VIII. The antibody offers a new class of medicines for hemophilia A, a life-threatening bleeding disorder caused by lack of factor VIII. The winners describe how biological insight drove the drug's development.

    Why it matters: Lasker award spotlights a bispecific antibody that created a new treatment class for hemophilia A.

Oct 7Wed
  1. biospace.com40

    Genmab and AbbVie’s Epkinly win, a rush of deals, Sarepta’s turnaround hopes, more

    Genmab and AbbVie's bispecific antibody Epkinly, approved in May 2023 for diffuse large B cell lymphoma after at least two prior systemic lines, cut risk of disease progression or death by 51% in a Phase 3 trial when combined with R-CHOP in the frontline setting. In deals, Shionogi bought IntraBio for $2 billion, Novartis committed up to $7.8 billion to Abogen Biosciences, Eli Lilly added up to $870 million with Gate Bioscience, and Sanofi and Regeneron renewed their collaboration with a $1 billion upfront. Sarepta shared Elevidys data in older Duchenne patients at the World Muscle Society meeting, with Jefferies citing upcoming readouts and an FDA decision on Amondys 45 and Vyondys 53.

  2. nature.com40

    Next-generation immune cell engagers for B cell depletion in autoimmune diseases

    Nature Reviews Drug Discovery has published a review of immune cell engagers as a strategy for deep B cell depletion in autoimmune diseases. It covers their mechanisms, clinical development and next-generation designs, including T cell, natural killer cell and gamma-delta T cell-engaging formats. It also draws lessons from haematological malignancies to improve the efficacy, safety and durability of immune modulation.

Oct 6Tue
  1. biospace.com48

    FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

    The FDA has extended its review of Novo's denecimig, an investigational bispecific antibody and next-gen factor VIII mimetic for prophylactic treatment of hemophilia A, citing ongoing facility remediation activities at an unnamed manufacturing site. The agency flagged no efficacy or safety deficiencies, and Novo, which submitted the drug in September 2025 with a decision originally slated for the third quarter, says it is addressing the FDA's requests and still preparing for a 2027 launch in adults and children. The FDA has not shared a new review timeline, and European regulators are also evaluating the programme.

    Why it matters: FDA manufacturing delay affects a potential hemophilia A approval and ties into Novo's broader Catalent-related quality problems.

  2. N Engl J Med84

    Obexelimab for the Treatment of IgG4-Related Disease.

    Weekly subcutaneous obexelimab, 250 mg for 52 weeks, cut the risk of IgG4-related disease flare requiring rescue therapy by more than half in a phase 3 trial of 194 patients (hazard ratio 0.44; flares in 26.8% vs. 54.6% with placebo). Complete remission at week 52 was reached by 37.1% versus 19.6%, and cumulative glucocorticoid rescue dose was 329.5 mg versus 929.8 mg. The results position this non-depleting anti-CD19/FcγRIIb antibody as an alternative to glucocorticoid-dependent management.

    Why it matters: Phase 3 evidence that a non-depleting B-cell-targeted antibody reduces flares and steroid exposure in IgG4-related disease.

Oct 2Fri
  1. biopharmadive.com65

    Novartis wagers almost $8B on a Chinese biotech’s RNA drugs

    Novartis will pay Abogen Biosciences $575 million up front in a deal worth as much as $7.8 billion, gaining access to the Chinese biotech's mRNA-encoded drugmaking technology and an option to license ABO2203, a T cell engager targeting CD3 and CD19 being studied in relapsed or refractory B-cell non-Hodgkin lymphoma. Abogen is eligible for up to $7.2 billion in milestone payments, and Novartis could license additional programs. The deal follows a series of Novartis trial failures in September, including three deaths in a paused autoimmune CAR-T trial.

    Why it matters: Large-pharma licensing of Chinese RNA-encoded T cell engager technology at near-record deal value signals a pipeline rebuild after trial failures.

  2. biospace.com64

    Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen

    Novartis will pay Suzhou-based Abogen Biosciences $575 million upfront, with up to around $7.2 billion in milestones plus royalties, to develop ABO2203, an mRNA-encoded CD3xCD19 T cell engager designed to deplete disease-causing B cells in vivo. First-in-human data in nine relapsed or refractory B cell non-Hodgkin lymphoma patients showed no CRS, dose-limiting toxicities or neurological complications, with 100% objective response at the highest dose. Novartis also gains options to license therapies from Abogen's AI-driven RNA platform; target indications were not disclosed.

  3. Nature70

    GPCR antagonism via rewiring of receptor trafficking and degradation.

    Bispecific antibody chimeras termed GTACs drive GPCRs into TfR1-mediated endocytosis and lysosomal degradation, achieving potent and selective downregulation of BILF1, RXFP1 and CCR6, targets that have been difficult to drug. GTACs completely inhibit receptor signalling, including constitutive signalling, with one to two orders of magnitude greater potency than conventional antibody antagonists. The work establishes induced endocytosis and rewired protein trafficking as a route to therapeutic GPCR modulation.

    Why it matters: It turns GPCR antagonism into receptor degradation, boosting potency over conventional antibodies by one to two orders of magnitude.

Sep 30Wed
  1. medrxiv.org72

    CD3-engaging bispecific antibodies convert human regulatory T cells into cytotoxic effectors

    CD3-engaging bispecific T cell engagers convert human FOXP3+ regulatory T cells into an AP-1-imprinted hybrid cytotoxic state that contributes to tumor clearance. In newly diagnosed multiple myeloma patients treated with BTCE-based induction in the phase 2 GMMG-HD10/DSMM-XX/MajesTEC-5 trial, single-cell sequencing showed Tregs expressing GZMA, GNLY and NKG7, and in vitro BTCE-exposed Tregs killed tumor cells in a target- and dose-dependent manner. IMiDs amplified and reshaped this cytotoxic program, supporting BTCE-IMiD combination regimens.

    Why it matters: Reframes Tregs as active cytotoxic effectors of bispecific antibody therapy and gives a mechanistic basis for BTCE-IMiD combinations.

Sep 15Tue
Sep 11Fri
  1. nature.com51

    Teclistamab versus lenalidomide-dexamethasone in high-risk smoldering multiple myeloma: a randomized phase 2 trial

    Teclistamab produced higher rates of complete clinical responses than lenalidomide-dexamethasone in patients with high-risk smoldering multiple myeloma in the randomized phase 2 ImmunoPRISM trial. Longer follow-up is needed to determine whether it durably prevents progression to multiple myeloma.

    Why it matters: First randomized comparison of teclistamab against lenalidomide-dexamethasone in high-risk smoldering myeloma.

Sep 10Thu
  1. nature.com51

    A bispecific CD3×CD19 antibody for systemic lupus erythematosus: a phase 1 trial

    A next-generation CD3×CD19 bispecific T cell engager given intravenously was well tolerated in patients with active systemic lupus erythematosus in a phase 1 trial, and most patients showed improvements in disease activity scores. The findings support further testing of B cell-directed T cell engagers in systemic lupus erythematosus.

    Why it matters: First-in-class tolerability and disease activity signal for a CD3×CD19 bispecific antibody in active SLE.

Aug 19Wed
  1. N Engl J Med88

    Talquetamab-Daratumumab in Relapsed or Refractory Myeloma.

    In a phase 3 trial of relapsed or refractory multiple myeloma after at least one prior line of therapy, talquetamab plus daratumumab (Tal-D) or with pomalidomide (Tal-DP) beat daratumumab-pomalidomide-dexamethasone (DPd) on progression-free survival: 24-month estimates of 81.3% and 77.6% versus 51.2%, with hazard ratios of 0.28 and 0.33. Complete response or better reached 71.1% and 69.0% versus 34.5%, and MRD-negative complete response 52.3% and 46.3% versus 15.9%. The results position GPRC5D-directed bispecific therapy earlier in the treatment sequence.

    Why it matters: Phase 3 data show talquetamab regimens outperforming standard daratumumab-based therapy in relapsed myeloma after just one prior line.

Aug 18Tue
  1. Nat Med60

    First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial.

    Ivonescimab plus paclitaxel or nab-paclitaxel as first-line therapy produced an objective response rate of 80.0% (95% CI 63.1-91.6) in 35 evaluable patients with locally advanced unresectable or metastatic triple-negative breast cancer, including 2 complete and 26 partial responses. In the 36-patient single-arm phase 2 trial, all patients had treatment-related adverse events, 58.3% were grade 3 or higher, and no treatment-related deaths occurred. The PD-1/VEGF bispecific plus chemotherapy pairing offers a first-line option for this population that merits further investigation.

    Why it matters: It tests a PD-1/VEGF bispecific antibody as first-line therapy in triple-negative breast cancer, where systemic options are limited.

Aug 15Sat
  1. BioCentury47

    Boulevard: Homing in on B cell biology in autoimmunity

    Deerfield-incubated Boulevard Bio launched with $65 million in aggregate funding to develop B cell-directed therapies for IgA nephropathy and other autoimmune diseases. Its assets include a Phase I long-acting APRIL x BAFF bispecific for IgA nephropathy plus two preclinical autoimmune therapies. Scientific co-founders are CAR T researcher Georg Schett and former Sanofi CSO Frank Nestle.

Aug 14Fri
  1. FiercePharma40

    Fierce Pharma Asia—Legend’s first profit; Taiho, Cullinan’s EGFR win; WuXi AppTec’s reprieve

    Legend Biotech posted its first profitable quarter, with $63 million in adjusted net income for the three months ended June, as interim CEO Alan Bash discussed expanding Carvykti amid competition from Johnson & Johnson's bispecifics. Taiho and Cullinan Therapeutics' EGFR inhibitor zipalertinib plus chemotherapy succeeded in a phase 3 trial in first-line EGFR exon 20-mutated non-small cell lung cancer, with FDA approval plans ahead. A federal judge granted WuXi AppTec a preliminary injunction blocking the Defense Department's 1260H Chinese military company designation, and China approved Akeso's ivonescimab with chemotherapy for first-line squamous NSCLC.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org