Shanghai, China, April 23, 2024- Novamab, a biotechnology company dedicated to the research and development of innovative Nanobody drugs, announced that its core product LQ036 (an IL-4Rα single-domain antibody) has completed the first patient dosing in Phase IIa clinical trials for the treatment of moderate to severe asthma.

The Phase IIa study is a Proof-Of-Concept (POC) study led by Su Nan, director of China-Japan Friendship Hospital. The main purpose is to evaluate the effectiveness of LQ036 single domain antibody aerosol in the treatment of moderate to severe asthma patients.

LQ036 is an inhaled nanobody drug targeting IL-4Rα, independently developed by Novamab with its own intellectual property rights, for the treatment of asthma and COPD. LQ036 can effectively inhibit the binding of IL-4Rα to IL-4 and IL-13, thereby blocking the signaling pathway and achieving regulation of immune function. This includes suppressing the differentiation of Th2 cells, alleviating allergic airway responses, and reducing the synthesis of IgE, thus playing a role in alleviating diseases such as asthma. The results of the completed Phase I clinical studies in Australia and China indicate that LQ036 has good safety and tolerability.

The principal investigator of this clinical trial, Director Su Nan from the Department of Respiratory and Critical Care Medicine (PCCM) at China-Japan Friendship Hospital, said, " 'Currently, all biological agents used clinically are administered subcutaneously, whereas LQ036 is administered orally through inhalation, which offers advantages in terms of systemic safety and rapid local onset of action; and it is consistent with the administration route of the standard of care (SOC) for asthma patients. As a product independently developed by a Chinese pharmaceutical company, I am very much looking forward to witnessing its effectiveness in asthma patients together with Luoqi, and to filling the clinical gap of inhaled preparations in the future."

Dr. Wan Yakun, the founder, chairman, and CEO of Novamab, said, " LQ036, as an inhaled IL-4Rα nanobody drug, has the potential to disrupt the current biological treatment approaches for respiratory diseases and fill the gap in the field of inhaled biological agents. Phase I study results conducted in healthy volunteers indicate that LQ036 has good safety and tolerability, and the data from the pharmacodynamic biomarker are particularly exciting. I am confident that the Phase IIa clinical study of LQ036 in asthma patients will also show positive efficacy and consistent safety as seen in the earlier stages. We look forward to the promising performance of LQ036 in trials with asthma patients and strive to bring good news to a large number of asthma patients as soon as possible.

About asthma

Up to now, asthma remains a globally recognized medical challenge, listed by the World Health Organization as one of the four major persistent diseases, and is the second leading cause of death and disability in the world after cancer. About 350 million people worldwide suffer from asthma, of which about 5% -10% of asthma patients still cannot effectively control their symptoms after treatment with inhaled small molecule drugs [1], indicating a significant unmet clinical need.

According to the GINA guidelines, antibody drugs are suitable for severe patients as an add-on control treatment, serving as a supplementary control medication to the existing medication regimen, which requires long-term use [2]. However, due to the large molecular weight (about 150 kDa) and poor stability of monoclonal antibodies, existing technologies cannot meet the requirements for inhalation administration of large molecules, and can only be treated through intravenous or subcutaneous administration.

Compared with systemic administration through intravenous or subcutaneous administration, inhalation administration has the advantages of good compliance, fast onset, low dosage, minimal systemic exposure, and fewer potential adverse events, making it suitable for a wider range of asthma patients [2]. However, so far, no inhaled macromolecular asthma drugs have been approved for marketing.

About Novamab

Shanghai Novamab Biopharmaceuticals Co., Ltd. is an innovative biopharmaceutical enterprise dedicated to the research and industrialization of nanobody drugs. The company was established in October 2017 and is located in the Shanghai International Medical Park. It has established a complete research and development, CMC, and pilot production platform and system, and is currently the only company in China with the capability for full-process development of nanobodies. Novamab has built a 500 L Pichia pastoris nanobody GMP pilot production workshop, filling an industry gap in this field with high scarcity and competitiveness. 

As of January 2024, more than 80 domestic and foreign invention patents have been applied for, and 29 have been authorized. Novamab has developed dozens of nanobody drugs, with a pipeline covering fields such as respiratory system, autoimmune, ophthalmology, and oncology. Currently, it has obtained four clinical approvals. The LQ036 and LQ043H products under development by Novamab have overturned the existing treatment methods for respiratory diseases, both of which are the world's first inhaled nanobody drugs of their respective target.

References

[1] O'Byrne PM, Panettieri RA Jr, Taube C, Brindicci C, et al. Development of an inhaled anti-TSLP therapy for asthma. Pulm Pharmacol Ther. 2023 Feb;78:102184.

[2] Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2023. Updated May 2023.（ Available from: www.ginasthma.org.）