Week In Review: Sino Biopharma Subsidiary Enters $307 Million Agreement For Rights To NASH Candidate

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Deals and Financings

Chia Tai-Tianqing Pharma, a subsidiary of Sino Biopharma (1177.HK), in-licensed Greater China rights to a therapy for non-alcoholic steatohepatitis from France’s Inventiva (IVA) in a $307 million deal (see story). Lanifibranor, Inventiva’s lead candidate, is an oral small molecule that induces anti-fibrotic, anti-inflammatory, and beneficial vascular and metabolic changes.

CTTQ will make a $12 million upfront payment and be responsible for up to $295 million in milestone payments, plus royalties. The company will either join the ongoing NATiV3 Phase III clinical trial of lanifibranor in NASH or run an independent study. 

CASI Pharma (CASI), a Maryland-Beijing biopharma, sold its 12% stake in its partner, Tianjin Juventas Biotech, for $34 million (see story). CASI and Juventas will continue to share commercialization rights to Juventas’ lead candidate, CNCT19, a CAR-T candidate that targets CD19 for B-cell lymphomas and leukemias.

In 2019, CASI acquired global rights to CNCT19 and a 20% stake in Juventas for $11.6 million. Since then, CASI agreed to split commercialization with Juventas rather than make a required payment to the company. Over the past year, CASI's market cap has dropped by 80%, and it has only $25 million in cash.

MilliporeSigma, a Merck KGaA subsidiary, opened a viral clearance laboratory in Shanghai as part of the first building phase of its new $29 million China Biologics Testing Center (see story). The 53,000 square foot center is MilliporeSigma’s first such facility in China.

The VC laboratory allows customers to conduct viral clearance studies in China from pre-clinical development to commercialization, a service that is increasing at a double-digit rate in China. The facility’s second phase, which is expected to open in late 2023, will offer cell line characterization and lot release testing services. 

Arnatar Biomedical, a Shanghai-San Diego startup, raised nearly $15 million in a Seed Round led by Shanghai’s Apricot Investment (see story). The company is developing its advanced antisense technology program to modulate the expression of target RNA with programable potency, onset, and duration of action using RNAi and antisense oligonucleotide (ASOs) platforms.

Arnatar aims to treat diseases in both liver and extra-hepatic organs for both common and rare disease indications. The company will use the Seed funding to build a unique antisense nucleic acid bidirectional regulation technology platform and to advance the development of several novel candidates. 

Immuno Cure, a Hong Kong biotech focused on DNA vaccines and immunotherapies, acquired 92.6% of Shanghai Teresa Healthcare, an electroporation company (see story). Teresa’s EP device delivers brief electrical pulses to improve penetration of DNA vaccines through cell membranes to increase gene expression and immune responses.

Immuno Cure already uses Teresa’s technology to deliver its two PD-1-Enhanced DNA vaccines, currently in clinical trials. Immuno Cure will pay for most of the transaction in cash. Teresa shareholders will also receive 1.5% equity in Immuno Cure, and the inventor of Teresa's EP technology, Professor Yuhong Xu, will continue to own her 7.4% stake in Teresa. 

Beijing Biocytogen Pharma (2315.HK) formed a strategic collaboration with Guangzhou FineImmune Biotech to co-develop cell-based therapeutic drugs targeting intracellular tumor-associated antigens (see story). Initially, Biocytogen will use its proprietary TCR-mimic antibody platform to discover antibody sequences that will be further developed using FineImmune’s proprietary cell therapy platform.

Because most tumor antigens are intracellular, Biocytogen has developed its TCR-mimic platform to discover antibodies to these targets, which can be developed into T cell engagers, bispecific/multispecific antibodies, and CAR-T therapies.

Trials and Approvals

RemeGen (9995.HK), a Yantai biotech, reported positive preliminary results from a confirmatory China Phase III trial of Teliacicept, a therapy for systemic lupus erythematosus (SLE) (see story). Teliacicept, a novel fusion protein, is being tested in multiple autoimmune diseases.

The candidate targets two cell-signaling molecules that are critical for B-lymphocyte development: B-cell lymphocyte stimulator (BLyS), and a proliferation inducing ligand (APRIL) that reduces B-cell mediated autoimmune responses. In March 2021, Teliacicept was granted conditional marketing approval in China for SLE. 

Belite Bio (BLTE), a San Diego subsidiary of Taiwan’s Lin Bioscience, has been approved to start China Phase III trials of its therapy for Stargardt Disease, the most commonly inherited retinal dystrophy (see story). LBS-008 is a novel oral therapy designed as an early intervention to prevent STGD1.

The global Phase III trial, which has already started in the US, the EU, Taiwan, and Australia, will test the safety and efficacy of LBS-008 in adolescent STGD1 patients. Belite’s portfolio targets currently untreatable eye diseases along with metabolic disease therapies. 

Frontera Therapeutics, a US-China gene therapy company, announced its lead candidate was approved to start China trials, targeting inherited retinal degenerations with a RPE65 mutation, a rare disease (see story).

FT-001 is an AAV gene therapy candidate administered by a one-time injection into the subretinal space of the eye to deliver a functional copy of the human RPE65 gene to the nuclei of retinal cells. The injection causes the expression of functional RPE65 proteins, improving a patient’s vision. In April, FT-001 was approved to start US trials. Frontera is headquartered in the Boston area with operations also in Suzhou. 

Chengdu Keymed Biosciences (2162.HK) announced that its Claudin 18.2-targeted ADC was granted Breakthrough Therapy Designation to treat advanced gastric and gastroesophageal junction cancer in China (see story). CMG901 is aimed at Claudin 18.2-expressing solid tumors.

Earlier this year, CMG901 was awarded Fast Track Designation in the US for a similar indication following Keymed’s Phase I trial of the candidate, which assessed the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMG901. Keymed currently has nine clinical-stage projects including three bi-specific candidates and one antibody. 

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