Wugen Commences Phase 1 Clinical Trial for WU-NK-101: Innovative Allogeneic Memory Natural Killer (NK) Cell Therapy Aimed at Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients
Wednesday, August 16, 2023
Wugen, a biotech firm in the clinical development stage, has initiated the dosing of patients in the Phase 1 clinical trial for WU-NK-101. This innovative therapy aims to treat patients suffering from relapsed or refractory acute myelogenous leukemia (AML). The U.S. Food and Drug Administration (FDA) has also granted Orphan Drug Designation (ODD) to WU-NK-101 for the treatment of AML.
WU-NK-101 is Wugen's primary memory natural killer (NK) cell therapy product. It comprises cells optimized for their anti-cancer properties. These cells possess a unique cytokine-induced memory-like (CIML) phenotype that boosts their anti-tumor activity, enhances their ability to move within the body, enables them to proliferate well, and grants them metabolic flexibility. All these characteristics contribute to the therapy's resilience when confronted with the challenging tumor microenvironment (TME). WU-NK-101 is produced using Wugen's proprietary MonetaTM manufacturing platform, which facilitates the efficient production of off-the-shelf memory NK cell-based therapies.
Dr. Jan Davidson-Moncada, Chief Medical Officer of Wugen, expressed that the start of the clinical trial signifies a significant advancement in their memory NK cell program. They believe that this approach offers distinct advantages over other NK cell therapy methods and holds promise for patients with various tumor types. Early clinical studies demonstrated impressive response rates in AML patients, even those with a heavy disease burden. The granted Orphan Drug Designation for WU-NK-101 is anticipated to assist in making this therapy more accessible to AML patients.
Kumar Srinivasan, Ph.D., President and CEO of Wugen, highlighted the importance of this milestone. He noted that WU-NK-101 is the first therapeutic candidate from their memory NK cell platform to enter clinical trials. Starting with AML, where there's a significant unmet need for novel treatments, Wugen aims to leverage their memory NK cell platform to develop next-generation allogeneic memory NK cell therapies that can revolutionize cancer care, including the treatment of solid tumors.
The Phase 1 clinical study is a global initiative involving an open-label approach, dose escalation, and cohort expansion. Its primary goal is to assess the safety and tolerability of WU-NK-101 in patients with r/r AML, and to determine the appropriate Phase 2 dose. The study will evaluate various aspects including safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial anti-leukemic activity of WU-NK-101. The administration of WU-NK-101 will involve three weekly infusions within a 28-day cycle. More details can be found on clinicaltrials.gov under identifier NCT05470140.
The design of the Phase 1 trial was outlined in an abstract published in the November 2022 supplemental issue of Blood, a journal of the American Society of Hematology.
Memory NK cells have been validated for safety and efficacy in AML through clinical studies. Furthermore, preclinical studies on WU-NK-101 for solid tumors suggest potential efficacy both as a standalone therapy and in combination with monoclonal antibodies.
The FDA Office of Orphan Products Development grants orphan designation to novel drugs or biologics developed for rare diseases or conditions affecting fewer than 200,000 U.S. patients. ODD offers various incentives, including potential marketing exclusivity for up to seven years, tax credits for clinical research expenses, support in clinical trial design, eligibility for annual grant funding, and exemption from Prescription Drug User Fee Act filing fees.
Regarding WU-NK-101, it represents an innovative immunotherapy utilizing the capabilities of memory natural killer (NK) cells to address both liquid and solid tumors. These memory NK cells are highly functional and enduring immune cells with enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. These unique attributes make them well-suited for cancer therapy compared to other NK cell treatments. Leveraging the MonetaTM platform, Wugen is advancing WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. While its current focus is on acute myelogenous leukemia (AML), Wugen's plans include initiating studies involving solid tumors in combination with cetuximab. Encouraging in vivo activity in various tumor indications, effectiveness in tumor microenvironments, resistance to immune suppression, and improved performance with checkpoint inhibitors have all been demonstrated in studies of WU-NK-101.
The MonetaTM platform is Wugen's proprietary manufacturing platform, facilitating a robust, efficient, and scalable process for generating memory natural killer (NK) cell therapies with enhanced anti-tumor functionalities. The platform employs cytokine fusion complexes for streamlined and consistent manufacturing, ensures safety by eliminating the need for feeder cells, and integrates cryopreservation for convenient dosing options for cancer patients.
