Amphivena Therapeutics to Present Data on Novel Cancer Immunotherapy at 2015 ASCO Annual Meeting

Positive Preclinical Study Results Support Advancement of Amphivena’s Proprietary Bispecific CD33/CD3-Targeting Therapeutic Candidate into Clinical Development for Treatment of Acute Myeloid Leukemia (AML) 

SAN FRANCISCO, CA, May 26, 2015 Amphivena Therapeutics, Inc., a developer of cancer immunotherapies, today announced that the company will present data from its novel cancer immunotherapy program in acute myeloid leukemia (AML) for the first time in three poster presentations at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29 – June 2, 2015 in Chicago. In multiple studies, Amphivena’s proprietary T-cell redirecting bispecific antibodies demonstrated potent and selective killing of CD33+ AML cells in vitro and impressive activity in AML animal models in vivo. Based on these positive data, Amphivena has selected a lead therapeutic candidate, named AMV-564, to advance into clinical development for the treatment of AML. 

 The details of Amphivena’s poster presentations at ASCO are as follows: 

Abstract Number: 3057 
Poster Board Number: 383 
Poster Title: In vitro and in vivo killing of AML using tetravalent bispecific CD33/CD3 TandAbs 
Session: Developmental Therapeutics – Immunotherapy 
Date and Time: Saturday, May 30 from 8:00 – 11:30 a.m. CT 
Location: S Hall A 

Abstract Number: 7067 
Poster Board Number: 56 
Poster Title: Construction and characterization of novel CD33/CD3 tandem diabodies (TandAbs) for the treatment of acute myeloid leukemia (AML) 
Session: Leukemia, Myelodysplasia, and Transplantation 
Date and Time: Sunday, May 31 from 8:00 – 11:30 a.m. CT 
Location: S Hall A 

Abstract Number: 7071 
Poster Board Number: 60 
Poster Title: Development of a bispecific tetravalent CD33/CD3 TandAb for the treatment of AML 
Session: Leukemia, Myelodysplasia, and Transplantation 
Date and Time: Sunday, May 31 from 8:00 – 11:30 a.m. CT 
Location: S Hall A 

 “We are excited to be sharing our promising study results with the oncology community at ASCO’s annual meeting, and to announce our therapeutic target and lead drug candidate,” said Jeanmarie Guenot, Ph.D., president and chief executive officer of Amphivena Therapeutics. “CD33 is a well validated target in the treatment of AML and we believe that AMV-564 possesses several competitive advantages that position it as a promising compound to best address this target.” 

Under terms of Amphivena’s ongoing agreement with Janssen Biotech, Inc. (Janssen), Janssen has the exclusive right to acquire Amphivena following approval of an Investigational New Drug (IND) application. As part of the agreement, Janssen has provided Amphivena with an initial upfront payment, as well as contingent payments based on achievement of predetermined milestones. 

About AMV-564 

AMV-564 is one of Amphivena’s proprietary first-in-class, tetravalent, bispecific TandAb antibodies. The novel immunotherapy recruits T-cells to eliminate cancer cells that express CD33, a receptor that is expressed on the majority of acute myeloid leukemias (AMLs) and is present on other hematologic malignancies. AMV-564 is bivalent for both CD33 on AML cells and CD3 on T-cells, forming a T-cell activating complex in the presence of target cancer cells. By maintaining the avidity for antigen as found in typical monoclonal antibodies, AMV-564 mediates potent and efficient tumor cell lysis. AMV-564 also offers pharmacokinetic advantages over smaller, monovalent bispecific constructs due to a molecule size that exceeds renal clearance limits. Amphivena is currently completing IND-enabling studies to advance AMV-564 into clinical development as a treatment for AML. 

About Amphivena 

Amphivena Therapeutics, Inc. is a cancer immunotherapy company based in San Francisco, California developing proprietary first-in-class, tetravalent, T-cell redirecting bispecific antibodies for the treatment of hematologic malignancies. The company’s lead drug candidate is AMV-564, a CD33/CD3-targeting treatment for acute myeloid leukemia (AML), which Amphivena is currently preparing to advance into clinical development. In July 2013, Amphivena raised $14 M in a Series A financing led by MPM Capital. Amphivena also has an ongoing agreement with Janssen Biotech, Inc. that grants Janssen the exclusive right at its discretion to acquire Amphivena following IND approval. For more information, please visit www.amphivena.com. 

CONTACTS: 

Amphivena Therapeutics, Inc. 
Jeanmarie Guenot, Ph.D. 
Chief Executive Officer and President 
jguenot@amphivena.com 
415-994-6455 

Vida Strategic Partners (media): 
Tim Brons 
tbrons@vidasp.com 
415-675-7402