Avalon Globocare Corp., of Freehold, N.J., a developer of cell-based technologies, said the company has officially started operation of Epicon Biotech Co. Ltd., a joint venture with Jiangsu Unicorn Biological Technology Co. Ltd., located in Jiangsu Province, China. Epicon occupies a 16,000-square-foot GMP laboratory space for processing, biobanking and preparation of clinical-grade products for cellular therapy. Epicon will play an essential role in facilitating a standardized GMP laboratory platform for Avalon's subsidiaries, Genexosome Technologies and Avactis Biosciences. One of its major initiatives is to establish the world's largest aqueous humor-derived exosome biobank to advance the next-generation of diagnostics and therapeutics for ophthalmologic diseases.

Beigene Ltd., of Beijing, selected Chalfont St. Giles, U.K.-based GE Healthcare Life Sciences' off-the-shelf biomanufacturing facility, Kubio, for large-scale production of its cancer monoclonal antibodies (MAbs). It will be located in Guangzhou, China, where an increasing number of biotech firms are establishing operations. The first phase of the facility is expected to be completed and operational in 2019. Beigene is already using GE Healthcare's Flexfactory, an integrated biomanufacturing platform, in its existing manufacturing plant in Suzhou, China, to manufacture MAbs for clinical trials.

Bioaegis Therapeutics Inc., of Morristown, N.J., said it closed a $4.1 million equity round and has begun patient enrollment in a phase Ib/IIa study of recombinant plasma gelsolin (rhu-pGSN) in community-acquired pneumonia in Australasia. The company is focused on an approach to address infectious, inflammatory and degenerative diseases through a portfolio built around rhu-pGSN technology.

Celltrion Inc., of Incheon, South Korea, said it signed an incubation agreement with Emory University in Atlanta to support the research and development of new drug candidates for atherosclerosis. Under the agreement, Celltrion will share its accumulated biologics development expertise with Emory University School of Medicine and the Wallace H. Coulter Department of Biomedical Engineering at Emory University and Georgia Institute of Technology, and provide research costs and manufacturing materials of new drug candidates for atherosclerosis. Celltrion will have a preferential right to acquire a license for inventions resulting from the arrangement.

Cynata Therapeutics Ltd., of Melbourne, Australia, said data from a preclinical model demonstrated that its Cymerus mesenchymal stem cells (MSCs) significantly ameliorate the effects of cytokine release syndrome (CRS), a potentially severe and life-threatening adverse reaction to cancer immunotherapy. Specifically, Cymerus MSC treatment is effective in protecting against CRS in murine models, with statistically significant improvements in body temperature and clinical scores relative to control animals. Cynata intends to partner with companies developing cancer immunotherapies to evaluate the treatment approach in humans.

Daiichi Sankyo Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J., are collaborating on a phase Ib trial to test the combination of Daiichi's HER2-targeting antibody-drug conjugate, DS-8201, plus PD-1 inhibitor Keytruda (pembrolizumab) in HER2-expressing advanced/metastatic breast and HER2-expressing or HER2-mutant non-small-cell lung cancers. Terms were not disclosed.

Fate Therapeutics Inc., of San Diego, negotiated a joint development and commercialization agreement with Osaka, Japan-based Ono Pharmaceutical Co. Ltd. for two off-the-shelf CAR T-cell candidates that will leverage Fate's induced pluripotent stem cell platform. Fate and Ono will jointly advance each candidate to a predefined preclinical milestone. They said the first candidate targets an antigen expressed on certain lymphoblastic leukemias, and that Fate retains global responsibility for development and commercialization with Ono having an option to assume responsibilities in Asia. The second candidate targets an antigen identified by Ono that is expressed on certain solid tumors, with Ono having an option to assume global responsibility for further development and commercialization and Fate retaining the right to co-develop and co-commercialize the candidate in the U.S. and Europe. For both collaboration candidates, Fate retains manufacturing responsibilities. Financial terms of the agreement were not disclosed.

Immutep Ltd., of Sydney, signed a clinical trial collaboration and supply agreement with Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, to evaluate in a phase I trial the combination of Immutep's lead immunotherapy product candidate, eftilagimod alpha (IMP-321), with Bavencio (avelumab), a human anti-PD-L1 antibody, in patients with advanced solid malignancies. Terms were not disclosed. Avelumab received accelerated approval by the FDA for the treatment of patients with metastatic Merkel cell carcinoma and previously treated patients with locally advanced or metastatic urothelial carcinoma, and is under further clinical evaluation across a range of tumor types under a global alliance between Merck and Pfizer.

Mithra Pharmaceuticals SA, of Liège, Belgium, signed an exclusive license and supply agreement with Pei Li Pharmaceutical Industrial Co. Ltd., of Taiwan, to commercialize Tibelia in Taiwan. The drug is a bioequivalent version of Livial (tibolone, Merck & Co. Inc.) developed by Mithra for use in hormone therapy. In addition to license fees, and dependent on receipt of marketing authorization, Mithra is eligible to receive guaranteed annual recurring revenues based on minimum annual quantities for the duration of the 10-year contract. In other news, Mithra finalized an exclusive license and supply agreement with Hyundai Pharm Co. Ltd., of South Korea, for the commercialization of its oral contraceptive, Estelle (estetrol E4 plus drospirenone), in South Korea. Under the terms of the 20-year contract, Mithra will be eligible for up-front and milestone payments, minimal annual quantities and sales-related royalties. Mithra will produce Estelle for the South Korean market at its contract manufacturing organization in Belgium.

Molecular Templates Inc., of Austin, Texas, said it priced an underwritten public offering of 8.2 million shares at $5.50 each for gross proceeds of $45.1 million. The underwriters have been granted a 30-day option to purchase up to 1.23 million additional shares. The company intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund its ongoing phase Ib and phase II studies and planned additional phase II studies for MT-3724 in diffuse large B-cell lymphoma; its share of development expenses in its CD38 collaboration with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan; its programs targeting HER2 and PD-L1; further preclinical development and drug discovery activities in its other programs and for working capital and general corporate purposes.

Neurimmune Holding AG, of Zurich, Switzerland, entered a collaboration with Ono Pharmaceutical Co. Ltd., of Osaka, Japan, focused on the development of human antibodies against a novel therapeutic target for neurodegenerative diseases. Under the terms, Neurimmune will conduct research to generate and validate human-derived monoclonal antibodies using its Reverse Translational Medicine technology platform. Ono will be exclusively responsible for worldwide development and marketing of products. Neurimmune will receive an up-front payment, research fees, success-based milestones on the research and development progress, as well as royalties on product sales. Details were not disclosed.

Novo Nordisk A/S, of Bagsvaerd, Denmark, is restructuring its R&D organization, cutting about 400 employees in Denmark and China, with the aim of accelerating expansion and diversification of its pipeline. The company plans to establish four transformational research units this year, which will operate as satellites and drive innovation in fields such as translational cardiometabolic research and stem cell research. Novo also said it will increase its investment in automation and digital capabilities, including machine learning and artificial intelligence.

Noxopharm Pty Ltd., of Sydney, said that, together with its majority-owned subsidiary, Nyrada Inc., it has discovered a way to inhibit IRAK4, "a protein widely regarded as the 'master switch' in the development of many forms of chronic inflammation, including autoimmune diseases." Preclinical programs now are being undertaken to identify the most appropriate therapeutic indications, with human studies likely in 2020, the company said.

Pharmacyte Biotech Inc., of Laguna Hills, Calif., said its partner, Austrianova Singapore Pte. Ltd., of Singapore, has successfully performed an additional pre-production "engineering run" using the Cell-in-a-Box encapsulated cells that will be used, in combination with low doses of cancer prodrug ifosfamide, for the treatment of locally advanced, nonmetastatic, inoperable pancreatic cancer. On the advice of Pharmacyte's chief scientific officer and Austrianova, which will be performing the full production process of Pharmacyte's trial material, it was decided that the first production run would be deemed an engineering/pre-production run to be conducted before the production run to produce trial material begins.

Propanc Biopharma Inc., of Melbourne, Australia, disclosed the execution of a research collaboration agreement with the University of Jaén in Spain, for the provision of research services and scientific technical advice for the company's POP1 drug discovery program. The goal for the program is to synthesize and develop a backup clinical compound to the company's lead product candidate, PRP. The development of the backup compound will be used for treating patients with limited therapeutic options for the treatment of solid tumors, the company said.

Replicel Life Sciences Inc., of Vancouver, British Columbia, and Ningbo, China-based Yofoto Health Industry Co. Ltd. have received Canadian and Chinese clearances needed to close Yofoto's C$5.1 million (US$3.9 million) purchase of Replicel common shares (TSXV:RP) and warrants. Yofoto will collaborate with Replicel on the further development and commercialization of the tendon regeneration cell therapy RCT-01, the skin rejuvenation cell therapy RCS-01 and an injection technology for dermal applications, RCI-02, excluding hair-related treatments, in greater China.

Sanbio Co. Ltd., of Tokyo, entered an equity and business alliance with Carenet Inc., of Tokyo; Medical Incubator Japan K.K., of Tokyo; Vital KSK Holdings Inc., of Tokyo; and Astem Inc., of Oita, Japan, regarding the appropriate use, adoption and stable distribution of regenerative cell medicine SB6-23. In the drug's development program targeting chronic motor deficit from ischemic stroke in the U.S., phase IIb trials are underway. Enrollment of 163 patients has been completed, and Sanbio plans to disclose results in the first half of the fiscal year ending Jan. 31, 2020, (February 2019 to July 2019) after a 12-month follow-up period. Sanbio is preparing for the development of SB-623 with an aim of launching the product in Japan ahead of anywhere else in the world.

Seattle Genetics Inc., of Bothell, Wash., received a $10 million milestone payment from Osaka, Japan-based Takeda Pharmaceutical Co. Ltd., triggered by Japanese Ministry of Health, Labour and Welfare approval for the use of Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine as first-line treatment for CD30-positive Hodgkin lymphoma patients.

Vaximm AG, of Basel, Switzerland, disclosed the signing of a development and commercialization collaboration agreement with China Medical System Holdings Ltd., of Shenzhen, China (CMS). CMS will have the full rights in China and other Asian countries (excluding Japan) to Vaximm's existing programs, enabling the development and commercialization of the pipeline of oral cancer immunotherapy candidates in the region. The parties will coordinate and share data from their respective clinical studies. Vaximm will also receive development and commercial milestones and royalties based on the achievement of sales milestones by CMS. In parallel with the agreement, CMS will make an equity investment in Vaximm as part of Vaximm's current series B financing.

U.S. President Donald Trump and South Korean President Moon Jae-in signed a revised trade agreement Monday that both leaders said would expand trade between the two countries. The changes made to the 2012 Korea-U.S. agreement include a commitment from South Korea to amend, this year, its premium pricing policy for global innovative drugs and to ensure nondiscriminatory and fair treatment for U.S. biopharma exports. The signing came as new U.S. tariffs kicked in on $200 billion worth of goods from China, including multiple drug ingredients, medical supplies and imaging equipment. Allen Goldberg, vice president of communications for the Association for Accessible Medicines, told BioWorld Asia that prices could go up for drugs using ingredients from China that are subject to tariffs. "It is essential that trade policy, whether Chinese tariffs or negotiations with Canada and Mexico, not undermine President Trump's efforts to bring down high drug prices for America's patients," he said.