Orion Biotechnology Canada Ltd | October 16, 2020
Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering GPCR-targeted therapeutics, today announced the results of their Phase 1 study of OB-002H which is an investigational candidate microbicide for HIV prevention. The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel. OB-002, a highly potent chemokine analog of CCL5 (a ligand for the CCR5 HIV co-receptor), has previously been shown to be completely protective in a non-human primate model of vaginal HIV transmission (Veazey R et al. JID 2009). The Phase 1 study design included open-label single-dose (vaginal and rectal) and multi-dose product (vaginal) administration of OB-002H gel to study participants followed by a randomised, double-blind, placebo-controlled multi-dose (vaginal) phase of product administration. During the multi-dose phase of the study, participants received study product once daily for five days. The study enrolled a total of 30 healthy volunteers in Warsaw, Poland at the BioVirtus Phase 1 Research Site. The product was well tolerated, and product-related genital adverse events were mild (Grade 1) or moderate (Grade 2) and transient.
Porton Advanced | April 25, 2022
Suzhou Porton Advanced Solutions Ltd. and Guizhou Sinorda Biomedicine Co. Ltd. announced a long-term strategic relationship in cell and gene therapy research and development and platform development.
Porton Advanced provides plasmids, cell therapy, gene therapy, oncolytic virus, mRNA treatment, and bacterial therapy as part of an end-to-end gene and cell therapy CDMO service platform. Sinorda Biomedicine focuses on the R&D of revolutionary drugs for digestive tract disorders, tumor immunotherapy, and oncolytic virus therapy and has multiple new drug projects in the clinical stage, thanks to its extensive expertise in domestic and international new drug filing. Jiangsu Tairui Sinorda Biomedicine Pharmaceutical Technology Co. Ltd., a subsidiary, conducts pre-clinical and clinical research on tumor immune pharmacology and efficacy.
Under the terms of the agreement, Porton Advanced will help Sinorda Biomedicine speed up the development, production, and registration of breakthrough cell therapies, such as its T-cell immunotherapy product for colorectal cancer, SND002 and other pipelines. Sinorda Biomedicine will partner with Porton Advanced to support its cell and gene therapy R&D and production.
The first collaborative initiative, SND002, has been approved for Phase II clinical trials in Europe. The product had previously been recognized by the Chinese National Science and Technology Major Project for "the Breakthrough New Drugs." The beginning of this key initial initiative allows Porton Advanced and Sinorda to combine resources and expertise, promising increased synergy in the clinical development and approval of Sinorda's SLN-T program.
"Sinorda Biomedicine has a proven track record in drug development in China, US and Europe. The company possesses great expertise in immunology and oncolytic viruses, as well as cutting-edge immune functional assays, technologies, and capabilities. I am excited to see how our end-to-end cell and gene therapy CDMO platforms and quality systems can complement these capabilities and enhance Sinorda's pipeline. Supporting Sinorda's development, production and regulatory filing and accelerating its cell therapy drugs to market is a great cause and a great opportunity. We look forward to the opportunity to help Sinorda establish advanced therapies that benefit patients globally."
Dr. Yangzhou Wang, CEO of Proton Advanced
CStone | October 29, 2020
CStone Pharmaceuticals declared today a permitting concurrence with Lego Chem Bio sciences, Inc, for the turn of events and commercialization of LCB71, a likely first-in-class/top tier immunizer drug form ("ADC").
Under the understanding, CStone gets the selective worldwide option to lead advancement and commercialization of LCB71 outside the Republic of Korea. LCB will get a forthright installment of US$10 million, and up to US$353.5 million in combined achievement installments, in addition to layered eminences.
Frank Jiang, M.D., Ph.D., Chairman and Chief Executive Officer of CStone, said: "We are very pleased to form this partnership with LCB, a leading ADC platform company, to obtain global rights to an asset with highly differentiated attributes in an exciting new field of oncology. The agreement adds the first ADC to CStone's development pipeline, and bolsters our precision medicine franchise with a new modality. We look forward to harnessing its full potential and bringing it to patients around the world."
LCB71 is a pre-clinical ADC going into Investigation New Drug ("IND") empowering contemplates. It targets ROR1 (receptor tyro sine kinase-like vagrant receptor 1), a high-potential ADC focus for different strong and hematological malignancies. ROR1 protein articulation is common in an assortment of malignancies including different types of leukemia, non-Hodgkin lymphoma, and bosom, lung, and ovarian tumors.
LCB71 has a restrictive tumor-actuated pyrrolobenzodiazepine ("PBD") expert medication poison that tends to the ordinary poisonousness issue related with conventional PBD payloads. It has shown total tumor hindrance over a few pre-clinical disease models, which may convert into a wide helpful record for a scope of strong and hematologic malignancies. Moreover, it uses site-explicit formation for an exact medication counter acting agent proportion. This backings serum half-life and improves its pharmacokinetic profile, and furthermore empowers homogeneous creation and huge scope fabricating.
Dr. Yong-Zu Kim, CEO and President of LCB, said: "We are pleased to have reached this agreement with CStone, which has demonstrated extensive oncology expertise, especially in global clinical development. This partnership puts LCB71 on a path to development and commercialization for patients worldwide. We are convinced that CStone is the right partner to secure the future of this important drug."
CStone is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established at the end of 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. With a strategic emphasis on immuno-oncology combination therapies, the Company has built an oncology-focused pipeline of 15 drug candidates, including five late-stage candidates at pivotal trials or registration stages. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
About LegoChem Biosciences
LegoChem Biosciences (LCB) is a clinical-stage biopharmaceutical company focusing on the development of next-generation novel therapeutics utilizing its proprietary medicinal drug discovery technology LegoChemistry and ADC platform technology ConjuAll. Since its foundation in 2006, LCB has focused on the research and development of Antibody-Drug-Conjugates (ADCs), antibiotics, anti-fibrotic and anticancer therapeutics based on proprietary platform technologies.
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