NKore BioTherapeutics Completes Pre-IND Meeting with FDA for NK101

NKore BioTherapeutics, Inc., a biotechnology company developing cell therapies for cancer, has announced the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA). This milestone marks a significant step forward in the company's efforts to advance its lead product candidate, NK101, toward clinical trials in the United States.

During the pre-IND meeting, NKore received valuable regulatory guidance from the FDA on key elements of the NK101 development program. These elements include chemistry, manufacturing, and controls (CMC), nonclinical pharmacology and toxicology, and the proposed clinical development program. The feedback provided by the FDA will help the company refine its manufacturing, nonclinical, and clinical development strategies, ensuring that NK101 is well-positioned for future IND submission and clinical trials.

Dr. Aaron U. Levy, Chairman and Chief Executive Officer of NKore BioTherapeutics, emphasized the importance of this meeting.

NK101 is an allogeneic Supercharged Natural Killer (sNK™) cell therapy built upon more than three decades of immunology research led by Dr. Anahid Jewett at the University of California, Los Angeles (UCLA). The company's proprietary platform is designed to enhance the innate cancer-fighting capabilities of Natural Killer cells while supporting the development of scalable, potentially off-the-shelf cellular immunotherapies across multiple oncology indications.

The pre-IND briefing package submitted by NKore included information regarding the intended manufacturing process, nonclinical data, and the proposed initial clinical trial design. The trial is intended to evaluate NK101 across multiple cancer indications using a basket-trial approach. NKore plans to incorporate the FDA's feedback into its ongoing development activities while completing the additional studies, analyses, manufacturing activities, and documentation necessary to support a future IND submission.

The company acknowledges the contributions of its employees, scientific and medical advisors, consultants, Board of Directors, shareholders, manufacturing partners, and research collaborators whose efforts have contributed to this milestone and to the continued advancement of the NK101 program.

The successful completion of the pre-IND meeting with the FDA direction as NKore advances NK101 toward a U.S. IND submission and future US clinical trials in cancer. This milestone is a testament to the company's commitment to bringing innovative cell therapies to patients in need. While there is substantial work ahead, the progress achieved to date establishes an increasingly strong foundation for what NKore intends to accomplish next.