Allogeneic anti-CD7 CAR T-cell therapy(Nanjing Bioheng Biotech))

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. (). 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. SOURCE Nanjing Bioheng Biotech Co., Ltd

Bioheng Biotech SAB Chairman Carl June/Courtesy Carl June. Renowned cancer immunologist Carl June wears many hats and holds many titles, including Pioneer of Chimeric Antigen Receptor T (CAR-T) cells, Perelman School of Medicine tenured professor and one of Time Magazine’s 100 most influential people of 2018. Now, he has added another one: Chairman and member of the Scientific Advisory Board at Nanjing Bioheng Biotech Co., Ltd. A graduate of the Naval Academy in Annapolis and Baylor College of Medicine in Houston, June broke out in 2012 when he saved the life of Emily Whitehead, a child suffering from relapsed acute lymphoblastic leukemia (ALL), with CD19 CAR-T. Ms. Whitehead, now a teenager who called June her “hero” in a Time Interview, is still tumor-free today. This began a new chapter in immuno-cell therapy – one many companies, including Bioheng Biotech, are actively writing. “It's a great honor to invite Professor Carl June to join and lead our scientific advisory board, marking another important milestone in Bioheng's development,” said Bioheng Chief Executive Officer Dr. Xiaohong He, Ph.D. “Our vision is to solve the bottleneck problem of immune-cell therapy drugs, to improve its safety and efficacy, and to bring down its cost, ultimately achieving accessibility to every patient. Professor Carl June's joining will put on 'wings' of Bioheng's dream.” Founded in 2017 and based in Nanjing, China, the clinical stage company focuses on novel immunotherapy and next-generation gene therapy development for cancer and other diseases. Bioheng specializes in "off-the-shelf" universal CAR-T cell therapy. In June, the company announced that the U.S. Food and Drug Administration had granted its UCAR T cell therapy product targeting CD7, CTD401, Orphan Drug Designation in T-cell acute lymphoblastic leukemia (T-ALL). This followed a lucrative $80 million Series B financing round in April. “I am very pleased to be Bioheng's advisory board Chairman. Bioheng has made impressive progress in both universal CAR-T and enhanced CAR-T for solid tumor, and achieved outstanding clinical results. I look forward to a faster clinical application and sooner benefit to cancer patients,” June said in a statement. The recipient of several prestigious awards, including the Leukemia and Lymphoma Society’s Lifetime Achievement award in 2002, the Paul Ehrlich and Ludwig Darmstaedter Prize in 2015 and Dan David Prize in 2021, June’s work led to the development and commercialization of the first FDA-approved gene therapy. Novartis’s Tisagenlecleucel (Kymriah) was approved in 2017 for the treatment of B-cell acute lymphoblastic leukemia (ALL). June is also co-founder of Tmunity Therapeutics, which is affiliated with the University of Pennsylvania and the University of Minnesota and focuses on translational T cell medicine. Tmunity launched in 2016 with $10 Million in equity financing from Penn Medicine. In 2019, along with the University of Pennsylvania and Parker Institute for Cancer Immunotherapy, Tmunity became the first in the U.S. to treat patients using CRISPR technology.