Deals and Financings
Innovent Biologics of Suzhou plans to raise $422 million in its Hong Kong IPO at a $2 billion valuation, according to multiple media reports. The company, formed in 2011, struck a major $1 billion collaboration with Lilly (NYSE:LLY) in 2015. It has a pipeline of 17 candidates (a combination of novel drugs and biosimilars), nine of them in clinical trials and four in Phase III tests. The underwriters will price the shares on October 23, with trading expected to start October 31.
HiFiBiO Therapeutics, a Boston, Paris and Shanghai company, acquired H-Immune, a French biotech with an in vitro immunization-based fully human antibody generation platform (IVI). HiFiBiO has developed its own immunotherapy discovery platform based on single-B-cell screening. It said H-Immune would complement its discovery efforts by identifying first-in-class targets for multiple types of immune cells. H-Immune brings with it a pipeline of novel early stage cancer candidates. Financial details of the acquisition were not disclosed.
iCell Gene Therapeutics, a New York-Zhongshan biopharma, formed a research partnership for its CD19 CAR-T therapy with LineaRx, a subsidiary of Applied DNA Sciences (NASDAQ:APDN) (see story). LineaRx is developing a non-viral, plasmid-free (NVPF) CAR-T cell manufacturing platform, which it intends to make available to CAR-T developers. The company will transform iCell's CD-19 candidate into LinCART19, a non-viral, plasmid free anti-CD19 CAR-T drug candidate. Financial details of the partnership were not disclosed.
Genecast Biotechnology of Beijing acquired exclusive China rights to the Tissue of Origin (TOO) test for difficult-to-identify tumors developed by Cancer Genetics (NASDAQ:CGIX) of New Jersey (see story). TOO, a microarray-based gene expression test, analyzes a tumor's genomic information to identify its origin, which helps to classify metastatic, poorly differentiated, or undifferentiated cancers. Founded in 2014, Genecast has developed circulating tumor DNA (ctDNA) detection technology that provides individualized cancer diagnoses. Last year, the company raised $18 million in a Series B round led by Tshinghua Holdings.
Trials and Approvals
Suzhou's Alphamab Oncology received US approval of an IND for KN026, its proprietary HER2 antibody. KN026, the company's lead drug, binds to two separate epitopes on HER2. The candidate started a Phase I China trial earlier this year, and Alphamab said the China trial is proceeding as expected. The company intends to test KN026 in patients with breast, gastric and lung cancer that over-express HER2. One week ago, Alphamab started an initial clinical trial in Australia of its humanized PD-L1/CTLA-4 bispecific antibody.
CStone Pharmaceuticals of Suzhou announced US approval of its IND for CS1001, a novel PD-L1 candidate. CStone said the trial approval was the company's first in the US. Developed using Ligand's OMT transgenic animal platform, CS1001 is a fully human, full-length anti-PD-L1 monoclonal antibody, designed to mirror a natural G-type immune globulin 4 (IgG4) human antibody. Because of its design, CStone believes CS1001 will reduce the risk of immunogenicity and potential toxicities. The company started China trials of CS1001 one year ago.
Ascletis Pharma (HK:1672) of Hangzhou reported that its second hepatitis C treatment, ravidasvir, has been included in China's list of Proposed Priority Review drugs. Ascletis has submitted an NDA for ravidasvir, a China Category 1 candidate, as part of a two-drug combination treatment, along with already-approved Ganovo®. The combination, an all-oral interferon-free regimen, produced a 99% cure rate in HCV patients after only 12 weeks of treatment in a China Phase II/III trial. Ascletis launched Ganovo three months ago, soon after approval.
Singlera Genomics, a San Diego-Shanghai diagnostics company, reported its ColonES blood-based colorectal cancer diagnostic showed high sensitivity and specificity in an early China test. In a 1,243 patient study, the ColonES device produced sensitivities of 93% for CRC and 88% for advanced adenomas, with a specificity of 99%. The device is aimed at early diagnosis. Its targeted next-gen sequencing is based on methylation haplotype signatures of circulating tumor methylated DNA (ctmDNA) in blood plasma.
Hutchison China MediTech (Chi-Med) [AIM:HCM] (NASDAQ:HCM) started a China Phase I trial of its novel spleen tyrosine kinase (Syk) inhibitor as a first line treatment in elderly patients with acute myeloid leukemia (see story). The molecule, HMPL-523, will be administered in combination with an approved nucleoside metabolic inhibitor. In September, Chi-Med's lead drug, Elunate® (fruquintinib), was approved in China as a third-line treatment for metastatic colorectal cancer, the first China-developed drug approved for a cancer indication.
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