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Results from five patients showed best responses of 2 partial responses (PR), 1 complete response with incomplete hematological recovery (CRi) and 1 complete response (CR).
Updated data show continued favorable safety profile and encouraging anti-tumor activity in adult patients treated with low doses of KUR-502. Study continues to accrue to higher doses.
BUFFALO, N.Y., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, announced today data from the ANCHOR Phase 1 study of KUR-502 to be highlighted in a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, being held from December 11th to December 14th, 2021. The data demonstrates that allogeneic CD19 CAR-NKT cells are well-tolerated and can mediate objective responses in B-cell relapsed/refractory non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL) patients even at the low doses tested.
“The early safety and clinical activity data are very encouraging,” said Carlos Ramos, M.D., Professor at the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and Houston Methodist Hospital and Principal Investigator. “The availability of a safe and effective off-the-shelf product would be a major advance in the care of these patients, and we are looking forward to treating additional patients at higher dose levels to further evaluate KUR-502.”
Dan Lang, M.D., President, Athenex Cell Therapy, Vice President, Corporate Development and Communication commented, “We are excited about these early promising results from our first-in-human allogeneic study of CD19 CAR NKT cells in heavily pre-treated patients, including two patients who had previously failed autologous CAR-T therapies. We are encouraged that we have been able to demonstrate homing of allogeneic CAR-NKT cells to tumor, which is a differentiating feature of this platform. We look forward to accelerating clinical enrollment by bringing on additional clinical sites to the current study to generate more data, and further characterize the unique features and benefits of NKT cells over other cell therapy products based on T cells and NK cells.”
Allogeneic NKT Cells Expressing a CD19-specific CAR in Patients with Relapsed or Refractory B-cell Malignancies: An Interim Analysis
The primary and secondary objectives of the phase I dose-escalation trial are to assess safety and anti-tumor activity of allogeneic NKT cells engineered to co-express a CD19-specific CAR, IL-15, and shRNAs targeting HLA class I and II molecules. Patients received a single infusion of 107 (DL 1) or 3×107 (DL 2) allogeneic CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine.
Four patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL, cohort A) were enrolled on DL 1 (NHL-1, -2, -3) and DL 2 (NHL-4), and 1 patient with relapsed acute B-lymphoblastic leukemia (ALL, cohort B) was enrolled on DL 1 (ALL-1). Allogeneic CAR-NKT cells were manufactured from the leukapheresis product of one HLA-unmatched healthy individual and cryopreserved.
The most common adverse effects observed were nausea and grade 3-4 hematologic toxicities related to the lymphodepletion chemotherapy. There were no early adverse events attributable to the cellular product except grade 1 cytokine release syndrome in one patient.
Of the 4 NHL patients, 2 had a partial response (NHL-1, -and -4) and 1 had a CR (NHL-2). The ALL patient achieved a CRi and showed no evidence of leukemia by morphology, flow cytometry, or next-generation sequencing at 4 weeks.
In vivo expansion of donor-derived NKT and CAR-NKT cells was detected in the peripheral blood of NHL-4 and ALL-1 that peaked at 1 week post-infusion in both cases as determined by flow cytometry and qPCR. While CAR-NKT cells were not detected in the peripheral blood of the first three NHL patients beyond three hours post-infusion, they were found in tumor tissues collected from the two biopsied NHL patients at up to 5 weeks post infusion. In patient NHL-2, a 2000-fold expansion of recipient NKTs with a skewed T cell receptor repertoire was also observed; this population peaked at 6 weeks post-treatment and remain elevated through 12 weeks.
About the Phase I Study of KUR-502 (Allogeneic CD19 CAR-NKT Cells) in Patients with Relapsed or Refractory B-Cell Malignancies (ANCHOR)
The phase I study is an open-label, dose-escalation study. NKT cells were isolated from the leukapheresis product of one HLA-unmatched healthy individual, transduced with the CAR, expanded ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Patients received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter of body surface area following lymphodepleting conditioning with cyclophosphamide/fludarabine. Adverse events were evaluated per NCI criteria. When accessible, patients underwent core biopsies of an involved site at 2-5 weeks post-infusion. Response to therapy was assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN guidelines (for ALL).
For further information about the study, visit ClinicalTrials.gov, identifier: NCT03774654.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived from four different technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) Cell therapy, and (4) Arginine deprivation therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates, including NKT Cell Therapy and related risks involved in drug development, clinical trials, regulation, uncertainties around regulatory reviews and approvals; our ability to pivot our business and to find new uses for the capacity at our Dunkirk manufacturing facility, once operational; our ability to scale our manufacturing and commercial supply operations for current and future approved products, and ability to commercialize our products, once approved; ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; the preclinical and clinical results for Athenex’s drug candidates, which may not support further development of such drug candidates; risks related to our ability to successfully integrate the business of Kuur into our existing businesses, including uncertainties associated with maintaining relationships with customers, vendors and employees, as well as differences in operations, cultures, and management philosophies that may delay successful integration and our ability to support the added cost burden of Kuur’s business; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex’s business; our history of operating losses and our need and ability to raise additional capital to continue as a going concern; uncertainties around our ability to enter into new financing agreements as we are unable to meet funding conditions under our existing financing agreements and access to capital thereunder; risks and uncertainties inherent in litigation, including purported stockholder class actions; risks and uncertainties related to the COVID-19 pandemic and its ongoing impact on our operations, supply chain, cash flow and financial condition; competition; intellectual property risks; uncertainties around our ability to successfully integrate acquired and merged businesses in a timely and cost-effective manner and to achieve synergies; risks relating to doing business internationally and in China; the risk of development, operational delays, production slowdowns or stoppages or other interruptions at our manufacturing facilities as well as our ability to find alternative sources of supply to meet our obligations and requirements; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.
Daniel Lang, MD