prnewswire | May 08, 2023
Frost & Sullivan announced that it has awarded Genomenon with the 2023 Global Technology Innovation Leadership Award. Each year, Frost & Sullivan presents this award to the company that has developed a product with innovative features and functionality that is gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables. Frost & Sullivan market analysts determined that Genomenon excels in many of the criteria and best practices identified as critical for the global pharma and clinical diagnostics genomics markets.
Genomenon is a genomic intelligence software company that combines AI-powered Genomic Language Processing (GLP) with expert review by genetic scientists to deliver the most comprehensive knowledgebase of genomic evidence available. Their fit-for-purpose combinatorial approach to identifying and indexing published genomic evidence gives them a unique advantage over other open access and commercial genomic data resources in this space.
Clinical diagnostic labs rely on Genomenon's Mastermind Genomic Search Engine to find critical information needed to diagnose rare genetic diseases and identify the most appropriate patient treatment options. Pharmaceutical companies engaged in the development of rare disease therapeutics partner with Genomenon to gain deep insights into the genetic drivers of disease. The Genomenon scientific team leverages information in the Mastermind knowledgebase to provide the genomic intelligence pharmaceutical companies need to better understand disease mechanisms, more accurately estimate disease prevalence, design clinical trials, and prepare documentation for regulatory approvals.
Pavel Zhebrouski, a best practices research analyst at Frost & Sullivan, observed, "Genomenon differentiates itself in the space by providing a unique combination of AI technology and human expertise. Genomenon empowers rare disease pharmaceutical and biotechnology companies to make informed decisions about promising candidates in their pipeline and help propel novel therapeutics to market. Its commitment to innovation and creativity, scientific rigor, and accuracy, while achieving commercial success, differentiates it from competitors," added Tejashri Khadilkar, Frost & Sullivan industry analyst.
Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.
Genomenon is an AI-driven genomics company focused on making genomic information actionable for patients with rare genetic diseases and cancer. Keeping pace with the ever-evolving body of knowledge within genomics, Genomenon connects current research with patient DNA to accelerate clinical decision-making and pharmaceutical drug discovery and development.
Globenewswire | May 18, 2023
Cellectis a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today presents clinical data on its Phase 1 AMELI-01 clinical trial (evaluating UCART123) that were unveiled in an oral presentation at the 64th American Society of Hematology (ASH) annual meeting, as well as preclinical data on multiplex engineering for superior generation of CAR T-cells, at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting.
Preliminary Clinical Data from the AMELI-01 Study Presented at ASH 2022
AMELI-01 is a Phase 1 open-label dose-escalation trial evaluating the safety, tolerability, expansion and preliminary activity of UCART123 given at escalating dose levels after lymphodepletion (LD) with either fludarabine and cyclophosphamide (FC) or FC with alemtuzumab (FCA) in patients with relapsed or refractory acute myeloid leukemia (r/r AML).
The oral presentation reviewed preliminary data from patients who received UCART123 at one of the following dose levels: dose level 1 (DL1) 2.5x105 cells/kg; dose level 2 (DL2) 6.25x105 cells/kg; intermediate dose level 2 (DL2i) 1.5x106 cells/kg; or dose level 3 (DL3) 3.30x106 cells/kg after lymphodepletion with FC ([n=8], DL1 – DL3) or FCA ([n=9], DL2 & DL2i).
Preliminary Safety Data
The FCA LD regimen resulted in robust lymphodepletion for greater than 28 days in all patients. Seven out of nine patients demonstrated UCART123 expansion, with maximum concentration (Cmax) ranging from 13,177 to 330,530 copies/μg DNA, an almost nine-fold increase compared with FC LD, and a significant increase in area under the curve (AUC) (0-28 days) (p=0.04; FC 10.2 vs. FCA 34.9).
Cytokine release syndrome (CRS) occurred in eight patients in the FC arm and nine patients in the FCA arm. In the FC arm, one patient experienced Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) and two patients experienced Grade 4 protocol-defined dose limiting toxicities (DLTs) secondary to CRS. In the FCA arm, two patients experienced Grade 5 DLTs secondary to CRS.
Patient Enrollment in a 2-Dose Regimen Arm
Overall, these preliminary data support the continued administration of UCART123 after FCA lymphodepletion in patients with r/r AML. Based on observed UCART123 expansion patterns and cytokine profiles, pursuant to an amended protocol, a second dose of UCART123 is given after 10-14 days to allow for additional UCART123 expansion and clinical activity without the use of additional lymphodepletion. The UCART123 cell expansion from the second dose of UCART123, in the setting of reduced disease burden, is expected to be safe and allow for clearance of residual disease.
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 23 years of experience and expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to treat diseases with unmet medical needs. Cellectis’ headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market and on Euronext Growth .
INDUSTRIAL IMPACT, MEDICAL
Prnewswire | April 27, 2023
LabCentral Ignite, a platform dedicated to advancing racial, gender and other representation and opportunity within the life sciences field, today launched IgniteVC in partnership with the Bioscience & Investor Inclusion Group (BIIG). BIIG is a grassroots effort driven by leaders from venture capital (VC) firms and startups. The new initiative aims to cultivate a highly inclusive life sciences venture capital community and support the growth of more diverse and inclusive portfolio companies from inception to success.
IgniteVC will provide VC firms and startups with practical tools, best practices, and a community of peers to advance their diversity, equity, and inclusion (DEI) goals. This new initiative will build upon years of work done by hundreds of leaders in BIIG, an unprecedented effort to promote DEI in life sciences innovation and investment.
"We are incredibly grateful for the time and expertise of the BIIG volunteers who have created a strong community and a set of unique resources that are now widely available. We look forward to welcoming them to our team as part of IgniteVC. Their hard work and dedication, along with the support of our sponsors, have been instrumental in launching IgniteVC," said Gretchen Cook-Anderson, LabCentral Ignite Executive Director.
Seed support for IgniteVC comes from founding sponsors Johnson & Johnson Innovation-JJDC, Inc., Mission BioCapital, and Third Rock Ventures. IgniteVC will be managed by LabCentral Ignite, which is set to hire a director this spring to lead VC community engagement, expansion, and planned global impact.
"The work that will be done by IgniteVC is critical to driving underrepresented groups into the life sciences sector as a viable career pathway," said Abbie Celniker, PhD, Partner at Third Rock Ventures. "By cultivating a more inclusive VC community and providing resources to support portfolio companies in implementing DEI best practices, IgniteVC is helping to create a more diverse and equitable life sciences ecosystem. We are proud to continue supporting this important work and look forward to seeing the impact it will have on our industry."
About LabCentral Ignite
The growing Ignite platform is dedicated to developing equity, inclusion, and opportunity within the life sciences field. Through a range of equity-driven programs and a growing member network of industry, startups, higher education, and nonprofits, Ignite connects underrepresented students, talent and innovators to academic, technical skills-building, mentoring, job placement, and board and leadership preparation opportunities that fuel biotech diversity and inclusively transform careers.