Week In Review: CICC Capital Closes $229 Million China Fund For Biologics

Harbour BioMed, a China-US-Dutch biopharma, was approved to start US clinical trials of its next-gen CLTA-4 antibody in patients with solid tumors (see story). The company discovered HBM4003, a fully human monoclonal heavy chain only antibody (HCAb), using its Harbour Mice® technology. The trial will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM4003 as a single agent. The US approval was the second in two days for the company. Yesterday, Harbour announced approval for a US IND of its PD-L1 candidate.

MapKure, a JV formed by Beijing's BeiGene  (BGNE) and SpringWorks Therapeutics of Connecticut, has dosed the first patient in an Australian trial of BeiGene's second-gen B-RAF inhibitor (see story). BGB-3245 is aimed at patients with advanced or refractory solid tumors that have B-RAF mutations. SpringWorks was formed in 2017 as a spin-out from Pfizer (PFE) with two Pfizer targeted small-molecule oncology drugs. MapKure is also starting a Phase I trial in the US of BGB-3245, which will be an expansion of the Australian trial.

Ascentage Pharma (HK: 6855) of Suzhou is approved to start a China Phase Ib/II clinical trial of APG-1387, a novel small molecule IAP inhibitor that induces apoptosis (see story). APG-1387 will be tested together with chemotherapy in patients with advanced pancreatic cancer. In preclinical tests, the candidate inhibited the growth of tumor cells, either as a monotherapy or in combination with targeted agents or chemotherapies. APG-1387 is the first IAP inhibitor to start China clinical trials. Ascentage develops novel therapies for cancers, chronic hepatitis B and age-related diseases.

Harbour BioMed announced US approval of an IND to conduct a Phase II trial of its PD-L1 candidate in patients with nasopharyngeal cancer (NPC) (see story). The US FDA also granted Orphan Drug Designation to HBM9167 for the indication. In 2018, Harbour acquired global rights (ex-China) to HBM9167 from Sichuan Kelun-Biotech in a $350 million deal. Kelun-Biotech is conducting Phase II China trials of the PD-L1 in patients with lymphoma and NPC. Harbour has R&D sites in Shanghai and Suzhou, headquarters in Boston and an antibody discovery operations in Rotterdam.

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