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Recent News from the Field

Posted By Connections Editor, Monday, August 31, 2015
Updated: Tuesday, August 25, 2015
Amphivena Therapeutics Presents Positive Data on Novel Acute Myeloid Leukemia (AML) Immunotherapy
Amphivena Therapeutics, Inc. announced positive data from several preclinical studies characterizing the company’s proprietary T-cell redirecting bispecific CD33/CD3-targeting antibodies as potential immunotherapeutics for the treatment of AML. Amphivena also announced selection of a development candidate, AMV--‐564, based on these compelling preclinical data.

Alnylam Reports Positive Initial Clinical Results for ALN-CC5, an Investigational RNAi Therapeutic Targeting Complement Component C5 for the Treatment of Complement-Mediated Diseases
Alnylam Pharmaceuticals, Inc. announced initial positive results from its ongoing Phase I/II clinical trial with ALN-CC5, an investigational RNAi therapeutic targeting complement component C5 for the treatment of complement-mediated diseases.

bluebird bio Reports New Beta-Thalassemia Major and Severe Sickle Cell Disease Data from HGB-205 Study at EHA
bluebird bio, Inc. announced long-term follow up of two patients with beta-thalassemia major and early safety and efficacy data in the first patient with severe sickle cell disease treated with LentiGlobin BB305 product candidate in the HGB-205 study.

Baxalta Reports Continued Progress on Phase I/II Clinical Trial of BAX335, Investigational Gene Therapy Treatment for Hemophilia B
Baxalta Incorporated reported continued progress on the Phase I/II open-label clinical trial assessing the safety and optimal dosing level of BAX 335, an investigational factor IX gene therapy treatment for hemophilia B.

Alnylam Reports New Positive Clinical Data for ALN-AT3, a Subcutaneously Administered, Investigational RNAi Therapeutic Targeting Antithrombin (AT) for the Treatment of Hemophilia and Rare Bleeding Disorders
Alnylam Pharmaceuticals, Inc. announced that new positive data from its ongoing Phase I clinical trial with ALN-AT3 – an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders.

Amgen Announces Positive BLINCYTO® (Blinatumomab) Phase II Study Results in Patients with Relapsed/Refractory Philadelphia Chromosome-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
Amgen announced the top-line results of a Phase II open-label, single-arm, multicenter trial to evaluate the efficacy and safety of BLINCYTO® in adults with relapsed or refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia.

ERYTECH Announces Two Positive DSMB Reviews
ERYTECH Pharma announced positive safety reviews after the completion of the first cohort in the company’s US Phase I study with ERY-ASP in acute lymphoblastic leukemia, and following the treatment of the first three patients with ERY-ASP in combination with Folfox in its Phase II study in pancreatic cancer.

TG Therapeutics Announces the Triple Combination of TG-1101, TGR-1202 and Ibrutinib Is Safe and Highly Active in Patients with Advanced B-Cell Malignancies
TG Therapeutics, Inc. announced clinical results from its ongoing study with TG-1101 (ublituximab), the company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with the company’s oral, once-daily, PI3K delta inhibitor, TGR-1202 and ibrutinib, a BTK inhibitor.

Chimerix Completes Targeted Enrollment for Brincidofovir Phase III SUPPRESS Trial
Chimerix, Inc. announced the successful enrollment of the targeted 450 patients in SUPPRESS, the Phase III trial evaluating brincidofovir for the prevention of clinically significant cytomegalovirus infection in hematopoietic cell transplant, also known as bone marrow or stem cell transplant recipients.

Celator® Pharmaceuticals Announces Positive Induction Response Results from Phase III Study of CPX-351 in Patients with High-Risk (Secondary) Acute Myeloid Leukemia
Celator Pharmaceuticals, Inc. announced final induction response rate results in the Phase III study comparing CPX-351 liposome injection to the standard of care regimen in patients with untreated high-risk (secondary) acute myeloid leukemia.

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