On January 10, 2020 OptiKira, LLC, a privately-held biotechnology company developing drugs that inhibit the unfolded protein response (UPR), reported that it has scheduled a company presentation at the upcoming Biotech Showcase being held in San Francisco from January 13-15, 2020, during the most important week in healthcare (Press release, OptiKira, JAN 10, 2020, View Source [SID1234552979]).

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Dr. Tim Pelura, President and Chief Executive Officer of OptiKira, will be presenting at the Biotech Showcase as follows:

Date: Monday, January 13, 2020
Time: 2:45 p.m. PST (5:45 p.m. EST)
Room: Franciscan B (Ballroom Level)
Venue: Hilton San Francisco Union Square, 333 O’Farrell Street, San Francisco, CA 94102 USA

About Biotech Showcase

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during one of the industry’s largest gatherings and busiest weeks.

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 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported a strategic outlook for 2020 outlining key priorities for its broad pipeline (Press release, Syndax, JAN 10, 2020, View Source [SID1234552980]).

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"We expect 2020 to be an exciting and transformative year for the Company, with significant data read outs anticipated for all three of our innovative pipeline programs, each addressing an unmet need for some of today’s most underserved patient populations," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, this includes the final overall survival readout for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we expect in the second quarter of 2020. Based on compelling survival data from the Phase 2b ENCORE 301 trial, we believe that the combination of entinostat and exemestane has strong potential to serve as an effective therapeutic option for the substantial number of patients who have progressed on first line hormone treatment. We are on track to file for regulatory approval in 2020 and to become a fully-integrated oncology company with the launch of entinostat in HR+ breast cancer expected in 2021."

Dr. Morrison added, "In 2020, we also expect meaningful data readouts from the Phase 1/2 AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias and the Phase 1 dose escalation trial of SNDX-6352, our anti-CSF-1R monoclonal antibody, in patients with cGVHD."

Anticipated Key Milestones for 2020

Entinostat

The Company continues to anticipate that the E2112 trial will reach 410 death events in the second quarter of 2020, triggering the final overall survival (OS) analysis. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.

A positive OS assessment would enable the Company to file for full regulatory approval in the U.S. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a clinically meaningful OS benefit over treatment with exemestane alone. The Company continues to actively engage in expanding its commercial and medical affairs activities, to support the planned launch of entinostat in the U.S.

SNDX-5613

Syndax anticipates presenting initial clinical data from its Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, the Company’s potent, highly selective oral Menin inhibitor, at a medical conference in the fourth quarter of 2020. Given that the AUGMENT-101 trial is open-label, meaningful interim data including pharmacokinetic, pharmacodynamic and efficacy data may be available earlier in the year.

The Phase 1 dose escalation portion of AUGMENT-101 is enrolling adults with relapsed/refractory acute leukemias, including patients with MLL-rearrangements and NPM1c mutations, to establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia, MLL-r acute myeloid leukemia (AML), and NPM1 mutant AML.

SNDX-6352

The Company has also initiated a Phase 2 expansion cohort for SNDX-6352, its anti-CSF-1R monoclonal antibody, for the treatment of chronic graft versus host disease (cGVHD). The decision to move to the Phase 2 expansion was driven by recently announced encouraging proof of concept results from the ongoing Phase 1 dose escalation trial in which the Company observed responses in all evaluable patients as of the data cutoff date, with no dose limiting toxicities reported.

The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks. The Company expects to present results from the Phase 1 trial, for which dose escalation remains ongoing, in the second half of 2020.

On January 10, 2020 Kronos Bio, Inc., dedicated to the development of first-in-class therapies that modulate historically undruggable targets, reported that Norbert Bischofberger, Ph.D., President and Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2020 at 10:30 a.m. Pacific Time (Press release, Kronos Bio, JAN 10, 2020, View Source [SID1234552996]). The event will be held in San Francisco at the Westin St. Francis.

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Launched in May 2018, the company announced a $105 million Series A financing in July 2019 to support the advancement of its Small Molecule Microarray platform (SMM). SMM is ideally suited for the rapid discovery of novel modulators or degraders of historically undruggable targets, such as transcription factors. Kronos has demonstrated SMM’s potential to identify compounds that bind to target proteins directly or interfere at nanomolar potency with protein activity. SMM enables discovery of hits that act through a variety of mechanisms, including disruption of protein-protein or protein-DNA interactions, or indirect modulation of target protein activity by binding to co-factors or other protein complex members.

On January 9, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education, reported that it will host the 2nd Annual Precision Medicine Symposium: An Illustrated Tumor Board (Press release, Physicians’ Education Resource, JAN 9, 2020, View Source [SID1234552942]). The dynamic symposium will take place April 17-18 at InterContinental New York Barclay in New York City and will be chaired by Andre H. Goy, M.D., chairman, executive director, and lymphoma division chief at John Theurer Cancer Center at Hackensack University Medical Center; and chief science officer and director of research and innovation at Regional Cancer Care Associates in Hackensack.

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"We look forward to hosting our precision medicine conference for the second year in a row," said Phil Talamo, president of PER. "This meeting is designed to take a targeted approach to treatment, focusing on how biomarkers and testing strategies can personalize care to patients, often times in a tumor agnostic setting."

Across a two-day, pan-tumor symposium, expert faculty will cover the latest topics in solid and liquid tumors, including lung, breast, gastrointestinal, genitourinary, skin cancers and hematologic malignancies. The educational meeting will feature high-impact sessions and keynote lectures that will focus on practical takeaways regarding the latest updates in next-generation sequencing, liquid biopsy and cytogenetic testing. The program will review updates in targeted treatment, including tumor-agnostic indications based solely on genomic markers and other biomarkers. The tumor board overall will emphasize the role of advanced genetic panel testing and the use of targeted therapies, with a focus on data that is most relevant to patient care.