ACET stock ran up 11% in morning trade on December 6, 2021, after the company released positive trial data.
Canaccord remains bullish on Adicet after ‘highly positive’ interim ADI-001 data
Canaccord analyst John Newman notes that Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T cell therapy, demonstrated overall response rate of 75% and complete response rate of 50% in n=4 efficacy evaluable patients, with 2/3 responses at the lowest dose level. ADI-001’s safety profile was “encouraging,” with no dose-limiting toxicities, graft versus host disease, immune effector cell-associated neurotoxicity syndrome or grade 3 or higher cytokine release syndrome, Newman adds, pointing out that more dosing cohorts are expected to be added, with additional data the first half of 2022. The analyst maintains a Buy rating and $28 price target on the shares, based on positive Phase 1 data for ADI-001 in non-Hodgkin’s lymphoma. He believes gamma delta T-cells have unique properties that could minimize rejection and help overcome immunosuppression in both hematologic malignancies and solid tumors.
Adicet Bio price target raised to $33 from $22 at Guggenheim
Guggenheim analyst Michael Schmidt raised the firm’s price target on Adicet Bio to $33 from $22 and keeps a Buy rating on the shares. Adicet presented strong early proof-of-concept data for its lead anti-CD20 gammadelta T cell therapy, ADI-001, which demonstrated 75% ORR, 50% CR and a clean safety profile in the first 4 efficacy evaluable aggressive lymphoma patients treated at low doses in the recently initiated Phase I dose escalation study, Schmidt tells investors in a research note. The data is tracking significantly above Street expectations and compares well with early, low-dose cohort data of other investigational allogeneic cancer cell therapies, including anti-CD19 CAR-T and anti-CD19 CAR-NK, Schmidt adds.
Adicet Bio Announces Positive Interim Clinical Data From First-Ever Allogeneic, Off-The-Shelf, Gamma Delta CAR T Investigational Cell Therapy
- 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
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.”
ACET stock technical analysis
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