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CIRCULOGENE’s Precision Genomic Profiling Technology Featured in Three AACR 2019 Abstracts

On March 25, 2019 CIRCULOGENE, advancing precision medicine through personalized molecular genetics testing, reported that it will be presenting three abstracts at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, March 29 – April 3, 2019, at the Georgia World Congress Center in Atlanta (Press release, Circulogene, MAR 25, 2019, View Source [SID1234534610]). The poster sessions demonstrate CIRCULOGENE’s rapid, powerful and full-spectrum diagnostics capabilities using proprietary sample preparation coupled with next-generation sequencing (NGS) techniques to assess tumor mutation load at the patient level, even from low-yield, poor quality samples.

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The three posters accepted for presentation are:

Abstract No. 437 / 9: "Combining circulating stromal cells with cell free DNA for increased sensitivity in profiling oncogenic mutations and indicates highly aggressive non small cell lung cancer," investigating the clinical potential of CIRCULOGENE’s Patient Mutation Load (PML) analysis from matched cfDNA, cancer-associated macrophage-like cells (CAMLs), and tumor tissue to evaluate progression free survival (PFS) and overall survival (OS) in non-small-cell lung cancer (NSCLC).
March 31, 2019, 1:00 p.m. – 5:00 p.m. Section 18.
Presenter: Daniel L. Adams, Creatv MicroTech Inc., Monmouth Junction, NJ
Abstract No. 1368 / 7: "Simultaneous cell-free RNA PD-L1 expression and MSI from the same single-tube of blood in solid tumors" investigates the feasibility of simultaneous cfRNA PD-L1 and MSI testing from the same single tube of blood in a liquid biopsy.
April 1, 2019, 8:00 a.m. – 12:00 p.m. Section 19.
Presenter: Glen J. Weiss, M.D., MBA, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA
Abstract No. 4227 / 17: "Salvage genetic testing on buccal swab samples using liquid in situ amplification identifies genetic mutations from previous test failures" presents findings on the application of liquid in situ amplification (LISA) followed by hereditary testing on previously failed buccal swab samples to yield a genetic testing result.
April 2, 2019, 1:00 p.m. – 5:00 p.m. Section 28.
Presenter: Glen J. Weiss, M.D., MBA, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA.
CIRCULOGENE is one of very few liquid biopsy laboratories with preliminary data on the clinical application of cfDNA patient mutational load. Built upon its current 50-gene targeted panel and bioinformatics, CIRCULOGENE’s PML analysis showed promising prognostic value in terms of PFS and OS in NSCLC patients. CIRCULOGENE is looking forward to conducting further studies to unlock the full potential of the PML to improve patient care.

"We’re particularly excited about the potential for using cfDNA (in conjunction with CAMLs) for identification of highly aggressive forms of NSCLC with unfavorable prognosis," said CIRCULOGENE Chief Scientific Officer Chen-Hsiung Yeh, Ph.D. "This research uses our Personalized Gene Profile (CGP) 50-gene panel to determine PML from a single blood sample with increased sensitivity and specificity compared to tumor biopsy. CIRCULOGENE’s unique sample preparation technology was exclusively selected for this study. Given the rarity of CAMLs in the blood, the starting material usually has just a few to several hundred purified CAMLs."

All poster sessions take place in Exhibit Hall B. The full text of Regular Abstracts accepted for presentation are posted on the AACR (Free AACR Whitepaper) Online Itinerary Planner.

The highly accurate, automated and scalable cell-free DNA and RNA technology platform from CIRCULOGENE enables comprehensive genomic testing services. These capabilities help oncologists and pathologists select the right clinical trials and the most effective cancer therapies available for their patients, as well as monitoring patient responses, drug resistance, minimal residual disease and relapse.

CIRCULOGENE is the only company that provides circulating DNA, RNA (somatic and germline), and MSI cancer immunotherapy testing from a single tube of blood. Industry-leading turnaround times ensure that complete testing results are available to physicians and their patients within one week, all from a single 4 mL tube of blood, no matter which test or how many tests are ordered.

CIRCULOGENE is a Clinical Laboratory Improvement Amendments (CLIA) certified and College of American Pathologists (CAP) accredited laboratory and is registered as a verified U.S. federal contractor. For more information, visit our website, connect with us on LinkedIn, Facebook and Twitter, email us at [email protected] or call 855-614-7083. Clinicians interested in ordering tests may visit the Contact page on CIRCULOGENE’s website.

F-star Presents New Data on its Tetravalent Bispecific Antibodies at the AACR 2019 Annual Meeting

On March 25, 2019 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel tetravalent bispecific antibodies that target the immune system to fight cancer, reported that new preclinical data on three immuno-oncology programmes will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, US, held from 29 March – 03 April 2019 (Press release, f-star, MAR 25, 2019, View Source [SID1234534609]).

Neil Brewis, CSO of F-star said "We are excited about this new preclinical data, as it demonstrates the full potential of our tetravalent molecules to leverage a superior anti-tumour response compared to other checkpoint monotherapies, alone or in combination. In addition, our drugs harness a potentially safer mode of action, independent of FcγR-binding, which has been reported to drive systemic cytotoxicity."

FS120 and FS222 are two proprietary F-star assets targeting members of the Tumour Necrosis Factor Receptor Super Family (TNFRSF). FS120 is a first-in-class dual agonist mAb² simultaneously targeting OX40 (CD134, TNFRSF4) and CD137 (4-1BB) while FS222 is an agonist/antagonist mAb² against CD137/PD-L1 (Programmed Death-Ligand 1). Both are on track for IND filings this year.

The preclinical presentations illustrate the synergistic benefit of F-star’s tetravalent mAb² and how both FS120 and FS222 individually outperform combinations of single agents in multiple assays. Furthermore, and in contrast to broader CD3-mediated immune stimulation, F-star programmes promote a more controlled activation of immune effectors. The mAb² also benefit from a safer FcγR-independent profile, especially regarding dose-limiting hepatotoxicity, as supported by data to be presented on FS222.

Finally, F-star will also share preclinical data on a third programme, FS118, a potentially first-in-class bispecific antagonist of LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1. The poster describes FS118’s potential to increase response rates by overcoming the LAG-3-mediated tumour evasion mechanism that often takes place following single agent checkpoint blockade. FS118 is currently investigated in a Phase 1 study in patients who have progressed on or after prior PD-1/PD-L1 containing therapy.

Eliot Forster, CEO of F-star said "We are creating a paradigm shift in the future of cancer treatment and believe our drugs will offer meaningful benefits to patients who are currently poorly responding or non-eligible to other immuno-oncology therapies. In addition, the mAb² format is poised to become a game changer in the industrial landscape, as it maintains the well-established and favourable manufacturing properties of IgG antibodies."

FS118 is under an exclusive option to Merck KGaA, Darmstadt, Germany.

Details of the posters are below:

FS120 communication: Dual agonist bispecific antibody targeting OX40 and CD137 mediates anti-tumour immunity and synergises with PD-1/PD-L1 blockade to improve survival in a syngeneic mouse model

Session Category: Immunology
Session Title: Therapeutic Antibodies 3
Session Date and Time: 01 Apr from 13:00 – 17:00
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
Poster Board Number: 22
Abstract Number: 2398

FS222 communication: FS222 mAb2, a bispecific conditional agonist antibody targeting CD137 and PD-L1, induces potent lymphocyte activation and has a favourable safety profile

Session Category: Immunology
Session Title: Therapeutic Antibodies 2
Session Date and Time: 01 Apr from 08:00 – 12:00
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
Poster Board Number: 09
Abstract Number: 1540

FS118 communication: LAG-3/PD-L1 mAb2 can overcome PD-L1-mediated compensatory upregulation of LAG-3 induced by single-agent checkpoint blockade

IMV Inc. to Present at Two Upcoming Investor Conferences

On March 25, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that IMV Chief Executive Officer Frederic Ors will present at the Spring Investor Summit and the HC Wainwright Global Life Sciences Conference during April 2019 (Press release, IMV, MAR 25, 2019, IMV Inc. to Present at Two Upcoming Investor Conferences [SID1234534608]).

Details on each conference and presentation are as follows:

Venue: Spring Investor Summit, being held April 1-2, 2019

Date of Presentation: Monday, April 1

Time: 8:30 a.m. ET

Location: JW Marriott Hotel, Essex House, New York City

Venue: HC Wainwright Global Life Sciences Conference, being held April 7-9, 2019

Date: Tuesday, April 9, 2019

Time: 10:40 a.m. BST

Location: Stratton Suite, Grosvenor House, A JW Marriott Hotel, London, UK

There will be a live webcast of both of these presentations available in the events, presentations and webcasts section of IMV’s website. Following the presentations, the webcasts will be archived for 90 days and a copy of the presentations will remain available in the same section of the website.

Janssen seeks to expand use of DARZALEX ® ▼ (daratumumab) combined therapy for newly diagnosed multiple myeloma patients not eligible for transplant

On March 25, 2019 Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Type II Variant Application to the European Medicines Agency (EMA) for DARZALEX ▼ (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of newly diagnosed patients with multiple myeloma who are not eligible for autologous stem cell transplantation (GATS) (Press release, Johnson & Johnson, MAR 25, 2019, View Source [SID1234534607]).

"Today’s submission brings us a little closer to our goal of improving treatment outcomes for people newly diagnosed with multiple myeloma," said José Antonio Burón Vidal, vice president of medical affairs, Europe, Middle East and Africa (EMEA) region, Janssen-Cilag Limited. "We are extremely grateful to the patients and researchers who have participated in the MAIA clinical trial program and look forward to working closely with regulatory authorities to gain approval for this new association."

The application is supported by data from the MAIA Phase 3 Study (MMY3008), which was presented at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). 1 The study showed that at a median follow-up of 28 months, daratumumab-Rd significantly reduced the risk of disease progression or death by 44 percent in patients with newly diagnosed multiple myeloma who were not not eligible for transplant compared to treatment with Rd alone (risk ratio [HR] = 0.56, 95% confidence interval [CI]: 0.43-0.73, p <0.0001). 1Median progression-free survival with daratumumab-Rd has not yet been reached, compared to 31.9 months for patients who received Rd alone. 1 The addition of daratumumab resulted in more pronounced responses compared to Rd alone, including increased rates of complete response (CR) or better (48% vs. 25%) and very good partial response (VGPR) or better ( 79% vs. 53%). 1As part of the study, patient health, functional capacity, symptoms, psychosocial well-being and life satisfaction were assessed through measures to assess changes in quality of life related to health using the questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) on the quality of life and the study EQ-5D-5L on the health profile of EuroQol. 2

The most common adverse events during treatment grade 3/4 for daratumumab-Rd (≥10 percent) included neutropenia (50%), lymphopenia (15%), pneumonia (14%), and anemia (12%). 1 Infusion-related reactions occurred in 41% of patients receiving daratumumab-Rd, of whom 3% were grade 3/4. 1 The incidence of the second primary invasive malignancy was 3% in the daratumumab-Rd group compared to 4% in the Rd group alone. 1 EISTs leading to death were 7% in the daratumumab-Rd group, compared to 6% in the Rd group. 1The safety profile of daratumumab was consistent with previous studies. 1,3,4,5,6,7

Daratumumab-Rd is being reviewed by the US Food and Drug Administration (FDA) as part of the Real-Time Oncology Review (RTOR) pilot program.

In Europe, daratumumab is indicated: 8

in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation
as monotherapy for the treatment of adult patients with recurrent and refractory multiple myeloma whose previous treatment included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated progression of the disease during the last treatment
in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy
#END#

About the MAIA 2 study
The randomized, open-label, multi-center Phase 3 study included 737 newly diagnosed patients with multiple myeloma eligible for high-dose chemotherapy and GATS, aged 45 to 90 years (median age 73). Patients were randomized to receive the combination of daratumumab-Rd or Rd alone in 28-day cycles. In the patients treated with daratumumab-Rd combination, patients received weekly 16 milligrams of daratumumab per kilogram (mg / kg) intravenously during cycles 1 and 2, every other week during cycles 3 to 6, and every 4 weeks from cycle 7. Patients in the daratumumab-Rd and Rd alone arm received lenalidomide 25 mg on days 1 to 21 of each 28-day cycle, and a weekly dose of 40 mg dexamethasone in each cycle. Patients from both treatment arms continued until disease progression or an unacceptable degree of toxicity.

About Daratumumab
Daratumumab is a novel genus that targets the CD38 gene, a surface protein that is highly expressed in multiple myeloma cells, regardless of the stage of the disease. 9,10 Daratumumab is thought to induce rapid tumor cell death through numerous immune-mediated mechanisms of action, including complement-dependent cytotoxicity and antibody-dependent cellular phagocytosis, as well as apoptosis in the course of time. which a series of cell steps inside the cell result in the death of the cell. 11A subset of suppressor cells derived from myeloid cells (CD38 + MDSCs), CD38 + regulatory T cells, and CD38 + B cells decreased with daratumumab treatment. 11 Daratumumab is being evaluated in a comprehensive clinical development program across a range of multiple myeloma therapies, including first-line and post-relapse therapies. 2,12,13,14,15,16,17,18 Ongoing or planned studies are being conducted to evaluate its potential in the treatment of other hematologic malignant and pre-malignant diseases in which CD38 is expressed, such as indolent myeloma . 19,20 For more information, please consultwww.clinicaltrials.gov .

For more information about daratumumab, please see the Summary of Product Characteristics at View Source .

In August 2012 , Janssen Biotech, Inc. and Genmab A / S entered into a worldwide agreement that granted Janssen an exclusive license to develop, manufacture and market daratumumab. 21

About Multiple Myeloma Multiple
myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterized by excessive proliferation of plasma cells. 22 More than 48,200 people have been diagnosed with multiple myeloma in Europe in 2018, and more than 30,800 patients have died. 23 Nearly half of newly diagnosed patients do not achieve five-year survival, 24 and nearly 29% of multiple myeloma patients die within one year of diagnosis. 25

Although the treatment may lead to a remission, unfortunately, patients will most likely experience a relapse because there is currently no cure. 26 The refractory multiple myeloma is a disease which progresses within 60 days following the last treatment of the patient. 27,28 Recurrent cancer refers to the return of the disease after a period of initial, partial or complete remission. 29While some patients with multiple myeloma have absolutely no symptoms, the majority of them are diagnosed because of symptoms that may include bone problems, low blood counts, elevated calcium levels, kidney problems, or infections. . 30 Patients who relapse after treatment with standard therapies, including IP and immunomodulatory agents have a poor prognosis and have few treatment options available. 31

Castle Biosciences Announces Presentation of 5-Year Prospective, Multicenter Clinical Outcome Study Confirming Accuracy and Impact of Uveal Melanoma Test

On March 25, 2019 Castle Biosciences, Inc., a cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported that it will present five-year outcomes from a prospective, multicenter study showing that DecisionDx-UM accurately predicts metastatic risk for patients with uveal melanoma and is used by physicians to make patient management decisions based on risk categories determined by the test (Press release, Castle Biosciences, MAR 25, 2019, View Source [SID1234534606]). The study will be presented at the International Society of Ocular Oncology (ISOO) Biennial Conference held March 22-26 in Los Angeles CA.

The CLEAR study (Clinical Application of DecisionDx-UM Gene Expression Assay Results) was designed to track clinical management and metastatic outcomes of patients with uveal melanoma who were tested with the DecisionDx-UM gene expression profile (GEP) test as part of their diagnostic work-up.

"An accurate understanding of metastatic risk is critical to guiding surveillance planning for patients with uveal melanoma since clinicopathologic staging alone is insufficient," commented investigator Thomas M. Aaberg, Jr., M.D., Assistant Clinical Professor at Michigan State University Medical School and ocular oncologist with Retina Specialists of Michigan, who presented the study. "The results from the CLEAR study are consistent with previous publications and confirm the accuracy and clinical utility of the DecisionDx-UM test in clinical practice."

Study Highlights:

89 patients from four centers were enrolled between March 2011 and January 2017. Median follow-up time for patients without metastasis was 4.7 years.
49 patients (55%) had a low-risk Class 1 test result; 40 patients (45%) had a high-risk Class 2 test result.
All patients with Class 2 test results were managed with high intensity surveillance (imaging and/or liver function tests every 3-6 months), while 80% of Class 1 patients were managed with low intensity surveillance (imaging and/or liver function tests at a maximum of once each year) (p<0.0001).
Overall, three (6%) Class 1 patients and 22 (55%) Class 2 patients developed metastasis (p<0.0001). Median time to metastasis was 3.2 years for Class 1 and 2.5 years for Class 2.
Five-year metastasis-free survival rates were 92% for Class 1 and 42% for Class 2 (p<0.0001).
In multivariate analysis including age, ciliary body involvement, largest basal diameter and tumor thickness, the DecisionDx-UM Class 2 result was the only statistically significant predictor of metastasis (p<0.0001).
These findings are consistent with results from previously published prospective studies documenting the accuracy of DecisionDx-UM and impact on patient management.
About DecisionDx-UM

DecisionDx-UM is a GEP test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of uveal melanoma in the majority of ocular oncology practices. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included GEP testing for the identification of Class 1 and 2 as a prognostic factor recommended for clinical care. In 2018, the National Comprehensive Cancer Network (NCCN) published guidelines on uveal melanoma that include the DecisionDx-UM test results of Class 1A, Class 1B and Class 2B as prognostic factors to guide clinical care. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies. In addition, the DecisionDx-UM test result has been shown to be a superior predictor of metastasis compared to chromosome 3 status, mutational status, AJCC stage, and cell type, as demonstrated in multiple studies.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.