Pharma Mar Starts Aplicov-PC Clinical Trial With Aplidin For Treatment Of Covid-19

PharmaMar | April 28, 2020

PharmaMar (MSE: PHM) has announced the start of the APLICOV-PC clinical trial with Aplidin® (plitidepsin), for the treatment of patients with COVID-19, which has been authorized by the Spanish Medicines and Healthcare Products Agency (AEMPS). This is a multicenter, randomized, parallel, open-label study to evaluate the safety profile and efficacy of three doses of plitidepsin in patients with COVID-19 requiring hospital admission. Three hospitals from Madrid (Spain) will participate in the study. Three cohorts of patients with three different dose levels will be included in the study to assess the efficacy and safety of plitidepsin at each dose level administered in patients admitted to hospitals with COVID-19. During this first stage, 27 patients will be recruited, to whom three doses will be administered. The viral load of the patients will be measured before and after the treatment, as well as a series of other parameters for clinical evolution. If the results were positive at this early stage, the trial would continue at the optimal dose after discussion with the regulator, with a larger cohort of patients.

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CRISPR Integration: CRISPR/Cas9 System for insertion in eukaryotic cells Compositions and use of CRISPR/Cas9 to integrate a new sequence of DNA after cutting genomic DNA. CRISPR-chrom: Improves access to the genome so that CRISPR-driven edits can be done more efficiently.


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MEDICAL

MediKarma Selects 1upHealth as its Interoperability Partner to Help Patients Acquire Their Medical Records from Hospital EMRs

1upHealth | June 07, 2022

MediKarma, Inc, a global leader in an AI-based patient engagement, education and navigation platform, has selected 1upHealth, the market leader offering healthcare's most complete FHIR® data platform, as its interoperability partner to help patients request and acquire their medical records through FHIR-based APIs. Fast Healthcare Interoperability Resources (FHIR®) is the future of healthcare that brings together claims and clinical information in one common standard to drive innovation. MediKarma, Inc. intends to upend the healthcare market by providing a consumer-focused platform with personalized human body visualization, a dynamic health score and an AI voice companion that answers the important, recurring question, "What do I do next?" By integrating seamlessly into a consumer's lifestyle and leveraging data from multiple sources, MediKarma reduces friction within the healthcare journey and provides the best next action, which enables an improved healthcare experience. The interoperability partnership between MediKarma and 1upHealth solves two significant user challenges: one, helping patients quickly access all of their medical and EMR records from multiple sources, and two, helping patients make sound decisions about the best way to enable continuous improvements in their personal healthcare. MediKarma's AI-enabled healthcare coach and daily health scores provide easy-to-access and Next Step information for the consumer. Finding a vendor with an accurate, easy-to-navigate records collection capability was paramount when selecting 1upHealth as an interoperability partner, The 1up|Health History app is easy to navigate and enables complete user health history to be integrated into the Medikarma workflow in under an hour." Kris Narayan, CEO of Medikarma. 1upHealth is leading healthcare's conversion to FHIR®, a standard that is based on the same web technologies that have transformed other industries such as retail, travel and finance, We purpose-built a modern data architecture to rebuild how healthcare accesses, stores, analyzes and shares data using a scalable, serverless environment." Joe Gagnon, CEO of 1upHealth. The 1up|Health History application enables individuals to connect and request their health data from the company's integrated network of 10,000+ clinical and payer endpoints. The disparate data is then ingested and conformed into clean FHIR® that is more timely, usable, and computable.

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Illumina Introduces New Pan-Cancer Companion Diagnostic to Match Patients with Rare Genetic Mutations to Targeted Therapy

Illumina | May 27, 2022

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight™ Oncology (TSO) Comprehensive (EU) test. This single test kit, recently launched across Europe, assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer. The CDx pan-cancer indication will allow identification of cancer patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions including NTRK1, NTRK2 or NTRK3, and may benefit from targeted therapy with Bayer's VITRAKVI® (larotrectinib), in accordance with the approved therapeutic labeling. TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test which combines less prevalent biomarkers with more prevalent ones in the same test, using a single biopsy specimen. This helps maximize the chances of identifying an actionable alteration so that patients can be treated with a targeted therapy or enrolled into a clinical trial based on their unique tumor genomic profile. The addition of this first CDx claim specific to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients harboring this genetic alteration with an opportunity to benefit from larotrectinib, a genomically matched treatment. This CDx claim, developed in partnership with Bayer, is the first of a series under development, building upon Illumina's broad portfolio of oncology partnerships with industry leaders to advance cancer diagnostics and precision medicine, We continue to focus on unlocking the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind—we don't want anyone to miss the opportunity to have their biomarker detected and gain access to a potentially life-saving therapy." Paula Dowdy, Senior Vice President and General Manager of Illumina for Europe, the Middle East, and Africa. Across most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be challenging to detect as these genes fuse with many different partners, many of them previously unknown. Most CDx tests are specific to one type of cancer, but the NTRK claim is pan-cancer, enabling TSO Comprehensive (EU) to target multiple solid tumor types and a broad range of known and novel gene fusion partners across all three NTRK genes. This helps maximize the chances of finding actionable information from each patient's biopsy, to inform treatment with larotrectinib. Since it launched four years ago, VITRAKVI has demonstrated high response rates and highly durable responses in adults and children with TRK fusion cancer, The CE marking of Illumina's TSO Comprehensive (EU) assay inclusive of NTRK gene fusion detection for VITRAKVI is an important advance in enabling precision oncology for patients in Europe. Assays that enable precision oncology through comprehensive genomic testing are crucial for informing optimal treatment plans and help to ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are evaluated comprehensively inclusive of NTRK gene fusions." Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Bayer's Oncology Strategic Business Unit. The performance of TSO Comprehensive (EU) with NTRK fu­sions was assessed by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431) and SCOUT (NCT02637687), were used to demonstrate the clinical effectiveness and safety of TSO Comprehensive (EU) in identifying NTRK1, NTRK2 and NTRK3 gene fusion positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was the overall response rate (ORR), measured as the patient presenting either a complete response, a surgical complete response or partial response, to larotrectinib. We were delighted to be the clinical study partner for Illumina in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel, TSO Comprehensive (EU) represents a powerful and versatile platform with a broad range of cancer-relevant content, and we recognize its value to our biopharma partners, for the development and delivery of companion diagnostics to further precision medicines." Professor Richard Kennedy, Global VP of Biomarker Development & Medical Director, Almac Diagnostic Services. Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock groundbreaking targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. About Illumina Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.

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DIAGNOSTICS

Biodesix Announces Research Agreement with Top US Cancer Center

Biodesix | June 06, 2022

Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. The initiation of this research program with MSK is a significant milestone for Biodesix. While the initial focus will be on developing a novel MRD test for solid tumors as an addition to our pipeline, Biodesix hopes to co-develop and validate a number of new test concepts under the agreement.” Scott Hutton, CEO, Biodesix. Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR™ platform, the Bio-Rad QX600™ ddPCR™ System. As part of Bio-Rad's continued growth in oncology and expansion into the field of molecular MRD monitoring, we are pleased that Biodesix is utilizing the advanced multiplexing QX600™ ddPCR™ System that will be launching later this year." Simon May, EVP & President, Life Science Group, Bio-Rad Laboratories. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer eight non-invasive tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19

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INDUSTRIAL IMPACT

Persephone Biosciences Closes $15M Seed Financing Round

Persephone Biosciences | July 20, 2022

Persephone Biosciences Inc., a synthetic biology company reimagining patient and infant health through the development of microbiome-based medicines, today announced that it has closed a $15 million seed financing round. The round was co-led by First Bight Ventures and Propel Bio Partners, and included investments from Y Combinator, Fifty Years, Susa Ventures, American Cancer Society’s BrightEdge Fund, Pioneer Fund, and ZhenFund among others. “This financing is a significant milestone for Persephone and the culmination of years of thoughtful engagement with forward-thinking investors and individuals who are committed to the vast potential of our platform and technology. We plan to deploy this capital to further expand our research and clinical programs across a range of therapeutic areas, as well as pursue new collaborations. With our ARGONAUT study ramping up, it is an exciting time for us. We are grateful for the support of all our stakeholders and their commitment and confidence in our vision.” Stephanie Culler, CEO and Co-founder of Persephone Biosciences Persephone was founded to leverage a unique understanding of the microbiome as a therapeutic approach for a number of indications, including infant health and oncology. The company’s ARGONAUT trial (NCT04638751) is the largest study ever conducted in the U.S. to identify biomarkers for cancer treatment and prevention by mapping the gut-immune axis. In December 2021, Persephone announced that Janssen Biotech, one of Janssen Pharmaceutical Companies of Johnson & Johnson, would collaborate with the company on the colorectal cancer patient arm of ARGONAUT, and on an arm of additional healthy individuals with varying cancer risk. Then in April 2022, Persephone announced a collaboration with Ginkgo Bioworks to enable the synthetic biology tools needed to develop the next generation of microbial therapies. About Persephone Biosciences Persephone Biosciences is pioneering the use of synthetic biology for the development of microbial products that impact patient and infant health. Persephone is building an end-to-end platform to industrialize the development of engineered cells that restore health to damaged human ecosystems. The company was founded in the summer of 2017 by synthetic and metabolic engineering pioneers, Stephanie Culler, Ph.D., and Steve Van Dien, Ph.D.

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Spotlight

CRISPR Integration: CRISPR/Cas9 System for insertion in eukaryotic cells Compositions and use of CRISPR/Cas9 to integrate a new sequence of DNA after cutting genomic DNA. CRISPR-chrom: Improves access to the genome so that CRISPR-driven edits can be done more efficiently.

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