Pipeline Overview - HiFiBio Therapeutics

Pipeline

We are developing next-generation immunotherapies for cancer and immunology & inflammation (I&I).

Innovative Immunotherapies

Our sustainable pipeline of immunomodulatory antibodies targets multiple cell types and key immunosuppressive or inflammatory mechanisms for the treatment of immunology and inflammation diseases (I&I).

We have three active Phase 1 clinical programs: the first-in-class TNFR2 agonist monoclonal antibody emunkitug (HFB200301, NCT05238883), the next-generation fully human OX40 agonist monoclonal antibody nuvustotug (HFB301001, NCT05229601), and the best-in-class BTLA antagonist monoclonal antibody HFB200603 ( NCT05789069). All three programs have successfully completed Phase 1a and are available for partnership.

Program	Discovery	Preclinical (IND)	Phase I	Phase II/III
Immuno-oncology
HFB200603* BTLA Antagonist
Emunkitug* (HFB200301) TNFR2 Agonist
Nuvustotug (HFB301001) OX40 Agonist
HFB200902	Gal-9 Antagonist
HFB101110	CCR8 Depletor
Immunology & Inflammation
HFB200604 BTLA Agonist
HFB100204	CXCR5 Depletor
HFB3024 KLRG1 Depletor
HFB2025	PD-1 Depletor
HFB2027	TNFR2 Agonist
Bispecifics	Novel targets