MEDTECH, INDUSTRY OUTLOOK
PRNewswire | June 01, 2023
Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced breakthrough improvements to the Tapestri® Platform and its core chemistry that enable highly confident detection of rare cells for a range of applications. With Tapestri® v3 chemistry, researchers can discover tiny numbers of single cells that, until now, easily escaped detection and influenced disease in invisible ways. At the same time, drug developers can use the new capabilities for a more complete understanding of their advanced therapies, potentially leading to safer, more effective medicines.
The new Tapestri® v3 chemistry increases the number of cells captured per sample by up to four times compared to the prior chemistry, a notable enhancement. With enhanced cell capture, the Tapestri® Platform can more reliably detect rare cells, opening incredible new possibilities like improving the assessment of measurable residual disease (MRD), a key metric used increasingly in clinical settings to estimate the risk of relapse with certain cancers.
In the case of MRD in hematological cancers, rare subclonal variants are commonly missed by bulk NGS due to its averaging effect, hindering the detection of relapse-driving clones that potentially offer new therapeutic targets. With Tapestri®'s expanded capabilities, new integrated multi-omics tools like the Tapestri® scMRD Assay for Acute Myeloid Leukemia (AML) will offer clinicians additional therapeutic insights, rather than providing a binary 'yes or no' answer to the presence of residual disease. A team of investigators from Memorial Sloan Kettering Cancer Center (MSK) using the assay has reported a high sensitivity of 0.01% limit of detection in data presented at Mission Bio's Tapestri® scMRD for AML Summit last year.
Tapestri®'s new capabilities also hold promise for cell and gene therapy developers looking to improve quality assessment throughout the therapy development process. Powered by Tapestri® v3 chemistry, the increase in cell throughput means Tapestri® Genome Editing Solution can measure gene editing outcomes at single-cell resolution – even for very low-frequency events like translocations, which can have significant effects on the safety of the therapy.
Tapestri® v3 is the latest example of Mission Bio's continued focus on customer-centric product and service development. The company has recently implemented additional quality control measurements including design and development, release, and documentation processes compliant with the ISO 9001 standard.
"Our customers' success is at the forefront of our mind," said Adam Abate, PhD, Co-founder and Interim Chief Executive Officer of Mission Bio. "Researchers and drug developers are demanding ever-greater sensitivity and highly robust products to effectively progress their research or advanced therapeutic program, and we are committed to serving our customers and helping them achieve their goals."
The new v3 reagents will be available for shipping starting in mid-June.
About Mission Bio
Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others.
INDUSTRIAL IMPACT, MEDICAL
Globenewswire | March 27, 2023
Iovance Biotherapeutics, Inc. a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel. Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.”
The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting with the FDA, Iovance is pursuing accelerated approval in this indication. Iovance also reached agreement with the FDA regarding the registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting. Startup activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for lifileucel in advanced post-anti-PD-1 melanoma.
Marc Hurlbert, Ph.D., CEO of the Melanoma Research Alliance (MRA), said, “MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people with advanced melanoma who have progressed following prior treatments. We hope for an FDA approval as quickly as possible for patients with significant unmet need who have no approved treatment options.”
Following receipt of the complete rolling BLA submission for lifileucel, the FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA to the FDA on an ongoing basis, enabling the FDA to begin review as early as possible as documents were received. The rolling BLA submission and eligibility for priority review are benefits available under the FDA’s guidance on expedited programs for serious conditions, which allow for an expedited six-month review from the time of BLA acceptance. In addition, the FDA previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.
MEDTECH, INDUSTRIAL IMPACT
Globenewswire | April 18, 2023
argenx SE and Genmab A/S announced that argenx and Genmab have entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas. The multiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.
“Our core mission is to innovate on behalf of patients by translating immunology breakthroughs into novel pipeline candidates. We do this through a model of co-creation which has led to eight molecules demonstrating human proof-of-concept in our pipeline,” said Tim Van Hauwermeiren, Chief Executive Officer, argenx. “Through our collaboration with Genmab, we are bringing together our combined antibody discovery, development and commercialization expertise to unlock insights on the disease pathways that we will address. This allows us to broaden our capabilities and maximize the opportunity to generate novel therapeutic antibodies within autoimmunity or cancer.”
“Genmab is entering the therapeutic area of immunology and inflammation as a steppingstone to achieving its vision that by 2030, our knock-your-socks-off “KYSO” antibody medicines will be transforming the lives of people with cancer and other serious diseases,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “By partnering with argenx, we will be able to combine our deep knowledge of the biology and therapeutic power of antibodies and have an opportunity to address patients’ needs in oncology as well as in immunology and inflammation.”
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., the EU and UK, and Japan. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises.