Nona Biosciences ("Nona"), a biotechnology company focused on advancing biologics discovery and development through proprietary technology platforms, has announced a strategic partnership with Lonza to create advanced single-domain antibody-based blood-brain barrier (BBB) delivery technologies for the treatment of central nervous system (CNS) disorders.

The collaboration will utilize Nona's proprietary Harbour Mice® fully human HCAb platform to identify and develop next-generation BBB-penetrating technologies based on single-domain antibodies. Recognized for its ability to generate fully human HCAbs and VHH binders with high affinity and favorable developability characteristics, the platform is expected to support the creation of a leading BBB delivery solution. This technology aims to facilitate the transport of a wide range of therapeutic agents into the CNS, opening new possibilities for CNS therapeutics and future licensing opportunities. Lonza will contribute its expertise in protein engineering, along with its GS Gene Expression System® and GlycoConnect® bioconjugation technologies, to optimize selected BBB-crossing candidates and expand their potential applications.

According to the agreement, Nona will receive upfront and option-related payments from Lonza. In addition, both companies will share revenue generated from future licensing arrangements arising from the partnership.

Dr. Jingsong Wang, Chairman of Nona Biosciences, stated that the collaboration reinforces the strength of Nona's technology platform and its strategic commitment to next-generation drug delivery solutions. He noted that Lonza's global presence, regulatory knowledge, and commercial manufacturing capabilities are expected to accelerate the advancement of Nona's BBB-crossing technology. He added that the partnership creates opportunities for licensing, commercialization, and long-term value generation while further strengthening Nona's position in CNS drug delivery and supporting improved patient outcomes.

Dr. Di Hong, Chief Executive Officer of Nona Biosciences, said that the company is pleased to work with Lonza on the development and commercialization of innovative BBB-crossing technologies for CNS diseases. He emphasized that the collaboration highlights the versatility and capabilities of the HCAb Harbour Mice® platform in generating differentiated, fully human single-domain binders capable of overcoming some of the most complex challenges in drug delivery. By combining Nona's platform technologies with Lonza's development and manufacturing expertise, he expressed confidence that the partnership can deliver next-generation BBB solutions and create new therapeutic opportunities for patients affected by severe CNS disorders.

Peter Droc, Head of Licensing at Lonza, stated that acquiring intellectual property rights related to Nona's BBB-crossing technology, together with the ongoing collaboration, will enable customers to more effectively advance promising CNS therapies into clinical and commercial applications. He added that combining the technology with Lonza's flexible CDMO services allows partners to engage at any stage of development—from technology licensing to integrated development and commercial-scale manufacturing—helping to simplify the process and accelerate the delivery of new treatments to patients.

Harbour BioMed, a global biopharmaceutical company focused on advancing innovative antibody-based therapies in immunology and immune-oncology, has announced the online publication of results from the first-in-human Phase I clinical trial (NCT05790694/CTR20221961) of HBM9378 (also referred to as SKB378 or WIN378).

The study, led by Dr. Min Xu, a respiratory medicine specialist at Chengdu Fifth People’s Hospital, appears in the peer-reviewed journal Drug Design, Development and Therapy. Findings from the trial highlight a strong safety profile and a prolonged half-life, supporting continued investigation of HBM9378 in patients with serious immune-related conditions.

HBM9378 is a fully human monoclonal antibody with an extended half-life that targets thymic stromal lymphopoietin (TSLP). It is being co-developed by Harbour BioMed and Kelun-Biotech. The randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study enrolled 50 healthy adults to assess safety, tolerability, pharmacokinetics (PK), and immunogenicity. Participants were divided into five dose groups—20 mg, 60 mg, 200 mg, 600 mg, and 900 mg—with each cohort consisting of ten individuals, eight receiving HBM9378 and two receiving a placebo.

Results showed that treatment-emergent adverse events (TEAEs) occurred at similar rates across both the treatment and placebo groups, with no evidence of increased safety concerns at higher doses. The median time to reach peak concentration (Tmax) ranged between 4.05 and 14.1 days, while the average half-life (T1/2) was between 55.0 and 65.8 days. Drug exposure, measured by Cmax and AUC, rose proportionally with increasing doses from 20 mg to 900 mg. Anti-drug antibodies (ADA) were detected in 5% of participants (2 out of 40), with no observed clinical effects or impact on drug exposure. Notably, no injection site reactions were reported in any group.

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, described the Phase I results as an important step forward in developing new treatments for immune-related diseases. He emphasized that the favorable safety profile and extended half-life strengthen confidence in the drug’s potential to address unmet needs in conditions such as severe asthma and chronic obstructive pulmonary disease (COPD).

Dr. Min Xu, Principal Investigator of the study, noted that HBM9378 was well-tolerated and demonstrated a promising pharmacokinetic profile in healthy volunteers. He added that its long half-life could allow for less frequent dosing, which may improve patient adherence and overall treatment outcomes. The findings pave the way for further clinical trials to evaluate the drug’s effectiveness in individuals with severe immunological disorders.