Week In Review: Livzon In-Licenses GERD Therapy In $127 Million Agreement

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Dna, Genetic Material, Helix, Proteins, Biology

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Deals and Financings

Livzon Pharmaceutical Group, a diversified Guangdong pharma, entered a $127.5 million agreement for China rights to a gastroesophageal reflux disease (GERD) therapy from Onconic Therapeutics of Korea (see story). Onconic will receive an upfront payment of $15 million and up to $112.5 million in milestones plus royalties on sales.

Zastaprazan is a P-CAB (potassium-competitive acid-blocking) candidate, a class of drugs that is replacing existing PPIs (proton pump inhibitors) for peptic ulcer disease, including GERD. Livzon will have exclusive rights to Zastaprazan in China, Taiwan, Hong Kong, and Macau. 

Gracell Biotech (GRCL), a Shanghai cell/gene therapy company, announced in a press release that it had entered an unusual, non-exclusive global deal with Seagen Inc. (SGEN) to conduct pre-clinical research on the company's cell therapy products and acquire (non-exclusive) rights to five of Seagen’s cell therapies (see story).

The press release was dated March 8, 2023, before Seagen announced it would be acquired by Pfizer (PFE) for $43 billion. Neither Gracell nor Seagen have issued a press release explaining the agreement, though Seagen has the excuse of a $43 billion sale that required its full attention. 

Shanghai Ark Biopharma renewed its co-development collaboration with Calibr, a division of San Diego’s Scripps Research, to develop AK0705, a potential first-in-class drug targeting an enzyme involved in respiratory inflammation (see story).

ArkBio will lead the preclinical development of the enzyme, with Calibr contributing its expertise. AK0705 is being developed to treat a broad spectrum of respiratory diseases, including chronic obstructive pulmonary disease. Ark, which specializes in pediatric and respiratory diseases, expects to start clinical studies of AK0705 in 2024. 

In January, Shanghai Base Biotech, a base editing company, completed an A1 financing that brought in tens of millions of dollars, according to a release (see story). BaseBio develops base editing tools and off-the-shelf Super-NK cell therapies. The financing will be used to advance the company's candidates in its base editing therapeutic pipeline, including eight general-purpose off-the-shelf Super-NK products and in vivo editing therapies.

The A1 round was led by Hong Kong's Great Eagle VC, BV Baidu Ventures, Xinxi Capital, Guangda Huitong, UK SPARK VC, and other investors. Previously, Base Biotech raised $14 million in Angel funding. 

Trials and Approvals

Shanghai Everest Medicines announced Xerava® (eravacycline) was approved in China to treat complicated intra-abdominal infections in adult patients (see story). Xerava, which will be Everest’s first commercialized drug, is a novel parenteral broad-spectrum, fluorocycline antibiotic of the tetracycline class.

It has shown broad in vitro activity against Gram-negative and Gram-positive pathogens with multidrug resistance. In 2018, Everest in-licensed Greater China rights for Xerava from Boston’s Tetraphase Pharma in a $43 million agreement. Xerava is already approved in the US, EU, and other parts of the world.

Shanghai Everest Medicines also reported its in-licensed kidney drug, Nefecon, met its Phase III endpoints in patients with primary IgA nephropathy (IgAN) (see story). In 2019, Everest acquired China rights to Nefecon from Sweden’s Calliditas Therapeutics (CALT) in an agreement worth up to $121 million.

Calliditas conducted the global Phase III trial, which enrolled 364 patients randomized 1:1 for Nefecon and placebo. Everest said the trial showed Nefecon is a disease modifying first-in-disease treatment for IgAN patients. The trial included a China arm that is expected to release final data in Q3 of 2023. 

Yantai-based Luye Pharma has completed enrollment in a China Phase III clinical trial of BA9101, a VEGFR inhibitor that is a biosimilar to Regeneron’s (REGN) Eylea (see story). Eylea is approved in the US to treat several ophthalmic indications, including Neovascular (Wet) Age-Related Macular Degeneration (wAMD).

Luye’s subsidiary, Boan Biotech, is running the trial together with its partner, Shanghai’s Ocumension, which acquired China commercialization rights to the drug. In a Phase I trial, BA9101 proved to be safe and well-tolerated. Luye paid $205 million in 2019 to acquire Boan and its portfolio of eight biosimilar candidates.

Shanghai Mabwell has started a Phase I trial of 9MW301, the company’s iron homeostasis regulating macromolecular drug (see story). The candidate is a mAb with an innovative target that Maxwell developed at its San Diego Innovation and R&D Center.

In China, the mAb is a Category 1 Therapeutic Biological Product. 9MW3011 has been approved to begin trials in China and the US for two rare disease indications: β-thalassemia and polycythemia vera. In January 2023, Mabwell out-licensed global rights (ex-China) for the drug to Disc Medicine (IRON) in a $412.5 million agreement. 

Guangzhou's Bio-Thera Solutions has started a China Phase I trial of BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4 (see story). The trial will enroll patients with advanced solid tumors to study the safety and tolerability of BAT8007 while determining the recommended Phase II dose (RP2D) of the candidate.

The trial will also evaluate the pharmacokinetics and preliminary efficacy in patients. Bio-Thera said Nectin-4 is overexpressed in urothelial carcinoma, breast cancer, non-small cell lung cancer, pancreatic cancer, esophageal cancer, and head and neck cancer. 

Nanjing Simcere Pharma will test its potential first-in-class anti-tumor necrosis factor receptor 2 (TNFR2) mAb with MSD's (Merck) anti-PD-1 therapy, Keytruda® (pembrolizumab) (see story). The trial, which will enroll patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL), will evaluate the safety and efficacy of SIM0235 as a monotherapy or in combination with Keytruda.

A Simcere subsidiary, Simcere Zaiming, will conduct the trial and retain worldwide commercial rights to SIM0235. Formed earlier this year, Simcere Zaiming focuses on Simcere’s innovative cancer therapeutics. 

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