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Mersana Therapeutics Announces Strategic Priorities and Goals for 2019 and Beyond

On January 4, 2019 Mersana Therapeutics, Inc., (NASDAQ:MRSN) a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet need, reported that after a strategic evaluation the Company will prioritize its resources to focus on the advancement of XMT-1536, a first-in-class ADC candidate targeting NaPi2b. As a result, Mersana and its partner, Takeda, plan to terminate the co-development collaboration for XMT-1522. Mersana will work with investigators to ensure that patients benefitting from XMT-1522 will continue to have access to the therapy as needed.

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"While still in early clinical development, we are encouraged with the safety, tolerability, and activity of XMT-1536 as well as the pace at which the current study is advancing. For this reason, we have decided to focus our resources on advancing XMT-1536, our first-in-class ADC candidate targeting NaPi2b, a clinically validated ADC target broadly expressed in ovarian and non-small cell lung cancer (NSCLC) adenocarcinoma, for which there remains a significant unmet medical need," said Anna Protopapas, President and CEO, Mersana Therapeutics. "We have made the difficult decision to terminate the further development of XMT-1522 despite a favorable emerging profile of efficacy and tolerability due to the competitive environment for HER2-targeted therapies."

"Looking forward, we’re very enthusiastic about our clinical progress with XMT-1536 and the expansion of our clinical pipeline," said Dirk Huebner, M.D., Chief Medical Officer, Mersana Therapeutics. "On behalf of the Company and our partner Takeda we want to thank the patients and their families for their participation in the study, as well as the investigators and our team for their diligent work on the clinical development of XMT-1522. We are committed to leveraging our proprietary ADC platforms to generate a differentiated pipeline of ADCs."

Update on XMT-1536

· XMT-1536 is a first-in-class ADC against a clinically validated target. Ovarian and non-small cell lung cancer (NSCLC) adenocarcinoma express NaPi2b and remain areas of significant unmet need. XMT-1536 has the potential to play a significant role in the treatment of these diseases.

· The data to date from the ongoing XMT-1536 dose escalation study indicate that the trial has reached clinically relevant dose levels but has not yet reached a maximum tolerated dose. The once-every-three-week regimen has been fully explored. The once-every-four-week schedule is currently being evaluated. The 20 mg/m2 dose cohort has been shown to be well tolerated and the 30 mg/m2 is currently being evaluated.

· As of December 31, 2018, the dose escalation study of XMT-1536, in multiple tumor types, includes eight heavily pretreated and evaluable ovarian cancer patients treated at clinically relevant doses. These patients are unselected for NaPi2b expression and had 3 to 11 (median 6) prior regimens in the platinum resistant or refractory setting. Of these eight patients, two achieved a partial response and the remaining six achieved stable disease. The higher dose levels currently being evaluated, as well as additional patient enrollment, provide the opportunity to further define and optimize the profile of XMT-1536.

Mersana Therapeutics 2019 Corporate Goals

XMT-1536

· The Company expects to select a dose for use in its Phase 1 expansion studies and to initiate enrollment of patients in the expansion cohorts in the first half of 2019. The expansion cohorts will focus on platinum-resistant ovarian cancer and NSCLC adenocarcinoma. The Company also plans to utilize its proprietary and validated immunohistochemistry assay to retrospectively determine NaPi2b expression to determine whether a companion diagnostic would facilitate the clinical development of XMT-1536.

· The Company plans to report Phase 1 dose escalation data in the first half of 2019.

Pipeline Expansion

· The Company expects to disclose its next clinical candidate in the second half of 2019 and is targeting the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2020.

Research and Discovery

· Mersana continues to build a pipeline of promising ADCs across a variety of tumor types with significant unmet need, leveraging its three proprietary ADC platforms (Dolaflexin, Dolasynthen, and Alkymer).

· The Company is applying its expertise in ADCs to optimize and validate Immunosynthen, a new platform designed to allow systemic delivery of a potent immunostimulatory molecule to provide optimal efficacy and tolerability.

· Mersana plans to disclose the progress of these research and discovery efforts at scientific meetings throughout the year.

Corporate Developments

· The Company is proactively evaluating the potential for strategic collaborations that maximize the value of each of its pipeline candidates and platforms.

· Mersana is focused on the continued recruitment and retention of top talent, while maintaining a culture of scientific excellence, focused execution, and patient needs.

Upcoming Events

· The Company will provide further details during its presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 9, 2019 at 3:00 pm PT.

Arvinas Receives Authorization to Proceed for its IND Application for PROTAC™ Therapy to Treat Patients with Metastatic Castration-Resistant Prostate Cancer

On January 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for ARV-110, an oral androgen receptor (AR) PROTAC protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Arvinas, JAN 4, 2019, View Source [SID1234532476]). Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in the first quarter of this year.

"This IND clearance is a key step forward for Arvinas and for the field of protein degradation," said John Houston, Ph.D., President and CEO of Arvinas. "Our PROTAC platform has demonstrated exciting promise in preclinical studies and represents an entirely new approach to treating patients with mCRPC and many other diseases. We hope ARV-110 will deliver a much-needed new therapeutic option for patients, and we expect to dose our first patient in the first quarter of 2019."

ARV-110 was developed using Arvinas’ proprietary technology platform – PROTAC (proteolysis-targeting chimera) protein degraders – that uses small molecules to harness the body’s own natural protein recycling system (the ubiquitin proteasome system) to selectively and efficiently remove disease-causing proteins. ARV-110 is a PROTAC protein degrader specifically designed to target and degrade AR, and has demonstrated activity in preclinical models of AR overexpression and AR mutations, which are both common resistance mechanisms to current standard-of-care agents in men with prostate cancer. The Phase 1 study will investigate the safety and tolerability of ARV-110 in patients with mCRPC who have progressed on at least two standard of care treatment regimens and includes exploratory measures of efficacy.

ViewRay Announces First Patient Enrolled in Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) Trial for Locally Advanced Pancreatic Cancer

On January 4, 2019 ViewRay, Inc. (Nasdaq: VRAY) reported the enrollment of the first patient in the Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) Trial, a multi-center, prospective clinical trial for locally advanced or borderline pancreatic cancer (Press release, ViewRay, JAN 4, 2019, View Source [SID1234532472]). The trial will explore the clinical benefits of precise, high dose radiation therapy enabled by MR-guidance combined with daily on-table adaptation in the treatment of pancreatic cancer.

Retrospective analysis of precise, high-dose MR-guided radiation therapy delivered using adaptive dose planning has shown promising results with locally advanced pancreatic cancer, suggesting the potential for improving overall survival relative to patients receiving lower radiation doses, without increasing the rate of serious gastrointestinal toxicity. The compelling nature of the retrospective data prompted the SMART trial, aimed at investigating in a controlled, prospective manner, the robustness of this outcome and tracking quality of life over a 5-year trial period.

"High-definition MR and daily treatment plan adaptation allow us to deliver ablative radiation doses safely to pancreatic cancer patients for the first time ever," said Parag Parikh, M.D., co-PI of the study and Director of GI Radiation Oncology and MR-Guided Radiation Therapy at the Henry Ford Cancer Institute in Detroit. "Through the SMART trial, we will build upon the promising experience from UCLA, Washington University, Amsterdam UMC, University of Miami and University of Wisconsin by further exploring MRIdian’s impact on associated toxicity, local control and patient outcomes in pancreatic cancer at multiple institutions around the world."

The SMART trial is the first prospective, multi-institutional study to deliver ablative doses of radiation to pancreatic cancer patients. It aims to enroll 133 participants with borderline resectable or inoperable locally advanced pancreatic cancer. In the single-arm study, participants will receive radiation therapy at a dose of 50 Gray in 5 fractions (treatment sessions) using ViewRay’s MRIdian. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary.

The trial’s primary outcome measure is grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment, with secondary measures including overall survival at two years, distant progression-free survival at six months, and changes in patient-reported quality of life.

"Early evidence on the use of MRIdian to treat locally advanced pancreatic cancer suggests the potential for significantly prolonged survival and lower toxicity rates. Through this rigorously designed study, we hope to further validate the long-term benefits of treatment on the MRIdian," said Scott Drake, President and Chief Executive Officer of ViewRay. "We believe MRIdian’s unique combination of real-time visualization, automated beam control, and daily on-table treatment adaptation has the potential to become the standard of care in radiation oncology."

Along with Parag Parikh, M.D. from Henry Ford Cancer Institute, the trial is led by Percy Lee, M.D. from the University of California Los Angeles.

For more information on the SMART trial, please visit View Source

About the SMART Trial

The SMART trial is designed to enroll 133 participants with borderline resectable or inoperable locally advanced pancreatic cancer. Patients must be 18 years and older and have documented non-metastatic disease after 3 months of systemic therapy. Radiation therapy will be delivered using ViewRay’s MRIdian at a prescribed dose of 50 Gray (Gy) in 5 fractions. Each participant will be aligned in the treatment system with MRI image-guidance. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary. The primary outcome measure of the study is grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment. Secondary measures include overall survival at two years, distant progression-free survival at six months and changes in patient reported quality of life (pre-treatment to 12 months post-treatment and for longer periods up to five years).

Sangamo Therapeutics To Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 4, 2019 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported that Sandy Macrae, CEO of Sangamo, will present a corporate overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9th at 11:30 a.m. PT in San Francisco (Press release, Sangamo Therapeutics, JAN 4, 2019, View Source [SID1234532471]). Dr. Macrae’s presentation will be followed by a separate Q&A session starting at 12:00 p.m. PT.

The presentation and Q&A session will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentation will be archived on the Sangamo website for two weeks after the event.

Quanterix Marks One-Year Anniversary of IPO with Key Milestones Accelerating Healthcare Disruption Ahead of Presentation at the 37th Annual J.P. Morgan Healthcare Conference

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.

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.