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OncoPep Announces Initiation of Phase 1b Clinical Trial of PVX-410 in
Triple Negative Breast Cancer

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.

Portola Pharmaceuticals Announces AndexXa™ (andexanet alfa), Betrixaban and Cerdulatinib Data to be Presented at 2016 American Society of Hematology Annual Meeting and Exposition

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]).

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.

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)

Myriad Genetics Will Present Results from Six Breast Cancer Studies at SABCS

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]).

"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

Cellectar Biosciences Announces Partnership with Radiopharmaceutical Specialists, CPDC, to Establish Manufacturing Capacity in Anticipation of CLR 131 Pivotal Trial and Commercial Production

On November 28, 2016 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "company"), an oncology-focused, clinical stage biotechnology company, reported it has selected Hamilton, Ontario-based Centre for Probe Development and Commercialization (CPDC), a well-respected GMP manufacturing organization specializing in radiopharmaceuticals, as a supplier of the company’s lead phospholipid drug conjugate (PDC), CLR 131 (Filing, 8-K, Cellectar Biosciences, NOV 28, 2016, View Source [SID1234516808]).

The company believes that CPDC will provide a cost-effective and long-term manufacturing solution. The partnership establishes manufacturing capacity at a level sufficient for both a pivotal trial and future large-scale commercial production. CPDC’s development of further production capability for CLR 131 will significantly enhance the company’s ability to support the anticipated clinical trial activity as it progresses through 2017 while also preparing for a pivotal study and, ultimately, commercialization.

"This partnership with CPDC signals an important milestone in the development of CLR 131; it reflects our confidence in the potential clinical utility of our lead compound and establishes an additional supply source as well as pivotal trial and commercial scale production," said Jim Caruso, president and CEO of Cellectar Biosciences. "As we prepare to initiate our NCI-supported Phase II trial of CLR 131 in multiple myeloma and other hematologic malignancies, it is imperative that we continue to identify optimal pathways to accelerate and further support its development."

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

OncoPep Announces Initiation of Phase 1b Clinical Trial of PVX-410 in Smoldering Multiple Myeloma and Upcoming Presentation of Positive Results from Phase 1/2a Clinical Trial at ASH

On November 28, 2016 OncoPep, Inc. reported the initiation of a Phase 1b clinical trial evaluating PVX-410, a multi -peptide therapeutic cancer vaccine, in patients with moderate or high -risk for progression smoldering multiple my eloma (SMM) , an asymptomatic precursor to multiple myeloma , which is a cancer of the plasma cells (Press release, OncoPep, NOV 28, 2016, View Source [SID1234516818]). The study, led by Noopur Raje, M.D. at Massachusetts General Hospital, will assess the safety and tolerability of PVX-410 in combination with durvalumab with or without lenalidomide. The trial initiation follows the successful completion of a Phase 1/2a dose escalation study of P VX -410 in patients with SMM, the results of which will be presented at the 58 th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held from December 3-6, 2016 in San Diego, California.

"We are encouraged by the results of the Phase 1/2a clinical trial, which demonstrated that PVX-410 is well -tolerated and may elicit a memory T cell response in patients with smoldering multiple myeloma," said Dr. Raje, Director of the Cente r for Multiple Myeloma at the Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School . "In the Phase 1b trial, we are looking to further evaluate the safety and tolerability of PVX-410 in combination with the checkpoint inhibitor, durvalumab, and the immunomodulatory drug, lenalidomide, in hopes that the combination will further augment a tar geted immune-mediated attack against SMM cells and ultimately prevent progression to multiple myeloma .

" The open label Phase 1b study is designed to evaluate the safety and tolerability of PVX-410 and durvalumab with and without lenalidomide in patients w ith SMM. Patients will receive either durvalumab alone, PVX -410 + durvalumab, or PVX -410 + durvalumab + lenalidomide over a three -month treatment phase. The study is expected to enroll approximately 26 patients at multiple trial sites, including Massachuse tts General Hospital. More information on the trial can be found at clinicaltrials.gov , identifier number NCT02886065.

Details of the Phase 1/2a data presentation at ASH (Free ASH Whitepaper) are as follows:

Title: "Final Results of a Phase 1/2a, Dose Escalation Study of PVX -410 Multi -Peptide Cancer Vaccine in Patients with Smoldering Multiple Myeloma (SMM) " Session: Myeloma: Therapy, excluding Transplantation: Poster I Date: Saturday, December 3, 2016 Time: 5:30pm – 7:30pm PST Location: Hall GH, San Diego Convention Center
Results of the Phase 1/2a clinical trial demonstrated that PVX-410 was well -tolerated , with a treatment-emergent adverse event (TEAE) profile that was consistent with that expected . PVX-410 was immunogenic as a monotherapy and in combination with lenalidomide , with the immune response to PVX -410 being enhanced by the addition of lenalidomide.

A total of 22 patients with moderate or high -risk SMM received six bi -weekly subcutaneous injections of PXV-410 at eit her a low dose, target dose, or target dose plus lenalidomide. All patients experienced at least one TEAE, the majority of which were Grade 1 in intensity and occurred within 2 days of PVX-410 injection. No deaths or study drug-related serious adverse events were reported.

An immune response to PVX -410 was demonstrated by an increase in the percentage of tetramer – and interferon- gamma -positive cells in the CD3 + CD8 + T cell population and increases from baseline in interleukin -2 -, tumor necrosis factor -alpha -, and CD137 -positive CD8 + T cells . Moreover , an increase in the effector memory T cell population was seen post -vaccination, a response that was enhanced by the addition of lenalidomide. Among the 12 monot herapy patients, five (two low -dose, three target -dose) experienced progression to active disease withi n nine months post -treatment, and seven had stable disease (SD) at follow -up month 12. Among the nine evaluable PVX ‑ 410 + lenalidomide patients, five achieved at least a minimal response, with 1 patient achieving a partial response . One of these five patients then progressed to multiple myeloma by month five post -treatment. Fou r patients had SD at follow -up month 12.

About Smoldering Multiple Myeloma
Smoldering multiple myeloma (SMM) is a plasma cell proliferative disorder with a high risk of progression to multiple myeloma (MM). It is estimated that SMM accounts for approximately 15% of all newly diagnosed cases of MM, and the annual risk of progressi on from SMM to symptomatic MM requiring treatment is estimated to be 10%. The current standard of care for SMM is watchful waiting, and approaches that intend to delay or prevent progression to symptomatic MM are needed.

About PVX -410
PVX -410 is a novel t herapeutic 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 multiple myeloma -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