Coronavirus Pandemic

Tianjin CanSinoBIO (HK: 6185) published positive results from a China Phase I trial of its COVID-19 vaccine in the prestigious British journal, The Lancet (see story). In the study, the Ad5 vectored COVID-19 vaccine was immunogenic at 28 days post-vaccination with only mild or moderate side effects. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and specific T-cell responses were noted from day 14 post-vaccination. The vaccine, which was based on CanSino's approved Ebola vaccine, has already started a Phase II trial.

Moderna (NSDQ: MRNA), a Boston-area mRNA company, reported positive early data from a Phase I trial of its coronavirus vaccine (see story). After two doses, the first four patients in each of two mRNA-1273 arms showed blood levels of binding antibodies at levels similar to patients who have recovered from COVID-19. There were no major side-effect problems in the two levels, though Moderna did stop testing a higher dosing cohort. Moderna said it expects to start a Phase III trial as soon as July.

Sinovac Biotech (NSDQ: SVA) of Beijing raised $15 million to conduct Phase II trials of its COVID-19 vaccine (see story). Advantech Capital and Vivo Capital have each advanced $7.5 million to Sinovac Research and Development, a Sinovac subsidiary, via a convertible loan that either bears interest or converts into a 7.5% share of Sinovac R&D . Sinovac began a Phase I trial of CoronaVac in April, followed by a larger Phase II immunogenicity and safety trial in May. The company has started building a vaccine production facility capable of producing 100 million doses of CoronaVac annually.

CanSino Biologics (HK: 6185) of Tianjin and Canada's Precision NanoSystems announced a partnership to develop a mRNA lipid nanoparticle (mRNA-LNP) vaccine against COVID-19 (see story). PNI will use its technology to discover the vaccine while CanSino will be responsible for development and commercialization. CanSino will have rights to the vaccine in Asia (except Japan). The agreement includes undisclosed payments and royalties. The molecule will be the second vaccine CanSino is developing for COVID-19: its adenovirus vector COVID-19 vaccine has already started China Phase II trials.

Deals and Financings

Peijia Medical (HK: 09996) of Suzhou completed a $302 million Hong Kong IPO for its medical device business (see story). Peijia has developed a line of transcatheter heart valves and neurointerventional surgery devices for stroke. The company sold 25% of its expanded share base in the offering at a market capitalization of $1.2 billion. The shares available for public investors were 1,183 times oversubscribed, showing strong interest. The stock is trading about 8% higher above the offering price.

Zentalis Pharma (NSDQ: ZNTL) of the US formed a Shanghai subsidiary, Zentera Therapeutics, with $20 million of capital to develop three Zentalis oncology candidates in China (see story). Zentalis, which recently raised $165 million in a NASDAQ IPO, develops small molecule candidates that target cancer pathways. The Zentera funding was led by Tybourne Capital Management and joined by OrbiMed Asia. Zentalis is headquartered in New York City with labs in San Diego. Anthony Sun, MD, CEO of Zentalis, will also serve as CEO of Zentera.

Qingdao Primedicine Pharma in-licensed greater China rights to a novel drug that lowers damage following a heart attack from Primary Peptides of Vancouver, Canada (see story). A clinical-stage company, Primary Peptides develops novel products based on disrupting specific protein-protein interactions. Previously, it has out-licensed China rights for other candidates to Simcere and Yabao Pharma. Primedicine is developing first-in-class treatments for addiction, Alzheimer’s disease, stroke, depression and other indications. Financial terms of the agreement were not disclosed.

Innovent (HK: 01801), a Suzhou biotech, announced a strategic collaboration with the MD Anderson Cancer Center of Houston to conduct US trials of its approved anti-PD-1 checkpoint inhibitor, Tyvyt® in patients with very rare cancers (see story). Innovent and MD Anderson will co-fund the trials, which will be conducted by MD Anderson. Upon commercialization for the rare forms of cancer, Innovent will make royalty payments to
MD Anderson, which will use the proceeds to fund care for uninsured patients.

Trials and Approvals

Apollomics, a US-China biopharma, will start a global Phase II trial of its c-MET inhibitor in two indications: non-small cell lung cancer (NSCLC) patients with a mutation that leads to MET exon 14 skipping, and patients who have any tumor type with MET amplification or fusions (see story). In its Phase I trial, APL-101 was found to be safe in NSCLC and GBM patients with c-MET dysregulations. APL-101 is being developed in China by Beijing Pearl Biotechnology, Apollomics' China partner.

I-Mab (NSDQ: IMAB), a Shanghai biopharma, announced approval to start a China Phase II trial of a novel long-acting recombinant human interleukin-7 (rhIL-7) in lymphopenic patients with glioblastoma multiforme (GBM) (see story). In late 2017, I-Mab in-licensed China rights to TJ107/HyLeukin-7™ (efineptakin alfa) from Korea's Genexine (KOSDAQ: 095700) in a deal worth up to $548 million. An immunotherapy, HyLeukin is based on interleukin-7, a factor in the proliferation and homeostasis of T cells.

Zai Lab (NSDQ: ZLAB) of Shanghai dosed the first China patient in a global Phase III trial of a novel treatment for carbapenem-resistant Acinetobacter baumannii infections (see story). Two years ago, Zai in-licensed Asia rights to durlobactam from Entasis Therapeutics in a $100 million agreement. Zai is directing the China arm of Entasis' global Phase III trial of a sulbactam-durlobactam (SUL-DUR) fixed-dose combination in patients with pneumonia and bloodstream infections caused by carbapenem-resistant A. baumannii.

CARsgen Therapeutics, a Shanghai CAR-T company, was approved to start US trials of a novel CT041 humanized anti-claudin18.2 autologous CAR-T therapy (see story). The first-in-class drug will be tested in patients with claudin18.2-positive gastric or pancreatic adenocarcinomas. CARsgen plans to start the US open label, multicenter Phase Ib clinical trial of CT041 in Q3 2020. Previously, the candidate was tested in an investigator-led China trial led by Professor Lin Shen at Beijing Cancer Hospital, Peking University.

Disclosure: none.