Week In Review: Structure Stages $161 Million US IPO For AI/Structure-Based Drug Development

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Deals and Financings

Structure Therapeutics (GPCR) raised $161 million in a successful US IPO to support development of its oral therapeutics portfolio aimed at chronic metabolic and pulmonary diseases (see story). The company, formerly known as ShouTi, uses advanced computational and structure-based technology for R&D of its products, which are designed to overcome limitations of current biologic and peptide drugs.

Schrödinger (SDGR), a New York City company that uses advanced molecule simulations to discover drugs, is a co-founder of Structure Therapeutics. The IPO priced at the top of its range and traded 73% higher. Structure is based in Shanghai and San Francisco. 

CS Pharmaceuticals, a London company with offices in Beijing and Shanghai, entered a $336 million agreement for greater China rights to a PRS inhibitor, Bersiporocin, for Idiopathic Pulmonary Fibrosis (IPF) from South Korea’s Daewoong (see story).

Daewoong will receive $76 million in upfront and development milestone payments, plus double-digit royalties on sales. CS, a company that brings rare disease and ophthalmology products to China, may extend the indication for Bersiporocin to other respiratory and fibrotic conditions. 

NeuShen Therapeutics, a Shanghai-Boston CNS biotech, announced a three-year Sponsored Research Agreement with UMass Chan Medical School to develop a gene therapy for amyotrophic lateral sclerosis (ALS) (see story). NeuShen is developing CNS therapies using its dual AAV-based gene and small molecule platforms.

The program will be under the direction of Dr. Guangping Gao, PhD, a well-known gene therapy researcher who has played an important role in discovering and characterizing a new family of adeno-associated virus (AAV) serotypes, which has advanced gene therapy research for currently untreatable human diseases. 

Shanghai CARsgen Therapeutics and Roche formed a collaboration to test a combination of CARsgen’s Claudin18.2-targeting mAb and Roche’s atezolizumab, a PD-L1 checkpoint inhibitor, in patients with gastric cancer (see story). Most of CARgen’s focus is on CAR-T candidates (including a Claudin18.2 CAR-T), but it is also developing a single mAb candidate -- AB011.

Roche will be responsible for the co-funded study, using its Morpheus Platform, a collection of Phase Ib/II clinical trials designed to address cancers with high unmet needs. The two companies will co-share the costs of the AB011 treatment arms. 

Hangzhou AnHeart Therapeutics, a precision medicine company, formed a collaboration to use two assays developed by Palo Alto’s Guardant Health (GH) as companion diagnostics to its ROS1 inhibitor (see story). AnHeart is conducting a global Phase II trial of taletrectinib in the US and EU. The trial is aimed at non-small cell lung cancer patients who are ROS1 positive – about 2% of the NSCLC population.

Patients will be screened by Guardant360® CDx, an approved circulating blood DNA test, and the tissue-based Guardant360 TissueNext™ assay. In mid-2021, AnHeart out-licensed China rights for the ROS1 candidate to Innovent (IVBXF) for $189 million in upfront and milestone payments. 

Trials and Approvals

Wuhan’s Nervtex announced China approval of its artificial intelligence-based system that analyzes the motor symptoms of Parkinson's disease (see story). The MoDAS (Movement Dysfunction Assessment Software) device is a First-in-Class product.

Using a smart phone to record a patient’s movement, the MoDAS device provides doctors with objective and quantitative information for clinical decision support. Nervtex says the device is the first video-based AI-powered medical device that is able to assess movement disorders. 

Beijing Help Therapeutics was approved to start China clinical trials of HiCM-188, a universal allogeneic iPS cell-derived cardiomyocyte therapy in patients with ischemic heart failure (see story). It has already begun similar trials in Japan and Germany. The therapy consists of highly purified allogeneic cardiac muscle cells that are reprogrammed from human iPS cells.

The transplanted cardiomyocytes are expected to couple electrically with the patient's myocardium to cause remuscularization. Founded in 2016, Help claims to be China’s first company to use induced pluripotent stem cells and mesenchymal stem cell technology to develop universal cell therapies for unmet needs in degenerative diseases. 

Gracell Biotech (GRCL), a Shanghai cell therapy company, was approved to start a US Phase Ib/II trial of its lead candidate in patients with relapsed/refractory multiple myeloma (RRMM) (see story).

GC012F is an autologous CAR-T therapeutic candidate that targets B cell maturation antigen (BCMA) and CD19. It is produced on Gracell's proprietary FasTCAR next-day manufacturing platform. In long-term investigator-initiated studies, GC012F showed a 100% minimal residual disease (MRD) negativity rate in all RRMM patients. 

HuidaGene Therapeutics, a Shanghai-New Jersey gene editing company, was cleared to start a US Phase I trial of a CRISPR-based genomic medicine for patients with inherited RPE65 retinal dystrophies (see story). RPE65 retinal dystrophies are a group of genetic diseases caused by mutations in the RPE65 gene that affect the retina, causing blindness in 100% of patients by age 40.

The company believes its optimized CRSPR/Cas-based RNA editing tools are smaller, more efficient, and more specific than the competition, allowing lower dosing of its AAV vectors. It expects the candidate will be a one-time therapy for RPE65 retinal disorders. 

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