Prior to the open of U.S. markets today, biotechnology firm Adicet Bio Inc. (ACET:NASDAQ), which is engaged in the discovery and development of off-the-shelf allogeneic gamma delta T cell therapies for cancer and other diseases, 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."
The company advised that the data reported pertained to the first four of six patients enrolled in the study treated with ADI-001 who had reached the 28-day assessment. It noted that the very first two patients in the trial were administered only the lowest dose level and were not graded based upon the study's designed protocol.
Adicet Bio reported that of the four patients evaluated after 28 days, two demonstrated complete responses (CR) and one showed partial response (PR) that investigators indicated was very close to a complete response. The company noted that all of the patients enrolled in the study had previously undergone extensive previous treatments with a median of five lines of prior systemic therapy. The firm stated that one of these participants who had received prior autologous CD19 CAR T "achieved complete response following a single infusion of ADI-001 administered at the lowest dose level."
Adicet Bio's President and CEO Chen Schor commented, "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. … 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."
Sattva Neelapu M.D., Professor in the Dept. of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center, remarked, "The unequivocal responses to ADI-001 in this heavily pre-treated patient population at such low dose levels are highly promising. … 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."
Adicet said that three of the first four participants in the study received ADI-001 at dose level one which is 30 million CAR+ cells with the remaining patient receiving the second dosage level set at 100 million CAR+ cells. The patient administered the highest dose demonstrated a CR, while in the lower dose amount, one showed a CR, one showed a PR which was just below the threshold of being classified as a CR and one patient was characterized as still having progressive disease (PD). The firm added that ADI-001 infusions were found to be generally well tolerated in the study which suggests that ADI-001 may offer a potentially wide therapeutic window.
"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."
—Francesco Galimi, Adicet Bio SVP and Chief Medical Officer
The company's SVP and Chief Medical Officer Francesco Galimi, M.D., Ph.D. stated, "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. … 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."
The company mentioned that ADI-001 is being developed as a treatment for B-cell non-Hodgkin's lymphoma. The firm described ADI-001 as "an investigational allogeneic gamma delta CAR T cell therapy that targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors."
The company indicated that the Phase I GLEAN multi-center trial of ADI-001 is planned to enroll approximately 78 adult patients that have previously been diagnosed with B cell malignancies and have either relapsed or are refractory to at least two prior treatment regimens. The primary purpose to the Phase 1 study is to assess ADI-001's safety, tolerability and efficacy and optimal dosage levels when used as a monotherapy.
Adicet Bio is a biotech firm focused on the discovery and development of innovative allogeneic gamma delta T cell therapies for cancer and other diseases. The company aims to harness the power of the immune system and listed that "it is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like targeting moieties to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients."
The company's investigative pipeline includes ADI-001, ADI-002 and ADI-00x which are being developed for treating B-cell Non-Hodgkin's Lymphoma, hepatocellular carcinoma (HCC), solid tumors and hematological cancers.
Adicet Bio started off the day with a market capitalization of around $313.2 million with approximately 31.96 million shares outstanding and a short interest of about 1.2%. ACET shares opened 39% higher today at $13.65 (+$3.85, +39.29%) over Friday's $9.80 closing price. The stock has traded today between $12.40 and $15.67 per share and is currently trading at $13.46 (+$3.66, +37.35%).
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