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Deals and Financings
In a blockbuster agreement, Guangzhou’s Akeso (OTCPK:AKESF) out-licensed ex-China rights to its bispecific PD-1/VEGF candidate in a deal worth up to $5 billion (see story). Summit Therapeutics (SMMT) of Menlo Park, CA will pay $500 million upfront and up to $4.5 billion in milestones, plus single digit royalties for rights to develop ivonescimab in the US, Canada, Europe and Japan. Akeso, which is developing ivonescimab in Phase III trials for various lung cancer indications, believes its candidate is the most advanced PD-1/VEGF candidate in the world.
Chengdu WestGene Biopharma completed a $21 million Series A Round to advance its portfolio of nearly 20 mRNA candidates, including its lead COVID-19 vaccine, which is in IND stage (see story). The company was founded in mid-2021 by a team of academicians from West China Hospital of Sichuan University. WestGene’s mRNA pipeline consists of mRNA drugs, vaccine adjuvants and novel adjuvants including anti-infection vaccines, tumor vaccines, anti-aging vaccines, obesity treatments, pulmonary fibrosis treatments and gene editing for rare/genetic diseases.
Suzhou GenAssist Therapeutics raised “millions of dollars” in an A round to support its gene editing drugs that target neuromuscular diseases (see story). Founded in 2020, the company owns global rights to TAM BE (Targeted AID-based Mutagenesis) base editing technology, which was discovered by one of its Founders, Xing Chang, PhD, who now serves as the company’s CSO. GenAssist is developing therapies for Duchenne Muscular Dystrophy (DMD) and Spinal Muscular Atrophy (SMA). The Series A financing was led by AstraZeneca-CCIG and included BV Baidu Ventures and Sequoia Capital.
Genscript Biotech (OTCPK:GNNSF), a US-China life science research tools and services company, is partnering with Allozymes of Singapore to build a synthetic biology library (see story). The two companies will combine their technologies to accelerate the enzyme discovery and development process. GenScript will be in charge of building the mutant libraries, while Allozymes will provide its fast, ultra-high-throughput screening service for applications in pharmaceuticals, cosmetics, and food and beverage.
Trials and Approvals
Two China biopharmas, Sinocelltech Group and Clover Biopharma announced that their recombinant COVID-19 products were approved to launch under emergency rules (see story). Shenzhou Cell Engineering, a unit of Beijing’s Sinocelltech, has developed a vaccine that showed efficacy against omicron strains BA.1 and BA.5 with potential use against future variants as well. Clover tested its candidate as an effective booster for people who had received two doses of an inactivated vaccine. At one point in 2021, GAVI, the UN vaccine alliance, had signed up to buy 414 million doses of the Clover vaccine booster.
SciClone Pharma’s (OTCPK:SCCPF) therapy for high-risk neuroblastoma was approved for use in China under conditional rules (see story). Danyelza is a humanized mAb that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. The drug was developed by New York’s Y-mAbs Therapeutics (YMAB) for pediatric patients one year of age and older along with adult patients who have relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. Two years ago, SciClone announced a $120 million agreement to acquire China rights for two neuroblastoma therapies from Y-mAbs.
Shanghai Ark Biopharma reported that its China NDA for a respiratory syncytial virus (RSV) infection therapy was accepted for review and granted Priority Review (see story). Ziresovir is a novel small-molecule RSV fusion (F) protein inhibitor that works by preventing viral entry into human cells. The molecule also suppresses virus transmission by blocking cell fusion via syncytia, a common problem during RSV infection. Ziresovir is a Class I novel drug, the first RSV therapy to complete a global Phase III clinical study and the first non-oncology drug granted Priority Review in China. It is Ark’s lead candidate.
Suzhou Innovent (OTCPK:IVBIY) started China trials of a PDE4 inhibitor that Innovent in-licensed from Denmark’s Union Therapeutics (see story). Orismilast (IBI353) is a next-gen PDE4 inhibitor with high potency for the PDE4 subtypes linked to inflammation that Union is currently developing as an oral therapy for psoriasis, atopic detritus and a third skin disease, HS. One year ago, Innovent acquired greater China rights to the candidate in a $267 million agreement ($20 million upfront) plus royalties.
Ascletis Pharma (OTCPK:ASCLF) will start China trials of its oral inhibitor that targets 3-chymotrypsin like protease (3CLpro) to treat COVID-19 (see story). The company said ASC11 showed higher potency in preclinical tests against SARS-CoV2 than Pfizer’s Paxlovid (nirmatrelvir), and it is effective against prevalent Omicron variants including BA.1 and BA.5. The Phase I trial will establish the best dose for Phase II studies plus determine whether ASC11 will require a ritonavir booster. Ascletis discovered ASC11 in-house using proprietary technologies including molecular docking.
Shanghai Hexaell Biotech was cleared to start China clinical trials of HepaCure, a novel device-drug combination aimed at restoring liver function in patients with acute-on-chronic liver failure (see story). The bioartificial liver support system is a promising alternative for partial liver functions such as metabolic detoxification and protein synthesis. HepaCure’s hiHeps cell therapy is a cell transdifferentiation technology that directly converts human fibroblasts derived from umbilical cords to hepatocyte like cells with liver cell functions. The drug-device has shown positive results in investigator-led studies.
Disclosure: none.
Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.
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