Businesswire | August 21, 2023
BioSkryb Genomics, a company transforming single-cell analysis by enabling the most complete multiomic view of the cellular ecosystem, from discovery to diagnostics, today announced the issuance of a composition of matter patent, US Patent 11,643,682 by the U.S. Patent and Trademark Office related to its novel Primary Template-Directed Amplification (PTA) method and applications for research, diagnostics, and treatment. The patent is exclusively licensed to BioSkryb by St. Jude Children’s Research Hospital.
As science continues to evolve, somatic mosaicism (variants accumulated in DNA after fertilization) has become more broadly accepted as a key influencer of biology and disease, including cancer, cardiovascular disease, and neurological disorders. The challenge in understanding this clonal differentiation and how it influences biological change has been underpinned by the lack of technologies that can provide a precise and holistic view of genomes of individual cells without artifacts or bias.
Primary template-directed amplification was invented to address these challenges by providing a highly accurate, scalable, and efficient nucleic acid amplification and sequencing method for research, diagnostics, and treatment. PTA is the flagship technology that drives BioSkryb’s industry-leading products, including ResolveDNA® and ResolveOME™, a first of its kind multiomic solution that provides whole genome and whole transcriptome analysis from the same single cell in a single workflow.
Since the founding of BioSkryb when the PTA technology was licensed, the company has dramatically improved the chemistry in terms of performance, throughput, and modality with these products, including the ability to utilize the chemistry for whole genome, whole exome, and panels across varying cell types and nuclei. In addition to optimizing the DNA-based chemistry, BioSkryb has further developed the technology by layering on the ability to analyze the corresponding transcriptome and proteome within individual cells allowing researchers and clinicians a complete and integrated view of the microenvironment of a cellular ecosystem, empowering breakthrough discoveries and ultimately improved understanding and treatment of complex diseases.
“This patent serves as not only as a cornerstone of BioSkryb’s IP portfolio, but as the foundation of our best-in-class single-cell analysis products,” said Suresh Pisharody, CEO, BioSkryb Genomics. “PTA is the unique engine that drives our ability to deliver comprehensive integrated multiomics and paves the way for next generation single-cell analysis and research that could lead to better outcomes for patients.”
“The performance of PTA, even in its infancy, was so remarkable that the BioSkryb founding team believed it could serve as the foundation for a company that could transform genomics,” said Jay West, CTO and Co-Founder of BioSkryb Genomics. “Since the filing of this original patent application, we have generated approximately 60 other patents and patent applications in several key geographical markets that have allowed us to build upon the original power of this transformational technology.”
As of August 2023, BioSkryb Genomics, Inc., owns or exclusively licenses one issued U.S. patent and three issued international patents (Europe, Australia, and Hong Kong). There are 58 pending patent applications, including 12 in the United States, 39 international applications, and 7 applications filed under the Patent Cooperation Treaty.
About BioSkryb Genomics
BioSkryb Genomics is a rapidly growing organization that is transforming single cell molecular discovery and analysis. Through its single cell whole genome and whole transcriptome amplification tools, scientists and clinicians can gain an unprecedented view of the genome, transcriptome, and proteome within a single cell to better understand the drivers, mechanisms, and management of complex disease. The company is headquartered in Durham, North Carolina.
Medical, Industry Outlook
Globenewswire | July 13, 2023
NANOBIOTIX a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTXR3.
NBTXR3 is currently being evaluated in several studies across solid tumor indications including NANORAY-312, a global Phase 3 pivotal study evaluating NBTXR3 for the treatment of patients with locally advanced head and neck cancer. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD-1 immune checkpoint inhibitors for patients with metastatic cancers.
Under the terms of the license agreement, in collaboration with the Interventional Oncology R&D Unit at Johnson & Johnson, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, excepting territories previously licensed to Nanobiotix partner LianBio. Dial-in information for a conference call Nanobiotix will host to discuss the agreement can be found below.
“As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world. For that, we needed to find the right partner, at the right time, with proven global development and commercialization capabilities,” said Laurent Levy, Nanobiotix chairman of the executive board. “We are delighted to collaborate with Janssen as we aim to improve the lives of patients with cancer around the world.”
Nanobiotix will receive near term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million, and in-kind regulatory and development support for study NANORAY-312 valued at up to $30 million that Janssen may provide at its sole discretion. Nanobiotix will maintain operational control of NANORAY-312 and all other currently ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply. Janssen will be fully responsible for an initial Phase 2 study evaluating NBTXR3 for patients with stage three lung cancer and will have the right to assume control of studies currently led by Nanobiotix.
Nanobiotix is eligible for success-based payments of up to $1.8 billion, in the aggregate, relating to potential development, regulatory, and sales milestones. Moreover, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion; and of up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen.
Following commercialization, Nanobiotix will also receive tiered double-digit royalties on net sales of NBTXR3.
“We expect this agreement, and the collaboration it enables, to further drive the expansion of NBTXR3 development and accelerate the realization of its promise for patients in need,” said Bart van Rhijn, Nanobiotix chief financial officer. “We look forward to maximizing the value of NBTXR3 for our global stakeholders.”
Separately, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) including, as part of capital increases without preferential subscription rights: (1) an initial tranche equal to the lower of 5% of the Company and $5 million; and (2) a second tranche of $25 million subject to certain maximum ownership caps in connection with a future financing.
The price of the initial tranche will be equal to $5.21 per American Depositary Share (“ADS”) if that price (1) is approved by Nanobiotix shareholders or (2) exceeds 85% of the volume-weighted average price (“VWAP”) of Nanobiotix ordinary shares on Euronext: Paris for three consecutive trading days, starting with the fourth trading day after the date of agreement, in each case if occurring within the ninety trading days following the date f the agreement. Also, JJDC may elect any time during that ninety-trading day period to instead consummate the initial tranche at a price per ADS equal to 85% of the VWAP of Nanobiotix ordinary shares on Euronext for three consecutive trading days starting with the fourth trading day after the date of the agreement. The second, $25 million tranche is conditioned upon, and at the same price as, a concurrent Nanobiotix financing with gross proceeds of at least $25 million (excluding the potential investment by JJDC) occurring prior to certain long-term development milestones or December 31, 2027, at the latest.
For illustrative purposes only1, in the event that the initial tranche is implemented at $5.21 per ADS, the dilutive impact for shareholders resulting from this capital increase would be 0.97% and JJDC group would own 2.65% of the Company’s share capital.
The transaction is subject to customary closing conditions and regulatory clearances including clearance by US antitrust authorities under the Hart-Scott-Rodino Act, and will become effective as soon as these conditions have been met.
As of the date the license agreement becomes effective, prior to utilizing the second tranche of equity investment outlined above and excluding near term development milestones, Nanobiotix expects to extend its cash runway into the first quarter of 2024.
Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The Company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.
PRNewswire | July 27, 2023
Invivoscribe is excited to announce that the LeukoStrat® CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo's VANFLYTA® (quizartinib).
The LeukoStrat CDx FLT3 Mutation Assay identifies FLT3-ITD positive AML patients who may be treated with this newly approved targeted therapy.
US Intended Use
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom RYDAPT® (midostaurin) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with AML for whom XOSPATA® (gilteritinib) treatment is being considered.
The LeukoStrat CDx FLT3 Mutation Assay is used as an aid in the assessment of patients with FLT3-ITD+ AML for whom VANFLYTA® (quizartinib) treatment is being considered.
The test is for use on the 3500xL Dx Genetic Analyzer.
"FDA approval of the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic to VANFLYTA is a significant milestone for patients with newly diagnosed FLT3-ITD positive AML," said Invivoscribe CSO, CEO, and founder Jeffrey Miller. "Timely and accurate testing for FLT3-ITD mutations in newly diagnosed patients is critical to identify those who may be eligible for treatment with VANFLYTA, and we are happy to collaborate with Daiichi Sankyo to help bring this important new therapy to patients."
AML is a blood cancer that affects the blood and bone marrow and is characterized by the rapid growth of abnormal white blood cells.1 AML has the lowest 5-year survival rate (31.7%) among people diagnosed with leukemia.2 About 25% of AML patients have a FLT3-ITD mutation which contributes to the growth and survival of cancer cells and is associated with a poor prognosis.
Previously, the LeukoStrat CDx FLT3 Mutation Assay was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for use as a companion diagnostic to select FLT3-ITD positive AML patients eligible for VANFLYTA in Japan.
Invivoscribe is a global, vertically-integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For nearly thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics, and provides expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization.