publication date: Jun 19, 2021
author/source: Richard Daverman, PhD
Deals and Financings
Shanghai's Zai Lab (NSDQ: ZLAB; HK: 9688) announced a four-drug immunonocology deal with MacroGenics (NSDQ: MGNX) worth over $1.4 billion (see story). Both companies will contribute IP to the products. Zai Lab will have Asian and/or global rights for up to four CD3- or CD47-based bispecific molecules from Macrogenics, plus Zai will have rights to MacroGenics' DART® and TRIDENT® multi-specific platforms. In return, Zai will provide MacroGenics with rights to specific CD47 IP for select tumor targets. Zai will make an upfront payment of $25 million and an investment of $30 million in MacroGenics, plus up to $1.4 billion in milestone payments.
Shanghai's HutchMed (formerly Hutchison Chi-Med) (NSDQ/AIM: HCM is planning to raise $600 million in a Hong Kong IPO (see story). HutchMed has launched two novel oncology drugs in China, and it has eight more candidates in development. The Hong Kong IPO is the third listing for the company, following its first on London's AIM exchange and then NASDAQ in the US. The company has a $4.3 billion market cap on NASDAQ. Cornerstone investors have agreed to purchase $325 million (54%) of the offered shares. HutchMed will set the purchase price on June 23.
Beijing's LinkDoc Technology, an AI driven healthcare company based on cancer patient data, filed to IPO on the NASDAQ exchange (see story). LinkDoc has been supported by Alibaba. The company structures cancer patient data, which it acquires from 330 top tier China hospitals, to support precision medicine and personalized care. So far, it has longitudinal data on 2.5 million oncology patients and has helped 3.5 million patients. During its most recent 12 months, LinkDoc booked $157 million in revenue and claims to have the largest China market share in its field. LinkDoc may be seeking to raise as much as $500 million.
HiFiBiO, a US-China biotech, closed a $75 million Series D financing to support clinical trials of its two leading antibody therapies for oncology (see story). HiFiBiO uses its proprietary single-B-cell functional antibody discovery platform, CelliGO™, to discover candidates. In addition to developing its own drugs, the company has formed several strategic discovery partnerships with pharmas and biotechs. The D round was led by new investor Mirae Asset, a global company. HiFiBiO is headquartered in Cambridge, Mass. with operations in Shanghai, Hangzhou, Paris and Hong Kong.
HuiGene Therapeutics, a Shanghai gene-editing company, closed a $62 million Series B round for its gene editing tools and drug discovery programs based on gene editing for rare diseases (see story). Founded in 2018, HuiGene says it focuses on the CRISPER-Cas editing system, based on the Cas19 protein and targeting ssRNA to edit RNA. Because this technology does not change DNA, the company says it offers better safety than competing gene editing programs. It is carrying out R&D of gene therapies for neurodegenerative diseases, visual disorders, hearing disorders and other diseases.
OncoNano Medicine, located in a suburb of Dallas, Texas, raised $50 million for its novel pH-based cancer products in a B round led by Advantech Capital, a China cross border investor (see story). Proceeds of the round will be used to support the Phase II US/EU clinical trials for pegsitacianine, a real-time imaging agent used in intraoperative surgical resection of solid tumors, and to accelerate development of ONM-501, a novel immunoncology molecule. OncoNano was founded by Jinming Gao, PhD, who received his BS from Peking University and PhD from Harvard.
Trials and Approvals
Suzhou Innovent Bio (HK: 01801) has dosed the first person in a China Phase II trial of a dual agonist treatment for obesity (see story). IBI362 is a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) that features once-weekly dosing. Innovent acquired China rights to the candidate from Lilly (NYSE: LLY), its global partner. In 2015, the two companies signed a $1 billion deal for Innovent's PD-1 along with a two-way partnership of other assets. The trial will evaluate the change from baseline body weight at week 24.
ImmVira of Shenzhen has dosed the first patients in a China/US Phase II trial of its lead drug, an oncolytic virus product (see story). MVR-T3011 is a proprietary next-gen, genetically modified oncolytic herpes simplex virus (oHSV) delivered to the tumor. It was developed on a novel virus backbone design that was driven by ImmVira's insights into oncolytic viruses and recombinant gene expertise. In its Phase I trials, MVR-T3011 showed promising safety and efficacy. It will be tested in solid tumors and melanoma.
Sirnaomics, a Maryland-Suzhou RNAi company, will add a China Phase IIb trial for its lead drug to the US trial, already underway (see story). The company will test STP705, a siRNA (small interfering RNA) candidate that inhibits TGF-β1 and COX-2 gene expression in patients with skin squamous cell carcinoma (in situ). Sirnaomics uses its polypeptide nanoparticle (PNP)-enhanced technology to deliver the drug. The trial will enroll 100 adult patients with isSCC in five to seven clinical sites in the US and China. STP705 is also approved for testing in cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar.
Beijing Jacobio Pharma (HK: 1167) has dosed the first two patients in a Phase I/IIa trial of its SHP2 inhibitor in patients with solid tumor cancers (see story). One year ago, Jacobio out-licensed global rights for two small molecule SHP2 inhibitors to AbbVie (NYSE: ABBV). AbbVie made a $45 million upfront payment to Jacobio, and the start of the trial triggers a $20 million milestone payment from AbbVie. The SHP2 inhibitor, JAB-3312, will be administered in combination with PD-1 antibody pembrolizumab and MEK inhibitor binimetinib.
Asieris Pharma of Shanghai has been approved to start US trials of its MetAP2 inhibitor in patients with muscle invasive bladder cancer (MIBC) (see story). APL-1202 is an oral reversible MetAP2 inhibitor with anti-angiogenic, anti-tumor activities that is also believed to modulate the tumor immune microenvironment. The MetAP2 inhibitor will be administered along with BeiGene's approved anti-PD-1 drug, tislelizumab. Asieris plans to accelerate patient enrollment in the US while it also files a Clinical Trial Application in China.