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DRUG CLASS:

CD137 agonist

21d
A Study of LVGN6051 Combined With Anlotinib in Patient With Soft Tissue Sarcoma (clinicaltrials.gov)
P1/2, N=39, Completed, Lyvgen Biopharma Holdings Limited | Recruiting --> Completed | N=65 --> 39 | Trial primary completion date: Mar 2025 --> Dec 2025
Trial completion • Enrollment change • Trial primary completion date • IO biomarker
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Focus V (anlotinib) • exlinkibart (LVGN6051)
22d
Phase 1 Trial of LVGN7409 (CD40 Agonist Antibody) as Single Agent and Combination Therapies in Advanced or Metastatic Malignancy (clinicaltrials.gov)
P1, N=66, Completed, Lyvgen Biopharma Holdings Limited | Active, not recruiting --> Completed | N=126 --> 66
Trial completion • Enrollment change • First-in-human
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dalnicastobart (LVGN7409) • exlinkibart (LVGN6051) • pradusinstobart (LVGN3616)
22d
A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
P2, N=64, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting
Enrollment closed
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paclitaxel • Loqtorzi (toripalimab-tpzi) • exlinkibart (LVGN6051)
22d
KEYNOTE-A31: Phase 1 Trial of LVGN6051 as Single Agent and in Combination With Keytruda (Pembrolizumab) in Advanced or Metastatic Malignancy (clinicaltrials.gov)
P1, N=105, Completed, Lyvgen Biopharma Holdings Limited | Active, not recruiting --> Completed | N=276 --> 105
Trial completion • Enrollment change • First-in-human
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Keytruda (pembrolizumab) • exlinkibart (LVGN6051)
23d
New P1/2 trial
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PD-L1 (Programmed death ligand 1)
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Libtayo (cemiplimab-rwlc)
23d
Preclinical characterization of IBD0333, a novel CD24×4-1BB bispecific antibody with tumor-dependent agonistic activity for cancer immunotherapy. (PubMed, Antib Ther)
IBD0333 is a tumor-conditionally activated anti-CD24×4-1BB bsAb that demonstrates potent antitumor efficacy along with a favorable safety and pharmacokinetic profile. These findings support its further clinical development.
Preclinical • Journal
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CD24 (CD24 Molecule)
27d
BGB-B2033-101: A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=392, Recruiting, BeOne Medicines | N=140 --> 392 | Trial completion date: Dec 2026 --> May 2028 | Trial primary completion date: Oct 2026 --> May 2028
Enrollment change • Trial completion date • Trial primary completion date • First-in-human
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AFP (Alpha-fetoprotein) • GPC3 (Glypican 3)
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Avastin (bevacizumab) • Tevimbra (tislelizumab-jsgr)
1m
Tri-specific Humabody CB307 Targeting CD137, Prostate-specific Membrane Antigen, and Human Serum Albumin Whole-body Biodistribution Measured with 89Zr-CB307 PET. (PubMed, Mol Cancer Ther)
Tumor biopsies confirmed radioactivity. 89Zr-CB307 selectively accumulated in PSMA-positive tumor lesions without specific uptake in PSMA-positive-normal or lymphoid tissues in patients with mCRPC.
Journal • IO biomarker
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FOLH1 (Folate hydrolase 1) • TNFRSF9 (TNF Receptor Superfamily Member 9)
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FOLH1 expression • FOLH1 positive
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CB307
1m
IgG2a-formatted 4-1BB agonism combined with S100A9 inhibition enhances T cell activation and tumor control in a preclinical model of multiple myeloma. (PubMed, J Exp Clin Cancer Res)
These findings establish the isotype-specific efficacy of 4-1BB agonists and support 4-1BB stimulation combined with TQ as a promising strategy to enhance durable immunotherapeutic responses in MM.
Preclinical • Journal • IO biomarker
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IFNG (Interferon, gamma) • NCAM1 (Neural cell adhesion molecule 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • S100A9 (S100 Calcium Binding Protein A9) • GZMB (Granzyme B) • CD86 (CD86 Molecule)
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tasquinimod (ABR-215050) • urelumab (BMS-663513)
1m
Trial completion date • Checkpoint inhibition
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PD-L1 expression
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Keytruda (pembrolizumab) • acasunlimab (GEN1046)
2ms
Quantitative Investigation of ATP Switch Concept of STA551 Through Combined In Vivo Tissue Distribution Studies and Physiologically Based Pharmacokinetic Modeling. (PubMed, AAPS J)
In conclusion, this combination approach successfully demonstrated the ATP switch concept of STA551 in vivo. These findings will help guide clinical trials for STA551 and the development of future switch antibodies.
PK/PD data • Preclinical • Journal
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TNFRSF9 (TNF Receptor Superfamily Member 9)
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STA551