Maxwell Biosciences Receives FDA Qualified Infectious Disease Product (QIDP) Designation for All-Cause Bacterial and Fungal PneumoniaAUSTIN, Texas — Tuesday, September 8, 2026 — Maxwell Biosciences, a biotechnology company developing a new class of immune-inspired anti-infective therapeutics, today announced that on May 5, 2026, the U.S. Food and Drug Administration (FDA) granted Qualified Infectious Disease Product (QIDP) designation to MXB-22,510-SC, Maxwell's investigational parenteral injectable drug candidate for the treatment of community-acquired pneumonia (CAP) and hospital-acquired (HAP) or ventilator-associated pneumonia (VAP) caused by confirmed or suspected bacterial or fungal pathogens. QIDP designation is available to antibacterial and antifungal drugs intended to treat serious or life-threatening infections and provides FDA Fast Track designation upon sponsor request and FDA Priority Review, which together provide for a faster drug development pathway and an expedited FDA review timeline. In addition, the designation permits a total of 10 years of market exclusivity after FDA approval. For pneumonia patients in urgent need, MXB-22,510-SC would allow medical professionals to rapidly treat suspected pneumonia cases before diagnostics to identify if the pathogen is bacterial or fungal. MXB-22,510-SC is the nature-inspired, lead systemic candidate from Maxwell's proprietary Claromer drug platform. Claromers are synthetic, thermally-stable, protease-resistant, low-molecular-weight peptidomimetics inspired by the pathogen-targeting functions of the human innate immune system. MXB-22,510-SC is designed to act directly on structural membrane features shared across almost all pathogen membranes, supporting broad activity against bacterial and fungal species, including drug-resistant pathogens."Patients with severe pneumonia frequently require urgent treatment before the causative pathogen is known," said Scotch McClure, Founder, Chairman & Chief Executive Officer of Maxwell Biosciences. "This designation directly aligns with the central objective of MXB-22,510-SC: a hyper broad-spectrum, direct-acting drug candidate successfully tested by the U.S. military (NMRC, WRAIR_ET and others) against more than 400 bacterial and fungal pathogens, designed to address both bacterial and fungal disease across major unmet medical needs. If successful in clinical development, MXB-22,510-SC could help physicians treat serious infections earlier and more effectively, with the potential to save many lives. It establishes an important regulatory path for our first systemic Claromer drug candidate and strengthens the foundation for global development, pharmaceutical co-development and commercialization partnerships."Maxwell is working with EY's strategy consulting arm, EY-Parthenon, to formulate the global development and commercialization strategy for MXB-22,510-SC, including market prioritization, clinical-development pathways, regional and global licensing opportunities and potential strategic partnerships with pharmaceutical companies."The breadth of this QIDP designation strengthens the strategic development profile of MXB-22,510-SC across severe pneumonia settings," said Sumeet Chandna, Partner at EY-Parthenon. "This drug candidate has the potential to address one of the largest global public health challenges at scale, save lives and expand access to effective therapies—especially in developing markets."The QIDP designation represents a regulatory milestone for Maxwell's Claromer platform. Maxwell is advancing MXB-22,510-SC toward FDA human clinical trials and plans to provide further updates as regulatory and development milestones are reached. Maxwell Biosciences is a preclinical-stage biotechnology company developing a new generation of broad-spectrum anti-infective therapeutics inspired by the human innate immune system. Its proprietary Claromer platform comprises synthetic, biostable peptidomimetics designed to target conserved structural features of bacteria, fungi, enveloped viruses and biofilms. Maxwell's lead programs are being developed in parenteral, intranasal, oral and topical formulations for serious infectious diseases. The platform is supported by more than a decade of research and an issued patent portfolio. Maxwell's mission is to create health for the world, safely and affordably.
