publication date: Mar 12, 2022
author/source: Richard Daverman, PhD
Deals and Financings
Adiso Therapeutics, a Concord, Mass. anti-inflammatory biotech, officially emerged from stealth mode with backing from Hong Kong's Morningside Ventures (see story). According to Endpoints News, Morningside has already invested $60 million in the company and has another $35 million earmarked for the company's B round, which will include a syndicate of investors. Other sources said Morningside has supported Adiso so far with $35 million. To form Adiso, Morningside rolled up an US-Irish microbiome biotech, Artugen, for which it has been the sole support, and an unidentified US company specializing in neutrophils.
Microbiotica, a UK microbiome drug company, completed a $67 million B Financing co-led by China's Tencent and Flerie Invest, a Swedish life science investor (see story). Although Tencent is primarily an internet company, it also delivers healthcare in China through its portal WeDoctor and has shown interest in novel drug technologies. Microbiotica will use the proceeds to conduct Phase Ib trials of its two lead oral Live Bacterial Therapeutics. MB097 is a predictive test of a patient's response to immune checkpoint drugs, and MB310 is aimed at treating ulcerative colitis via a fecal transplant.
SalubrisBio of Maryland received $32 million from its parent, Shenzhen Salubris Pharma, to develop its portfolio of complex novel biologic products (see story). SalubrisBio’s lead asset is an antibody-based NRG-1 fusion protein, the first bi-specific antibody to start trials for a cardiovascular indication. JK07 is currently in a Phase I test among heart failure patients with reduced ejection fraction. The investment will support the ongoing Phase Ib trial plus two additional Phase Ib trials in 2022, while the company expands its R&D pipeline. SalubrisBio develops products for unmet needs in cardiovascular diseases, cancer and neurodegenerative diseases.
Shanghai Nuance Pharma (NSDQ: CYTO) acquired China rights to a nasal spray developed by Switzerland's Altamira Therapeutics in a $23.5 million agreement (see story). Bentrio™ (AM-301) is a drug-free nasal spray that forms a protective gel layer on the nasal mucosa, protecting against airborne viruses and allergens. It may also be effective against SARS-CoV-2. Nuance will make an upfront payment of $1 million and pay Altamira up to $22.5 million in milestones. Eventually, Nuance will have the right to manufacture the product in China and pay royalties on sales.
WuXi AppTec (SHA: 603259; HK: 2359), China's largest CRDMO, formed a partnership with Orbit Discovery, an Oxford, UK peptide discovery company (see story). Following discovery, Orbit will offer clients WuXi AppTec’s downstream services. These include peptide optimization, peptide production and manufacturing, giving clients quick access to clinically relevant data and materials. In addition, Orbit will offer WuXi AppTec's expertise in cell line and assay development and biophysical analysis. Orbit's discovery operations are based on its novel bead and microfluidic technology platforms that improve functional screening throughput.
Johnson & Johnson (NYSE: JNJ) is currently talking with two China biopharmas about forming partnerships, though it did not name either company (see story). J&J has a very good reason for being interested in China. Four years ago, its subsidiary, Janssen Pharma, formed a $1 billion partnership for Nanjing Legend Bio's CAR-T multiple myeloma therapy. At the time Legend (NSDQ: LEGN) wasn't particularly well known, but its CAR-T posted very high efficacy rates in a early trial. One week ago, Carvykti™ (cilta-cel) was approved for a US launch.
Government and Regulatory
The US Securities and Exchange Committee warned three China biopharmas that their US-listed ADRs face delisting in three years time. The three companies (see story), Beigene, Zai Lab and Hutchmed, were singled out because they have filed their 2021 annual reports to US regulators. Last year, the US passed a law requiring US-listed companies to submit their financial reports to a US auditor. That's a problem because China prohibits its companies from letting a foreign group audit their finances. The company have three years to solve the problem or they will be de-listed.
Trials and Approvals
The Shanghai Mental Health Center has been approved to launch its Virtual Reality-based therapy for acrophobia, the fear of heights (see story). It is the first VR device approved in the world for any specific phobia. The VR application exposes patients to specific situations that trigger the condition while using traditional psychotherapy to blunt their negative reactions. The VR device combined with psychotherapy successfully passed clinical trials. Known as “Specific Fear Rehabilitation Training Software,” it was approved last month as a Class II medical device for psychological training.
Beijing Eucure Biopharma, a Biocytogen subsidiary, has dosed the first patient in a Phase I trial of a dual drug therapy for patients with advanced solid tumors (see story). The Australia-China trial will test a combination of Eucure's anti-OX40 and its anti-CTLA-4 mAbs. In earlier trials, Eucure has tested both candidates separately, determining that each was well tolerated and safe. Biocytogen develops novel drugs using its two proprietary mice strains to develop fully human antibody drugs, while Eucure is responsible for clinical development of Biocytogen's R&D candidates.
Gan & Lee (SHA: 604087), a Beijing diabetes pharma, has started a US Phase I trial of its glucagon-like peptide-1 receptor agonist (GLP-1RA), a therapy for type 2 diabetes (see story). GLP-1 is an incretin that stimulates insulin secretion and inhibits glucagon when blood glucose is high. The Phase I trial will determine the safety and tolerability of GZR18 in healthy volunteers and establish its pharmacokinetic (PK) profile. Gan & Lee, which developed the first domestic China biosynthetic human insulin, has launched five diabetes products in China.