On November 29, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that the first patient has been dosed in its Phase 1b clinical trial of TRC105 in combination with Opdivo (nivolumab) in patients with non-small cell lung cancer (Press release, Tracon Pharmaceuticals, NOV 29, 2017, View Source;p=RssLanding&cat=news&id=2319234 [SID1234522312]).

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"Endoglin is expressed on activated myeloid derived suppressor cells, a cell type implicated in tumor resistance to immunotherapy. To date, we have observed promising signs of activity with our endoglin antibodies in combination with PD-1 inhibitors in a number of preclinical syngeneic mouse tumor models," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are excited to advance a combination of TRC105 with an immune oncology agent into the clinic to further assess our antibody’s immunomodulatory activity."

About the Phase 1b Clinical Trial of TRC105 and Opdivo in Lung Cancer

The Phase 1b clinical trial is an open-label, dose-escalation and expansion cohort study of TRC105 and Opdivo in patients with non-small cell lung cancer that have received prior chemotherapy. The primary objectives of the Phase 1b study are to assess the safety of TRC105 when given with Opdivo, determine its recommended Phase 2 dose with Opdivo and evaluate the response rate. The trial incorporates tumor biopsy testing to correlate tumor myeloid cell infiltration with response, in order to allow for potential biomarker-directed therapy of lung cancer patients.

Further details of the study are available on www.clinicaltrials.gov, identifier NCT03181308.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in the pivotal Phase 3 TAPPAS trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

On November 29, 2017 Bristol-Myers Squibb Company (NYSE: BMY) reported 33 presentations from Company-sponsored studies, collaborations and investigator-sponsored research evaluating Opdivo (nivolumab), Sprycel (dasatinib) and Empliciti (elotuzumab), will be featured at the 59th Annual Meeting & Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta, Ga. from December 9-12 (Press release, Bristol-Myers Squibb, NOV 29, 2017, View Source [SID1234522302]).

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Presentations across tumor types, including Hodgkin and non-Hodgkin lymphomas, leukemia and multiple myeloma, reinforce Bristol-Myers Squibb’s deep expertise in hematologic cancers and commitment to advancing science to improve patient outcomes.

Data to be presented by Bristol-Myers Squibb include:

Classical and Non-Hodgkin Lymphoma

Results from a phase 1/2 study of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma
Author: A. Herrera
Abstract: #649
Oral Session: 624. Hodgkin Lymphoma and T/NK Cell-Lymphoma-Clinical Studies: Hodgkin Lymphoma Immunotherapy studies; nodular lymphocyte predominant Hodgkin Lymphoma clinical studies
Monday, December 11, 10:30 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Nivolumab treatment beyond investigator-assessed progression: outcomes in patients with relapsed/refractory classical Hodgkin lymphoma from the phase 2 CheckMate -205 study
Author: J. Cohen
Abstract: #650
Oral Session: 624. Hodgkin Lymphoma and T/NK Cell-Lymphoma-Clinical Studies: Hodgkin Lymphoma Immunotherapy studies; nodular lymphocyte predominant Hodgkin Lymphoma clinical studies
Monday, December 11, 10:45 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Nivolumab for newly diagnosed advanced-stage classical Hodgkin lymphoma: results from the phase 2 CheckMate -205 study
Author: R. Ramchandren
Abstract: #651
Oral Session: 624. Hodgkin Lymphoma and T/NK Cell-Lymphoma-Clinical Studies: Hodgkin Lymphoma Immunotherapy studies; nodular lymphocyte predominant Hodgkin Lymphoma clinical studies
Monday, December 11, 11 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Safety and efficacy of the combination of ibrutinib and nivolumab in patients with relapsed non-Hodgkin lymphoma or chronic lymphocytic leukemia
Author: A. Younes
Abstract: #833
Oral Session: 642. CLL: Therapy, excluding Transplantation: New Agents, Infections and PET/CT
Monday, December 11, 5:30 PM EST, Georgia World Congress Center, Building B, Level 5, Murphy BR 3-4
Expression of major histocompatibility complex class II, but not MHC class I, predicts outcome in patients with classical Hodgkin lymphoma treated with nivolumab (programmed death-1 [PD-1] blockade)
Author: M. Roemer
Abstract: #1450
Poster Session: 621. Lymphoma-Genetic/Epigenetic Biology: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Cost effectiveness of nivolumab for the treatment of relapsed/refractory classical Hodgkin lymphoma after failure of autologous stem cell transplantation and treatment with brentuximab vedotin treatment in Australia
Author: M. Tan
Abstract: #2166
Poster Session: 904. Outcomes Research-Malignant Conditions: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Effect of nivolumab on patient-reported outcomes in patients with relapsed/refractory classical Hodgkin lymphoma after autologous transplantation: results from the multicohort phase 2 CheckMate -205 study
Author: A. Engert
Abstract: #3441
Poster Session: 904. Outcomes Research-Malignant Conditions: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Economic burden in U.S. patients with relapsed or refractory classical Hodgkin lymphoma treated with brentuximab vedotin or chemotherapy after failure of autologous hematopoietic cell transplantation
Author: C. Chen
Abstract: #4705
Poster Session: 902. Health Services Research-Malignant Conditions: Poster III
Monday, December 11, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Multiple Myeloma

Elotuzumab plus lenalidomide/dexamethasone vs Ld in patients with newly diagnosed multiple myeloma: phase 2, randomized, open-label study in Japan
Author: N. Takezako
Abstract: #434
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Upfront Therapy for Multiple Myeloma: Induction and Maintenance
Sunday, December 10, 12:15 PM EST, Georgia World Congress Center, Building C, Level 1, Hall C4
Duration of treatment of multiple myeloma regimens in patients with relapsed or refractory multiple myeloma: findings in U.S. clinical practice settings
Author: R. Potluri
Abstract: #1844
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Treatment sequencing patterns observed in patients treated initially with lenalidomide/dexamethasone combination as frontline multiple myeloma therapy
Author: C. Chen
Abstract: #3127
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Treatment patterns and associated outcomes in patients with relapsed or refractory multiple myeloma in the U.S. and non-U.S. countries: findings from PREAMBLE
Author: R. Vij
Abstract: #3123
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Healthcare resource utilization and costs associated with different treatment modalities of relapsed/refractory multiple myeloma patients in the U.S.: findings from PREAMBLE
Author: D. Kuter
Abstract: #3157
Poster Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Leukemia

CA180-372: An international collaborative phase 2 trial of dasatinib and chemotherapy in pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia
Author: S. Hunger
Abstract #98
Oral Session: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Advances in the Treatment of ALL
Saturday, December 9, 9:45 AM EST, Georgia World Congress Center, Building C, Level 2, Hall C211-C213
Dasatinib discontinuation in patients with chronic-phase chronic myeloid leukemia and stable deep molecular response
Author: N. Shah
Abstract: #314
Oral Session: 632: Chronic Myeloid Leukemia: Therapy: Treatment Discontinuation, Dose Reduction and Prognostic Indicators
Sunday, December 10, 7:45 AM EST, Georgia World Congress Center, Building A, Level 4, Marcus Auditorium
Impact of earlier vs. later monitoring on disease progression and economic outcomes among patients with chronic myeloid leukemia in the real-world setting
Author: E. Jabbour
Abstract: #2175
Poster Session: 904. Outcomes Research—Malignant Conditions: Poster I
Saturday, December 9, 5:30-7:30 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Cytogenetic and molecular responses by two years in SIMPLICITY, an observational study of chronic-phase chronic myeloid leukemia patients in routine clinical practice
Author: J. Cortes
Abstract: #2894
Poster Session: 632. Chronic Myeloid Leukemia: Therapy: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2
Economic modeling of the potential impact of chronic myeloid leukemia monitoring on healthcare costs
Author: E. Jabbour
Abstract: #3378
Poster Session: 902. Health Services Research—Malignant Conditions: Poster II
Sunday, December 10, 6-8 PM EST, Georgia World Congress Center, Building A, Level 1, Hall A2

On November 29, 2017 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead development candidate IMO-2125 in combination with Ipilimumab for the treatment of anti-PD-1 refractory metastatic melanoma in combination with ipilimumab therapy (Press release, Idera Pharmaceuticals, NOV 29, 2017, View Source [SID1234522339]). FDA’s Fast Track program is designed to expedite the development and review of drugs and biologics to treat serious or life-threatening conditions with non-clinical or clinical data demonstrating the potential to address unmet medical needs. Such drugs may qualify for Fast Track designation.1

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"This Fast Track designation represents another positive step for the development of IMO-2125 and is a clear recognition of the serious unmet need that exists for patients who do not benefit from anti-PD-1 therapy," stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer. "We’re thrilled with the dramatic response rate that has been observed to date so far with IMO-2125 in combination with ipilimumab and are eager to continue enrolling more patients through both the Phase 2 expansion of our ongoing trial and initiating the Phase 3 trial early next year."

About Fast Track Designation1
Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions. A drug that is intended to treat a serious or life-threatening condition with nonclinical or clinical data that demonstrate the potential to address an unmet medical need may qualify for Fast Track designation. When Fast Track designation is requested later in development, available clinical data should demonstrate the potential to address an unmet medical need. There are opportunities for frequent interactions with the review team for a fast track product. In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission.

About IMO-2125
IMO-2125 is a toll-like receptor (TLR) 9 agonist that received orphan drug designation from the FDA in 2017 for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors in refractory melanoma patients. Currently approved immuno-oncology treatments for patients with metastatic melanoma, specifically checkpoint inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy making them so-called "refractory." The combination of ipilimumab and IMO-2125 appears to activate an immune response in these patients who have exhausted all options. Intratumoral injections with IMO-2125 are designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths. The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016. Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.

On November 28, 2017 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that Will Lewis, President and Chief Executive Officer of Insmed, will present at the Nasdaq 37th Investor Conference in London on Tuesday, December 5, 2017 at 9:15 a.m. GMT (Press release, Insmed, NOV 28, 2017, View Source [SID1234522273]).

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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

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The presentation will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. The webcast will be archived for a period of 90 days following the conclusion of each live event.

On November 28, 2017 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, reported that Paul C. Grint, M.D., Chief Executive Officer, will present a company overview at the LD Micro 10th Annual Main Event, on Tuesday, December 5, 2017, at 10:30 a.m. PST (1:30 p.m. EST), in Los Angeles (Press release, AmpliPhi Biosciences, NOV 28, 2017, View Source [SID1234522269]).

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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

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The presentation will be available on the Events and Presentations page in the Investor Relations section of AmpliPhi’s website at www.ampliphibio.com.