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Week in Review: Zhaoke Signs $130 Million Deal for Vision-Improving Eyedrops
Deals and Financings
Zhaoke Ophthalmology of Hong Kong acquired China/Southeast Asia rights for two eyedrop candidates designed to improve near vision from Seattle’s Visus Therapeutics in a $130 million deal (see story). Brimochol PF and Carbachol PF are investigational, once-daily therapeutics that reduce the size of the pupil, resulting in a “pinhole effect,” allowing only centrally focused light rays to enter the eye. This sharpens near and intermediate images. ZKO will make a $15 million upfront payment and up to $115 million in milestones, plus royalties. ZKO will enroll patients in Phase III trials in the territories to meet the trials’ goals.
Nanjing InxMed announced a $15 million B+ funding round to develop its novel therapies that target the stroma microenvironment and drug resistance for hard-to-treat solid tumors (see story). InxMed will use the funds for US/China clinical trials of its lead drug, IN10018, a selective adenosine triphosphate competitive FAK inhibitor. IN10018 has received Fast Track designation in the US and Breakthrough Designation in China to treat platinum-resistant ovarian cancer. InxMed believes the candidate will prove to be effective alone and in combination with immunotherapies, chemotherapies and targeted therapies. The Series B+ round was funded entirely by Hyfinity Investments. Earlier this year, InxMed completed a $50 million B round.
Coherus Biosciences (NSDQ: CHRS) of Redwood City, CA, returned the US rights to market an Innovent (HK: 1801) Avastin biosimilar to Innovent (see story). Coherus announced the move in its Q1 earnings call with analysts, blaming the COVID-19 epidemic for slowing its development of the biosimilar. Coherus has signed several big deals to market China-developed drugs in North America, a major part of its business plan. However, during the first three months of 2022, it also dissolved a partnership with Junshi Biosciences (HK: 1877; SHA: 688180) for an Eylea (aflibercept) biosimilar. Coherus paid Junshi $11.5 million in costs related to the discontinuation.
Trials and Approvals
Jiangsu Hengrui Medicine (SHA: 600275) announced that a combination of its PD-1 and VEGFR inhibitors met its efficacy endpoints in patients with newly diagnosed liver cancer, outperforming Bayer’s Nexavar (see story). The global Phase III trial tested the combination therapy for overall survival. Hengrui has already filed for China approval of the combination and plans to seek US approval as well. Hengrui and its US partner Elevar started US trials for the combination in 2019, so they have efficacy data in US patients. The lack of that data caused the US to reject two China-developed immunotherapies recently.
Tonghua Dongbao Pharma (SHA: 600867) has dosed the first person in a China Phase III trial of an Ultra-Rapid insulin developed by Adocia (Paris: ADOC) of Lyon, France (see story). The trial will enroll 1300 people with type 1 and type 2 diabetes in 100 China sites. As part of a two-drug deal,, Tonghua Dongbao in-licensed China and South-East Asia rights to BioChaperone® Lispro from Adocia for $10 million upfront and $35 million in milestones, plus royalties. The second Adocia diabetes therapy in the deal is a fixed-ratio glargine and lispro combination.
CARsgen (HK: 2171), a Shanghai CAR T-cell company, reported positive results in the journal Nature Medicine for its Claudin18.2 CAR T in patients with solid tumor cancers (see story). Interim results from an investigator-led Phase I trial showed the CT041 was effective in patients with advanced gastrointestinal cancers and gastroesophageal junction adenocarcinoma. In 37 patients, the objective response rate was 48.6% with a disease control rate of 73%. CARsgen said that, currently, CT041 is the world's first and only CAR T-cell candidate to start a confirmatory Phase II clinical trial in solid tumor cancers.
Shanghai Zhimeng Biopharma has dosed the first participant in a US Phase I study of its novel small-molecule KCNQ2/3 selective opener for refractory epilepsy (see story). Epilepsy is an imbalance between neuronal excitation and inhibition, which is caused by dysfunction in ion channels, especially the potassium (K+) channels. Zhimeng’s CB03 is a new generation of KCNQ2/3 potassium channel opener with improved chemical and metabolic stability, antiepileptic activity and safety. Its highly selective ion channel targeting is designed to avoid the side effects of previous ion channel drugs.
Ascletis Pharma (HK: 1672) of Hangzhou was approved to start US trials of its in-licensed PD-L1 as an immune restoration/functional cure of AIDS (HIV-1) (see story). ASC22 will be administered to HIV-infected patients who are already receiving antiretroviral therapy. The Phase I/II trial will: (1) evaluate the safety of ASC22 (2) determine whether ASC22 1.0 mg/kg, given once every four weeks, improves HIV-1-specific cellular immune responses; and (3) evaluate the effects of ASC22 versus placebo on latency reversal of HIV. Ascletis in-licensed the PD-L1 from Alphamab for viral indications.
Singapore SCG Cell Therapy Pte has been approved to conduct China and Singapore trials of its autologous T-cell receptor T-cell therapy for hepatitis B virus related hepatocellular carcinoma (HCC), the most common form of liver cancer (see story). SCG101 activates T-cells by recognizing the epitope of the hepatitis B virus surface antigen, which redirects T-cells against the HBV antigens. SCG develops novel immunotherapies for common infections and their cancers using T cell therapies, antibodies and therapeutic vaccines. Headquartered in Singapore, SCG also has operations in China and Germany.
Shanghai Elpiscience was cleared to start US trials of a first-in-class bispecific antibody that targets two major immunosuppressive mechanisms in the tumor microenvironment (see story). ES014 is an anti-CD39xTGF-β bispecific that simultaneously targets the CD39-adenosine and TGF-β pathways. Elpiscience will test the drug in patients with advanced solid tumors. An immunoncology company, Elpiscience now has five molecules in clinical trials including an CD39 monotherapy. One year ago, Elpiscience closed a $105 million Series C round to start US trials of its portfolio of 15 innovative molecules.