1. Clear MoA.
CD40 is a cell-surface member of the TNF receptors superfamily. CD40 is extensively expressed on APC. Upon activation, CD40 can license dendritic cells to promote antitumor T cell activation and re-educate macrophages to destroy tumor stroma. anti-CD40 IgG subclass binds both activating S(hFcγRIIA) and inhibitory (hFcγRIIB) IgG receptors. Anti-CD40 can only have anti-tumor effects when it selectively binds to FcyRⅡB.
2. Excellent preclinical efficacy:
(1) Cross with human and rhesus monkeys, not with mouse/ rats.
(2) No immunotoxicity: no ADCC activity, lower CDC activity than APX004M.
(3) Higher tumor-killing activity and higher immune memory effect than RO7009789 and APX005M in vivo.
(4) Excellent safety: MTD= 30 mg/kg in rhesus monkeys; Plasma cytokine concentrations (IFNγ, TNFα, IL6, IL1β, IL2, IL4) were not abnormally increased after mAb administration.
3. Excellent PhaseⅠclinical result:
(1) No DLTs or SAEs observed in the dosages tested (0.01mg/kg through 0.1mg/kg).
(2) One patient with metastatic melanoma treated with a low dose (0.03 mg/kg) of the CD40 mAb achieved SD.
4. Good market potential:
It is estimated that the number of new pancreatic cancer patients worldwide will reach 486,300 in 2028, and the pancreatic cancer drug market will reach US$4.1 billion.
1. Asset type: CD40 mAb
2. Indication: Advanced solid tumors
4. Research phase: Phase 1
5. Cooperation demands: License-out or co-development
6. Research progress：
1) Completed preclinical development
2) Phase I clinical trials were initiated to evaluate the safety, tolerability, pharmacokinetics and efficacy of candidate antibodies for advanced malignancies.
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