MEDICAL

Biosynth Carbosynth Further Expands Life Sciences Platform with Acquisition of Aalto Bio Reagents

Carbosynth | May 30, 2022

Bio_synth_Carbosynth
Biosynth Carbosynth (“Biosynth”), a supplier of critical materials to the life science industry, announces today the acquisition of Aalto Bio Reagents (“Aalto”), a leading developer and provider of biological materials to the in-vitro diagnostic (IVD) and vaccine development industry in the field of emerging disease.

The acquisition represents a further milestone in Biosynth’s development, which broadens its capabilities and offering to the IVD industry. Aalto’s product portfolio includes an extensive range of proteins, antigens, antibodies, disease state human plasma and biospecimens used by the leading diagnostics and vaccine development companies around the world working on emerging diseases and disease variants.

This acquisition marks the next phase of our ambitious journey to become a leading global supplier and partner to the biopharma and diagnostics industries. It allows us to offer an expanded range of products to our IVD customers including complex biochemicals, peptides and biological materials. We are pleased to welcome Aalto and its employees and look forward to working with them to continue to grow our offering to the diagnostics industry.”

Dr. Urs Spitz, CEO and President of Biosynth.

We are delighted to be joining forces with Biosynth, a world-renowned supplier with a broad portfolio of critical products and services across biopharma and diagnostics. Aalto’s industry leading products and key focus on emerging disease are an excellent fit with Biosynth’s products, and we see huge opportunities for the platform to be at the forefront of developing new innovative products and supplying our customers with an even greater scale and diversity of products they need to solve the diseases of the future.”

Philip Noone, CEO of Aalto.

Spotlight

Single-cell omics has emerged as an exciting new technology allowing for unprecedented discovery in a variety of bio-related fields. However, while there are a slew of cutting-edge products for single-cell analysis, it has become painfully clear that cell sorting and single-cell isolation could benefit from innovative technology as well.

Spotlight

Single-cell omics has emerged as an exciting new technology allowing for unprecedented discovery in a variety of bio-related fields. However, while there are a slew of cutting-edge products for single-cell analysis, it has become painfully clear that cell sorting and single-cell isolation could benefit from innovative technology as well.

Related News

MEDTECH

Aeglea BioTherapeutics Announces European Medicines Agency Validation of Marketing Authorization Application for Pegzilarginase

Aeglea BioTherapeutics, Inc. | August 19, 2022

Aeglea BioTherapeutics, Inc. a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced that a Marketing Authorization Application for pegzilarginase for the treatment of Arginase 1 Deficiency has been submitted to and successfully validated by the European Medicines Agency. The MAA was submitted by Immedica Pharma AB, Aeglea's commercialization partner in Europe and the Middle East. Pegzilarginase is a novel, recombinant human arginase 1 enzyme that in clinical trials has been shown to normalize the elevated levels of the amino acid arginine in patients with ARG1-D, a rare, progressive disease characterized by high levels of arginine. People living with ARG1-D experience severe spasticity-related mobility limitations, seizures, developmental delay, intellectual disability, and early mortality. "For progressive diseases like ARG1-D, every day that passes without an approved therapy increases the disease burden and worsens the outcome for patients and their families. If approved, we believe pegzilarginase has the potential to benefit these families. We are thrilled with the progress being made with the validation of the MAA and look forward to continuing to work with and support our partner Immedica throughout the EMA review process." Anthony G. Quinn, M.B., Ch.B., Ph.D., president and chief executive officer of Aeglea Dr. Quinn continued, "I would like to thank all the patients, families, investigators, staff and advocates who participated in our clinical trials and helped in the advancement of pegzilarginase, potentially the first health authority-approved treatment to address the underlying driver of ARG1-D, elevated arginine levels." Immedica's MAA submission includes data from multiple clinical studies in ARG1-D, including the double-blind, placebo-controlled PEACE Phase 3 study and its ongoing long-term extension, a Phase 1/2 clinical trial and an open-label extension study. Results from these trials demonstrate that pegzilarginase is able to rapidly and sustainably lower arginine levels and showed improvements in measures of mobility. In the PEACE study, most treatment-emergent adverse events were mild or moderate in severity and there were no discontinuations due to treatment-emergent adverse events. The EMA has granted pegzilarginase Orphan Drug Designation. About Pegzilarginase in Arginase 1 Deficiency Pegzilarginase is a novel recombinant human enzyme engineered to degrade the amino acid arginine and has been shown to rapidly and sustainably lower levels of the amino acid arginine in plasma. Aeglea is developing pegzilarginase for the treatment of people with Arginase 1 Deficiency (ARG1-D), a rare debilitating and progressive disease characterized by the accumulation of arginine. ARG1-D presents in early childhood and patients experience spasticity, seizures, developmental delay, intellectual disability and early mortality. The PEACE Phase 3 clinical trial met its primary endpoint with a 76.7% reduction in mean plasma arginine compared to placebo. Additionally, 90.5% of pegzilarginase treated patients achieved normal plasma arginine levels. The arginine lowering was accompanied by a positive trend in Gross Motor Function Measure Part E, a measure of patient mobility. Aeglea's Phase 1/2 and Phase 2 Open-Label Extension (OLE) data for pegzilarginase in patients with ARG1-D demonstrated clinical improvements and sustained lowering of plasma arginine. Pegzilarginase has received multiple regulatory designations, including Rare Pediatric Disease, Breakthrough Therapy, Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as Orphan Drug Designation from the European Medicines Agency. About Aeglea BioTherapeutics Aeglea BioTherapeutics is a clinical-stage biotechnology company redefining the potential of human enzyme therapeutics to benefit people with rare metabolic diseases with limited treatment options. Pegzilarginase achieved the primary endpoint of arginine reduction in the PEACE Phase 3 clinical trial and has received both Rare Pediatric Disease and Breakthrough Therapy Designations. Aeglea also has an ongoing Phase 1/2 clinical trial of AGLE-177 for the treatment of Homocystinuria. AGLE-177 has been granted Rare Pediatric Disease Designation. Aeglea has an active discovery platform focused on engineering small changes in human enzymes to have a big impact on the lives of patients and their families.

Read More

MEDTECH

Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy

Applied StemCell Inc. | August 30, 2022

Applied StemCell, Inc. a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space. The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASC’s team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products. “We are very excited to move forward with the expansion of our cGMP facility. Our team has been working closely with our clients to ensure delivery of high-quality clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP cleanrooms, we will be able to assist a greater number of researchers focused on cell and gene therapy.” Dr. David Lee, Ph.D., Head of GMP and Quality President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. stated, “We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry. Our unique platform of GMP-grade allogeneic iPSC and TARGATTTM gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.” Construction will begin within the next month, and the company has already begun the staff hiring process. ASC hopes to have the expansion completed and a team built that will be ready to take on as much as 4 times more new projects early next year. About Applied StemCell, Inc. ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing. With over 13 years of gene-editing and stem cell expertise, ASC offers comprehensive and customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing technologies, facilitate site-specific, large cargo transgene integration and the development of allogenic cell products.

Read More

INDUSTRIAL IMPACT

Active Motif and EpiCypher Execute Cross-Licensing Agreement and End Ongoing Litigation Involving Targeted Transposition Technology for Epigenomics

EpiCypher and Active Motif | August 01, 2022

CUT&Tag is a targeted transposition technique that allows high-resolution genomic mapping of histone modifications and chromatin-associated proteins through the precise insertion of DNA sequences into the genome using the Tn5 transposase enzyme. EpiCypher and Active Motif each own or control patents covering complementary aspects of targeted transposition. Active Motif and EpiCypher have leveraged their respective IP to independently create successful genomic mapping tools that allow researchers to employ targeted transposition / CUT&Tag for advanced epigenomics research. Since 2020, there has been a patent dispute between the companies that culminated in patent infringement litigation. EpiCypher and Active Motif have recently agreed to put their differences aside and today announced the signing of a global settlement ending the ongoing litigation, and a mutual cross-licensing agreement of their respective intellectual property. These developments will effectively resolve all outstanding legal issues between the two companies in the targeted transposition / CUT&Tag space. The companies agreed that both Active Motif and EpiCypher's IP are equally valid, and that both sets of IP are required to commercialize products and services that use technology involving targeted transposition techniques such as CUT&Tag. As part of the cross-licensing agreement, EpiCypher and Active Motif each agreed to provide to the other company a non-exclusive, royalty-bearing license to enable commercialization of products, kits, and services that use targeted Tn5 / CUT&Tag-based workflows. The companies also agreed to pool their IP and work together to sublicense targeted tagmentation technology for emerging fields of use, including single cell and spatial genomics assays. This places Active Motif and EpiCypher in a very strong position in the targeted transposition market. "Today's announcement is great for EpiCypher, Active Motif, and our collective customers", said Dr. Martis Cowles, Chief Business Officer of EpiCypher. "The Partnership between EpiCypher and Active Motif is a natural fit, and we look forward to working with Active Motif to maximize the impact of CUT&Tag technology on chromatin science and drug development". "Targeted transposition technology has become increasingly important in simplifying the study of Protein-DNA interactions. We are pleased to be collaborating with EpiCypher to bring targeted transposition to the research and biotech communities." Ted DeFrank, President and CEO of Active Motif. Joe Fernandez, the Founder of Active Motif About EpiCypher EpiCypher® is dedicated to developing transformative epigenetic solutions that advance the science of epigenetic regulation and improve human health. Most recently, EpiCypher has been at the leading edge of chromatin profiling technology with highly sensitive CUTANA™ epigenomic mapping assays for ChIC, CUT&RUN, and CUT&Tag. The Company also manufactures and sells the largest collection of defined "designer" nucleosomes on the market and offers a range of high-throughput nucleosome-based assays and services for chromatin research and drug development. About Active Motif Active Motif, Inc. is dedicated to developing, manufacturing and delivering epigenetics-based research tools to analyze nuclear function. Its customers include scientists from academic and government institutions; biotechnology and pharmaceutical companies. Active Motif operates globally through its corporate headquarters in Carlsbad, California and offices in Shanghai China, Tokyo Japan and Waterloo Belgium. Active Motif applies a multi-disciplinary approach to create new and modify existing technologies to meet the current and future needs of life science researchers.

Read More