Deals and Financings

CICC Capital closed a $229 million investment fund for biologics, with investments coming mainly from Chinese organizations inside and outside the biopharma industry (see story). In November of last year, CICC teamed up with AstraZeneca (AZN) to raise up to $1 billion over several years to back China life science startups. Shortly after, CICC announced its own fund, which has now closed slightly above its $213 million goal. Some of the money will go to companies making COVID-19 vaccines and therapies.

Cyagen Biosciences Suzhou closed a $41 million Series B financing that it will use to expand its genetically modified rodent business (see story). The round included investments from funds managed by CMS Capital, two GF Securities entities and Guanghua Investment. Founded in 2011, Cyagen claims to be the world's largest provider of custom-engineered mouse and rat models, offering transgenic, knockout, knock-in, CRISPR, and ES-cell based models. It also offers a comprehensive series of stem cell products for research use, including cell lines, media and differentiation kits.

Invetx of Boston, an animal health biologics company, announced a $15 million Series A financing led by Anterra of Boston and joined by two Invetx collaborators, AbCellear (HK: 2269) and WuXi Biologics (see story). AbCellular is a Vancouver-based company that discovers biotech candidates for partners. WuXi Biologics, a global biologic CDMO based in China, will collaborate with Invetx on development and manufacturing. Invetx plans to apply the breakthroughs of biotechnology to animal health. Its team, which combines staff with human biotech and animal health experience, expects the company will start its first clinical trial this year.

Trials and Approvals

Gilead Sciences (GILD) has started two Phase III clinical trials of remdesivir in adults diagnosed with COVID-19 (see story). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily in Asian countries. One study will randomize 400 patients with severe cases of COVID-19 to receive either five or 10 days of remdesivir. The second trial will randomize 600 patients with moderate disease to receive five or 10 days of remdesivir or standard of care alone.

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.

Coronavirus Outbreak

Harvard University and the Guangzhou Institute of Respiratory Health will collaborate to fight COVID-19 over the next five years in an effort funded for $115 million (see story). The funding was provided by China Evergrande Group. The researchers plan to elucidate the basic biology of the virus, which will be used to design therapeutics/vaccines, develop accurate rapid diagnostics and identify biomarkers. The effort will include Harvard Medical School researchers, led by Dean George Q. Daley, along with Dr. Nanshan Zhong of the Guangzhou Institute, a pulmonologist and epidemiologist who heads China's 2019n-CoV Expert Taskforce. Dr. Zhong discovered the SARS vaccine in 2003.

WuXi Biologics (HK: 2269) of Shanghai formed a collaboration with San Francisco's Vir Biotech (VIR) to develop mAbs that treat COVID-19 (see story). By examining people who survived the SARS infection, Vir used its technology to identify several mAbs that bind to SARS-CoV-2. It will test these molecules to see if they are effective treatments for COVID-19. WuXi, which will be in charge of developing and manufacturing any promising candidates, will have China rights to any approved treatments developed by the collaboration, while Vir will own rest-of-the-world commercialization rights.

Gilead Sciences has started two Phase III clinical trials of remdesivir in adults diagnosed with COVID-19 (see story). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily in Asian countries. One study will randomize 400 patients with severe cases of COVID-19 to receive either five or 10 days of remdesivir. The second trial will randomize 600 patients with moderate disease to receive five or 10 days of remdesivir or standard of care alone.

Ascletis Pharma (HK: 1672) of Hangzhou started a China trial of its combination of Ganovo® and Ritonavir as a COVID-19 treatment (see story). The trial, led by Dr. Hongyi Chen, the director of the Ninth Hospital of Nanchang, has already discharged three patients who met China standards for recovery from the infection. Ganovo®, Ascletis' oral protease inhibitor for hepatitis C virus, was approved for China use in June 2018. Ritonavir is a generic antiretroviral often used as part of combination treatments for HIV/AIDS.

Moderna (MRNA) shipped its first batch of mRNA-1273, a coronavirus vaccine, for a US Phase I clinical trial scheduled for April (see story). The company prepared the candidate in 42 days from initial sequencing of the virus, which it called an "indoor record." It described mRNA-1273 as an mRNA vaccine that encodes for a prefusion stabilized form of the Spike (S) protein. Moderna, a Cambridge, MA company developing messenger RNA (mRNA) therapeutics and vaccines, said manufacturing of the initial batch was underwritten by Oslo's Coalition for Epidemic Preparedness Innovations (CEPI).

Clover Biopharma of Chengdu entered into a research collaboration with GlaxoSmithKline (GSK) to test its COVID-19 vaccine candidate with GSK's pandemic adjuvant system (see story). Using its Trimer-Tag© technology, Clover has produced a S-Trimer subunit vaccine that resembles the native trimeric viral spike. It works by preventing entry of the virus into cells. Paired with an adjuvant, Clover's vaccine could be dosed at lower levels, allowing vaccinations for more people. GSK apparently has several adjuvants to offer. Clover claims to have one of the largest commercial-scale cGMP biomanufacturing capabilities in China.

AmCham Shanghai’s Healthcare Committee held a conference call to discuss the impact of the coronavirus (COVID-19) epidemic on China healthcare businesses (see story). Ten executives participated in the call, noting (among other issues) that distribution has been adversely affected, staff shortages are widespread, patient visits to hospitals are paradoxically lower, and revenues would be affected in the first quarter and possibly beyond. The discussion was moderated by ChinaBio's Greg Scott, the Chair of AmCham Shanghai’s Healthcare Committee, and participating companies included big pharmas, private hospitals, medical devices, diagnostics and medical supply companies. AmCham Shanghai printed a summary of the discussion, which ChinaBio® Today has reprinted with their permission.