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0 > Adicet Bio Adicet Bio Announces Positive Interim Clinical Data From First - Ever Allogeneic , Off - The - Shelf , Gamma Delta CART Investigational Cell Therapy December 6 , 2021 • Complete and near complete responses observed with ADI - 001 starting at lowest dose level in Phase 1 study for the treatment of B - cell Non - Hodgkin's Lymphoma ( ORR = 75 % , CR = 50 % ) • No ADI - 001 - related serious adverse events , including GVHD , neurotoxicity or high - grade CRS have been reported to date • Evidence of in vivo expansion and circulating pharmacodynamic biomarkers consistent with ADI - 001 activation • Favorable safety and clinical activity reinforces the potential of Adicet's first - in - class allogeneic , off - the - shelf gamma delta CAR T cell platform • Company to hold webcast today at 5:30 am PT / 8:30 am ET MENLO PARK , Calif . and BOSTON , Dec. 06 , 2021 ( GLOBE NEWSWIRE ) -- Adicet Bio , Inc. ( Nasdaq : ACET ) , a biotechnology company discovering and developing first - in - class allogeneic gamma delta CAR T cell therapies for cancer and other diseases , today announced positive interim data from its dose escalation Phase 1 study evaluating the safety and tolerability of ADI - 001 , Adicet's investigational therapy targeting CD20 for the potential treatment of B - cell Non - Hodgkin's Lymphoma . As of the November 22 , 2021 data cutoff , six patients had been enrolled and received ADI - 001 . The first two patients enrolled in the lowest dose level tested did not reach the day 28 assessment and were not evaluable for efficacy per protocol . Three of the four evaluable patients achieved responses , including two complete responses ( CR ) and one partial response ( PR ) that investigators characterized as near complete response . Patients were heavily pre - treated , with a median of five lines of prior systemic therapy , including a patient who had received prior autologous CD19 CAR T , and achieved complete response following a single infusion of ADI - 001 administered at the lowest dose level . " We are extremely excited to see such profound early complete responses in our Phase 1 dose - finding study evaluating ADI - 001 as monotherapy among patients with very advanced cancer starting at our first dose level of 30 million CAR + cells , " said Chen Schor , President and Chief Executive Officer of Adicet Bio . " Data to - date suggest that ADI - 001 is highly clinically active . We look forward to reporting additional data in the first half of 2022 and to rapidly progressing our pipeline to realize the full potential of our gamma delta CAR T cell platform for patients . ” " The unequivocal responses to ADI - 001 in this heavily pre - treated patient population at such low dose levels are highly promising , " said Sattva Neelapu M.D. , Professor in the Department of Lymphoma / Myeloma at The University of Texas MD Anderson Cancer Center . " These data suggest that ADI - 001 has the potential to be an effective treatment option for B cell malignancies if confirmed in further clinical testing . ADI - 001 does not require gene editing and provides complementary innate , adaptive , and CAR mediated antitumor effects which may improve durability and minimize emergence of tumor resistance . " Of the four efficacy evaluable patients , three received ADI - 001 at dose level one ( 30 million CAR + cells ) and one received ADI - 001 at dose level two ( 100 million CAR + cells ) . In dose level one , one patient achieved a CR , one patient achieved a PR that was characterized as near CR and one patient had progressive disease ( PD ) . In dose level two , the first patient achieved a CR . All evaluable patients had been heavily pre - treated with a median of five lines of prior systemic therapies . Of the three patients who achieved PR or better under Lugano 2014 criteria ( ORR = 75 % , CR = 50 % ) , one had diffuse large B - cell lymphoma ( DLBCL ) with five prior lines of therapy including two cycles of anti - CD19 CAR T cell therapy , one had follicular lymphoma transformed into a large B - cell tumor with four prior lines of therapy , and the third had mantle cell lymphoma with five prior lines of therapy . These patients achieved two CRs and a near CR . Overall , ADI - 001 infusions were generally well - tolerated . No dose - limiting toxicities , graft vs host disease ( GvHD ) , Immune Effector Cell - Associated Neurotoxicity Syndrome ( ICANS ) or grade 3 or higher Cytokine Release Syndrome ( CRS ) have been reported to - date , suggesting a potentially wide therapeutic window for ADI - 001 . A significant increase in circulating IL - 15 was observed during the 28 - day window following lymphodepletion , potentially providing cytokine support for the proliferation of ADI - 001 . Emergence of circulating ADI - 001 in the blood was observed by quantitative polymerase chain reaction and by flow cytometry , demonstrating expansion of ADI - 001 in patients . Elevations in additional circulating cytokines , primarily IL - 2 and IL - 8 were observed during the first 14 days from dosing , consistent with the activation profile of ADI - 001 and similar to the observed time - to - peak for cytokines previously reported in association with autologous alpha - beta CAR T cells . Importantly , no meaningful increases in IL - 6 were seen in association with ADI - 001 , except for one patient who experienced COVID - 19 infection , suggesting reduced likelihood for ICANS and high - grade CRS . " It is remarkable to see our early preclinical studies translate to the clinic . The preliminary safety and efficacy data from low - dose ADI - 001 collected to date indicate the potential for a broad therapeutic window . Without the need for gene editing and its associated safety concerns , our platform is designed to preserve the natural innate and adaptive anti - tumor activity of gamma delta CAR T cells , which we believe may lead to better durability , " said Francesco Galimi , M.D. , Ph.D. , Senior Vice President and Chief Medical Officer of Adicet Bio . " As we look to expand into additional cohorts , we plan to leverage our scalable off - the - shelf manufacturing process to meet future needs . We look forward to advancing our novel allogeneic gamma delta T cell pipeline for cancer patients . ” Table 1 : Summary of ADI - 001 interim data from two dosing cohorts * : Dose Level Age / Sex B - cell lymphoma subtypes # Prior lines of therapies Prior CAR Best Response ( BOR ) by Lugano Criteria T ? ( 2014 )