Serapha Bio Names Key Leadership to Advance Gene Therapy for AATD

Serapha Bio, a clinical-stage genetic medicines company focused on transforming the treatment of alpha-1 antitrypsin deficiency (AATD), has announced the appointment of key senior executives to its leadership team. Kenneth T. Mills has been appointed as Chief Executive Officer and a member of Serapha’s Board of Directors. Additionally, Daphne Karydas has been named President and Chief Financial Officer, Weston Miller, MD, as Chief Medical Officer, Nina Hunter, PhD, as Chief Development Officer, and Shiva G. Fritsch as Chief Corporate Affairs Officer.

Mills brings over two decades of executive leadership in the biotechnology industry, most recently serving as President, CEO, and director of Tagworks Pharmaceuticals B.V., a precision oncology company. Karydas, with more than two decades of financial leadership, most recently served as President and CFO of Flare Therapeutics. Miller, a seasoned medical professional with over two decades of clinical development experience, has previously held roles at Epicrispr Biotechnologies, Graphite Bio, and Astellas Gene Therapies. Hunter, with close to two decades of regulatory and drug development leadership, has most recently worked as SVP, Global Regulatory Strategy and Quality at REGENXBIO. Fritsch, with over two decades of experience guiding the growth and strategic evolution of biopharmaceutical companies, previously served as Chief Communications and People Officer at REGENXBIO.

The appointments come as Serapha Bio prepares to advance its lead program, SERP-01, an in vivo base editing therapy designed to correct the most severe disease-causing SERPINA1 E342K (PiZZ) point mutation. This therapy aims to restore the production of functional M-AAT while reducing the toxic Z-AAT, addressing both the liver and lung manifestations of AATD with a single intravenous administration. The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a Phase 2/3 clinical trial of SERP-01 in PiZZ AATD patients, with the company planning to initiate the trial in late 2026 or early 2027.

Positive proof-of-concept data from an ongoing investigator-initiated trial (IIT), conducted through a collaboration between clinical sites in China and Germany, were presented at the European Respiratory Society (ERS) Congress. The data showed dose-dependent increases in AAT levels above the protective threshold, substantial reductions in disease-causing Z-AAT protein, and direct correction of the target mutation at its source following a single treatment, with no bystander or off-target editing detected.

Mills expressed his excitement about the potential of SERP-01, stating, "We've assembled a team of proven leaders spanning genetic medicines, regulatory strategy, clinical development, manufacturing, and commercialization. Each of these leaders has helped build and operate successful biotechnology companies focused on rare and life-threatening diseases, and I'm thrilled to partner with them as we advance SERP-01 through global clinical development."

Karydas added, "The emerging data from the ongoing IIT are extremely compelling and a major driver of my conviction in joining Serapha. That, combined with the unique opportunity to build alongside Ken and this leadership team of proven operators, is why I’m thrilled to join Serapha at this stage."

Serapha Bio continues to expect its previously announced merger with Boundless Bio, Inc. (Nasdaq: BOLD) to close in the fourth quarter of 2026, subject to the satisfaction of customary closing conditions, including approval by the stockholders of each company. In support of the proposed merger, Serapha has secured commitments for pre-closing private investments of approximately $230 million from a syndicate of investors co-led by RTW Investments and RA Capital Management, with participation from Janus Henderson Investors, Decheng Capital, Vivo Capital, Casdin Capital, LifeSci Venture Partners, Logos Capital, Balyasny Asset Management, and Eventide Asset Management.