Corporate Banner
Satellite Banner
RNAi
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Adaptimmune Announces Opening of Phase I/IIa Clinical Trial

Published: Thursday, July 25, 2013
Last Updated: Thursday, July 25, 2013
Bookmark and Share
Adaptimmune announced that it has opened a Phase I/IIa, multiple-site, two-cohort, open-label clinical trial in ovarian cancer.

Researchers will investigate the safety, bioactivity and effectiveness of treating patients with their own T cells after genetically engineering the cells to enhance their antitumor properties.

“T cells are the foot soldiers of the human immune system, attacking invaders like bacteria, viruses and cancer,” says Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy and the study chair. “We believe that by modifying the T cells so that they express a high-affinity receptor for a protein that is a known cancer/testis (CT) antigen, we can fully exploit their ability as cancer killers.”

During the trial, T cell receptors (TCRs) that have been developed using Adaptimmune’s unique TCR enhancement technology will be deployed to target two CT antigens, NYESO-1 and LAGE-1. They will be transferred to the patients’ T cells in a process for autologous T cell manufacturing developed by Carl June, MD, and Bruce Levine, PhD, at the Perelman School of Medicine at the University of Pennsylvania, Pa., and then licensed to Adaptimmune. Manufacturing will be performed centrally by Progenitor Cell Therapy in Allendale, N.J.

Adaptimmune is the regulatory sponsor, owns the core T cell receptor technology, and is funding the study. Dr. Odunsi is the lead clinical investigator at RPCI and protocol Chair. Mihaela Cristea, MD, associate clinical professor, Medical Oncology, is the lead clinical investigator at City of Hope.

The study is opening on the heels of promising clinical data emerging in sarcoma and myeloma studies, where the same engineered T cell product is under investigation. Interim data from these studies was presented at the American Association for Cancer Research Annual Meeting in March and American Society for Cell and Gene Therapy Annual Meeting in May of this year.

Ovarian carcinoma is the fourth-most-common cancer in women, accounting for approximately 22,000 new cases and 15,000 deaths per year in the United States. With standard therapy, long-term response rates are low, and the five-year survival rate for advanced ovarian cancer is only 30%. The clinical trial focuses on this unmet medical need and will include patients who are resistant to chemotherapy and/or have received more than two lines of chemotherapy for their ovarian cancer.

Infusion of the CT antigen-specific T cells will occur following a brief treatment with relatively high dose of “lymphodepleting” chemotherapy to prepare the patient’s immune system for the gene-modified T cells. Previous clinical trials for different cancer indications have demonstrated that the lymphodepleting chemotherapy procedure is safe and promotes reconstitution of the immune system with the gene-modified T cells.

Dr. Odunsi is also the Chair of Gynecologic Oncology at RPCI and has been studying NY-ESO-1 vaccines in immunotherapy clinical trials for ovarian cancer patients since 2002. “NY-ESO is a very promising tumour antigen that I have worked with for years under the umbrella of the Cancer Vaccine Collaborative (CVC) Program of the Cancer Research Institute and the Ludwig Institute for Cancer Research,” says Dr. Odunsi. “This technology basically allows us to genetically engineer a powerful T cell response in patients against the NY-ESO-1 antigen, which is very exciting.”

Stephen J. Forman, MD, director of the T Cell Therapeutics Research Laboratory at City of Hope, initially brought the Adaptimmune technology to City of Hope due to his long-standing interest in adoptive and engineered T cell therapy for cancer. “The evaluation of this therapy in both hematologic and solid tumors will help us to understand the function of the engineered T cells in different tumor settings,” says Dr. Forman, chair of the Department of Hematology & Hematopoietic Cell Transplantation and holder of the Francis and Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation. “I’m very enthusiastic to have this study join our programs at City of Hope, and to be able to offer our patients these novel and promising therapies.”

A myeloma study using this technology is also planned at the site.

A total of six patients will be enrolled in the ovarian trial. Only patients capable of responding to the therapy — those with the correct tissue marker (HLA-A*0201) and whose tumor expresses NY-ESO-1 and/or Lage-1 — will be enrolled. Enrollment is expected to complete within six to nine months. If data are promising, the study may be extended to include more patients.

“We are enormously pleased to be working with world leaders in immunotherapy for cancer,” says James Noble, CEO of Adaptimmune. “Ovarian cancer is an important clinical indication with which to evaluate our CT antigen specific TCRs because of the dismal prognosis of current standard care for advanced ovarian cancer, so the effects of the T cell immunotherapy can be rapidly assessed.”
Additional study details and contact information for patients interested in finding out more about participation can be found at clincialtrials.gov, under trial identifier number NCT01567891.
Both City of Hope and Roswell Park Cancer Institute are National Cancer Institute-designated Comprehensive Cancer Centers.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,400+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Adaptimmune, Universal cells Collaborate
The companies have announced that they have entered into a collaboration and exclusive license agreement for the development of allogeneic T cell therapies.
Wednesday, December 02, 2015
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Tuesday, July 21, 2015
Adaptimmune Secures $104 Million in Series A Financing
Company will use funding to advance programmes in multiple cancer indications.
Friday, September 26, 2014
Adaptimmune Announces Full-time Appointment of James Noble as CEO
Appointment will become effective from 31st March.
Thursday, March 27, 2014
Adaptimmune Awarded £2.1m from the Biomedical Catalyst Fund
The prestigious award supports Adaptimmune’s clinical pipeline expansion.
Tuesday, March 25, 2014
Adaptimmune Announces Interim Results from a Phase I/II Trial of Engineered T Cells
Study continues to report encouraging response rates, safety and proof of mechanism.
Thursday, December 12, 2013
NeoStem’s Subsidiary, PCT Enters into Services Agreement with Adaptimmune
PCT to provide cell product development and manufacturing for Adaptimmune’s clinical trials.
Thursday, January 24, 2013
Adaptimmune Announces Preliminary Results from an Early Phase Trial of Gene Engineered T Cells
Study reports encouraging response rates, and data support safety and preliminary proof of mechanism.
Tuesday, December 11, 2012
Investigators to Present Preliminary Findings for Adaptimmune’s Gene Engineered T Cells in Myeloma
Presentation of data at the annual ASH meeting on Monday 10 December.
Monday, November 19, 2012
Adaptimmune Announces New Board Appointments
Dr Jonathan Knowles joins the Board as a non-executive director and Dr Helen Tayton-Martin, Adaptimmune’s Chief Operating Officer, becomes an executive director both with immediate effect.
Monday, September 26, 2011
Adaptimmune Announces New Board Appointments as Clinical Programmes Get Underway
Company prepares to open trials in further cancer indications in 2012.
Thursday, September 22, 2011
Adaptimmune Announces Opening of Phase I/II Clinical Trial for Metastatic Melanoma
The Phase I/II, two cohort, open label clinical trial in metastatic melanoma opens at Washington University, St. Louis, Missouri.
Monday, June 20, 2011
Scientific News
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
New Blood Test for The Earlier Diagnosis of Breast Cancer Spread
Researchers at University of Westminster have confirmed that a new blood test can detect if breast cancer has spread to other parts of the body.
First Gene Therapy Successful Against Human Aging
American woman gets biologically younger after gene therapies.
Targeting an ‘Undruggable’ Cancer Gene
RAS genes are mutated in more than 30 percent of human cancers and represent one of the most sought-after cancer targets for drug developers.
Altered Metabolism of Four Compounds Drives Glioblastoma Growth
Findings suggest new ways to treat the malignancy, slow its progression and reveal its extent more precisely.
Improving Engineered T-Cell Cancer Treatment
Purdue University researchers may have figured out a way to call off a cancer cell assassin that sometimes goes rogue and assign it a larger tumor-specific "hit list."
Uncovering How Some Breast Cancers Resist Treatment
A targeted therapy for triple-negative breast cancer (TNBC), the most aggressive form of breast cancer, has shown potential promise in a recently published study.
Characterizing Cancerous Genomic Variations
Tested on large tumor genomics database, REVEALER method allows researchers to connect genomics to cell function.
Activating Cancer-Killing Immune Cells
A UCL research team have discovered that cutting off a sleep-switch on immune cells inside a tumour wakes up the cells and enables the immune system to hunt down and destroy cancer.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!