publication date: Mar 13, 2021
author/source: Richard Daverman, PhD
Deals and Financings
Shanghai Haohai Biological (HK: 6826; SHA: 688366) announced a $527 million agreement to develop Eirion Therapeutics' aesthetic dermatology products in China (see story). Haohai will pay $8 million upfront and make a $32 million investment in Eirion Series A Preferred Stock. It will also provide up to $43 million in development funds and be responsible for paying up to $444 million in sales milestones. Haohai is a well-established company that markets a large variety of products in China and global markets. Eirion is located in Woburn, MA.
Arctic Vision, a Shanghai ophthalmology company, completed a Series B financing of over $100 million led by Loyal Valley Capital (see story). The company has in-licensed greater China rights to three products, including a commercial-stage therapy for uveitic macular edema. In 2020, Arctic, which was incubated by Nan Fung Life Sciences and Pivotal BioVenture Partners China, completed a $32 million Series A funding. Arctic plans to use the latest proceeds for clinical development of its portfolio, plus building in-house R&D and increasing business development.
CASI Pharma (NSDQ: CASI), a Maryland-Beijing in-licensing company, acquired greater China rights to a cancer drug developed by Cleave Therapeutics in an $85 million agreement (see story). CB-5339 is a novel valosin-containing protein that inhibits p97. CASI and Cleave will develop CB-5339 in hematological malignancies and solid tumors. CASI will make a $5.5 million upfront payment and invest another $5.5 million in Cleave. It will also make up to $74 million in milestone payments, plus pay royalties.
Shanghai Delonix Bioworks, a startup biotech developing synthetic biology vaccines, closed a $14 million seed financing (see story). Delonix's synthetic biology and antigen discovery platforms are designed to offer rational design and programming of bacteria to create vaccines with better safety and efficacy. Its current lead programs target anti-microbial resistance. The seed round was led by Boehringer Ingelheim Venture Fund and IDG Capital. ZhenFund and an undisclosed investor also participated.
WuXi Biologics (HK: 2269) of Shanghai out-licensed a panel of mAbs to Exelixis aimed at a pre-clinically validated target (see story). Exelixis, a San Francisco area biotech, will use its technology to develop antibody-drug conjugate, bispecific and certain other novel tumor-targeting biologics applications, based on the mAb panel. Exelixis will make a "modest" upfront payment to WuXi Bio for the license and also be responsible for milestone payments and royalties on any products developed from the WuXi Bio research.
Shanghai's AlphaBio in-licensed Asia rights to Wugen's novel universal natural killer (NK) and T-cell therapies for cancer (see story). The agreement will include rights to manufacture universal off-the-shelf memory NK and CAR-T cells to treat solid tumors, T-cell malignancies, acute myeloid leukemia and multiple myeloma. The technology is designed to overcome the drawbacks of CAR-T drugs. Wugen acquired the technologies from Washington University of St. Louis, MO, where both entities are located. So far, Wugen remains a pre-clinical company.
I-Mab (NSDQ: IMAB), a Shanghai biopharma, formed two new collaborations, one with Complix of the EU and the other with Shanghai Affinity Biopharma, to discover differentiated drug candidates (see story). Complix's Cell Penetrating Alphabodies (CPAB) platform discovers candidates for intractable intracellular drug targets and masked antibodies for targeted tumor-site activation. Affinity focuses on finding candidates that become active only in the tumor micro environment. I-Mab said the new partners will be paid milestones, though it did not release further details of the agreements.
Yangzhou Uni-Bio (HK: 00690 formed a partnership with Singapore's DotBio to co-develop next-gen, best-in-class synthetic retinal therapeutics (see story). The companies will use the DotBody platform to generate multiple multi-valent and/or bi-specific stabilized and single-domain antibody candidates to discover therapies for conditions that cause visual impairment or blindness globally. Uni-Bio will be responsible for R&D of the candidates, clinical trials and commercialization. DotBio will receive upfront and research payments, plus milestones and royalties.
Suzhou Kintor Pharma (HK: 9939) reported that proxalutamide, its androgen receptor agonist, reduced mortality risk in newly hospitalized COVID-19 patients by 92% (3.7% vs 47.6%) (see story). It also shortened median hospital length stay by 9 days (median of 5 days vs 14 days). The results came from a investigator-led trial in Brazil that enrolled 588 patients and compared proxalutamide plus standard care to standard care alone. Kintor is developing proxalutamide for COVID-19, prostate cancer and breast cancer.
Trials and Approvals
China Oncology Focus (COF), a Lee's Pharm (HK: 950) affiliate, was approved to start a China Phase III trial of its anti-PD-L1 antibody as a first-line treatment for non-small cell lung cancer (see story). In 2014, COF in-licensed socazolimab from San Diego's Sorrento Therapeutics (NSDQ: SRNE). The China trial will be a multicenter, randomized, double blinded, parallel-group clinical combination test of socazolimab and chemotherapy. The Phase III approval was based on positive results from an earlier Phase Ib trial.
Jiangsu Alphamab Oncology (HK: 9966) was approved to start a US Phase II trial of its PD-L1/CTLA-4 bispecific antibody in patients with thymic carcinoma, a rare disease (see story). Alphamab said inoperable or metastatic thymic carcinoma, although rare, is highly aggressive with no approved treatments. In an Australian Phase I trial, KN046 showed a 75% disease response rate and 100% disease control rate in patients with the disease. Alphamab has already dosed the first thymic carcinoma patient in a pivotal China Phase II trial.
Shanghai Gannex Pharma, a subsidiary of Hangzhou's Ascletis (HK:1672), reported positive topline results from the China cohort of a Phase II trial for its nonalcoholic steatohepatitis (NASH) treatment (see story). The randomized, placebo-controlled trial tested ASC40, a novel oral, once-daily fatty acid synthase (FASN) inhibitor, developed by Sagimet Biosciences of San Mateo, CA. In 2019, Ascletis led a $25 million Series E financing of Sagimet in return for China rights to the candidate.
BeiGene (NSDQ: BGNE; HK: 06160) of Beijing started a global Phase I trial of BGB-15025, a novel hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with advanced solid tumor cancers (see story). BGB-15025 is a small molecule oral inhibitor of HPK1, a kinase downstream of the T cell receptor signaling pathway that is thought to play a key role in T cell activation. BeiGene will test BGB-15025 as a monotherapy and in combination with its approved anti-PD-1 antibody, tislelizumab.