Greater cfDNA Recovery May Help Accelerate Development of Cancer Liquid Biopsy Applications

PHASE Scientific | June 22, 2020

PHASE Scientific, a high-growth biotechnology company that develops innovative sample preparation technologies, announced new findings at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting II. The study presented by MD Anderson Cancer Center evaluates the efficacy of PHASE Scientific's liquid phase DNA isolation method (PHASIFY™) in improving cancer liquid biopsy sensitivity. Early-stage cancer diagnostics and cancer screening applications are limited by low yields of extracted cell-free DNA (cfDNA) from plasma samples. PHASE Scientific has developed a novel liquid phase DNA isolation method that leverages aqueous two-phase systems (ATPS) to purify and concentrate circulating cfDNA, which can result in increased cfDNA recovery and improved mutant signal detection. "PHASE Scientific's technology has shown a significant improvement against conventional solid phase methods for extracting circulating cell-free tumor DNA," says presenter Dr. Filip Janku, MD, Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center. "The ability to enable such an increase of cfDNA yield in patient plasma samples is vital for improving downstream molecular diagnostic sensitivity, efficiency, and cost." The study compared cfDNA recovery and mutation detection from plasma samples extracted with a conventional solid phase method (QIAamp Circulating Nucleic Acid kit - QCNA) and our liquid phase method (PHASIFY™ MAX cfDNA extraction kit). 89 plasma samples from patients with diverse advanced cancers with known BRAF, KRAS or NRAS mutation status were tested.


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OPKO Health Acquires ModeX Therapeutics, Gains Proprietary Immunotherapy Technology with a Focus on Oncology and Infectious Diseases

OPKO Health | May 10, 2022

OPKO Health, Inc. (NASDAQ: OPK), a multinational biopharmaceutical and diagnostics company, today announced the acquisition of ModeX Therapeutics, Inc. a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases. OPKO acquired ModeX for $300 million in OPKO common stock. Founded in October 2020 with headquarters in Natick, Mass., ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms. The design of these multi-specifics is amenable to gene-based delivery by mRNA or DNA vectors. The ModeX product portfolio includes cancer immunotherapies that combine four specificities into one protein to improve targeting and immune killing, as well as masking or “stealth” technology to improve tumor-specific killing and reduce side effects. For viral diseases, the lead targets of a broad and potent multi-specific antibody portfolio include HIV and SARS-CoV-2. A vaccine for Epstein-Barr virus is also in development. The acquisition of ModeX Therapeutics significantly broadens our technology foundation and expands our product pipeline to include multi-specific multi-functional antibodies focused on a range of cancers and infectious diseases, with applicability to other therapeutic areas. We believe the promise of better outcomes for patients treated with these multi-specific antibodies represents a next generation of large molecule therapeutics and the next chapter of OPKO, We welcome ModeX’s co-founders Dr. Zerhouni and Dr. Nabel, as well as Alexis Borisy to our Board of Directors, and Dr. Zerhouni and Dr. Nabel to OPKO’s executive management team. The ModeX executive team brings to OPKO a wealth of experience, knowledge and industry contacts, which we expect will have a tremendous long-term positive impact on OPKO as we advance their technology and product pipeline and leverage potential synergies with our current portfolio in diagnostics and therapeutics.” Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. Elias Zerhouni, M.D., Co-Founder and Chairman of the Board of ModeX, has been appointed President and Vice Chairman of the Board of Directors of OPKO. Dr. Zerhouni brings extensive experience in academia, government and industry as a leading authority on emerging trends and issues in medical care and biomedical research and development. A physician scientist with an academic background in imaging and biomedical engineering, Dr. Zerhouni most recently served as President of Global Research & Development and Executive Vice President of Sanofi. Dr. Zerhouni also served as Director of the National Institutes of Health (NIH), Senior Fellow for Global Health Research at the Bill and Melinda Gates Foundation, Presidential U.S. Envoy for Science and Technology, and Professor and Chair of the Russell H. Morgan Department of Radiology and Biomedical Engineering, Executive Vice Dean and Dean for Research at the Johns Hopkins School of Medicine. Dr. Zerhouni was elected to the National Academy of Medicine and to the National Academy of Engineering. He serves on the Board of the Lasker Foundation, the Foundation for NIH, the Davos Alzheimer’s Collaborative and Research!America. He received the 2017 Scripps Executive of the Year Award for the pharmaceutical industry and the French Legion of Honor in 2008. He has been a director of Danaher Corporation since 2009. Being part of OPKO represents a transformative opportunity for both companies. We anticipate it will accelerate ModeX’s product pipeline focused on unmet needs in oncology and infectious diseases and the development of our innovative technologies, and also will take advantage of synergies with OPKO’s programs, ModeX has operated quietly since we were founded 18 months ago on the basis of over 10 years of prior foundational work. We have assembled a world-class executive team with outstanding public and private sector leadership experience to advance our programs. Our lead drug candidate is already in the clinic while several others in late preclinical stages are expected to enter clinical development in 2023. We were enticed to join OPKO by its leadership’s vision and enthusiasm for strengthening our mutual potential for breakthrough innovation.” Dr. Zerhouni. Gary Nabel, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of ModeX, has been appointed Chief Innovation Officer of OPKO and joins OPKO’s Board of Directors. Dr. Nabel, a renowned virologist and immunologist, served as Chief Scientific Officer and Senior Vice President of Sanofi where he directed the breakthrough laboratory that developed tri-specific products now in early clinical development. He is the founding director of the NIH’s Vaccine Research Center, working on vaccines and broadly neutralizing antibodies against HIV, influenza, SARS, Ebola, Chikungunya and Epstein-Barr virus. He was previously an investigator at the Howard Hughes Medical Institute at the University of Michigan. In recognition of his expertise at the forefront of virology, immunology, gene therapy and molecular biology, Dr. Nabel was elected to the National Academy of Medicine, is a fellow of the American Association of Physicians and the American Academy of Arts Sciences, and was awarded the Geoffrey Beene Builders of Science Award from Research!America. Alexis Borisy, the Lead Independent Director of ModeX, also joins OPKO’s Board of Directors. Mr. Borisy is a leading biotechnology entrepreneur and investor with more than 25 years of experience, including founding, serving as Chief Executive Officer and/or Chairman of nine NASDAQ-listed companies. He co-founded and served as either the Chief Executive Officer or Chairman of Blueprint Medicines, Foundation Medicine, Relay Therapeutics, Tango Therapeutics, Celsius Therapeutics and CombinatoRx. With the additions of Dr. Zerhouni, Dr. Nabel and Mr. Borisy to OPKO’s Board, the number of Directors expands to 13. About OPKO Health, Inc. OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

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Amberstone Biosciences Secures $12 Million Series A Financing to Advance Immuno-Oncology Pipeline of Tumor Microenvironment Activated Therapeutics

Amberstone Biosciences, Inc. | January 04, 2022

Amberstone Biosciences an emerging biotherapeutics company with unique expertise in conditionally active immunotherapeutics, today announced the completion of a $12 million Series A financing round. The funding was led by Viva BioInnovator, Co-win Ventures and Sinovation Ventures, with additional support from ChangRong Capital, Lifespan Investments and existing shareholders. Amberstone will use the proceeds from the financing to advance its highly differentiated tumor microenvironment activated therapeutic programs including bispecific antibodies and immunocytokines to the investigational new drug application (IND) enabling stage. “We are tremendously grateful for the strong support from our new and existing investors. With our unique Tumor Microenvironment Activated Therapeutics programs, we aim to develop safer and more effective therapies to benefit cancer patients. The funding and broad expertise and resources in the field provided by our investors will take us another step closer to our mission.” Amberstone Biosciences President and CEO, George Wu, PhD “Amberstone’s T-MATE therapeutic molecules enabled by its innovative single-cell discovery engine represents a real breakthrough in immune-oncology. We are thoroughly impressed by Amberstone team's rich experience in the cancer biology space. Viva is excited to work with Amberstone and syndicate partners to support its mission to provide next-generation innovative treatment options to patients,” said Han Dai, PhD, Chief Innovation Officer of Viva Biotech and Head of Viva BioInnovator. “T cell immunotherapy has encountered great challenges in the complex microenvironment of solid tumors. The T-MATE molecules discovered through Amberstone’s world-leading cross-disciplinary drug discovery engine will break through the bottleneck of traditional methods and bring new hope to the treatment of solid tumors. Co-win Ventures is thrilled to work with Amberstone’s team and co-investors to explore the next generation of immunotherapies in solid tumors,” said Xin Huang, MD/PhD, a managing partner of Co-win Ventures. “The expertise and strengths of Amberstone core team synergize well with one another. We are optimistic with the company’s uncapped growth potential. Amberstone exemplifies our firm’s investment strategy and mission to support deep-tech innovative entrepreneurs and companies,” said Sinovation Ventures’ partner in healthcare, Mr. Peter Wu. About Amberstone Biosciences, Inc. Incorporated in 2018, Amberstone Biosciences is an emerging biotherapeutics company developing a novel class of targeted and conditionally active immunotherapeutics to treat solid tumor cancers and other diseases. Amberstone Biosciences’ pipeline is driven by an innovative high-throughput single-cell functional discovery platform and strong expertise in an interdisciplinary field of biology, engineering, and therapeutic development. About Viva BioInnovator As the venture arm of Viva Biotech Holdings, Viva BioInnovator is dedicated to investing globally in biotech innovations that address unmet medical needs across multiple therapeutic areas. Leveraging Viva Biotech’s rich experience and technical advantages in novel drug R&D, Viva BioInnovator has built a strong track record in providing both cash and in-kind services its portfolio companies worldwide. About Co-win Ventures Founded in 2009, Co-win Ventures focuses on early-stage companies in healthcare and TMT sectors and advocates a team culture of equality, transparency, sharing and innovation. It has operated 17 independent US dollar and/or RMB funds and has invested in over 140 companies, including Taimei Medical Technology, Genecast, Huake Precision, Cytek, InnoLight Technology, Memsensing, Eastsoft, New Vision, Aolian Electronics, and Sanchao Advanced Material among others. About Sinovation Ventures Founded by Dr. Kai-Fu Lee in 2009, Sinovation Ventures is committed to nurturing the next wave of deep-tech entrepreneurs and companies. Sinovation is headquartered in Beijing and operates in multiple major cities. With over US$2.7 billion under management, Sinovation is a leading tech VC firm with a unique “TECH VC” model that is uniquely enhanced by its Artificial Intelligence Institute led by Dr. Lee. Sinovation invests in artificial intelligence, healthcare tech, robotics/automation, semiconductor, enterprise software, and digital lifestyle areas. To date, Sinovation has invested in over 400 companies.

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Genetic Leap and Astellas Establish Research Collaboration to Develop RNA-targeted Small Molecules for Oncology Target

Genetic Leap | March 11, 2022

Genetic Leap today announced a research collaboration agreement with Astellas Pharma, Inc. to develop novel RNA-targeted small molecule therapeutic candidates against an undisclosed oncology target. Under the terms of the agreement, Genetic Leap will deploy its platform to discover and validate RNA-targeted small molecules against an undisclosed oncology target selected by Astellas. The agreement provides Astellas with certain rights to intellectual property on candidates discovered and developed under the collaboration that are directed against the program target. Further details of the collaboration were not disclosed. About Genetic Leap Genetic Leap's vision is to lead the next giant leap in human healthcare by developing today the incredible therapeutics of the future. To accomplish this, Genetic Leap built paradigm-shifting AI technologies that find the causal factors in disease and correct these factors with precision RNA therapy that is safe, convenient, and reversible. The company is leveraging its platform to advance a pipeline that spans internal as well as partnered programs, across both novel and known (but traditionally undruggable) targets.

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Aanika Biosciences First Biotech Company to Receive Bermuda Monetary Authority’s Approval for Reinsurance Innovation Hub

Aanika Biosciences, | February 25, 2022

Aanika Biosciences, an emerging biotech company using microbial based technologies to protect the safety and security of our food system, announced today it has received acceptance into the Bermuda Monetary Authority’s (BMA) Innovation Hub. The program will allow reinsurers to explore how the application of Aanika’s traceability and prevention technology can help reduce the magnitude and size of claims while lowering premiums and expanding protection for the food and agriculture industry. Reinsurance is an almost $500 billion global industry that allows insurance carriers to offload portfolio risks to reinsurers and hedge funds. Aanika estimates its technology could help in the underwriting of nearly $100 billion in premiums linked to contamination, recalls, crop insurance as well as non-safety related claims linked to ESG practices and general product liability. Bermuda is one of the largest hubs for the reinsurance market in the world and the center of innovation in the space. Prior to co-founding Aanika, CEO Vishaal Bhuyan spent more than a decade in finance focused on investing, managing and co-authoring multiple books on insurance-linked derivatives related to human longevity, overfishing and water scarcity. “Climate change will wreak havoc on our food system – potentially accelerating contamination outbreaks, diseases and natural disasters that are damaging and outright destroying crops around the world. ,” says Bhuyan. “ The insurance industry is not yet equipped to handle the volatility of risk and magnitude of loss - and is operating with a massive blind spot. In recent years insurers have adopted machine learning, satellite data and blockchain technologies to increase efficiency and more accurately price risks, but this will be the first use of synthetic biology to better prepare and protect themselves and their policyholders.” The proof-of-concept initiative approved by the BMA will enable Aanika to partner with insurance carriers to develop ‘test policies’ for the U.S. food and agricultural market that mandate applying the microbial technology in their supply chain. This improved ability to distinguish identical commodities from each other will increase transparency throughout the claims process beyond what is possible with digital technologies alone. Aanika co-founder and Chief Science Officer Dr. Ellen Jorgensen says this is a unique and unprecedented opportunity to unlock the potential of synthetic biology. “We need stable, scalable, actionable solutions now to build a more resilient global food supply, which means finding inventive ways of looking at the problem,” says Dr. Jorgensen. “The Aanika science team has developed a way to adapt nature to meet this challenge, and it will be exciting to see how leveraging it in an unconventional way like reinsurance can have immediate as well as long-term benefits.” By tapping into the reinsurance industry, Aanika will be able to commercialize biological innovations in ways that have never been done before. Aanika’s goal is to capture a fee on every policy that is essentially microscopically tethered to the product while using its growing pipeline of “secondary functions” to further enhance the stability and shelf life of said product – reducing the probability and magnitude of a claim. About Aanika Biosciences Aanika Biosciences was co-founded in 2018 by Vishaal Bhuyan after he personally experienced the consequences of ordering fresh, ethically sourced seeds and receiving stale, contaminated products instead. He made it his mission to create a safer food supply by finding a way to track, trace and authenticate products. Aanika’s customized microbial-based tags help companies gain valuable insights about their supply chains, help their customers make better consumption choices, and create a more sustainable world. About Bermuda Monetary Authority The Bermuda Monetary Authority (Authority or BMA) regulates Bermuda’s financial services sector. The Authority was established by statute in 1969. Its role has evolved over the years to meet changing needs in the financial services sector. Today it supervises, regulates and inspects financial institutions operating in the jurisdiction. It also issues Bermuda’s national currency, manages exchange control transactions, assists other authorities with the detection and prevention of financial crime, and advises Government on banking and other financial and monetary matters.

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