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ContactSteve Hinnant2021-10-26T14:49:16+00:00

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BioCytics Successfully Completes a Key Regulatory Milestone with Recent FDA INTERACT Meeting

Huntersville, NC, November 18, 2025—BioCytics is pleased to announce they successfully reached a regulatory milestone for de-risking clinical development plans with a productive FDA INTERACT meeting during which they discussed manufacturing immune cell therapies at the point of care.

This INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting is a first step in getting feedback from the FDA regarding the feasibility of BioCytics’ cell therapy platform development plans. By accepting this meeting and reviewing the plans, the FDA is indicating that BioCytics’ immuno-oncology tumor treatment protocol efforts, the first of which is called BioCytics Immune Fraction #1 (BCyIF-1), show enough pre-clinical scientific potential to warrant continued research development and upscaling manufacturing efforts. This milestone feedback from the FDA speaks volumes for BioCytics’ work towards a future Investigational New Drug (IND) submission. It solidifies plans of getting to first-in-human clinical trials in 2027, with the ultimate goal of treating solid tumors.

Dr. John Powderly, Oncologist and President of BioCytics said “We are delighted to have received insightful feedback from the FDA regarding development of BioCytics BCyIF-1, a cellular therapy to be manufactured at the point of care. The FDA’s willingness to review our pre-clinical research data and hold the INTERACT meeting with us results in substantially reduced regulatory risk as we move towards a future IND. It is fantastic to have our early research validated and to be able to enter confidently into our IND-enabling and manufacturing efforts.”

About BioCytics, Inc.

BioCytics, founded in 2005, is a privately held health technology company located in Huntersville, North Carolina. BioCytics is researching autologous Adaptive Cell Therapy (AACT) to develop an immuno-oncology platform for treating solid tumors with the patient’s own immune cells. AACT is a revolutionary point-of-care cell manufacturing process designed to generate nongenetically modified effector cell fractions for all stages of all solid tumors. For more information, please visit Biocytics.com or find us on LinkedIn.

About Carolina BioOncology Institute, PLLS

Carolina BioOncology Institute (CBOI), a cancer treatment and clinical trial facility, is co-located with BioCytics, in Huntersville, NC. CBOI is an independent community-based cancer research clinic that serves the Southeast region as a referral hub for metastatic cancer patients’ access to Phase I clinical research trials. For more information, please visit Carolinabiooncology.org or LinkedIn.

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Media Contact:

Jennifer Montague

j.montague@biocytics.com

980-441-1150

Dr. Powderly’s Episodes on the “TIL Talks” Podcast

· Link to Episode #12

A discussion of advancements in immunotherapy, particularly focusing on Peripheral Tumor Infiltrating Lymphocytes (TIL) and their potential in cancer treatment.

Dr. Powderly shares insights from his experience as an oncologist and the work being done at the Carolina Bio-Oncology Institute. They explore the logistics of cell therapy, the importance of decentralization in treatment access, and the challenges faced in personalized medicine. The discussion also highlights the significance of patient awareness regarding clinical trials and treatment options available to them.

They emphasize the need for patients to take an active role in their treatment options and the potential for regulatory changes to improve access to innovative therapies. The discussion also highlights the significance of understanding the differences between in vivo and ex vivo therapies and the future of cancer treatment.

· Link to Episode #16

In this conversation, Chris and Dr. John Powderly discuss the intricate relationship between neoantigens, vitiligo, and immunotherapy in cancer treatment. They explore Chris's personal journey as a melanoma survivor, the science behind neoantigens, and the implications of autoimmune responses.

The discussion emphasizes the importance of patient advocacy, effective communication between healthcare providers, and the impact of lifestyle changes on health outcomes. They also touch on the unique challenges of mucosal melanoma and the future of immunotherapy, highlighting the need for patient education and empowerment.

· Link to Episode #18

In this episode of TIL Talks, Chris White welcomes back Dr. John Powderly to discuss the latest advancements in immunotherapy research and the importance of empowering patients to seek out clinical trials. They delve into the critical role of nutrition and gut health in cancer treatment, emphasizing the impact of dietary choices on recovery. The conversation also highlights the dangers of processed foods, synthetic additives, and environmental toxins, urging listeners to adopt healthier lifestyles. Finally, they discuss the significant benefits of regular exercise for cancer patients and the need for awareness regarding microplastics and their potential health risks.

John Powderly MD and Chris also discuss various aspects of cancer survivorship, including the risks associated with imaging, the emotional toll of scan anxiety, and the importance of mental health support for patients and their families. They emphasize the need for community involvement, the significance of finding purpose in survivorship, and the advancements in cancer treatment. The conversation also highlights the critical role of blood donation in supporting cancer patients and the ongoing need for awareness and education in the field.

· Link to Episode #19

In this episode of TIL Talks, Chris White and Dr. John Powderly discuss the evolving landscape of digital health in oncology, focusing on the challenges of electronic health records (EHRs), the Open-EHR movement aimed at standardizing clinical data, and the importance of patient empowerment in accessing their health information.

They explore the future of clinical trials, the role of AI in healthcare, and innovations in early cancer detection, emphasizing the need for collaboration among healthcare professionals to improve patient outcomes.

· Link to Episode #22

In this engaging conversation, Chris White and Dr. John Powderly delve into the intricate relationship between immunotherapy and vitiligo, exploring how the immune response can be harnessed to combat cancer.

They discuss historical insights into cancer treatment, the significance of animal models in research, and the groundbreaking advancements in checkpoint inhibitors that have transformed cancer therapy. The dialogue emphasizes the importance of understanding the immune system's mechanisms and the potential for personalized medicine in future treatments.

· Link to Episode #23

In this episode of TIL Talks, Chris White and Dr. John Powderly continue and pick up from their last recording and discuss the advancements in immunotherapy and cell therapy, focusing on the mechanisms of checkpoint inhibitors, the challenges of immune resistance, and the importance of personalized medicine.

They explore the role of the tumor microenvironment, the significance of patient-centric approaches, and the regulatory challenges faced in the development of cell therapies. The conversation emphasizes the need for innovative solutions in point-of-care manufacturing and the future directions of cancer treatments.

Some Key takeaways include the significance of clinical trials, the complexities of immune resistance, and the future potential of personalized cell therapies. As research continues to evolve, it is essential for patients and families to stay informed and consider participating in clinical trials to access cutting-edge treatments.

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