On January 4, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, is marking a little over one year since becoming a public company with significant milestones on its path toward revolutionizing healthcare (Press release, Quanterix, JAN 4, 2019, View Source [SID1234532470]). Quanterix’ Chief Executive Officer, President and Chairman will highlight these achievements and future plans during a presentation at the upcoming 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on Wednesday, Jan. 9, 2019 at 2 p.m., PST.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Since going public and listing on the Nasdaq on Dec. 7, 2017 – in one of the most successful IPOs of its kind in recent years – Quanterix has continued to achieve accelerated double-digit, year-over-year revenue growth in each full quarter since the IPO. This has been driven by major investments in the company’s flagship Simoa technology, product expansion, acquisition, publications, global commercialization and accelerating market adoption of digital biomarkers for research.

"The past year has been rewarding for us as a company and we are showing no signs of slowing down," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman of Quanterix. "We are committed to delivering on our promise of advancing the science of precision health and driving today’s healthcare revolution forward. Today we are empowering new advances in disease diagnosis and monitoring, and helping drug makers develop better drugs, and tomorrow we aspire to detect and prevent diseases before they even take hold. We’re already making a tremendous impact in neurology research and are now seeing incredible potential in immunoncology and immunotherapy monitoring as well, where the ability to determine the efficacy and toxicity of drugs earlier could save significant healthcare costs and save lives. We’re excited to return to J.P. Morgan to offer greater insight around our vision, 50% year-to-date growth through Q3’18, Q4’18 expectations and progress toward our greater mission of helping battle cancer and neurodegenerative diseases."

Significant 2018 Achievements:

Launched the SR-X Ultra-Sensitive Biomarker Detection System in January 2018, less than one month after public offering, offering researchers lower-cost and smaller footprint access to Simoa technology.
Acquired Aushon BioSystems and successfully integrated the two companies. The acquisition included a CLIA certified laboratory, expanding services and accelerating entry into pharmaceutical drug trial services, as well as access to novel immunoassay technology to which Simoa sensitivity algorithms are being applied to deliver next-generation Simoa capabilities.
Initiated a collaboration with DestiNA Genomics in an effort to transform microRNA biomarker detection, bringing together high-specificity and ultra-sensitivity for the first time.
Gained unrestricted rights back for its Simoa technology in IVD markets with the termination of a license agreement with bioMérieux.
Increased new publications dramatically by 145, bringing the total to 360 (nearly 50% growth).
Rapid adoption of proprietary Neurofilament light chain (NfL) assay, a biomarker previously mainly measured only in cerebral spinal fluid, but by using Simoa, researchers have shown it can be measured in blood and correlated to central spinal fluid (CSF) results. This advance has enabled many novel applications critical for advancing the early detection, treatment and prevention of neurological diseases, including multiple sclerosis (MS); Parkinson’s disease; Alzheimer’s disease; brain cancer; and traumatic brain injuries (TBIs).
Invited by the FDA to present recent progress and potential future strategy for NfL to senior agency officials.
Announced partnerships with Abbott Labs for blood screening and Oncogenesis for a cervical cancer screening test.
Launched a test bed/early access program for a new next-generation 10-plex Simoa planar array for oncology research and drug development with a benchtop imager called the SP-X Imaging and Analysis System.
Increased headcount from 149 to 181 (>20%) and expanded the leadership team with the hiring of Jackson Streeter, M.D., to lead corporate development and strategy, formerly Chief Medical Officer and Chief Executive Officer of Banyan Biomarkers and Dawn Mattoon, Ph.D., to lead strategic market and assay technology, formerly Head of Product Development at a leading antibody provider.
Ranked number 299 on Deloitte’s Technology Fast 500 and received several noteworthy recognitions for Quanterix’ Chief Executive Officer’s visionary leadership for healthcare disruption.
Last month was added to the Nasdaq Biotechnology Index (NBI) as part of the annual re-ranking and attracted additional analyst coverage.
Was lead sponsor for Powering Precision Health (PPH) annual summit held for the first time in Amsterdam, now an independent, nonprofit entity.
"We are proud of these achievements as they help demonstrate the power of our technology and the disruptive innovation Quanterix is leading in the field of precision health," continued Hrusovsky. "We feel there is still enormous opportunity in front of us as we facilitate industry collaboration, drive research advancement and fuel growth as we pursue minimally invasive digital biomarker disruption in oncology, neurodegeneration, immunology, infectious disease and inflammation.

Webcast Information
To access the live webcast of Quanterix’ presentation at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 9, 2019 at 2 p.m., PST, please visit the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. Replays of the webcast will be available for a limited period following the conference.

On January 4, 2019 Adaptive Biotechnologies, an immune-driven medicine company, reported that it will enter into a worldwide collaboration and license agreement with Genentech, a member of the Roche Group, to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers (Press release, Adaptive Biotechnologies, JAN 4, 2019, View Source [SID1234532469]). The collaboration will combine Genentech’s global cancer immunotherapy research and development leadership with Adaptive’s proprietary T-cell receptor (TCR) discovery and immune profiling platform (TruTCR) to accelerate a transformational new treatment paradigm of tailoring cellular therapy for each patient’s individual cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled that Genentech has selected Adaptive as a partner to develop neoantigen directed T-cell therapies, a personalized approach to cellular therapy," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Genentech brings an industry-leading team of scientists and drug development experts who could potentially enable our patented TCR discovery and immune profiling platform to help as many patients as possible."

Adaptive offers a pioneering technology platform to rapidly identify T-cell receptors (TCRs) that can most effectively recognize and directly target specific neoantigens, which are proteins generated by tumor-specific mutations not present in normal tissues. Through this partnership, Adaptive will utilize the investigational TCR discovery platform to identify the optimal TCRs to most effectively target each patient’s neoantigens for treatment. Genentech will engineer and manufacture a personalized cellular medicine to deliver to each patient. The goal is to harness the vast majority of therapeutically relevant, patient-specific neoantigens and advance the next generation of cellular therapies in oncology.

"We believe targeting neoantigens could be the most effective approach for harnessing a person’s immune system to fight cancer," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This partnership, which combines Adaptive’s pioneering platform for identifying T-cell receptors with Genentech’s cancer immunology expertise, has the potential to change the way cancer is treated and bring us one step closer to truly personalized healthcare."

"Cellular therapy approaches in cancer have been limited by the inability to effectively screen and translate the immune response to patient-specific neoantigens. Accurate recognition of such neoantigens is a major driver in the activity of novel immunotherapies," added Harlan Robins, Ph.D., head of innovation and co-founder of Adaptive Biotechnologies. "Given Adaptive’s unique ability to read and access the immune system at unprecedented scale and precision, Adaptive and Genentech can potentially jointly develop a patient-specific approach to treating cancer."

Under the terms of the agreement, Adaptive will receive $300 million in an initial upfront payment and may be eligible to receive more than $2 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, and royalties on sales. Genentech will have responsibility for clinical, regulatory, and commercialization efforts, and Adaptive will be responsible for patient-specific screening on a global basis.

Adaptive will continue to use its TCR discovery and immune profiling platform to collaborate in the development of cellular therapies in other disease areas, including autoimmune conditions and infectious diseases.

The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to occur in the first quarter of 2019.

Chad Robins, Adaptive CEO, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 8 at 11:30 am PT/2:30 pm ET. Robins will also participate in a panel presentation, Reinventing the Disease Continuum Through Precision Health, on January 7, 2019 at 5:00 pm PT/8:00 pm ET to discuss the impact of immune profiling on the future of immune-driven medicine.

About the TruTCR Screening Platform in this Collaboration

Adaptive’s TruTCR screening platform enables the discovery of TCRs against any type of clinically relevant antigen at high throughput. The platform can be used to identify antigens that are shared among patients as well as those that are specific to individual patients. In this collaboration, TruTCR will be used to identify and characterize clinical-grade superior TCRs for attractive antigen binding and tumor cell killing activity plus safety properties by querying hundreds of antigens simultaneously with high sensitivity. To initiate clinical development, the collaboration will first leverage Adaptive’s growing library of well-characterized antigen-specific TCRs that have been screened against thousands of known cancer antigens in patients. The ultimate goal, however, is to screen and select a patient’s own potent TCRs targeting their own most relevant neoantigens as a personalized therapy. This individual patient screening process will be implemented as part of the manufacturing process for each treated patient to custom tailor a cell therapy medicine for that specific patient’s cancer.

On January 4, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is reported to provide an update on operational and strategic developments at NuGenerex Immuno-Oncology (previously Antigen Express), a wholly-owned subsidiary (Press release, Generex, JAN 4, 2019, View Source [SID1234532468]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The protocol for the Phase II clinical trial of pembrolizumab (Keytruda) in combination with the AE37 Peptide Vaccine in patients with metastatic triple negative breast cancer is under review at the Institutional Review Board (IRB) with oversight of this NSABP Foundation managed study. Site selection has begun, and study drugs are being packaged for shipment to study sites.

"With the initiation of the AE37/PD-1 Inhibitor combination trial and the advancement of the company’s clinical development partnership with Shenzhen BioScien for AE37 in prostate cancer, we have validated the Ii-Key technology, as a viable immunotherapy platform," said Richard Purcell, SVP of R&D at Generex. "The Ii-Key can activate a CD-4 T-cell immune response against any peptide to which it is linked. Given the advances in immunotherapy in the last couple of years, and the potential combinations with checkpoint inhibitors like pembrolizumab, NuGenerex Immuno-Oncology is positioned, with years of clinical experience in immunotherapy of cancer, to explore a range of opportunities for the Ii-Key technology in personalized medicine using tumor-associated antigens and neo-antigens for tumor-specific cancer therapy. To that end, Generex has initiated partnering discussions with synergistic companies to explore co-development and collaborative R&D opportunities for immunotherapeutic product development."

NuGenerex Immuno-Oncology Spin-Out & Stock Dividend

Generex President & Chief Executive Officer Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only advance the NuGenerex Immuno-Oncology core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. As part of our strategy, we are exploring opportunities to spin-out NuGenerex Immuno-Oncology as a separate DTC-eligible SEC registered company." Mr. Moscato stated that following the spin-out, NuGenerex Immuno-Oncology is expected to seek to list its common stock on a national stock exchange. "The spin-out of NuGenerex Immuno-Oncology into a separate, publicly traded entity has been the focus of the Generex strategic development plan in cancer drug development," Mr. Moscato indicated. "The Ii-Key technology has been underappreciated for too long, as we have advanced the immunotherapy field with the largest breast cancer vaccine study ever conducted, and now the results of that trial have led to an exciting combination Phase II trial with AE37 plus Ketruda in triple negative breast cancer. We believe this spin-out will help to unlock the true value of the Ii-Key technology for our stockholders as it creates a pure play in immunotherapy, which will foster investment and collaboration."

The spin-out will be accomplished by the issuance of one or more dividends of NuGenerex Immuno-Oncology stock to Generex stockholders. The record dates in respect of such dividends are yet to be determined and will be announced in due course. The stock dividends will enable Generex stockholders to directly participate in the promising future of NuGenerex Immuno-Oncology as well as create a large shareholder base with the potential for substantial liquidity on an immediate basis. That liquidity will be further enhanced should NuGenerex Immuno-Oncology be successful in attaining a national stock exchange listing, and should provide NuGenerex Immuno-Oncology with ready access to the capital markets to finance its on-going clinical and regulatory initiatives.

Following the issuance of stock dividends, Generex expects to retain a controlling interest in NuGenerex Immuno-Oncology, but the exact proportion of the shares to be held by Generex has not yet been determined.

Subject to market conditions and the satisfaction of regulatory requirements, it is expected that the NuGenerex Immuno-Oncology spin-out will occur sometime following the upcoming Annual Meeting of the Generex stockholders. Generex has formed a committee to seek qualified professionals to populate NuGenerex Immuno-Oncology’s Board of Directors, Scientific Advisory Board, and executive management team. Further announcements in respect of the status of the spin-out are expected to be made over the course of the coming months.

On January 4, 2019 OncoNano Medicine, Inc. reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ONM-100, an intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery (Press release, OncoNano Medicine, JAN 4, 2019, View Source [SID1234532467]). In addition, OncoNano received Fast Track designation from the FDA for ONM-100.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ONM-100 is the first product from a platform based upon the OncoNano’s library of unique micelles that respond to pH variability. Specifically, ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which will allow surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras. The OncoNano micelle platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. OncoNano is currently concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.

"These two positive responses from the FDA reflect the progress that we have made on ONM-100," said Kathy Rath, Vice President, Regulatory Affairs at OncoNano Medicine. "The Fast Track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time."

"We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day," said Yalia Jayalakshmi, Vice President, Clinical Development at OncoNano Medicine. "With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a Phase 2 clinical study in 2019."

On January 4, 2019 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported that Sanjiv Patel, M.D., president and chief executive officer, is scheduled to present an overview of the company’s business and scientific objectives at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 10, 2019 at 11:00 a.m. PT (2:00 p.m. ET) (Press release, Relay Therapeutics, JAN 4, 2019, View Source [SID1234532466]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!