On August 28, 2024 Harbour BioMed ("HBM", or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, reported its interim results for the six months ended June 30, 2024 (Press release, Harbour BioMed, AUG 28, 2024, View Source [SID1234646174]).

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Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented, "In the first half of 2024, Harbour BioMed remained profitable, demonstrating the Company’s remarkable resilience and adaptability in challenging market conditions. Our global operations continue to open new avenues for future growth. Our outstanding performance has validated the feasibility of the Two-Engine strategy, driven by Harbour Therapeutics and Nona Biosciences. We are confident in our ability to enhance value creation and drive sustainable growth by fully unlocking the tremendous potential of our core innovation engine."

The Company reported revenues of US$23.7 million for the first half of 2024, achieving an overall profit of approximately US$1.4 million, with a solid cash balance exceeding US$183 million.

Harbour Therapeutics: Robust Portfolio and Differentiated Pipeline

The Company has a robust and diversified pipeline with potentially differentiated drug candidates in immuno-oncology and inflammatory and immunology diseases. Key products include HBM9161, HBM4003, HBM9378 and HBM1020. The Company aims to deliver at least one IND submission generated from the discovery engine each year.

Batoclimab (HBM9161) is a novel, fully human anti-FcRn (neonatal fragment crystallizable receptor) monoclonal antibody which has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. In June 2023, the National Medical Products Administration (NMPA) of China accepted the BLA of batoclimab for the treatment of gMG, while in December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the BLA for batoclimab to the NMPA in June 2024, which was shortly accepted in July 2024. According to the analysis of the Open-Label extension clinical trial up to November 2023, the data demonstrated consistent efficacy and safety of batoclimab in long-term disease management. Its clinical results were published in JAMA Neurology in March 2024.

Batoclimab received the "Breakthrough Therapy Certificate" from the NMPA in 2021 and achieved a positive outcome in the proof-of-concept study for treating Chinese gMG patients in July 2021. The positive topline results of its Phase III clinical trial were announced in March 2023.

In October 2022, the Company entered into an agreement with NBP Pharma, a wholly owned subsidiary of the CSPC Group, to co-develop batoclimab in Greater China. The Company believes that the collaboration with CSPC Group enables the Company to optimize the market potential and advance the clinical development of batoclimab, so as to further maximize the value of batoclimab in Greater China.

Porustobart (HBM4003) is a next-generation, fully human anti-CTLA-4 antibody targeting cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). It is the first internally developed molecule generated from HCAb Harbour Mice platform. Porustobart is the first fully human heavy chain only anti CTLA-4 antibody entered into clinical development worldwide, and has favourable properties compared with conventional anti-CTLA-4 antibodies in pre-clinical settings. Notably, porustobart exhibits unique, favourable properties including significant Treg cell depletion and optimized pharmacokinetics for improved safety. While increasing the potential to selectively deplete intratumoral Treg cells via enhanced antibody-dependent cellular cytotoxicity (ADCC) strategy, the Company believes porustobart will be able to break the significant immune-suppressive barrier of anti-cancer immunotherapies in solid tumors. Porustobart has great potential to overcome the efficacy and toxicity bottleneck of the current CTLA-4 therapies, positioning it as a key product in cancer immunotherapy.

The Company has implemented a global development plan for porustobart across multiple solid tumor types, with adaptive treatment designs. Positive data on efficacy and safety have been read out from the monotherapy trial targeting advanced solid tumors, as well as the trials of combination treatment with PD-1 inhibitor for melanoma, NEN, and HCC. In January 2024, patient enrolment for combination therapy with a PD-1 inhibitor for advanced colorectal carcinoma was initiated.

HBM9378 is a fully human monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), developed from H2L2 Harbour Mice platform. It inhibits the TSLP-mediated signalling pathway by blocking the interaction between TSLP and its receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization, and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. HBM9378 features fully human sequences, which reduce the risk of immunogenicity and improve bioavailability compared to other TSLP-targeting competitors. Its optimized long half-life and outstanding biophysical properties provide dosing and formulation benefits.

HBM9378 has entered the clinical development stage in collaboration with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech). In February 2022, HBM9378 received IND approval from the NMPA for the treatment of severe asthma and initiated the Phase I trial in China. In October 2023, HBM9378 completed the Phase I clinical trial, and the initiation of its Phase II clinical trial is now ongoing. The Company is also preparing the IND application for a second indication, chronic obstructive pulmonary disease (COPD), for HBM9378.

HBM1020 is a first-in-class, fully human monoclonal antibody generated from Harbour Mice platform, targeting B7H7/HHLA2. As a newly discovered member of the B7 family, B7H7/HHLA2 expression is found non-overlapping with PD-L1 expression in multiple tumor types, suggesting it may play a key role for tumor cells to escape immune surveillance beyond PD-L1 mechanisms. HBM1020 is the first product targeting B7H7/HHLA2 in clinical stage globally. With its excellent product design and target features, the Company believes that HBM1020 has significant potential to address unmet medical needs in the treatment of solid tumors, particularly in patients with low PD-L1 expression and those resistant to PD-(L)1 therapies. The Company initiated a Phase I clinical trial in the U.S. in May 2023 and has since completed multiple dose levels. The latest progress of HBM1020 will be presented at the ESMO (Free ESMO Whitepaper) Congress 2024.

Engaged in the discovery and development of differentiated antibody therapeutics in the areas of immuno-oncology and immunology, the Company are also exploring and developing multiple programs, including novel and challenging antibody therapeutics across various disease areas.

In oncology field, alongside monoclonal antibodies (mAbs) such as HBM1022 (CCR8) and HBM9014 (a LIFR-targeting mAb), the Company is also generating bispecific antibodies from the HBICE platform, featuring innovative designs and differentiated mechanisms such as HBM7020 (BCMAxCD3), HBM9027 (PD-L1xCD40), and HBM7004 (B7H4xCD3). In addition, leveraging the advantages of the Harbour Mice platform and utilizing the XDC platform, the Company is exploring more therapeutic modalities in oncology, including HBM9033 (a MSLN-targeted ADC) and other ADC/RDC programs in early stages.

In the inflammatory and immunology field, the Company has built a robust preclinical pipeline, encompassing bispecific and multi-specific antibody programs in targeting Type 2 pathways and for other inflammatory and immunology conditions.