NANJING and HANGZHOU, China, Sept. 26, 2022 /PRNewswire/ -- Nanjing Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company focused on developing novel cellular immunotherapy, today announced that a phase I clinical study results of RD13-01, an anti-CD7 universal CAR-T therapy product, have been published in the reputable academic journal, Cell Research. (https://www.nature.com/articles/s41422-022-00721-y).
The results published with the title of "CD7-targeted allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: A phase I clinical study" was from a first-in-human, single-arm, dose-escalation phase I clinical study. The primary objective of the study was to assess the safety and tolerability of RD13-01, while the secondary objectives were to assess the preliminary anti-tumor activity and characterize the pharmacokinetics of RD13-01. Patients were given a lymphodepletion chemotherapy with fludarabine, cyclophosphamide, and etoposide before RD13-01 infusion. RD13-01 demonstrated a manageable safety and tolerability profile, no DLT, GvHD or ICANS was observed, and no patients experienced = grade 3 CRS. Of the 11 patients included in efficacy analysis, 9 (82%) achieved an objective response. Of the 8 patients with leukemia, 6 (75%) achieved MRD-CR/CRi.
"T cell malignancies are highly aggressive hematological tumors which are generally associated with poor prognosis. In particular relapsed or refractory (r/r) disease has dismal outcomes with a 5-year overall survival (OS) rate lower than 20%, there is an urgent medical need to develop novel therapies for this type of disease," said the PI of this study, He Huang, MD, PhD, Professor of hematology, President of The First Affiliated Hospital, Zhejiang University School of Medicine. "Besides the marked attenuated cytokine release syndrome (CRS) safety profile and impressive efficacy enhancement, I am also impressed with the availability and accessibility of RD13-01 for these patients with uncommon aggressive malignancies. The interval between enrollment and infusion was no more than 7 days, and no patients enrolled failed to receive RD13-01 infusion due to disease progression, leukapheresis or manufacture failure. It is expected that allogeneic CAR-T cell products provide more choices to address the unmet medical needs."
"We are proud to have our innovative allogeneic CAR-T studies published in a reputable, peer-reviewed scientific journal," said Jiangtao Ren, PhD, Co-founder and Chief Scientific Officer of Bioheng, "We developed healthy donor-derived, CD7-targeted CAR-T cells (RD13-01) with genetic modifications to resist fratricide, GvHD and allogeneic rejection, as well as to potentiate antitumor function. It is easy to use with excellent safety and efficacy. Collectively, these promising results demonstrate our next generation allogeneic CAR-T platform's potential to maximize CAR-T's functionality to eradicate malignant tumors. Further phase II investigations are warranted to evaluate the long-term safety and efficacy in larger scales."
About RD13-01
RD13-01 is allogeneic CAR-T cell therapy targeting CD7 with genetic modifications to resist fratricide, graft-versus-host-disease (GvHD) and allogeneic rejection, as well as to potentiate antitumor function. It is the first proprietary product based on Bioheng's next-generation generic CAR-T technology platform. It has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) on June 20, 2021.
About Bioheng
Bioheng is a clinical-stage biotech company focused on developing novel cellular immunotherapies. Majority of its pipelines are allogeneic CAR-Ts, which is used for the treatment of hematologic and solid tumors. Allogeneic CAR-T could ease the obstacles of high cost, length and difficult manufacturing and individualized manufacturing associated with autologous CAR-T, and could increase the affordability and accessibility in CAR-T treatment.
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The results published with the title of "CD7-targeted allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: A phase I clinical study" was from a first-in-human, single-arm, dose-escalation phase I clinical study. The primary objective of the study was to assess the safety and tolerability of RD13-01, while the secondary objectives were to assess the preliminary anti-tumor activity and characterize the pharmacokinetics of RD13-01. Patients were given a lymphodepletion chemotherapy with fludarabine, cyclophosphamide, and etoposide before RD13-01 infusion. RD13-01 demonstrated a manageable safety and tolerability profile, no DLT, GvHD or ICANS was observed, and no patients experienced = grade 3 CRS. Of the 11 patients included in efficacy analysis, 9 (82%) achieved an objective response. Of the 8 patients with leukemia, 6 (75%) achieved MRD-CR/CRi.
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"T cell malignancies are highly aggressive hematological tumors which are generally associated with poor prognosis. In particular relapsed or refractory (r/r) disease has dismal outcomes with a 5-year overall survival (OS) rate lower than 20%, there is an urgent medical need to develop novel therapies for this type of disease," said the PI of this study, He Huang, MD, PhD, Professor of hematology, President of The First Affiliated Hospital, Zhejiang University School of Medicine. "Besides the marked attenuated cytokine release syndrome (CRS) safety profile and impressive efficacy enhancement, I am also impressed with the availability and accessibility of RD13-01 for these patients with uncommon aggressive malignancies. The interval between enrollment and infusion was no more than 7 days, and no patients enrolled failed to receive RD13-01 infusion due to disease progression, leukapheresis or manufacture failure. It is expected that allogeneic CAR-T cell products provide more choices to address the unmet medical needs."
"We are proud to have our innovative allogeneic CAR-T studies published in a reputable, peer-reviewed scientific journal," said Jiangtao Ren, PhD, Co-founder and Chief Scientific Officer of Bioheng, "We developed healthy donor-derived, CD7-targeted CAR-T cells (RD13-01) with genetic modifications to resist fratricide, GvHD and allogeneic rejection, as well as to potentiate antitumor function. It is easy to use with excellent safety and efficacy. Collectively, these promising results demonstrate our next generation allogeneic CAR-T platform's potential to maximize CAR-T's functionality to eradicate malignant tumors. Further phase II investigations are warranted to evaluate the long-term safety and efficacy in larger scales."
About RD13-01
RD13-01 is allogeneic CAR-T cell therapy targeting CD7 with genetic modifications to resist fratricide, graft-versus-host-disease (GvHD) and allogeneic rejection, as well as to potentiate antitumor function. It is the first proprietary product based on Bioheng's next-generation generic CAR-T technology platform. It has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) on June 20, 2021.
About Bioheng
Bioheng is a clinical-stage biotech company focused on developing novel cellular immunotherapies. Majority of its pipelines are allogeneic CAR-Ts, which is used for the treatment of hematologic and solid tumors. Allogeneic CAR-T could ease the obstacles of high cost, length and difficult manufacturing and individualized manufacturing associated with autologous CAR-T, and could increase the affordability and accessibility in CAR-T treatment.
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