On December 7, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported that it will present at the 2018 BMO Capital Markets Prescriptions for Success Healthcare Conference at 1:20 PM ET on Wednesday, December 12, 2018. Live audio of the presentation can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event (Press release, Pacira Pharmaceuticals, DEC 7, 2018, View Source;p=RssLanding&cat=news&id=2379929 [SID1234531942]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On December 7, 2018 Agendia, Inc., a world leader in precision oncology, reported findings from two key studies presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) this week, reinforcing the utility and benefits of its MammaPrint 70-Gene Breast Cancer Risk-of-Recurrence and BluePrint Breast Cancer Molecular Subtyping tests (Press release, Agendia, DEC 7, 2018, View Source [SID1234531959]). Both studies underscore the growing importance of genomic testing in helping physicians to personalize breast cancer treatment management.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BluePrint reclassifies 85 percent of HER2-positive, and clarifies HER2-equivocal breast cancers in a real-world diagnostic setting1

The first study addressed challenges acknowledged within the Aphinity and ExteNET trials regarding the potential benefits of added HER2-targeted treatment in breast cancer as well as the uncertainty regarding the nature of tumors classified as HER2 "equivocal" by traditional immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). A previous trial showed that BluePrint reclassified almost half of HER2-postive/ER-positive patients identified as HER2-positive using IHC/FISH to the Luminal subtype with differential neoadjuvant treatment response.2,3

In this study, Agendia scientists analyzed HER2-positive and HER2-equivocal cancers (as defined by the 2013 CAP Guidelines), comparing IHC/FISH status from pathology results to BluePrint molecular subtype in a real-world diagnostic setting. In IHC/FISH HER2-amplified tumors, BluePrint reclassified 85 percent to non-HER2 molecular subtypes, mostly Luminal-type for ER-positive tumors and Basal-type for ER-negative tumors. BluePrint also classified all HER2-equivocal tumors to non-HER2 subtypes, Luminal and Basal, which could not be derived from IHC/FISH. No HER2 "equivocal" cancers by IHC/FISH displayed a HER2-driven genotype.

Dr. William Audeh, chief medical officer at Agendia, said: "The findings from this real-world study indicate that additional therapeutic options should be considered for some women with clinically HER2-positive cancers with genomic profiles of Luminal or Basal subtypes. These data also provide further precision to clarify the clinical uncertainty regarding the HER2 "equivocal" subtype. This study further reinforces the critical role BluePrint plays in helping to inform more personalized treatment decisions by adding to a growing body of evidence demonstrating the importance of tumor molecular subtyping in breast cancer."

MammaPrint identifies 46 percent of patients under 50 years of age with an intermediate recurrence score as Low Risk4

The second study reevaluated data from the PROMIS (PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score) trial using the same subgroup analyses that was used in the TAILORx trial. It aimed to establish greater certainty regarding the benefits of chemotherapy among female breast cancer patients under 50 with an intermediate recurrence score from the 21-gene assay (RS 18-30). The new analyses found 46 percent of these women had a low genomic risk of recurrence as assessed by MammaPrint and were unlikely to benefit from chemotherapy. Researchers also found that in the MINDACT trial, MammaPrint patients younger than age 45 and between the ages of 45-55 who also have a Low Risk result had a favorable 5-year distant metastasis-free survival of 95-98 percent in both clinically low and high risk groups.

Dr. Hatem Soliman, medical director of clinical trials at the Moffitt Cancer Center and lead study author, said: "The TAILORx trial raised important questions about the benefits of chemotherapy in women under 50, so we were pleased to see that our new subgroup analysis of the PROMIS data, using the same approach as seen in TAILORx, showed that MammaPrint provides greater certainty regarding which women are unlikely to benefit from chemotherapy. Patient quality of life, in the short-term and longer-term, is paramount, so the role of MammaPrint in signaling where physicians can safely de-escalate their patients’ treatments, and thus side effects, is important."

A full list of abstracts featuring MammaPrint and BluePrint presented during SABCS can be viewed here: View Source(2018NOV)%20-%20SABCS%202018%20Abstract%20Summary%20interactive.pdf

1. BluePrint molecular subtyping versus HER2 assessment by immunohistochemistry and FISH in the real-world diagnostic setting. Poster presented at SABCS. December 2018; San Antonio, Texas.

2. Whitworth P, et al., Chemosensitivity Predicted by BluePrint 80-Gene Functional Subtype and MammaPrint in the Prospective Neoadjuvant Breast Registry Symphony Trial (NBRST). Ann Surg Oncol. 2014; 21(10): 3261–3267.

3. Pathological complete response in basal subtype tumors predicts improved distant metastasis free survival in the NBRST trial. Poster presented at ASCO (Free ASCO Whitepaper) 2018; Chicago, Illinois.

4. MammaPrint identifies 46% of patients, age ≤50 years with oncotype RS 18-30, as low risk and safe to forgo chemotherapy. Poster presented at SABCS. December 2018; San Antonio, Texas.

About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

On December 6, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported that data from the Phase 3 RECOVER clinical study was presented during the 2018 San Antonio Breast Cancer Symposium (SABCS) (Press release, Spectrum Pharmaceuticals, DEC 6, 2018, View Source [SID1234531926]). These data confirm the efficacy and safety of ROLONTIS (eflapegrastim) in reducing the Duration of Severe Neutropenia (DSN) in breast cancer patients treated with chemotherapy. ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing treatment with myelosuppressive cytotoxic chemotherapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Despite available treatments, neutropenia remains a critical issue for patients undergoing chemotherapy that puts them at risk for developing life threatening infections," said Lee Schwartzberg, MD, FACP, lead investigator, professor of medicine and division chief, hematology/oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. "The robust data from both Phase 3 studies demonstrate that ROLONTIS has the potential to be a valuable option in the management of neutropenia for patients undergoing treatment with chemotherapeutic agents."

The data released yesterday in a poster presentation from the ROLONTIS Phase 3 RECOVER study (n=237) showed that in Cycle 1, the mean DSN±SD was 0.31±0.688 days for ROLONTIS and 0.39±0.949 days for pegfilgrastim, demonstrating non-inferiority (p<0.0001). The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles (all (p<0.0001)). Incidence of severe neutropenia was 20 percent versus 24 percent in the eflapegrastim and pegfilgrastim arms respectively, with a relative risk reduction of 14 percent in favor of eflapegrastim. There were no statistically significant differences on secondary endpoints such as time to absolute neutrophil count (ANC) recovery, depth of ANC nadir, and incidence of febrile neutropenia between treatment arms across all cycles. None of the ≥Grade 3 study drug related adverse events (AE) occurred in >2% of the patients and included hematologic and bone pain related AEs in both arms.

The RECOVER trial is the second ROLONTIS Phase 3 study to meet the primary efficacy endpoint of non-inferiority in mean DSN. Results from ADVANCE, the first ROLONTIS Phase 3 study, were announced at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and presented at the Multinational Association in Supportive Care in Cancer Annual Meeting (MASCC) earlier this year.

"The RECOVER study is the second Phase 3 study to confirm non-inferiority data and comparable safety profile between ROLONTIS and the current standard of care," said Joe Turgeon, chief executive officer of Spectrum Pharmaceuticals. "Data from both studies, which enrolled 643 patients combined, will be used to support the BLA filing which is expected to be submitted by the end of the year. If approved, we look forward to having a unique opportunity to launch and compete in this large market with the first novel G-CSF in more than 15 years."

About RECOVER

The RECOVER study is a Phase 3, randomized, open-label, active-controlled, multicenter study that enrolled 237 breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized in a 1:1 ratio to receive either ROLONTIS (n=118) or pegfilgrastim (n=119). The primary study endpoint was the DSN in Cycle 1 of chemotherapy (absolute neutrophil count [ANC] <0.5×109/L), based on central laboratory assessment of ANC over a 21 day cycle. There were a total of four cycles evaluated in this study. Secondary endpoints included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at cycle one. Patients with stage I to stage IIIA breast cancer were treated on day one of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On day two of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg).

On December 6, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it will host an investor breakfast meeting on Tuesday, December 11, 2018 at the Convene Conference Center near Grand Central Terminal in New York, N.Y (Press release, BioLineRx, DEC 6, 2018, View Source;p=RssLanding&cat=news&id=2379754 [SID1234531943]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The investor meeting schedule is as follows:

7:45 am EST – Registration and breakfast
8:10-9:30 am EST – Formal presentations

Location:

Convene Conference Center
101 Park Avenue South (near Grand Central Terminal)
New York, N.Y.
(888) 730-7307

The event will feature presentations by Ezra Cohen, MD, FRCPSC, FASCO, from UC San Diego, who will discuss the progress made in the clinical development of immunotherapies beyond checkpoint inhibitors; and Manuel Hidalgo, MD, PhD, from Beth Israel Deaconess Medical Center, Harvard Medical School, on the unmet medical need in treating patients with pancreatic cancer. Both KOLs will be available to answer questions at the conclusion of the event.

BioLineRx’s management team will provide an update on the Company’s clinical development of BL-8040 and AGI-134, as well as a review of recent corporate achievements and the Company’s strategy for 2019. BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4 in late clinical development for the treatment of solid tumors, acute myeloid leukemia (AML) and stem-cell mobilization for bone-marrow transplantation. AGI-134 is a synthetic αGal novel immunotherapy currently in Phase 1/2a development for solid tumors.

Ezra Cohen, MD, is co-Director of the San Diego Center for Precision Immunotherapy and an internationally renowned translational researcher. A physician-scientist, his recent National Institutes of Health-funded work in the study of epidermal growth factor receptor inhibitors in head and neck cancer has contributed to the understanding of the biology of this critical signaling network, integration of these agents into standard of care, and definition of mechanisms to overcome resistance. He recently served as chair of the NCI Head and Neck Cancer Steering Committee that oversees NCI-funded clinical research (including all NCI Cooperative Group trials) in this disease. Dr. Cohen is also Associate Director for Translational Science and leader of the Solid Tumor Therapeutics research program at Moores Cancer Center. Among other roles, he is chair of the Protocol Review and Monitoring Committee (PRMC) and serves as a member of the Cancer Council, and the Cancer Center’s Executive Committee. He has also been the principal investigator on multiple studies of novel agents in head and neck cancer and other solid tumors in all phases of development. Dr. Cohen recently served as editor-in-chief of Oral Oncology.

Manuel Hidalgo, MD, PhD, is Director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and Chief of the Division of Hematology-Oncology at Beth Israel Deaconess Medical Center (BIDMC). He is also the Theodore W. and Evelyn G. Berenson Professor of Medicine at Harvard Medical School. An internationally renowned oncologist, Dr. Hidalgo is a world leader in the testing and development of new agents for pancreatic and other solid tumor cancers. He oversees all BIDMC clinical cancer programs. Dr. Hidalgo is a founder of the Pancreatic Cancer Research Team (PCRT), a private nonprofit cooperative group dedicated to rapid drug development in pancreatic cancer. He is a former member of the Science Committee of Cancer Research UK and a member of the Special Conferences Committee of the American Association of Cancer Research and Scientific Advisory Board of Pancreatic Cancer Action Network. He is also the Director of the Vail Course "Methods on Clinical Cancer Research." Dr. Hidalgo is scientific editor of Cancer Discovery.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay of the event will be accessible here. If you would like to ask a question during the live Q&A portion of the event, please submit your request via email.

On December 6, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has filed a request with the U.S. Food and Drug Administration ("FDA") for Orphan Drug Status for its drug candidate WP1066 (Press release, Moleculin, DEC 6, 2018, View Source [SID1234531927]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Clinical progress with WP1066 has been encouraging," commented Walter Klemp, Moleculin’s Chairman and CEO. "Given its potential to address rare and difficult to treat cancers, including glioblastoma, we believe WP1066 is well positioned to qualify for Orphan Drug Status."

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.