publication date: Feb 26, 2022
author/source: Richard Daverman, PhD
Deals and Financings:
Zhongmei Huadong Pharma announced a $662 million agreement to develop two Kiniksa Pharma (NSDQ: KNSA) anti-inflammatory drug candidates in southeast Asia (ex-Japan) (see story). Kiniksa, a Boston area company, develops molecules that modulate immunological pathways. Huadong will have rights to Kiniksa’s Arcalyst®, a US approved treatment for recurrent pericarditis, and mavrilimumab, a clinical-stage therapy for rheumatoid arthritis. Huadong will pay $22 million upfront and be responsible for up to $640 million in milestones, plus royalties. Zhongmei Huadong is a division of Huadong Medicine (SHZ: 0963).
Odeon Therapeutics, a Hong Kong-Shanghai biopharma, has acquired China rights for two cancer therapies from Taiwan's OBI Pharma in a $200 million agreement (see story). Odeon will develop OBI-999, a novel antibody-drug conjugate, and OBI-833, a therapeutic cancer vaccine targeting the tumor antigen Globo H. Both candidates target a wide variety of solid tumor cancers. Odeon will make a $12 million upfront payment to OBI and pay up to $188 million in milestones, plus royalties. It will be responsible for all China development costs.
Beijing Lepu Biopharma (HK: 2157) completed a $116 million Hong Kong IPO and has traded only slightly lower, despite a generally skeptical global reception for pharmaceutical initial offerings recently (see story). The IPO was priced at HK$7.13 per share and the company's shares closed down one cent. Lepu is developing a portfolio of in-licensed oncology candidates, including antibodies, oncolytic viruses and combination therapies. Its lead products are PD-1 and PD-L1 candidates. Lepu Bio was started as the drug development division of Lepu Medical (SHZ: 300003), a medical device and equipment company.
Trials and Approvals
CANbridge (HK: 1228) of Beijing was approved to launch CAN108 under the Early and Pilot Implementation Policy in China's Boao Lecheng International Medical Tourism Pilot Zone (see story). CAN108 is a therapy for a rare liver disease, alagille syndrome, in patients who are one year old and above. One year ago, CANbridge acquired China rights to CAN108 from Mirum Pharma of the US to treat three rare liver disease indications: Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia. The Boao Lecheng Zone allows access to the drug before it is formally approved.
Simcere Pharma (HK: 2096) reported trilaciclib met its primary endpoint in a China Phase III study by decreasing the duration of neutropenia caused by chemotherapy (see story). Trilaciclib, a myeloprotective drug, was administered to patients with extensive-stage small cell lung cancer (ES-SCLC). Two years ago, Simcere in-licensed China rights to the drug from G1 Therapeutics (NSDQ: GTHX) of North Carolina in a $170 million agreement. The data will be included in a China NDA that will be reviewed under Priority Review rules. Simcere has also completed enrollment of trilaciclib trials for colorectal cancer and triple-negative breast cancer.
Shanghai's Stemirna Therapeutics plans to start a Phase III trial in Brazil of its mRNA vaccine for COVID-19 (see story). The unnamed vaccine has already completed a Phase I trial in Laos, and a Phase II test is underway. In June 2021, Stemirna raised $200 million in venture capital to expand its operations and underwrite development of the COVID vaccine. The company now has the capacity to produce 400 million vaccines per year. Stemirna is developing a portfolio of mRNA vaccines for more than 10 immunoncology and infectious disease indications.
Sirnaomics (HK: 2257) reported positive interim data from a US Phase II trial of STP705, a siRNA (small interfering RNA) drug, for patients with cutaneous basal cell carcinoma (see story). A total of 15 patients were enrolled, five in each of three cohorts of a dose escalation trial. In the two largest dose cohorts, three of the five patients experienced a complete response, while one in the lowest dose group also had a complete response. In general, patients showed an improved or stable cosmetic result with no significant cutaneous skin reactions. Sirnaomics is a Maryland-Suzhou siRNA company.
SyMap Medical, a Suzhou medical device company, has completed enrollment in a Phase I trial that tests its targeted renal denervation (RDN) device in patients with uncontrolled hypertension (see story). The company will use its catheter and mapping devices, SyMapCath I™ and SymPioneer ®™, to ablate renal sympathetic nerves. SyMap says its system maps renal nerves and provides real time feedback throughout the procedure. SyMap develops novel device therapies for major cardiovascular and pulmonary diseases including hypertension, heart failure, arrhythmia, asthma and early-stage lung cancer.
Innovent Biologics (HK: 01801) reported the first patient has been dosed in a China trial of its universal modular Claudin 18.2-targeting CAR-T cell product (see story). The study is an investigator-initiated clinical trial that will test IBI345 in patients with Claudin18.2-positive solid tumors. IBI345 is the first product to emerge from Innovent's $2 billion CAR-T collaboration with Roche, announced two years ago. Roche is doing the discovery work on CAR-T candidates, while Innovent is in charge of conducting clinical trials. Roche holds an option to in-license ex-China rights to the products.
Chengdu Revotek was approved to start a clinical trial of its autologous stem cell 3D bioprinting product for patients with Peripheral Artery Disease (PAD) (see story). Established in 2014, Revotek is developing REVOVAS, a universal bio-ink that allows scaffold-free bioprinting. The product itself is made up of Revotek's BioBricks®, a complex of cells and biomaterials that includes seed cells, a nuclear layer and a shell layer. The clinical study, which will be conducted in Chengdu's West China Hospital, is Revotek's first stem cell 3D bioprinting product to start human trials.