INDUSTRIAL IMPACT
Legend Biotech Corporation | February 14, 2022
Legend Biotech Corporation, a global, clinical-stage biotechnology company developing and manufacturing novel therapies, has achieved two milestones under its collaboration agreement with Janssen Biotech, Inc. for ciltacabtagene autoleucel (cilta-cel), resulting in aggregate payments to Legend Biotech of $50 million. Cilta-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy.
Legend Biotech entered into the agreement with Janssen to develop, manufacture and commercialize cilta-cel for the treatment of multiple myeloma. Under the agreement, Legend Biotech received an upfront payment of $350 million and is entitled to receive additional payments upon achievement of landmarks for development, production performance, regulatory and sales.
The global agreement specifies a 50-50 cost and profit-sharing agreement in all markets, excluding Greater China, where the split is 70 percent for Legend and 30 percent for Janssen. Including the payments announced above, Legend has achieved $250 million in milestone payments during the collaboration.
About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the United States and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In addition to a Breakthrough Therapy Designation (BTD) granted in the United States in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. Food and Drug Administration (FDA) in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.
About Legend Biotech
Legend Biotech is a global, clinical-stage biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
We are currently engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.
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MEDICAL
Lilly | January 28, 2021
Eli Lilly and Company, Vir Biotechnology, Inc. also, GlaxoSmithKline plc declares a collaboration effort to assess a mix of two COVID-19 therapies in low-risk patients with mild to direct COVID-19. Lilly has extended its progressing BLAZE-4 trial to assess the organization of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (otherwise called GSK4182136) 500mg, two killing antibodies that quandary to various epitopes of the SARS-CoV-2 spike protein. This unique collaboration effort denotes the first occasion when that monoclonal antibodies from discrete organizations will be united to explore expected results.
Bamlanivimab is a neutralizing antibody coordinated against the spike protein of SARS-CoV-2 designed to obstruct viral connection and entry into human cells, in this manner killing the infection. Bamlanivimab emerged out of the collaboration among Lilly and AbCellera to make antibody therapies for the avoidance and treatment of COVID-19. Bamlanivimab is approved for emergency use for the treatment of mild to direct COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
"Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized."
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INDUSTRIAL IMPACT
Second Genome | March 03, 2022
Second Genome, a biotechnology company that leverages its proprietary platform to discover and develop precision therapies and biomarkers, announced today it has completed its multi-year collaboration with Bayer to discover proteins for potential development of next-generation insect-control products. During the collaboration, Second Genome generated and explored environmental metagenomes that include genomic information from bacteria that are yet to be identified and cultured.
"We are proud to have successfully executed a collaboration with Bayer following our discovery of thousands of novel proteins using our machine learning-enabled platform that have the potential to be developed into next-generation products. The discoveries Second Genome made are an important validation for the broad potential of our platform to develop novel therapeutic approaches for human health."
Karim Dabbagh, Ph.D., President and Chief Executive Officer of Second Genome
Under the terms of this multi-year agreement, Second Genome generated a large microbial metagenomic dataset that was subsequently evaluated using a machine learning driven platform to identify novel insecticidal proteins.
"With our vast human datasets, as well as our platform's machine learning, metagenomic and data standardization and analytic capabilities, we can efficiently analyze vast and geographically diverse data to advance Second Genome's pipeline of precision therapeutics and biomarkers and collaborators' portfolios," said Susannah Cantrell, Ph.D., Chief Operating Officer and Chief Business Officer of Second Genome. "We look forward to continuing to demonstrate the potential of our approach through additional industry collaborations in the health care field as we advance our lead mucosal healing and oncology programs toward the clinic this year."
About Second Genome
Second Genome is a biotechnology company that leverages its proprietary technology-enabled platform to discover and develop transformational precision therapies based on novel microbial genetic insights. We built a proprietary drug discovery platform with machine-learning analytics, customized protein engineering techniques, phage library screening, mass spec analysis and CRISPR, that we couple with traditional drug development approaches to progress the development of precision therapies for wide-ranging diseases. Second Genome is advancing lead programs in IBD and cancer into IND-enabling studies. We also collaborate with industry, academic and governmental partners to leverage our platform and data science capabilities. We hold a strategic collaboration with Gilead Sciences, Inc., utilizing our proprietary platform and comprehensive data sets to identify novel biomarkers associated with clinical response to Gilead's investigational medicines. We also hold a strategic collaboration with Arena Pharmaceuticals to identify microbiome biomarkers associated with clinical response for their lead program in gastroenterology, etrasimod.
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