Adaptimmune has announced the publication of dual abstracts in issue of the Journal Blood, which report preliminary results from an early phase study using patients’ own T cells that have been genetically altered to attack multiple myeloma (MM) cells.
Lead investigators for the study will be presenting the data on December 10th at the annual meeting of the American Society of Hematology (ASH).
The trial was designed as a single arm open label extension study where patients are given standard of care (autologous stem cell transplant) in conjunction with modified T cells.
The critical step in this new approach is that the infused T cells have been genetically engineered to carry receptors that help the T cells recognize and attack a tumor, while sparing healthy tissue.
Study objectives are to evaluate the safety, bioactivity and anti-tumor effect of infusion of patients’ own T cells that have been genetically modified to express a high affinity T cell receptor (TCR) specific for a type of tumor antigen (protein) known as a cancer testis antigen (CT antigen). The target CT antigens in the study are NY-ESO-1 and LAGE-1.
The initial six patient phase is complete and patients have reached a minimum of six month follow-up for assessment of tumor response to the treatment.
Based on the encouraging preliminary results, which will be reported at the conference, the study has been extended to a target enrollment of 26 patients.
To date, infusion of modified T cells have been well tolerated. The data to be reported at the ASH meeting demonstrates prolonged persistence of modified T cells, homing of the cells to marrow (the site of tumor), and suggests anti-tumor activity.
Multiple myeloma is a hematologic cancer localized to the bone marrow. With standard therapy, long- term response rates are low, and the median survival for patients with this disease is three to five years.
The clinical trial focuses on this unmet medical need and includes patients who have received prior treatment for their myeloma or who have disease considered to be high risk, and who are eligible for an autologous stem cell transplant (auto-SCT).
Auto-SCT is the transplant of a patient’s own stem cells, which is a standard of care for treatment of multiple myeloma in the U.S. Infusion of the gene modified T cells occurs just following auto SCT.
Presentations at the ASH meeting will be made on Monday, December 10, in non-overlapping sessions.
Dr. Aaron Rapoport, the Chair of the clinical study, will present abstract 472 entitled “Adoptive Transfer of Gene-Modified T-Cells Engineered to Express High-Affinity TCRs for Cancer Testis Antigens (CTAs) NY-ESO-1 or Lage-1, in MM Patients Post Auto-SCT”.
Dr. Michael Kalos, the lead correlative scientist on the study, will present abstract 755 entitled “Prolonged T Cell Persistence, Homing to Marrow and Selective Targeting of Antigen Positive Tumor in Multiple Myeloma Patients Following Adoptive Transfer of T Cells Genetically Engineered to Express an Affinity-Enhanced T Cell Receptor against the Cancer Testis Antigens.”
In addition, Dr. Carl June, study sponsor and recipient of the 2012 prestigious Ernest Beutler Award for major translational advances, will present data from the study at the Beutler Lecture, also on Monday.
“I am very pleased to speak about this promising study at ASH this year,” says Dr. June. “Adaptimmune’s technology is an important component of the next generation of cancer therapies predicated on harnessing the power of the T cell.”
“From a clinical perspective, I am encouraged by these preliminary findings which will enable us to continue to evaluate T cell therapy for myeloma, and I look forward to the opportunity to present the data for review in a national forum,” says Dr. Rapoport.
Despite the preliminary nature of the study, we have learned a lot already from our careful and integrated analyses of blood, marrow and serum in these patients,” says Dr. Kalos. “This allows us to correlate the engraftment, cytokine production and also changes in target tumor antigen over time, and to demonstrate anti-tumor activity of the infused cells in vivo”.
“We are tremendously pleased with the emerging clinical data in our myeloma programme,” says Dominic Smethurst, Medical Director at Adaptimmune. “We are working with a world class team of investigators, who are very engaged with ensuring the clinical advancement of this technology.”