Date: 2016-12-03
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 58th American Society of Hematology (ASH) Annual Meeting
Company: Atara Biotherapeutics (USA - CA)
Product: CMV-CTL
Action
mechanism: cell therapy/immunotherapy product. Atara's CMV-CTL utilizes a technology in which T-cells are collected from the blood of third-party donors and then exposed to CMV antigens. The resulting activated T-cells are then expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen, or HLA, matched patient, providing an allogeneic, cellular therapeutic option for patients. In the context of CMV infection, Atara's CMV-CTL finds the cells expressing CMV and kills them. CMV-CTL is currently being studied in an ongoing Phase 2 clinical trial.
Disease: refractory cytomegalovirus (CMV) chorioretinitis, meningoencephalitis
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On December 3, 2016, Atara Biotherapeutics announced that its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) are reporting Phase 2 results for Atara's allogeneic T-cell product candidate, CMV-CTL, during the 58th ASH Annual Meeting being held in San Diego, California. Data from the Phase 2 trial describe the efficacy and safety of CMV-CTL in the treatment of 15 patients with documented CMV mutations conferring resistance to anti-viral therapies. Patients had received a median of 3 prior therapies before receiving allogeneic CMV-CTL. CMV-CTL is an investigational therapy in which a healthy donor's T-cells are stimulated to recognize CMV antigens, or viral proteins, expressed in the cells of patients infected with CMV. * On December 6, 2015, Atara Biotherapeutics announced that its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) are reporting additional Phase 2 clinical data for Atara's CMV-CTL product candidate during the 2015 ASH Annual Meeting. The data describe the safety and efficacy of CMV-CTL in the treatment of patients with refractory CMV chorioretinitis and meningoencephalitis. Dr. Susan Prockop, M.D. and colleagues are reporting the following positive clinical data from an ongoing Phase 2 clinical trial and patients treated under compassionate use:
Dr. Susan Prockop, M.D. and colleagues are reporting the following clinical results from the trial:
Response Rate: 73.3% with 6 complete responses (CR) and 5 partial responses (PR).
6-month Overall Survival: 72.7% in responders (CR+PR) versus 25% in non-responders.
Safety: 16 grade ? 3 serious adverse events (SAE) deemed possibly related to CMV-CTL among 66 patients.
The ASH 2016 oral presentation, titled "Third Party CMV-Specific Cytotoxic T Cells for Treatment of Antiviral Resistant CMV Infection after Hematopoietic Stem Cell Transplant," will take place this morning, Saturday, December 3, at 7:30 a.m. PT in Grand Hall B of the Manchester Grand Hyatt in San Diego, CA. Presentation Includes Response Rate, 6-month Overall Survival, and Safety Results in Hematopoietic Stem Cell Transplant (HCT) Patients with CMV Mutations Conferring Resistance to Antiviral Therapy.
12 patients were treated with either primary donor derived (n=1) or third-party derived (n=11) CMV-CTL. Patients had received a range of 3 to 6 prior therapies before treatment with CMV-CTL. The overall response rate among the 11 evaluable patients was 73% (8/11) including 7 complete responses and 1 partial response.
CMV-CTL infusions were well tolerated and no patient developed de novo graft versus host disease (GvHD) or a flare of prior GvHD.
The ASH 2015 poster presentation is titled "Successful Treatment of Refractory CMV Chorioretinitis and Meningoencephalitis with Adoptive Transfer of Third Party CMVpp65 Specific T-Cell Lines."
