Bioheng Biotech News, Reviews & Resources

Positive results from a phase 1 clinical study of RD13-01, an anti-CD7 universal CAR-T therapy product, have been published in reputable academic journal, Cell Research. China-based Bioheng Biotech Co. Ltd, a clinical-stage biotechnology company focused on developing novel cellular immunotherapy made the announcement today (September 27). 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 1 clinical study’ was from a first-in-human, single-arm, dose-escalation phase 1 clinical study. Primary objective 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 dose limiting toxicity (DLT), graft vs host disease (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS) was observed, and no patients experienced grade 3 or less cytokine release syndrome (CRS). Of the 11 patients included in efficacy analysis, nine (82%) achieved an objective response. Of the eight patients with leukemia, six (75%) achieved measurable residual disease-complete remission with incomplete count recovery (MRD-CR/CRi). Dismal outcomes Principal investigator of this study, He Huang, said: “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 five-year overall survival rate lower than 20%, there is an urgent medical need to develop novel therapies for this type of disease. “Besides the marked attenuated cytokine release syndrome 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 seven 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." RD13-01 is allogeneic CAR-T cell therapy targeting CD7 with genetic modifications to resist fratricide, 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. CAR-T studies It received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia on June 20, 2021. “We are proud to have our innovative allogeneic CAR-T studies published in a reputable, peer-reviewed scientific journal," said Jiangtao Ren, 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.”

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