Deals and Financings

According to Bloomberg, I-Mab BioPharma (NSDQ: IMAB) of Shanghai is shopping its CD-47 immunoncology candidate to various global biopharmas with hopes of forming a $2 billion collaboration (see story). I-Mab believes TJC4 is a potential global best-in-class CD47 because it binds to a unique epitope on CD47 that leads to only minimal red blood cell binding. In pre-clinical studies, it did not cause anemia, thrombocytopenia or the so-called "antigen sink effect." Like other CD47 candidates, TJC4 works by preventing microphages from being neutralized by the patient's immune system.

Mabwell Biotech, based in Shanghai's Zhangjiang Hi-Tech Park, raised an impressive $278.5 million in a Series A round (see story). Founded in 2017, the company has absorbed or started nine biopharmaceutical R&D and production companies. Mabwell focuses on developing large molecule drugs including mAbs and long-acting recombinant proteins, building a portfolio of more than thirty candidates that target oncology, autoimmune, infectious and ophthalmic diseases. So far, it has started clinical trials for six candidates, three of which are being tested in Phase III trials. It hopes to launch its first product this year.

Ocumension Therapeutics, a Shanghai biopharma incubated by 6 Dimensions Capital, filed for a Hong Kong IPO (see story). Just three years old, Ocumension is developing 16 ophthalmology drugs in China that it has in-licensed. The portfolio includes four candidates in or near clinical development. The company's most advanced product is an intravitreal sustained-release corticosteroid implant to treat uveitis. Ocumension says it has acquired China rights to three of ten ophthalmic drugs approved in the US since 2015, but not available in China. The company is also developing its own ophthalmology drugs.

Suzhou SmartNuclide Biopharma, a company developing innovative drugs for nuclear medicine, completed a $14 million Series B financing led by Ruihe Investment (see story). SmartNuclide Biopharma is a clinical-stage company developing biological products for cancer patients, including diagnostics and therapeutics. Proceeds from funding will be used to advance the company's current R&D projects, including the Phase III clinical trial and launch of its lead drug, SNA001. Also contributing to the B round were Jiuyo Capital, Zhongyu Yingjia Health Investments and Xieyao Kexin Venture Capital.

Denovo Biopharma, a San Diego-Beijing precision medicine company, announced plans to acquire Tocagen's retroviral replicating vector platform (see story). The assets include Tocagen's investigational gene therapy and drug regimen for oncology: Toca 511 and Toca FC, along with several early-stage candidates, including programs targeting PD-L1 and other immunoncology targets. Denovo develops biomarkers to define patient populations in which abandoned drugs are effective. The company said the Tocagen assets will expand its portfolio while continuing its emphasis on precision medicine.

OrigiMed (Shanghai), a precision medicine company, formed a collaboration with Germany's Bayer (XETRA: BAYN) to develop a China in vitro companion diagnostic (CDx-IVD) to detect NTRK gene fusions (see story). Bayer's larotrectinib (Vitrakvi®) is a TRK inhibitor approved in the US (2018) and EU (2019) to treat adult and pediatric patients with solid tumor TRK fusion cancers. Larotrectinib is being developed globally, including in China. OrigiMed uses high-throughput analysis together with bioinformatics and clinical data to match patients with targeted therapies, immunotherapies and clinical trials.

Trials and Approvals

RemeGen, a Yantai biopharma, was cleared to start a US Phase II trial of its HER2 antibody drug conjugate (ADC) in patients with HER2 positive metastatic or unresectable urothelial cancer (UC) (see story). One year ago, RemeGen reported a China Phase II trial of RC48 (disitamab vedotin) produced a 51% objective response rate in the same population. Earlier this month, RemeGen closed a $100 million funding co-led by Lilly Asia Ventures and Lake Bleu Capital. The company has filed a China NDA for its lead drug, telitacicept, a fusion protein aimed at lupus.

Hua Medicine (HK: 2552) of Shanghai reported positive data from a US Phase I test of its type 2 diabetes treatment, dorzagliatin, both as a monotherapy and paired with a SGLT-2 inhibitor (see story). The trial showed a synergistic effect in dual administration of dorzagliatin and empagliflozin, but no adverse PK results. Hua says dorzagliatin is a first-in-class, dual-acting glucokinase activator, designed to restore glucose homeostasis in T2D patients by the improving glucose sensor function. Hua expects dorzagliatin will become a first-line T2D therapy either as a mono- or combination treatment.

Suzhou Innovent Bio (HK: 01801) dosed the first patient in a pivotal China Phase II registrational trial of parsaclisib, a novel and selective PI3Kδ inhibitor (see story). The trial is aimed at testing the efficacy and safety of parsaclisib in patients with indolent lymphoma -- either recurrent/refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). In 2018, Innovent acquired greater China rights from Incyte for three clinical-stage candidates, including parsaclisib. Incyte is already testing parsaclisib in several non-Hodgkin lymphomas and in myelofibrosis, diffuse large B-cell lymphoma and autoimmune hemolytic anemia.

Shanghai Green Valley Pharma has been given permission to start a US arm of its global Phase III trial of its novel treatment for Alzheimer's, which is derived from marine brown algae (see story). The product was approved and launched last year in China following clinical trials. Oligomannate (GV-971) is a mixture of acidic linear oligosaccharides, delivered orally. In the China Phase III trial, patients who received oligomannate showed a mean gain of 2.54 in their ADAS-Cog12 Scores. The treatment is thought to work by reshaping the balance of gastrointestinal microbiota.

Coronavirus Pandemic

Clover Bio Australia, a division of Sichuan Clover Biopharmaceuticals, announced a $3.5 million investment from CEPI, the Coalition for Epidemic Preparedness, to develop a COVID-19 vaccine (see story). The company will use the money to start an Australian Phase I trial of its COVID-19 S-Trimer vaccine candidate, a vaccine based on Clover Bio’s proprietary Trimer-Tag© platform. The platform, which is usually used to develop cancer candidates, produces the spike proteins of the COVID-19 virus in a native trimeric form.

Atreca (NSDQ: BCEL), IGM Biosciences (NSDQ: IGMS) and BeiGene (NSDQ: BGNE; HK: 06160) formed a three-way collaboration to discover and develop engineered immunoglobulin IgM and IgA antibodies targeting SARS-CoV-2 (see story). BeiGene will support clinical development of the product using its global clinical trial team. To speed development, the companies not established the financial terms of the agreement, leaving that task until later. They hope to have a candidate ready to begin clinical testing in the first half of 2021. Atreca is located in South San Francisco, IGM in Mountain View, California, and BeiGene in Beijing.

Disclosure: none.