publication date: Nov 6, 2021
author/source: Richard Daverman, PhD
Deals and Financings
LianBio (NSDQ: LIAN), a Princeton-Shanghai company, raised $325 million in its NASDAQ IPO at a market capitalization of $1.9 billion to support its drug in-licensings for China (see story). LianBio was formed by Perceptive Advisors as a way for the US company to participate in China's market. It has access to the China rights for Perceptive's portfolio of life science companies, though it doesn't have a lock on those rights. Perceptive seeded the company originally, which then raised $310 million from outside investors soon after breaking out of stealth mode one year ago.
Beijing Clover Biopharma (HK: 1297) completed a $260 million IPO in Hong Kong. The company will use the proceeds to continue development of Trimer-Tag™ vaccines, Trimer-Tag™ oncology candidates and Fc-fusion candidates (see story). Its most advanced product is a S-Trimer-Tag COVID-19 vaccine. The company plans to file for emergency use approval of the vaccine in China, the EU and with WHO in Q4 of 2021. It expects conditional approvals by the middle of 2022. Clover expects to supply up to 414 million doses of its COVID-19 vaccine through COVAX.
In June of this year, Beijing BeiGene (NSDQ: BGNE; HK: 06160) announced a global collaboration to develop and commercialize four natural killer-based cell therapies discovered by San Diego's Shoreline Biosciences (see story). BeiGene made a $45 million upfront payment and will be responsible for (unspecified) milestones, plus additional R&D funding and royalties. Shoreline is developing off-the-shelf, standardized and targeted natural killer and macrophage cellular immunotherapies, which it derives from induced pluripotent stem cells (iPSC), primarily for cancer. Today, Shoreline closed a $140 million B round led by Ally Bridge Group.
Chengdu's HitGen (SHA: 688222) formed a strategic alliance with Cambridge Molecular of the UK to offer CM's DeepDELve 2 pipeline that identifies potential ligands for drug targets (see story). HitGen's drug discovery platform for small molecules and nucleic acid drugs is based on DNA encoded chemical libraries (DELs), fragment-based drug discovery (FBDD) and structure-based drug design (SBDD) technologies. It currently contains over 1 trillion novel drug-like small molecules and macrocyclic compounds. CM's DeepDELve 2 analyzes selected DEL candidates to identify ligands that are appropriate and commercially available.
A HitGen subsidiary (SHA: 688222) has formed a new company to discover small molecule inhibitors for undisclosed oncology targets (see story). The HitGen subsidiary, Vernalis Research of Cambridge UK, joined with Copenhagen's Hannibal Innovation to create Dania Therapeutics. Dania will develop novel drug candidates based on innovative science from the labs of Professor Kristian Helin at the University of Copenhagen and Dr. Karl Agger. Dr Helin's research has centered on cell cycle control, epigenetics and cancer. Vernalis will earn equity in Dania in return for its services. HitCen is based in Chengdu.
CANbridge, a Beijing rare disease biopharma, announced a two-year sponsored gene therapy research agreement for Duchenne muscular dystrophy, a rare childhood neuromuscular disease (see story). CANbridge will fund research at the University of Washington in Seattle that will be directed by Jeffrey Chamberlain, PhD, professor in the Departments of Neurology, Medicine and Biochemistry. Dr. Chamberlain is well-known for his research into the use of gene therapies for muscle diseases. In particular, his lab has been studying muscular dystrophy mechanisms, including dystrophin structure, and gene therapy approaches.
Trials and Approvals
Shanghai Junshi Bio (HK: 1877; SSE: 688180) and its US partner Coherus Bio (NSDQ: CHRS) reported the US FDA will review their BLA for Junshi's PD-1 (see story). Toripalimab was administered in combination with gemcitabine and cisplatin as a first-line treatment for advanced recurrent or metastatic nasopharyngeal carcinoma, Toripalimab was also tested as a monotherapy as a second-line therapy for recurrent or metastatic NPC after platinum-based chemotherapy. Earlier this year, Coherus in-licensed US rights to toripalimab in a $1.1 billion agreement.
TransThera Sciences (Nanjing) has been granted US Fast Track Designation for its Phase II Cholangiocarcinoma (CCA) therapy (see story). TT-00420 is a spectrum selective kinase inhibitor that has shown high potency against a variety of clinically identified FGFR2 mutations. The FTD is based on positive clinical results from a Phase I study of TT-00420. In 2019, TT-00420 was granted US Orphan Drug Designation for Cholangiocarcinoma. TransThera develops small molecule drug therapies for oncology, inflammatory and cardiovascular diseases.
Suzhou Kintor Pharma (HK: 9939) has begun a Phase Ib/II trial of its ALK-1 antibody in combination with Alphamab's PD-L1/CTLA-4 bispecific antibody (see story). The Taiwan trial will enroll patients with solid tumors, especially hepatocellular carcinoma (HCC). The study will focus on the safety, tolerability, pharmacokinetics and antitumor activity of the ALK-1 antibody, a potential first-in-class antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis. In 2018, Kintor acquired global rights to the ALK-1 antibody from Pfizer (NYSE: PFE).
Shanghai Antengene (HK: 6996) reported its IND was approved to start US trials of a bi-specific mAb for metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL) (see story). ATG-101 is a novel bispecific antibody aimed at blocking the binding of immunosuppressive PD-L1/PD-1 while also inducing 4-1BB stimulation. In pre-clinical animal models ATG-101 demonstrated anti-tumor activity in animal models of tumors that progressed on anti-PD-1/L1 treatment. Antengene said ATG-101 is its first in-house developed novel candidate to start clinical trials.