Global Roundup: Two Big Deals Highlighting Biopharma Growth in China and More

Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

China has one of the fastest growing biopharma ecosystems in the world, and two recent deals highlight that significance.

Pfizer and recently-launched LianBio forged a collaboration to pursue an innovative business development opportunity to expand the development of novel therapeutics in China. Few details of the deal were announced, but the companies said they will be “dedicated to advancing best-in-class therapies for patients, leveraging both LianBio’s and Pfizer’s clinical development, regulatory and commercial expertise.” Pfizer will contribute up to $70 million of non-dilutive capital toward in-licensing and co-development.

For Pfizer, this follows on a $200 million investment in CSTone Pharmaceuticals in September to support the development of a checkpoint inhibitor aimed at the oncology market in China.

Last month, LianBio raised $310 million to advance the company’s innovation mining platform and diversified portfolio of product candidates, including late-stage cardiorenal and oncology assets for Asian markets.

In addition to the Pfizer and LianBio focus on China, Florida-based Generex Biotechnology closed a $50 million licensing and development agreement with a consortium of partners in China for the Ii-Key vaccine platform technology from Generex subsidiary NuGenerex Immuno-Oncology. The fee provides for the exclusive use of the Ii-Key vaccine platform for infectious disease and cancer in China and its territories. The agreement includes the first Ii-Key platform project for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine in China, with a $5 million upfront licensing fee, 100% funding for manufacturing, development and commercial registration, a $20 million success fee for approval Ii-Key- SARS-CoV-2 vaccine in China, and royalty payments for COVID vaccine sales in China with the potential to reach several billion dollars, the company said.

SynOx – Ireland’s SynOx Therapeutics Ltd., a spinout of Celleron Therapeutics, secured a €37 million Series A financing co-led by HealthCap and Medicxi and joined by investors Forbion and Gimv. In addition to the financing, the company secured rights for the clinical development of emactuzumab, a clinical-stage humanized IgG1 CSF-1R targeted antibody designed to target and deplete macrophages in the tumor tissue under a license agreement with Roche. The financing will enable SynOx to continue the development of emactuzumab, for the treatment of diffuse tenosynovial giant cell tumors (“TGCT”), also known as pigmented villonodular synovitis (“PVNS”), and other indications. Emactuzumab has shown a favorable safety profile in patients and encouraging efficacy for TGCT, a rare disease characterized by the proliferation of macrophages in the synovial tissue in the joint and tendon sheath.

Calypso Biotech – Netherlands-based Calypso completed dosing of the first cohorts of healthy patients in its Phase I clinical trial of CALY-002, a novel humanized monoclonal antibody neutralizing IL-15. CALY-002 is the lead program of the company’s differentiated pipeline of IL-15-targeting biologics that will be investigated in multiple auto-immune diseases. Calypso Biotech selected Celiac Disease and Eosinophilic Esophagitis as its first targets. Both are diseases with high unmet medical need where IL-15 causes inflammation, and tissue destruction.

Lead Pharma – Also based in The Netherlands, Lead Pharma entered into a collaboration and license agreement with Roche to develop oral small molecules to treat a broad range of immune mediated diseases. The companies will collaborate in research activities up to the selection of a pre-clinical candidate after which Roche will be responsible for further development and global commercialization. Under the terms of the agreement, Lead Pharma will receive an upfront payment of €10 million, and will be eligible to receive research funding and pre-clinical milestone payments; total potential payments including research, development, regulatory and sales milestones may add up to an aggregate of €260 million, plus royalties on worldwide sales.

Seqirus – Australia’s Seqirus, a wholly-owned subsidiary of CSL Limited, will construct a new world-class biotech manufacturing facility in Australia to supply influenza vaccines. The state-of-the-art facility will use innovative cell-based technology to produce influenza vaccines for use in both influenza pandemics and seasonal vaccination programs – and will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere. The facility will also manufacture Seqirus’ proprietary adjuvant MF59, as well as “unique products” Important to Australia’s public health needs – including antivenom for Australian snakes, spiders and marine creatures, and the world’s only human vaccine for Q-Fever.

Abivax – France’s Abivax received the Best Technology Award at the European Mediscience Awards 2020 event for ABX464, an innovative drug candidate with a novel, unique mechanism of action that could be used to treat a number of chronic inflammatory bowel diseases, particularly ulcerative colitis and Crohn’s disease. ABX464 is also being tested in rheumatoid arthritis and, more recently, in Covid-19 to evaluate its potential to prevent hyper-inflammation and to inhibit the replication of the SARS-CoV-2 virus in high-risk patients.

AiDx Medical -- Dutch digital health start-up AiDx Medical was announced as the winner of the Digital Health & Medical Devices category of the Hello Tomorrow Global Challenge. Their AiDx ASSIST technology is a low-cost, portable diagnostic system, which combines an optical input with AI to produce an intelligent microscope. This allows automated screening of tropical parasitic diseases such as malaria, which affects 228 million people each year and results in 435,000 deaths.

Ysopia – French biotech company Ysopia Bioscience received funding approval from Bpifrance and the European Regional Development Fund through the Nouvelle-Aquitaine Region for a total of €1.55M. This new funding will help drive the company’s biotherapeutics pipeline forward. This funding will be used to advance the clinical development of the company’s lead biotherapy, Xla1, targeting obesity and associated metabolic diseases, and to support the preclinical development of another candidate addressing inflammatory bowel diseases.

ProBioGen – Berlin-based ProBioGen AG closed a master service agreement with Asahi Kasei Pharma. ProBioGen will use its proprietary technologies, like the CHO.RiGHT cell line development platform and DirectedLuck transposase technology, to enable Asahi Kasei Pharma to advance their biologics pipeline. BV100 is being developed for the treatment of serious hospital infections caused by Carbapenem resistant Acinetobacter baumannii.

BioVersys – Switzerland-based BioVersys initiated Phase I testing of BV100, a potential breakthrough hospital antibiotic to treat serious infections caused by Carbapenem Resistant Acinetobacter baumannii (CRAB) in indications of ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI), for which there are little to no effective and safe treatment options. BioVersys has developed a proprietary human IV formulation of BV100 for the CRAB hospital market and elucidated the unique mode of action that accounts for its tremendous potency and coverage of clinical CRAB isolates.

Osivax -- French startup Osivax has been announced as the winner of the Drug Discovery category in the Hello Tomorrow Global Challenge. The company is developing next generation universal vaccine for both current and future influenza type A and Type B variants. The platform could also provide a universal coronavirus vaccine, complementing vaccines currently in development for COVID-19. Osivax’s OligoDOM technology platform brings a new approach to viral disease control. Conventional flu vaccines target the outer membranes of the virus. Osivax’s platform targets the internal part of the virus, providing a universal vaccine that can be used on an ongoing basis. This has been shown in independent trials to be 70%.

Relief Therapeutics – Swiss-based Relief Therapeutics Holding tapped Syneos Health to run the European clinical trial in severe COVID-19 induced lung injury, as well as future trials in other indications to be conducted in Europe.