CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Biocytogen | January 05, 2023
RenNano™, a fully human heavy-chain antibody platform developed by Biocytogen Pharmaceuticals Co., Ltd., has been launched officially. RenNano™ joins RenMab™ and RenLite® as the newest member of the RenMice™ family. All three RenMice™ technologies from Biocytogen work together to speed up the search and development of entirely human monoclonal, bispecific/multispecific, and single-domain antibodies (sdAbs, or nanobodies).
Camels and sharks produce heavy-chain-only antibodies (HCAb), indicating their variable domains (VHH or sdAb) are functional without pairing with the light chain. Still, humans and mice produce antibodies that require heavy and light chain coupling to be effective. Because of their molecular weight and size, sdAbs can enter solid tumor tissues and breach the blood-brain barrier. Additionally, the sdAb's larger CDR3 region allows for detecting the otherwise concealed epitopes of GPCRs and other challenging targets.
Nanobodies offer their benefits, but it's challenging to use animals that naturally make HCAbs, like camels, in large numbers to create monoclonal antibodies due to their size, slow reproduction rate, and limited offspring supply. However, humanizing camelid antibody sequences for pharmaceutical use adds another layer of complexity and time to the drug development process.
Accordingly, Biocytogen modified the constant area of the entirely human RenMab™ model to create the RenNano™ Mouse, which is genetically modified to manufacture HCAbs. RenNano™ Mouse is one of the world's most comprehensive human antibody platforms due to the substitution of the mouse genes with the complete human heavy chain variable genes.
About Biocytogen
Biocytogen, a global biotechnology company, is at the forefront of developing cutting-edge methods for studying and creating new antibody-based pharmaceuticals. Biocytogen has streamlined the entire drug development process by integrating its drug efficacy screening platforms and clinical solid development expertise with its proprietary RenMab™, RenLite®, and RenNano™ platforms for the fully human monoclonal antibody, bispecific/multispecific antibody, and nanobody develo
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MEDTECH, AI
Quantum-Si | January 10, 2023
The leading Protein Sequencing Company™, Quantum-Si, recently announced that it signed a partnership and license agreement with Biovista to offer customers more significant proteomic insights beyond their protein sequence output.
Biovista utilizes artificial intelligence in multiple formats to analyze enormous data repositories and visualize non-obvious networks and connections between proteins, diseases, and drug mechanisms of action. The partnership enhances Quantium-Si's services significantly by making proteomic-to-drug workflows more efficient for researchers.
Biovista's VIZIT™ exploration tool will be incorporated into Quantum-Si's cloud-based suite of analytic tools, allowing researchers to visualize the connections between the protein sequences identified during their experiment to diseases, other proteins, and post-translational modifications. Thus, researchers can identify potential disease-specific mechanisms and biomarkers more efficiently and effectively.
"Quantum-Si's protein sequencing technology in concert with Biovista's database and visualization technology can aid in the discovery of new proteins for future therapeutic targets associated with disease," said Jeff Hawkins, CEO of Quantum-Si. He further stated, "The potential can also extend to discovering new biomarkers for clinical research and diagnostics."
(Source- Business Wire)
"Quantum-Si is leading the next generation of real-world meaningful sequencing," said Dr. Aris Persidis, Biovista's Co-Founder and President. "We are excited to see deep sequencing and insight generation now available in one integrated platform," he concluded.
(Source- Business Wire)
About Quantum-Si
Quantum-Si, The Protein Sequencing CompanyTM, is dedicated to revolutionizing the rapidly expanding field of proteomics. It provides the first-of-its-kind, end-to-end, universal single-molecule detection solutions, allowing to build, experiment, and discover on its platform regardless of their existing products. In addition, its proprietary Time Domain Sequencing technology eliminates the reliance on color as an identification method, a barrier for any application outside of genomics, where only four colors are required.
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INDUSTRY OUTLOOK
Puma Biotechnology, Inc. | March 16, 2023
Puma Biotechnology, Inc., a biopharmaceutical company, recently announced the online publication of the Phase II TBCRC041 randomized clinical trial results in JAMA Oncology. The trial investigated the use of alisertib, an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A, alone or in combination with fulvestrant in postmenopausal women with endocrine-resistant, HER2-negative metastatic breast cancer who were previously treated with fulvestrant.
The Phase II randomized clinical trial was conducted via the Translational Breast Cancer Research Consortium and included patients previously treated with CDK 4/6 inhibitors and everolimus.
The trial enrolled 91 evaluable patients, with baseline characteristics balanced between the two arms of the trial. However, more patients in the alisertib plus fulvestrant arm had previously received chemotherapy for metastatic disease (47.8% in the alisertib alone arm vs. 68.9% in the alisertib plus fulvestrant arm). In each arm of the trial, all patients had earlier been treated with CDK 4/6 inhibitors. Everolimus was previously administered to 37% of patients in the alisertib alone arm and 57.8% in the alisertib plus fulvestrant arm.
The trial's efficacy results indicated that nine partial responses were observed in the 46 evaluable patients in the alisertib alone arm, leading to an overall response rate of 19.6%. The median duration of response was 15.1 months, with a clinical benefit rate of 41.3% at 24 weeks. The projected median progression-free survival (PFS) was 5.6 months. Nine of the 45 evaluable patients in the alisertib plus fulvestrant arm of the study responded, for an overall response rate of 20.0%. There was one patient who had a complete response and eight patients who showed partial responses. The median duration of response was 8.5 months, with a clinical benefit rate of 28.9% at 24 weeks. The median PFS was expected to be 5.4 months.
The most prevalent grade 3 or higher adverse events in the alisertib alone arm of the trial were neutropenia (43.4%), anemia (19.6%) and leukopenia (17.4%). The most prevalent grade 3 or higher adverse events in the alisertib plus fulvestrant arm of the study were neutropenia (42.2%), leukopenia (31.1%), lymphopenia (15.6%), fatigue (11.1%), and anemia (8.9%).
About Puma Biotechnology, Inc.
Puma Biotechnology, Inc. is a leading biopharmaceutical company specializing in the development and commercialization of innovative treatments for cancer. Its flagship product is Nerlynx (neratinib), an oral tyrosine kinase inhibitor approved by the USFDA for the extended adjuvant treatment of HER2-positive early-stage breast cancer. In addition to Nerlynx, it has a robust pipeline of product candidates in various stages of development. The company is firmly committed to research and development and collaborates with leading academic institutions and research organizations to advance the understanding of cancer and develop new therapies.
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