04 Oct 2016

Daiichi Sankyo Announces New Strategic Immuno-Oncology Research Collaboration with AgonOx

 Tokyo, Japan and Parsippany, NJ – (October 4, 2016) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has entered into a strategic collaboration with AgonOx, Inc., a privately held biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, to develop an undisclosed immuno-oncology target.

 Under terms of the agreement, Daiichi Sankyo and AgonOx will collaborate on preclinical development of the program. Following preclinical assessment, Daiichi Sankyo has an exclusive option to research, develop, manufacture and commercialize the program worldwide.  Financial terms of the agreement were not disclosed.

 “We are excited to collaborate with AgonOx, which has extensive expertise in validating the expression and function of immuno-oncology targets,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “While this collaboration will help strengthen our immuno-oncology capabilities, it also aligns with our overall mission of discovering and delivering science that can change the standard of care for patients with cancer.”

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to push beyond traditional thinking to align world-class science to create innovative treatments for patients with cancer. The oncology pipeline of Daiichi Sankyo continues to grow and currently includes more than 20 small molecules and monoclonal antibodies with novel targets in both solid and hematological cancers. Compounds in phase 3 development include: quizartinib, an oral FLT3-ITD inhibitor, for newly-diagnosed and relapsed/

refractory FLT3-ITD+ acute myeloid leukemia (AML); pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT), also known as pigmented villonodular synovitis (PVNS) and giant cell tumor of the tendon sheath (GCT-TS), which also is being investigated in combination with anti-PD1 immunotherapy, pembrolizumab, in a range of solid tumors; and tivantinib, an oral MET inhibitor, for second-line treatment of MET-high hepatocellular carcinoma in partnership with ArQule, Inc. 

 About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000

 

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20 Oct 2014

AGONOX’S OX40 PLATFORM BEING UTILIZED IN MEDIMMUNE’S PHASE 1 OX40 AGONIST STUDY

PORTLAND, Oregon

AgonOx, a biotechnology company focused on immunotherapy development, today announced that its OX40 platform is being utilized in MedImmune’s Phase I trial of its humanized OX40 agonist, MEDI6383. MedImmune is the global biologics research and development arm of AstraZeneca.

OX40 agonists are under clinical development to determine their anti-tumor effect, as they may enhance T-cell stimulation and promote the immune system’s potential to kill tumor cells.MedImmune licensed the OX40 agonist platform in 2011 from AgonOx as the result of a partnership between the Providence Cancer Center and AgonOx, a spin-off company from the Providence Cancer Center.

The phase I multi-center trial (NCT02221960) is designed to evaluate the safety and tolerability of MEDI6383 as a treatment for patients with solid tumors.

This new clinical trial builds upon the translational research and clinical evaluation of an OX40 agonist conducted at the Robert W. Franz Cancer Research Institute at Providence Cancer Center by a research team led by Andrew Weinberg, Ph.D. and Brendan Curti, MD.

“Immuno-oncology is one of the most promising areas of clinical stage drug development today,” said Andrew Weinberg, AgonOx founder and president, and inventor of the OX40 platform for cancer therapy licensed by MedImmune. “The evaluation of this new OX40 agonist, MEDI6383, represents an opportunity to improve immune-based cancer therapies.”

Providence Cancer Center, one of the sites selected by MedImmune to participate in the clinical trial, has recently enrolled their first patient.

“We are excited to be opening a new chapter in OX40 clinical development that is based on the pioneering work of Dr. Weinberg and the team at Providence Cancer Center,” said Dr. Curti, medical oncologist and director of the Providence Biotherapy Program at Providence Cancer Center.

“Using the body’s own immune system as a defense against cancer has been our center’s goal for over 20 years,” said Walter J. Urba, M.D., Ph.D., oncologist and director, Robert W. Franz Cancer Research Center in the Earle A. Chiles Research Institute, Providence Cancer Center. “I am pleased at the prospect of offering this potentially life-saving trial to patients at our center.”

AgonOx is a privately held, biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer. In 2011, in partnership with Providence Health & Services-Oregon, AgonOx entered into an exclusive global partnership with MedImmune, the global biologics arm of AstraZeneca, to develop its OX40 agonist program. Visit http://agonox.com.

Providence Cancer Center, a part of Providence Health & Services, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. The main area of investigation at the Center is immunotherapy, a specialized field of study focused on triggering the immune system to fight cancer. Visit www.providence.org/cancer.

Contacts

AgonOx, Inc.
Grant Risdon, PhD, 206-794-0351
grant.risdon@agonox.com
or
Providence Cancer Center
Jean Powell Marks, 503-215-6433
jean.marks@providence.org

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31 Oct 2011

AGONOX PARTNERS WITH MEDIMMUNE FOR DEVELOPMENT OF OX40 AGONISTS IN CANCER THERAPY

Companies enter into global partnership to advance immune stimulators

PORTLAND, OR Oct. 31, 2011 – AgonOx today announced that it has entered into an exclusive global partnership with MedImmune, the global biologics arm of AstraZeneca, to develop agonists using its OX40 platform. MedImmune will lead further preclinical and clinical studies of this tumor-specific T-cell immunity stimulator for the potential treatment of cancer. “We are very pleased to collaborate with MedImmune to advance our OX40 agonist programs,” said AgonOx CEO Llew Keltner, M.D., Ph.D. “MedImmune has impressive capabilities in immuno-oncology, and we believe offers great potential for eventually bringing therapies utilizing the OX40 mechanism to trigger tumor-specific immune responses to patients.” 

"As the inventor of the OX40 agonist technology, it is gratifying to work with a strong partner to take this significant scientific and therapeutic discovery forward," said Andrew Weinberg, Ph.D., Managing Partner of AgonOx.

MedImmune will also support further OX40 research at Providence Cancer Center, where the foundational preclinical and clinical development of OX40 has been conducted. Additional details of the agreement will not
be disclosed. 

"Typically, the first line of defense against cancer in the body is the immune system," said Walter Urba, M.D., Ph.D., Director of Cancer Research at the Robert W. Franz Cancer Research Center, Portland, Oregon. "OX40 agonists have shown very intriguing preclinical and clinical behavior in specific activation of T-cells to attack tumors, and I am pleased to have MedImmune engaged in moving OX40 forward into additional human studies."

“Our Foundation has been pleased to support the early fundamental and clinical investigations through Drs. William Redmond and Brendan Curti of the Providence Portland Medical Center,” states Howard Soule, Ph.D., Executive Vice President and Chief Science Officer, the Prostate Cancer Foundation.  “We are pleased that a strong partner is now on board to help accelerate development and delivery of this investigational immunotherapy to patients.”
 

About OX40

OX40 is a protein transiently expressed on the surface of effector T-cells, but only after activation of the T-cells by immune-stimulating antigens, including tumor antigens. Binding OX40 with either anti-OX40 antibodies or OX40 ligand compositions has been shown to inhibit apoptosis in such T-cells, causing T-cell proliferation, immune attack on tumors, and sometimes very distinct tumor-specific therapeutic responses.

About AgonOx

AgonOx is developing OX40 agonists and other immune system activators for use in cancer therapy. Research in the field of T-cell modulation conducted worldwide with OX40 and other agents has demonstrated that the use of T-cell modulating therapies in combination with specific anti-tumor therapies has the potential for yielding benefits for patients with cancer. AgonOx is focused on the development of immune system modulators in combination with other therapies, and is actively seeking combination therapies for in-licensing or partnering. Combination therapies of interest include cytotoxic agents, other immunologic modifiers, and tumor ablation techniques and devices. AgonOx is a closely held private company.

About MedImmune

MedImmune, the global biologics arm of AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland.  For more information, visit MedImmune’s website at www.medimmune.com.

About Providence Cancer Center

The Robert W. Franz Cancer Research Center is a world-class research facility located inside the Earle A. Chiles Research Institute at Providence Health & Services in Portland, Oregon.  Founded in 1993 by Dr. Urba and a team of internationally recognized scientists, the Robert W. Franz Cancer Research Center today garners more than $2 million annually in federal grants and has a research staff of 60.  The main area of investigation at the Center is immunotherapy, a specialized field of study focused on triggering the immune system to fight cancer. 
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21 Sep 2011

FOR IMMEDIATE RELEASE

AGONOX ANNOUNCES ISSUANCE OF U.S. PATENT FOR OX40 LIGAND FUSION PROTEINS AND USE IN CANCER THERAPY 

Patent provides additional protection for AgonOx's OX40 agonist platform

PORTLAND, OR September 26, 2011 – AgonOx today announced that the U.S. Patent 7,959,925, “Trimeric OX40 Immunoglobulin Fusion Protein and Methods of Use” was issued recently.  “The OX40 Ligand Fusion Protein has shown high potency for enhancing tumor-specific T-cell immunity in preclinical studies, and this patent adds to the extensive protection AgonOx has in place covering other approaches to use OX40 in the fight against cancer,” said Andrew Weinberg, Ph.D., Managing Partner of AgonOx and pioneer in the discovery and development of OX40.

The issued patent covers both a range of compositions of OX40 Ligand Fusion Proteins and the methods for the use of this family of compounds to stimulate tumor-specific T-cell immunity.  AgonOx holds exclusive rights to the patent from Providence Cancer Center in Portland, Oregon, where the majority of the discovery, preclinical, and clinical work defining OX40 has been conducted.  Coverage of the OX40 Ligand Fusion Protein family adds to AgonOx’s patents covering use of anti-OX40 Antibodies to stimulate tumor-specific T-cell immunity.  

“OX40 is emerging as an exciting target in immuno-oncology, with greatly increased interest following the approval by the FDA of Ipilimumab (Yervoy, BMS) this year,” said AgonOx CEO Llew Keltner, M.D., Ph.D.  “AgonOx continues to expand the potential approaches to OX40 as a promising mechanism for stimulating specific immune attack on patients’ tumors.”

About OX40

OX40 is a protein transiently expressed on the surface of effector T-cells, but only after activation of the T-cells by immune-stimulating antigens, including tumor antigens.  Binding OX40 with either anti-OX40 antibodies or OX40 ligand compositions has been shown to inhibit apoptosis in such T-cells, causing T-cell proliferation, immune attack on tumors, and sometimes very distinct tumor-specific therapeutic responses.  Although many approaches to stimulation of T-cell tumor responses have been attempted over the past few decades, OX40 agonists — which uniquely stimulate ongoing responses to antigens — have the promise for both strong patient benefit and minimal side effects.  In numerous preclinical studies, the ability of OX40 to stimulate tumor-specific CD4+ and CD8+ (memory) T-cells has been documented.  A 30-patient Phase I dose-ranging trial of an anti-OX40 monoclonal antibody verified the preclinical results and demonstrated strong statistically significant correlation between increased T-cell proliferation in patients who did not clinically progress after anti-OX40 treatment.  Additional clinical studies of OX40 agonists in patients with prostate cancer are ongoing, and a breast cancer clinical trial will begin soon.

About AgonOx

AgonOx is developing OX40 agonists for use in cancer therapy.  Research in the field of T-cell modulation conducted worldwide with OX40 and other agents has demonstrated that the use of T-cell modulating therapies in combination with specific anti-tumor therapies has the potential for yielding dramatic benefits for patients with cancer.  AgonOx is focused on the development of OX40 in combination with other promising therapies, and is actively seeking combination therapies for in-licensing or partnering, to augment AgonOx’s OX40 development and pending marketing partnership with a major pharmaceutical company.  Combination therapies of interest include cytotoxic agents, other immunologic modifiers, and tumor ablation techniques and devices.  AgonOx is a closely held private company.
 

About Providence Cancer Center

The Robert W. Franz Cancer Research Center is a world-class research facility located inside the Earle A. Chiles Research Institute at Providence Health & Services in Portland, Oregon. Founded in 1993 by Dr. Walter Urba and a team of internationally recognized scientists, the Robert W. Franz Cancer Research Center today garners more than $2 million annually in federal grants and has a research staff of 60.  The main area of investigation at the Center is immunotherapy, a specialized field of study focused on triggering the immune system to fight cancer.