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Syntrix Pharmaceuticals Announces Dosing of First Patient in Phase 1/2 Clinical Trial of SX-682 in Combination with KEYTRUDA® (pembrolizumab) in Metastatic Melanoma

On June 20, 2019 Syntrix Pharmaceuticals reported that it has dosed the first patient in its Phase 1/2 clinical trial that will combine SX-682 with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Syntrix, JUN 20, 2019, View Source [SID1234537202]). SX-682 is an oral dual inhibitor of CXCR1 and CXCR2 (CXCR1/2) being developed for the treatment of cancer.

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This open-label clinical trial will evaluate the safety, tolerability, immune response markers, and overall response rates achieved with SX-682 in combination with KEYTRUDA in up to 77 patients with metastatic melanoma. The study is being conducted at the Massachusetts General Hospital and Dana-Farber Cancer Institute.

Patients will receive daily SX-682 monotherapy for three weeks followed by treatment with daily SX-682 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the three-weeks of monotherapy and combination treatments, as well as clinical outcomes observed over the course of the trial. Syntrix expects to report initial clinical data from the trial in the first half of 2020.

"CXCR1/2 is involved in virtually all human tumor types, where it suppresses anti-tumor immunity," said Stuart Kahn, MD, chief medical officer at Syntrix. "This clinical trial will allow us to explore the potential synergies between SX-682 and KEYTRUDA and offers the potential to treat metastatic melanoma that is otherwise poorly responsive to checkpoint inhibitors."

In preclinical studies, SX-682 enhances both PD-1 immune checkpoint blockade and T cell receptor engineered T cell immunotherapies (JCI Insight, Nature and Cancer Cell). Effects include a reduction of myelosuppressive cells in the tumor microenvironment and augmentation of NK and T cell infiltration into the tumor site. Clinical studies show an inverse correlation between CXCR1/2 ligands in the blood and survival of patients treated with anti-PD1 therapy.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

ABOUT SX-682: SX-682 is a clinical-stage oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2). CXCR1/2 are a combined "master switch" of the immunosuppressive tumor microenvironment. Clinical studies have shown an inverse correlation between blood CXCR1/2 ligands and anti-PD1 response and survival. SX-682 has been validated in major solid tumor models, where it exhibits mono-agent activity, blocks metastasis, depletes MDSCs, activates infiltration and killing by immune effector cells, reverses chemo-resistance, and enhances anti-PD1.

NCCN and AstraZeneca Seek Opportunities to Improve Outcomes in Advanced Ovarian Cancer

On June 20, 2019 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) is collaborating with AstraZeneca, a global, science-led biopharmaceutical company, to further quality in cancer care for people with advanced ovarian cancer (Press release, AstraZeneca, JUN 20, 2019, View Source [SID1234537201]). This follows a recently announced and still active request for proposals, also in collaboration with AstraZeneca, on innovative approaches for improving care in unresectable stage III and IV non-small cell lung cancer. Letters of intent are due Monday, July 22, 2019, for this new opportunity, which is available to researchers at any of the 28 NCCN Member Institutions.

"Advanced and recurrent ovarian cancer remains a treatment challenge," explained Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "It’s currently the deadliest gynecologic cancer, and requires a coordinated, multi-disciplinary approach. With this project, we’re looking for research that focuses on how to optimize multiple facets of management effectiveness by harnessing innovative technologies or addressing knowledge gaps."

Some areas of particular interest for proposals include:

Adhering to standard of care management
Delivering care through innovative methods (e.g. telemedicine and/or coordination of care between academic centers and community practices)
Improving adoption of appropriate genetic testing
Discovering new strategies for sharing and implementing novel findings expeditiously
Creating shared decision-making models
Improving the use of supportive services
Utilizing technology to enhance quality of life in patients
Proposals that are reproducible, scalable, rapidly implementable, and provide quantifiable outcome measures are preferred. NCCN ORP is also interested in discovering concepts to reduce financial toxicity, manage care across multiple facilities, increase clinical trial enrollment, and enhance shared decision-making and patient information.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of patients with cancer. Collaboration between NCCN Member Institutions is strongly encouraged in order to cultivate interactive sharing of knowledge and expertise, and to utilize the combined strengths of members. For more information and to read the entire Request for Proposals, visit NCCN.org/ORP.

ImaginAb to Present at SNMMI 2019 Annual Meeting

On June 20, 2019 ImaginAb, Inc., a clinical stage immuno-oncology imaging company, reported that it will attend and present at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held June 22-25, 2019, at the Anaheim Convention Center in Anaheim, California (Press release, ImaginAb, JUN 20, 2019, View Source [SID1234537200]).

ImaginAb will be presenting at the following sessions during the conference.

Imaging the Immune System: CD8+ and Beyond
Ian Wilson, CEO will present during the CMIIT Emerging Technologies session: Emerging Technologies – A Look into the Future of Molecular Imaging and Therapy
Date & Time: Sun, June 23, 5:30 PM – 5:45 PM PDT
Location: Room 201D

PET scanner harmonization for multi-center clinical trials using 89Zr tracers in partnership with Clinical Trials Network (CTN)
Abhinay Joshi, Director of Imaging and Imaging Technologies, ImaginAb, Inc., will be presenting during the session MTA II: Data Analysis & Management Posters
Date & Time: Tuesday, June 25, 3:00 PM – 4:30 PM PDT
Location: Exhibit Hall A

ImaginAb’s lead product, CD8 tracer 89Zr-Df-IAB22M2C (89Zr), is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Currently, in Phase II multi-center clinical trials at world-renowned imaging and cancer centers in North America, the 89Zr ImmunoPET agent detects and visualizes CD8 T cells using ImaginAb’s ‘minibody’ technology. This provides highly-specific, quantitative assessment of the immunological status of individual cancer lesions within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

ImaginAb, in partnership with CTN, has for the first time, implemented the harmonization of image acquisition and reconstruction parameters which are essential in undertaking multi-center 89Zr Immuno-PET imaging clinical trials.

The SNMMI 2019 Annual Meeting – the premier educational, scientific, research and networking event in nuclear medicine and molecular imaging – provides physicians, technologists, pharmacists, laboratory professionals and scientists with an in-depth view of the latest research and development in the field as well as providing insights into practical applications for the clinic.

ImaginAb will be based at Booth 783 in the Exhibition Hall, and in addition to presenting at the conference, will be hosting meetings with clinical investigators, pharmaceutical companies, and partner organizations.

For further information or to schedule a meeting, please contact:

ImaginAb
Ian Wilson
Email: [email protected]
Phone: +1 310 645 1211

Optimum Strategic Communications
Mary Clark, Supriya Mathur
Email: [email protected]
Phone: +44 20 3950 9144

Adaptive Biotechnologies Announces Private Payor Coverage of clonoSEQ for Detecting and Monitoring MRD in Patients with Lymphoid Blood Cancers, Expanding Access to Over 140 Million People in the United States

On June 20, 2019 Adaptive Biotechnologies reported that it has secured contractual agreements or positive medical policies for the clonoSEQ Assay with several of the largest national private health insurers in the United States, as well as significant regional coverage, bringing the total number of covered lives to more than 140 million (Press release, Adaptive Biotechnologies, JUN 20, 2019, View Source [SID1234537199]). The agreements and medical policies expand access to clonoSEQ for minimal residual disease (MRD) testing in patients with lymphoid cancers. clonoSEQ is the first and only FDA-cleared test for assessing and monitoring MRD in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL), helping to track a patient’s cancer and inform treatment decisions. clonoSEQ announced Medicare coverage in January 2019, and private insurer access has steadily increased in the first half of 2019. Coverage of clonoSEQ testing is generally consistent with the assay’s FDA label and includes assessment of MRD at multiple time points throughout therapy to monitor treatment responses and help predict outcomes in patients with MM and ALL.

"There are over 600,000 patients living with lymphoid blood cancers in the United States alone. As patients are living longer than ever before due to new therapies, clinicians need a better tool to monitor disease burden and treatment response on a regular basis," said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. "This positive momentum provides patients with a standardized, accurate and sensitive tool to inform personalized treatment decisions. We look forward to continuing to work with payors around the country to ensure patients in need have access to clonoSEQ."

About the clonoSEQ Assay

The clonoSEQ assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. clonoSEQ testing is covered by Medicare and an expanding list of private payors in alignment with the FDA label.

clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.

AngioDynamics to Report Fiscal 2019 Fourth Quarter and Full-Year Financial Results on July 10, 2019

On June 20, 2019 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that it will report financial results for the fourth quarter and fiscal year 2019 before the market open on Wednesday, July 10, 2019 (Press release, AngioDynamics, JUN 20, 2019, View Source [SID1234537198]). The Company’s management will host a conference call at 8:00 a.m. ET the same day to discuss the results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13691777.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Wednesday, July 10, 2019, until 11:59 p.m. ET on Wednesday, July 17, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13691777.