Acepodia Announces Preliminary Clinical Data From Phase 1 Clinical Trial of ACE1831, First-Ever Anti-CD20 Antibody Conjugated Allogenic Gamma Delta T Cell Therapy for Non-Hodgkins Lymphoma
Acepodia (6976:TT) released preliminary data from its Phase 1 clinical trial of ACE1831, an anti-CD20 antibody conjugated allogeneic gamma delta T cell therapy for non-Hodgkin's lymphoma. Initial results show a complete response and disease stabilization at the lowest dose level, with no serious adverse events observed. The therapy activates both innate and adaptive immune responses, potentially offering a more comprehensive immune response than standard CAR-T cell therapies.
One out of five patients demonstrated a complete response, and three out of five experienced disease stabilization with a single dose of ACE1831 at the lowest dose level.
The durability of the clinical response was observed for three months after treatment.
No ACE1831-related serious adverse events or dose-limiting toxicities were reported at the lowest dose level.
The therapy activates both innate and adaptive immune responses by direct killing of tumor cells, tumor opsonization, and recruitment of T cells through cytokine secretion.
The trial is ongoing, and additional data is needed to assess long-term efficacy and safety.
The results are based on a small sample size of patients, and further studies with a larger patient population are required for definitive conclusions.
Insights
The lack of serious adverse events such as graft-versus-host disease, neurotoxicity, or cytokine release syndrome further highlights the potential safety profile of ACE1831 compared to traditional CAR-T therapies. Its off-the-shelf, non-genetically engineered nature could also translate into lower manufacturing complexities and costs, possibly expediting the treatment's time-to-market and accessibility.
Investors should note, however, that phase 1 trials primarily focus on safety and efficacy must be established in larger, more comprehensive studies. The positive preliminary data could lead to increased investor confidence and potentially higher stock valuations for Acepodia in anticipation of future developments. Nonetheless, the biotech sector is known for its volatility and further data will be critical to solidify these early positive results.
For patients with non-Hodgkin's lymphoma, especially those refractory to existing therapies, these developments could imply more effective and safer treatment options in the future. However, it's critical to understand that efficacy and durability beyond the three-month mark must be scrutinized in subsequent trial phases. Retail investors should bear in mind the early stage of these findings and the long road ahead before potential FDA approval and market availability.
Investors should observe the company's burn rate and capital-raising activities, as continued development will require substantial investment. Stock movement in the short term may reflect investor enthusiasm for the novel technology and early clinical success; however, the inherent risks of drug development necessitate a cautious approach. The true value inflection point will likely come with later phase trial results and potential commercialization strategies.
- First dosing dohort was completed with complete response and disease stabilization identified at three months at the lowest dose level in the Phase 1 study
- No ACE1831-related serious adverse events, including GvHD, neurotoxicity, high-grade CRS or dose limiting toxicities were observed
- Results shared during a fireside chat hosted by William Blair & Company on May 7th, 2024. An archived recording will be available for 7 days following the event at https://www.acepodia.com/newsroom/media/.
Key Results From Preliminary Clinical Data
- One out of five patients demonstrated complete response (CR) and three out of five patients experienced disease stabilization (SD) with single dose of ACE1831 at the lowest dose level. Among those patients, one CR and two SD patients were previously treated with CD19 CAR-T.
- Durability of clinical response was observed for three months after a single dose of ACE1831.
- The lowest dose of ACE1831 was well tolerated with no ACE1831-related serious adverse events or dose limiting toxicities. Dose escalation is ongoing.
ACE1831 is Acepodia's first cell therapy to enter clinical development from its proprietary ACC platform, which uses biorthogonal chemistry to conjugate gamma delta 2 (γδ2) T cells with antibodies targeting CD20. The platform, based on the pioneering work of 2022 Nobel Prize laureate Dr. Carolyn Bertozzi that applied click chemistry to living systems, creates an off-the-shelf, non genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxity and other side effects associated with CAR-T cell therapies. The preliminary data demonstrates that ACE1831 activates both an innate and adaptive immune response by direct killing of tumor cells, tumor opsonization, and recruitment of T cells through cytokine secretion, and may therefore generate a more comprehensive immune response than standard CAR-T cell therapies.
"This ongoing trial is the first to demonstrate potential clinical benefit to patients using biorthogonal chemistry and opens the door to a powerful, new approach for cell therapy that overcomes limitations of current CAR-T cell therapies and is more accessible to patients," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "We are encouraged to see a robust and durable effect after a single treatment at the lowest dose, and remain focused on the continued development of this first-of-its kind treatment option."
The first-in-human, phase 1 trial is an open-label, dose escalation study that aims to evaluate the safety and tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed/refractory non-Hodgkin's lymphoma. The multi-center trial is expected to enroll up to 42 patients in
About ACE1831
ACE1831 is an off-the-shelf gamma delta T cell therapy candidate developed from Acepodia's proprietary ACC platform. ACE1831 targets CD20-expressing hematological cancers using anti-CD20 antibody conjugated gamma delta T cells. Taking advantage of the high expression of NK cell activating receptors of the gamma delta T cells to scavenge the malignant blood cells, ACE1831 has demonstrated in models enhanced cytotoxicity against cancer cells both in vitro and in vivo. ACE1831 is currently being evaluated in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin's lymphoma.
About Acepodia
Acepodia is a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as natural killer and gamma delta T cells to create novel ACE therapies, which have increased binding strength against tumors that express low levels of tumor antigens.
Acepodia is made up of seasoned leaders and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative, effective, and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visit www.acepodia.com and follow Acepodia on Twitter and LinkedIn.
View original content:SOURCE Acepodia Inc.
FAQ
What is the purpose of the Phase 1 clinical trial of ACE1831?
The Phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed/refractory non-Hodgkin's lymphoma.
How was the preliminary data from the trial shared?
The results were shared during a fireside chat hosted by William Blair & Company on May 7th, 2024, and an archived recording is available for 7 days following the event at https://www.acepodia.com/newsroom/media/.
What is the unique feature of Acepodia's ACC platform?
Acepodia's ACC platform uses biorthogonal chemistry to conjugate gamma delta 2 (γδ2) T cells with antibodies targeting CD20, creating an off-the-shelf, non-genetically engineered version of CAR-T cell therapy that may offer a more comprehensive immune response.
