On November 28, 2016 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that the company will present preclinical data highlighting the development of its lead molecule BT1718 (Press release, Bicycle Therapeutics, NOV 28, 2016, View Source [SID1234516821]). This program is the first example of its Bicycle Drug Conjugate technology which allows toxins to be targeted to tumour types of high unmet medical need. These data will be presented at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) 2016 Symposium on Molecular Targets and Therapeutics to be held in Munich, Germany from November 29th through December 2nd, 2016.

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Details for the poster presentations at the 28th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) are as follows:

Title: Development of BT1718, a Bicycle Drug Conjugate (BDC) targeting MT1-MMP for treatment of solid tumours

Session: Molecular target agents 1

Poster #: P013

Date & Time: Nov. 29, 11:45 a.m. – 6:30 p.m. CET

Title: Design and characterization of a high affinity and selective bicyclic peptide binder to MT1-MMP for development of a treatment for solid tumours

Session: Drug Design

Poster #: P024

Date & Time: Nov. 30, 10:15 a.m. – 5:00 p.m. CET

On November 28, 2016 Zymeworks Inc., a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer, reported that its abstract has been accepted for Poster Presentation at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held from December 3-6, 2016 in San Diego, California (Press release, Zymeworks, NOV 28, 2016, View Source [SID1234516820]).

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Zymeworks will present at the following session:

Session Information: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I
Abstract Title: ZW38, a Novel Azymetric Bispecific CD19-Directed CD3 T Cell Engager Antibody Drug Conjugate with Controlled T Cell Activation and Improved B Cell Cytotoxicity
Date: December 3, 2016
Time: 5:30 p.m. – 7:30 p.m. PST
Location: San Diego Convention Center, Hall GH

On November 28, 2016 ORN-OncoPep, Inc. reported that a Phase 1b clinical trial is underway to evaluate PVX-410, a multi-peptide therapeutic cancer vaccine, as an adjuvant treatment in patients who have completed all planned therapy for stage II or III triple negative breast cancer (TNBC) (Press release, OncoPep, NOV 28, 2016, View Source [SID1234516819]). The study, led by Steven Isakoff, M.D., Ph.D. at Massachusetts General Hospital, will assess the safety and tolerability of PVX-410 in combination with the checkpoint inhibitor durvalumab.

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"In this Phase 1b clinical trial, we are looking to evaluate the safety of PVX-410 alone and in combination with durvalumab, and to determine whether the vaccine and durvalumab can work together to assist immune system recognition of TNBC," said Dr. Isakoff, Associate Director for Breast Cancer Clinical Research at the Massachusetts General Hospital Cancer Center and Assistant Professor in Medicine at Harvard Medical School. "We are hopeful that this approach will allow immune system recognition of cancer-associated antigens and result in a targeted immune response that can be utilized as a possible adjuvant treatment for stage II or III TNBC."

"The initiation of this Phase 1b clinical trial of PVX-410 in TNBC marks an important milestone in OncoPep’s development," said Doris Peterkin, Chief Executive Officer of OncoPep. "We are now developing PVX-410 in two oncology indications, TNBC and smoldering multiple myeloma, in which we are hopeful that the vaccine will provide enhanced immune targeting of cancer cells for improved patient outcomes."

The multi-center, open label Phase 1b study is designed to evaluate the safety, tolerability, and immune response to PVX-410 alone and in combination with durvalumab in an adjuvant setting in patients who have completed all planned therapy for stage II or III TNBC. Patients will receive six bi-weekly intramuscular injections of PVX-410, which will be given in combination with an intravenous infusion of durvalumab on the day of the 4th and 6th PVX-410 injection. The study is expected to enroll approximately 20 patients at multiple treatment centers, including Massachusetts General Hospital, Beth Israel Deaconess Medical Center, and Dana-Farber Cancer Institute. More information on the trial can be found at clinicaltrials.gov, identifier number NCT02826434.

About Triple Negative Breast Cancer
Triple negative breast cancer (TNBC) is a form of breast cancer that lacks the three receptors found most commonly on breast cancer cells: estrogen receptor (ER), progesterone receptor (PR), and hormone epidermal growth factor receptor 2 (HER-2). TNBC accounts for approximately 15-20% of all breast cancer cases and is more likely to spread and recur than other forms of breast cancer.

About PVX-410
PVX-410 is a novel therapeutic cancer vaccine currently in Phase 1b clinical trials in smoldering multiple myeloma and triple negative breast cancer. PVX-410 consists of four peptides from unique regions of three cancer-associated antigens and is designed to elicit an immune response to the targeted tumor antigens. PVX-410 was granted orphan drug designation from the U.S. Food and Drug Administration in 2013.

On November 28, 2016 Portola Pharmaceuticals (Nasdaq: PTLA) reported that clinical and preclinical results from studies of all three of its investigational drugs — AndexXa (andexanet alfa), betrixaban and cerdulatinib — will be presented at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is taking place from December 3-6 at the San Diego Convention Center (Press release, Portola Pharmaceuticals, NOV 28, 2016, View Source;p=RssLanding&cat=news&id=2225808 [SID1234516814]).

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AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Betrixaban, which has Fast Track designation from the FDA, is an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Cerdulatinib, an oral, dual Syk/JAK kinase inhibitor, is in development to treat patients with resistant or relapsed hematologic cancer.

The abstracts are now available at View Source Following are details of the oral and poster presentations, which will include additional data not available in the abstracts.

AndexXa (andexanet alfa)

Abstract Title: Reversal of betrixaban-induced anticoagulation in healthy volunteers by andexanet alfa
Publication #: 143
Presenting Author: Mark Crowther, M.D., MSc, FRCPC, Professor, Department of Medicine, Hematology and Thromboembolism and Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario
Oral Session Name: 332. Antithrombotic Therapy: Anticoagulation and Bleeding
Presentation Date and Time: Saturday, December 3, 1:00 p.m. PT
Presentation Location: Room 30
Abstract Title: Andexanet alfa reverses anticoagulation effects of enoxaparin and associated bleeding in a rabbit acute hemorrhage model
Publication #: 1445
Presenting Author: Pamela B. Conley, Ph.D., Vice President, Biology, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 3, 5:30-7:30 p.m. PT
Location: Hall GH
Abstract Title: Andexanet alfa, a universal antidote under development for Factor Xa inhibitors, reverses rivaroxaban-induced inhibition of thrombin generation initiated by the intrinsic coagulation pathway independent of TFPI
Publication #: 3831
Presenting Author: Genmin Lu, Ph.D., Senior Scientist, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Betrixaban

Abstract Title: The safety and efficacy of full versus reduced dose betrixaban in the Acute Medically Ill VTE (venous thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial
Publication #: 3824
Presenting Author: Russell Hull, MBBS, University of Calgary, R.A.H. Faculty of Medicine, Alberta, Canada
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Cerdulatinib

Abstract Title: Regulation of B-cell receptor signalling by the tumour microenvironment in chronic lymphocytic leukemia (CLL) and its impact on adhesion and miRNA expression
Publication #: 351
Presenting Author: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton, Southampton, UK
Oral Session Name: 641. CLL: Biology and Pathophysiology, excluding Therapy: CLL Microenvironment: Cell Intrinsic and Extrinsic Factors
Presentation Date and Time: Sunday, December 4, 10:00 a.m. PT
Location: Room 5AB
Abstract Title: Genetic or CD40L-mediated loss of Iκbα is associated with resistance to the dual SYK/JAK inhibitor cerdulatinib in DLBCL cell lines
Publication #: 2768
Presenting Author: Greg Coffey, Ph.D., Senior Scientist II, Portola Pharmaceuticals
Poster Session Name: 605. Molecular Pharmacology, Drug Resistance — Lymphoid and Other Diseases: Poster II
Presentation Date and Time: Sunday, December 4, 6:00-8:00 p.m. PT
Location: Hall GHNovember 28, 2016) – Portola Pharmaceuticals (Nasdaq: PTLA) reported that clinical and preclinical results from studies of all three of its investigational drugs — AndexXa (andexanet alfa), betrixaban and cerdulatinib — will be presented at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is taking place from December 3-6 at the San Diego Convention Center.

AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Betrixaban, which has Fast Track designation from the FDA, is an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Cerdulatinib, an oral, dual Syk/JAK kinase inhibitor, is in development to treat patients with resistant or relapsed hematologic cancer.

The abstracts are now available at View Source Following are details of the oral and poster presentations, which will include additional data not available in the abstracts.

AndexXa (andexanet alfa)

Abstract Title: Reversal of betrixaban-induced anticoagulation in healthy volunteers by andexanet alfa
Publication #: 143
Presenting Author: Mark Crowther, M.D., MSc, FRCPC, Professor, Department of Medicine, Hematology and Thromboembolism and Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario
Oral Session Name: 332. Antithrombotic Therapy: Anticoagulation and Bleeding
Presentation Date and Time: Saturday, December 3, 1:00 p.m. PT
Presentation Location: Room 30
Abstract Title: Andexanet alfa reverses anticoagulation effects of enoxaparin and associated bleeding in a rabbit acute hemorrhage model
Publication #: 1445
Presenting Author: Pamela B. Conley, Ph.D., Vice President, Biology, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 3, 5:30-7:30 p.m. PT
Location: Hall GH
Abstract Title: Andexanet alfa, a universal antidote under development for Factor Xa inhibitors, reverses rivaroxaban-induced inhibition of thrombin generation initiated by the intrinsic coagulation pathway independent of TFPI
Publication #: 3831
Presenting Author: Genmin Lu, Ph.D., Senior Scientist, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Betrixaban

Abstract Title: The safety and efficacy of full versus reduced dose betrixaban in the Acute Medically Ill VTE (venous thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial
Publication #: 3824
Presenting Author: Russell Hull, MBBS, University of Calgary, R.A.H. Faculty of Medicine, Alberta, Canada
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Cerdulatinib

Abstract Title: Regulation of B-cell receptor signalling by the tumour microenvironment in chronic lymphocytic leukemia (CLL) and its impact on adhesion and miRNA expression
Publication #: 351
Presenting Author: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton, Southampton, UK
Oral Session Name: 641. CLL: Biology and Pathophysiology, excluding Therapy: CLL Microenvironment: Cell Intrinsic and Extrinsic Factors
Presentation Date and Time: Sunday, December 4, 10:00 a.m. PT
Location: Room 5AB
Abstract Title: Genetic or CD40L-mediated loss of Iκbα is associated with resistance to the dual SYK/JAK inhibitor cerdulatinib in DLBCL cell lines
Publication #: 2768
Presenting Author: Greg Coffey, Ph.D., Senior Scientist II, Portola Pharmaceuticals
Poster Session Name: 605. Molecular Pharmacology, Drug Resistance — Lymphoid and Other Diseases: Poster II
Presentation Date and Time: Sunday, December 4, 6:00-8:00 p.m. PT
Location: Hall GH

On November 28, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that the Company will present six breast cancer studies at the 2016 San Antonio Breast Cancer Symposium (SABCS) being held Dec. 6-10, 2016 in San Antonio, Texas (Press release, Myriad Genetics, NOV 28, 2016, View Source [SID1234516813]).

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"Myriad Genetics is proud to offer the highest-quality molecular diagnostic tests designed to help prevent breast cancer and improve health outcomes for those with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "We’re excited to present six new studies at SABCS this year, including data on: EndoPredict, a second-generation test that predicts the risk of recurrence; myRisk Hereditary Cancer, the gold standard test to identify people at risk for hereditary breast cancer; and myChoice HRD, an innovative, novel companion diagnostic test to identify optimal pharmaceutical decisions for patients."

A list of the Myriad presentations at SABCS is below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS16.

EndoPredict Presentation

Title: Comprehensive comparison of prognostic signatures for breast cancer in TransATAC.
Presenter: Ivana Sestak.
Date: Friday, Dec.9, 2016: 4:15 p.m. CT.
Location: S6-05; General Session 6 – Hall 3.
myRisk Hereditary Cancer Presentations

Title: Genetic testing for Hereditary Breast and Ovarian Cancer Syndrome among women with a personal diagnosis of breast cancer in patients with Medicaid as compared to patients with private insurance.
Presenter: Paul Baron.
Date: Thursday, Dec. 8, 2016: 5:00 – 7:00 p.m. CT.
Location: Poster P3-10-06.

Title: Trends in age of breast cancer diagnosis for women with pathogenic variants in genes associated with increased breast cancer risk.
Presenter: Heidi Gorringe.
Date: Thursday, Dec. 8, 2016: 5:00 – 7:00 p.m. CT.
Location: Poster P3-08-04.
myChoice HRD Presentations

Title: Homologous repair deficiency (HRD) as a measure to predict the effect of carboplatin on survival in the neoadjuvant phase II trial GeparSixto in triple-negative early breast cancer.
Presenter: Gunter von Minckwitz.
Date: Wednesday, Dec. 7, 2016: 5:00 – 7:00 p.m. CT.
Location: Poster P1-09-02.

Title: BRCA1 methylation status, silencing and treatment effect in the TNT trial: A randomized phase III trial of carboplatin compared with docetaxel for patients with metastatic or recurrent locally advanced triple negative or BRCA1/2 breast cancer (CRUK/07/012).
Presenter: Andrew Tutt.
Date: Friday, Dec. 9, 2016: 3:15 p.m. CT.
Location: S6-01; General Session 6 – Hall 3.

Title: Evaluation of tumor infiltrating lymphocytes (TILs) and their association with homologous recombination deficiency and BRCA1/2 mutation status in triple-negative breast cancer (TNBC): A pooled analysis.
Presenter: Melinda Telli.
Date: Saturday, Dec. 10, 2016: 7:30 – 9:00 a.m. CT.
Location: Poster P6-09-09.
For more information about these presentations, please visit the SABCS website at View Source