On January 10, 2020 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that its President, Chairman and Chief Executive Officer, Kevin Hrusovsky, will be presenting on the company’s growth and vision for the fourth consecutive year at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Quanterix, JAN 10, 2020, View Source [SID1234552995]). Hrusovsky’s session will take place on Wednesday, Jan. 15, 2020 at 4 p.m., PST (7 p.m., EST) in California East, Westin St. Francis, with a Q&A session directly following at 4:30 p.m., PST (7:30 p.m., EST) in the Yorkshire Room, Westin St. Francis.

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In the two years since the Company’s very successful initial public offering, Quanterix has continued to achieve accelerated double-digit, year-over-year growth in each full quarter. The Company has had several critical milestones and achievements, including strategic acquisitions and agreements, multiple product launches that build on the renowned Simoa technology platform, new additions to its leadership team, raised nearly $120 million in 2019, continued growing in scientific publications and expanded the biomarker menu.

"Our team is relentless in its drive to change how researchers and pharmaceutical companies approach drug development and early disease detection using biomarkers," said Hrusovsky. "Our customers and collaborators have made strong strides across neurology, with a groundswell of groundbreaking research validating neurofilament light (Nf-L) as a blood-based biomarker for measuring neurodegeneration. Oncology is witnessing a similar opportunity with Simoa. We are excited to discuss the unprecedented opportunity we have before us in the research markets and ultimately clinical diagnostic markets."

Significant 2019 Achievements:

Launched the Simoa HD-X Analyzer, which delivers improved flexibility and sensitivity across a broad assay menu to empower more efficient and accurate biomarker analysis. Built upon the Company’s flagship Simoa HD-1 platform, HD-X shipments began one quarter ahead of schedule following a successful Early Access Program. Customer feedback on the HD-X has been positive with the instrument delivering a five-fold improvement in operational efficiency along with other key enhancements.
Raised an aggregate of $119 million in gross proceeds via an at-the-market equity (ATM) facility and a follow-on primary offering to fuel further innovation and commercial growth.
Acquired UmanDiagnostics AB, the preeminent developer of Nf-L protein antibodies. The acquisition positioned Quanterix to fully support and capitalize on the growing opportunities for Nf-L detection as it relates to the diagnosis, prognosis and monitoring of a wide range of conditions including Alzheimer’s disease, MS, Parkinson’s disease, traumatic brain injury, ALS, Huntington’s disease and others. This acquisition protects the Company’s strong leading Nf-L position and enhances its growth outlook.
Powered more than 85 percent of the Nf-L biomarker research presented at the American Academy of Neurology’s Annual Meeting and nearly 50 publications at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) with its Simoa technology.
Increased publications dramatically by 238, bringing the total to 600 (over 65 percent growth).
Entered into multiple license and supply arrangements for access to Quanterix’ proprietary Nf-L antibodies. The Siemens Healthineers arrangement, marks a critical step toward a clinically relevant Nf-L test for patients. In the second arrangement, Quanterix will supply Nf-L antibodies to Bio-Techne.
Extended the Company’s oncology footprint with the launch of the Simoa SP-X Imaging and Detection System, 10-Plex Simoa CorPlex Cytokine Panel, and broad menu of additional multiplex panels, offering researchers a robust and highly-sensitive solution to test the efficacy and toxicity of immuno-oncology based therapeutics.
Strengthened the Company’s leadership team with the election of Sarah Hlavinka to its Board of Directors, and hiring of Amol Chaubal as Chief Financial Officer, Tatiana Plavina, Ph.D.(formerly of Biogen) as Vice President of Clinical Biomarker Strategy, Hether Ide (formerly of Thermo Fisher Scientific) as Vice President of North American Sales, and Andy Keys (formerly of SomaLogic) as Vice President of Worldwide Pharma Service Sales.
Moved to a new headquarters in Billerica, Mass., which contains the Company’s CLIA-certified lab, Simoa Accelerator Lab and expanding workforce under one roof.
Was the lead sponsor of the fourth-annual Powering Precision Health Summit (PPH) held in Barcelona, a conference dedicated to addressing the critical role of biomarkers in eradicating diseases such as Alzheimer’s and cancer. The summit was sold out and created significant momentum for Quanterix products.
"This past year was a testament to what can be accomplished when you bring the right people, determination and technology together," continued Hrusovsky. "We are encouraged by how our growth catalysts have all lined up for 2020 and feel our market opportunity is compelling."

Webcast Information

To access the live webcast of Quanterix’ presentation at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 15, 2020 at 4 p.m., PST, please visit View Source To access the subsequent Q&A session with Hrusovsky on Wednesday, Jan. 15, 2020 at 4:30 p.m., PST, please visit View Source Replays of the webcasts will be available for a limited period following the conference.

On January 10, 2020 Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic G-NK (FcRγ-deficient Natural Killer) cell therapy to treat multiple cancers, and Lonza reported a strategic partnership (Press release, Indapta Immuno Therapeutics, JAN 10, 2020, View Source [SID1234552994]). Indapta also announced its founding leadership team and scientific advisors.

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Under the terms of the agreement, Lonza will manufacture Indapta’s off-the-shelf, allogeneic G-NK cell therapy under current good manufacturing practices (cGMP) for use in clinical studies. Indapta will leverage Lonza’s process development capabilities and expertise to ensure a robust, reproducible and scalable cGMP process. Process development and manufacturing will take place in Lonza’s state-of-the-art cell and gene therapy manufacturing facility in Houston.

"We believe our first-in-class, off-the-shelf, allogeneic G-NK cell therapy will drive the next critical phase in the evolution of cancer therapies following CAR T-cell therapies," said Guy DiPierro, founder and chief executive officer of Indapta Therapeutics. "Current autologous CAR T-cell therapies have proven efficacy in various hematologic cancers but have been beset with serious clinical and manufacturing challenges. By providing an off-the-shelf solution with our G-NK cell therapy, we can eliminate the need for a patient-specific therapy. Additionally, because our investigational cell therapies are not engineered, they are likely to be more effective, less costly and have a simpler regulatory pathway."

"Lonza, with its demonstrated expertise in cell therapy manufacturing, is the ideal strategic partner to help us advance our clinical program and scale the production of our G-NK cell therapy," said Ronald Martell, co-founder and executive chairman of Indapta Therapeutics. "We are currently completing Investigational New Drug-enabling studies and plan to submit an IND application in late 2020 and initiate a first-in-human Phase 1/2 study in early 2021."

"Indapta’s world-class team of NK cell scientists and clinicians and cell therapy experts has created an innovative off-the-shelf immuno-oncology therapy based on a subset of cancer-killing NK cells that could make a truly meaningful impact in the treatment of hematologic malignancies and solid tumors," said Scott Waldman, chief strategy officer at Lonza.

Alberto Santagostino, senior vice president, head of Cell & Gene Technologies at Lonza, added, "with our long-standing experience in cell therapy manufacturing, we are committed to providing Indapta with the expertise, resources and services it needs for cGMP manufacturing to advance its promising program into the clinic and beyond."

About Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing off-the-shelf, allogeneic FcεRIγ-deficient NK cells, known as G-NK cells.i,ii,iii These proprietary cells are a specific and potent subset of NK cells with specialized anti-tumor activity when used in combination with a monoclonal antibody. G-NK cells are NK cells that have undergone an epigenetic change after coming into contact with cytomegalovirus (CMV)-infected cells. As a result, they lack the FcεRIγ signaling adapter and, instead, use a different adapter protein, which predisposes them to a far more activated state of antibody-dependent cell-mediated cytotoxicity (ADCC) in the presence of a monoclonal antibody. When the monoclonal antibody binds to the tumor target and to the Fc receptor on G-NK cells, it initiates the release of dramatically more immune-stimulating cytokines and cell-killing enzymes than conventional NK cells, causing the direct killing of tumor cells and driving tumor cell death. G-NK cells have been demonstrated to be safe; in vivo studies demonstrate they do not cause graft-vs-host disease or cytokine release syndrome, which can occur with CAR-T cell therapies.

Preclinical research, conducted under NIH grants by scientists at the University of California, San Francisco (UCSF), demonstrated the safety and efficacy of G-NK cells administered in combination with a therapeutic monoclonal antibody. Clinical models of multiple myeloma and lymphoma demonstrated improved survival, a statistically significant decrease in tumor growth, and a statistically significant increase in the activity of the monoclonal antibody without causing graft-vs-host disease. When administered in combination with a monoclonal antibody, G-NK cells have been shown to be highly persistent (lasting four to nine months), to have the ability to preferentially bind to a therapeutic monoclonal antibody in the presence of a tumor cell, and to demonstrate superior ADCC function compared with conventional NK cells. Under a second Indapta NIH grant, researchers at Stanford University will be conducting in vivo studies in additional tumor models.

Indapta’s off-the-shelf G-NK cell therapy is differentiated from an autologous therapy in that it is not necessary to collect cells from each individual patient and produce a unique therapy for every patient. Rather, it is derived from cells from healthy volunteers, which are highly functional and persistent. Indapta’s process for producing G-NK cell therapy for use as an immunotherapy involves taking blood from CMV-seropositive donors, identifying and sorting G-NK cells from these samples, and expanding G-NKs cells using the company’s proprietary, patented expansion method, which preferentially expands and activates GNK cells. Indapta has also developed a proprietary method for freezing and storing the G-NK cells in a GMP master cell bank for use as off-the-shelf allogeneic outpatient immunotherapy in cancer patients.

Developing off-the-shelf G-NK cells may sidestep some of the clinical and financial challenges presented by other, more customized and engineered immuno-oncology approaches, which involve time-consuming and costly manufacturing processes and often can only be delivered in specialized centers. The manufacturing COGS for Indapta’s program will be relatively inexpensive compared to CAR-T or engineered NK cell therapies. Additionally, the regulatory approval process for Indapta’s program may be more straightforward than that for autologous CAR-T cell therapy or engineered NK cells because it does not involve complicated cell engineering.

Not only are G-NK cells widely available from multiple sources, they have the potential to be used in combination with multiple monoclonal antibodies to treat numerous types of cancer (e.g., multiple myeloma, lymphoma, leukemia, melanoma, ovarian, colorectal, renal, liver, breast and lung).

Indapta’s Founding Management Team

Guy DiPierro, Founder and Chief Executive Officer, has over 15 years of experience founding, building, funding and attracting world-leading talent to specialty pharma companies. Prior to Indapta, he was the founder, CEO, chairman and inventor at Chrono Therapeutics. Earlier in his career, he served as Executive Vice President and General Counsel of AMGI Capital. Before that, he was a corporate M&A and technology licensing attorney at Brown and Wood (now Sidley Austin) and Squadron Ellenoff (now Hogen Lovells). He is the inventor on 11 granted U.S. patents and over 36 global and pending patents.
Ronald Martell, Co-Founder and Executive Chairman, has founded, led, built and/or managed a number of unique businesses in the biotech industry during the last 30 years. They include Encellin, ORCA BioSystems, Cetya Therapeutics, HAVAH Therapeutics, Achieve Life Sciences, Sevion Therapeutics, KaloBios, NeurogesX, Poniard Pharmaceuticals, and ImClone Systems. He is currently the president and CEO of Nuvelution Pharma.
Catherine Polizzi, Chief Intellectual Property (IP) Counsel, is a partner at Morrison Foerster, where she assists emerging and established companies in obtaining patents, provides strategic portfolio counseling and management around breakthrough therapies in a variety of areas, including cancer immunotherapy, and offers strategic advice regarding freedom of operation and other forms of IP assessment. She was head IP attorney for Juno Therapeutics, which was acquired by Celgene for $9 billion in part on the strength of the patent portfolio that she crafted.
Austin Bigley, Ph.D., Acting Director of Research and Development, is a member of the Department of Health and Human Performance at the University of Houston. He is an NK cell expert, particularly in how CMV infection modulates NK cell activity against hematologic malignancies; NK cell expansion; ADCC; and the monoclonal antibody-NK cell cytotoxicity domain.
Kathy Leach, Ph.D., Chemistry, Manufacturing & Controls (CMC) and Quality Advisor, was formerly a director of CMC Quality & Analytics at Juno Therapeutics, where she was responsible for the quality strategy and management of key CMC programs for the company’s cell therapy products. Earlier in her career, she was a product quality director at Amgen and a formulation/analytical research scientist at Immunex.
Indapta’s Scientific Advisors

Nina Shah, M.D., Associate Professor, Department of Medicine, UCSF. A hematologist specializing in the treatment of multiple myeloma, Dr. Shah treats patients at the Hematology and Blood Marrow and Transplant Clinic at UCSF. She has expertise in the intersection of immunology and oncology and helping patients fight multiple myeloma by boosting their immune system.
Sungjin Kim, Ph.D., Scientific Founder of Indapta; Inventor and Associate Professor, Department of Medical Microbiology and Immunology, University of California, Davis
John Sunwoo, M.D., Scientific Founder of Indapta; Professor, Stanford University School of Medicine
Todd A. Fehniger, M.D., Ph.D., Associate Professor of Medicine, Washington University School of Medicine
Vaughn Smider, M.D., Ph.D., Associate Professor, Molecular Medicine, The Scripps Research Institute
Arun Witta, M.D., Ph.D., Associate Professor, Department of Laboratory Medicine, UCSF

On January 10, 2020 Fusion Pharmaceuticals Inc., a privately-held, clinical-stage precision oncology company developing next-generation radiopharmaceuticals, reported that Chief Executive Officer John Valliant, Ph.D., will present an overview of the Company at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Fusion Pharmaceuticals, JAN 10, 2020, View Source [SID1234552993]). The presentation will take place on Thursday, January 16, 2020 at 11:00am PST.

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On January 10, 2020 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that in 2019 it entered into agreements with nine new companies (Press release, Adimab, JAN 10, 2020, View Source [SID1234552992]). In addition, Adimab announced the expansion of 11 of its current partnerships and the achievement of 62 technical and development milestones across numerous collaborations.

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Over the past 11 years, Adimab has partnered with over 70 companies for the discovery of therapeutic IgGs and bispecific antibodies, resulting in more than 315 therapeutic programs originating from the Adimab Platform. In 2019, Adimab and its partners added 55 new therapeutic programs. New alliances for 2019 include collaborations with Amagma Therapeutics, Black Belt Therapeutics, BYOMass Inc., Galderma, iOmx Therapeutics, Nextpoint Therapeutics, TRex Bio, and VelosBio. In addition, Adimab expanded its collaborations with Acceleron, Alector, Biotheus, Boehringer Ingelheim, Celgene (now a Bristol-Myers Squibb company), Innovent Biologics, Inc., Novartis, Regeneron, Scholar Rock, Takeda Pharmaceuticals, and others.

In 2019, Adimab also entered into a new Platform Transfer agreement with Takeda Pharmaceuticals.

"We are very happy with the number of new 2019 partnerships," said Guy Van Meter, Chief Business Officer of Adimab. "That said, our most important success metric from a deal perspective is partners coming back for expansions. More than 70% of our current partners, once they have seen our capabilities, have expanded their relationships with us."

"Historically, Adimab has positioned itself as the industry leader for generating the highest quality therapeutic IgGs with exquisite specificity and excellent developability profiles," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab. "We are increasingly expanding into adjacent areas; for example, we are engineering more and more IgGs and non-IgGs derived from other technologies. We are working with many types of bispecific molecules, and our new proprietary CD3 binders have been used in more than ten partnerships."

In the last six years, Adimab has worked with an increasing number of smaller companies backed by leading venture capital firms. Following successful antibody discovery campaigns, many of these companies have gone on to partner their programs with larger pharmaceutical companies. To date, more than 15 programs developed by venture-backed partners have been out-licensed to larger pharma companies. Transactions publicly announced in 2019 include: a Black Belt Therapeutics program out-licensed to CASI Pharmaceuticals, a Dragonfly program out-licensed to Abbvie, Iconic granted an option to Exelixis, Iconic granted an option to Novartis, among others.

On January 10, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, reported that CEO Dr. James A. Hayward and leadership of the Company’s majority-owned subsidiary, LineaRx, Inc., will be meeting with members of the global investment community from January 13 to 15, 2020 in San Francisco concurrent with the JP Morgan 38th Annual Healthcare Conference, the world’s largest healthcare investment symposium (Press release, Applied DNA Sciences, JAN 10, 2020, View Source [SID1234552991]).

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In addition, Dr. Hayward will present an overview of the Company, including its supply chain platform, its diagnostic platform for the blood-based capture of metastatic cells, and review the linear DNA platforms in nucleic acid delivery, gene expression, non-integrated DNA replication, and its robust pipeline of more than 15 contract research opportunities with top cancer, gene therapy, vaccine and RNA partners at the Biotech Showcase 2020 at 3:00 pm PT on Tuesday, January 14, 2020. Dr. Hayward’s presentation will be webcast live at: View Source;tp_key=6924765b8a.