Porustobart

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- 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, today announced its interim results for the six months ended June 30, 2024. 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 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. Nona Biosciences: An Efficient Value Creation Engine As a pioneer in innovative antibody platform technology, the Company continues to empower the innovators in the industry and support its collaborators from I to ITM (Idea to IND) through Nona Biosciences. By leveraging flexible business models and robust internal discovery capabilities, Nona Biosciences is maximizing platform value by combining the strengths of the Company with those of its collaborators. To fully utilize the unique platform technologies, Nona Biosciences continues to explore the expansion of platform technology applications, generating impactful values for the Company. The Company has established partnerships with over 25 industry pioneers and academic researchers, further expanding its collaboration network both in China and globally. In February 2024, Nona Biosciences entered into a collaboration agreement with Boostimmune, a biotech company dedicated to developing next-generation anti-cancer therapies via modulating immune systems. The collaboration aims to leverage Nona Biosciences' proprietary H2L2 Harbour Mice® to accelerate the development of ADCs against novel targets. In May 2024, Nona Biosciences entered into a license agreement with Astra Zeneca for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology. Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction, is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona Biosciences is eligible to receive payments for the option programs should Astra Zeneca exercise these options. In July 2024, Nona Biosciences entered into a collaboration agreement with Alaya.bio, a biotechnology company developing a novel polymeric delivery platform, to precisely target and reprogram cells in situ and thus to significantly simplify the way CAR-T cell therapies are being developed, manufactured and administered. Nona Biosciences continuous to optimize, upgrade and further develop its technology, establishing a robust antibody discovery platform, protein engineering platform, conjugation technology platform, HCAb-CAR screening platform and delivery technology platform to use mRNA-encoding target gene as immunogen to tackle difficult targets. These platforms enable the Company to address more novel and challenging drug targets globally. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions. The proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please visit SOURCE Harbour BioMed

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, March 28, 2024 /PRNewswire/ -- 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 immune-oncology and immunology, released annual financial results of full year 2023. "We made progress in two significant undertakings in 2023, the third financial year since listing on the Main Board of the Stock Exchange of Hong Kong: preparing Harbour Therapeutics to operate as a faster, more focused clinical-stage next-generation therapeutics company and initiating Nona Biosciences to leverage our unique global patent-protected technology platforms to empower global therapeutic innovation. We recorded a significant increase in our revenue, demonstrating the Company's excellent global business development capabilities," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "We are navigating a fiercely competitive world that is going through rapid changes, facing human being's fundamental quest for longevity and quality of life, and having a greater demand for biotechnological breakthroughs and innovative therapeutics. We've been well-positioned in the new era to achieve results that will propel the Company to new heights and create robust business value." FULL YEAR 2023 FINANCIAL HIGHLIGHTS Harbour BioMed recorded the profit of US$22.8 million for the year ended 31 December 2023. This is the first time that the Company has recorded a net profit on its annual financial statements. Other financial highlights include: Revenue: The revenue for the full year 2023 is US$89.5 million, which increased significantly by US$48.8 million, or 119.9%, compared with US$40.7 million for the year ended 31 December 2022. Our revenue primarily consists of molecule license fee, research service fee and technology license fee. The increase is primarily attributed to license out and collaboration agreement with Pfizer, Cullinan Oncology and Kelun-Biotech. Research and development costs: The research and development expenses decreased by 66.6%, from US$135.1 million in 2022 to US$45.1 million in 2023. This decrease was primarily attributable to the combined impact of (i) optimized investments in our clinical programs and our molecule assets in discovery and pre-clinical stages; and (ii) the efficient implementation of cost control measures. Administrative expenses: The administrative expenses decreased by 28.6%, from US$27.3 million in 2022 to US$19.5 million in 2023. ROBUST PORTFOLIO AND DIFFERENTIATED PIPELINE Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is individually responsible for the development of the Company's product pipeline. Focused on oncology and immunology, Harbour Therapeutics has a robust and diversified pipeline of more than ten potentially differentiated drug candidates, four of which are in clinical development stage. Batoclimab (HBM9161), porustobart (HBM4003), HBM7008 and HBM1020 are the main products. Batoclimab, as the clinically most advanced FcRn inhibitor being developed in Greater China, has the potential to be a breakthrough treatment for a wide spectrum of autoimmune diseases in Greater China. Harbour Therapeutics completed the treatment of patients in early 2023 and announced the positive topline results of the phase III clinical trial of batoclimab for the treatment of generalized myasthenia gravis (gMG) in March, which is also the first positive pivotal trial outcome for batoclimab worldwide. This marks a major milestone as it is the Company's first product to complete phase III clinical trial and be poised for commercialization to benefit the gMG patients. The Company also initiated open-label extension clinical trial in 2022 and completed enrolment in March 2023. As the cut-off of open-label extension clinical trial for gMG in November 2023, the data showed sustainable efficacy and safety of batoclimab in long-term disease management. Porustobart (HBM4003) is the next-generation, fully human heavy chain only anti-CTLA-4 antibody generated from the HCAb platform. It is also the first fully human heavy chain only antibody which has entered into clinical development around the world. In 2023, Harbour Therapeutics conducted the global clinical development program of porustobart for multiple types of solid tumors, and positive data of efficacy and safety profile have been read out in the ongoing trials of neuroendocrine neoplasms and hepatocellular carcinoma. Another example demonstrating Harbour Therapeutics' strong research capabilities is the discovery of HBM7008, a novel product targeting B7H4 and 4-1BB. Developed from the immune cell engager platform HBICE®, HBM7008 is the only bispecific antibody against these two targets globally. Leveraging and integrating the expertise in biology and antibody engineering and the unique characteristics of HBICE® platform, HBM7008 showed exciting performance both in efficacy and safety profile at pre-clinical stage. In 2022, the Company conducted the phase I trials in the U.S. and Australia. In February 2023, to maintain a leading position in the development of this first-in-class asset, the Company entered into a co-development collaboration with Cullinan Oncology, to expand its study process in the U.S., Europe and Australia. HBM1020 is a first-in-class fully human monoclonal antibody generated from Harbour Mice® platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which potentially plays a more important role for tumor cells to escape immune surveillance. HBM1020 is the first product against B7H7 in clinical stage globally. With its excellent product design and target features, HBM1020 presents great potential to address huge unmet medical needs on solid tumors. Driven by the Company's leading drug innovation and discovery engine, new assets are continually being developed, of which HBM1020, HBM1022, HBM1007 and HBM9033 obtained the IND clearance from the U.S. FDA to initiate clinical study in the U.S. in 2023, and HBM9027 obtained the IND clearance from U.S. FDA in the first quarter of 2024. In addition, we have a number of pre-clinical stage products in the pipeline, including HBM7004, HBM1047 and HBM9014, which have shown great potential for development. PLATFORM-VALUE-MAXIMIZED BUSINESS COLLABORATIONS In 2023, the Company continued to expand its business collaborations with leading academic institutions and select industrial partners focusing on innovation and efficiency across the world. The business collaboration model is not only limited to out-licensing, but also to engage with academic institutions or other leading innovative pioneers in the industry for co-development and incubation of joint ventures on next-generation innovative therapy. With flexible business models built around proprietary technologies and platforms, the Company can and will maximize its platform value to address global unmet medical needs. Assets Collaboration of Harbour Therapeutics Harbour Therapeutics has entered into several external collaborations in terms of pipeline licensing and collaborations. In 2023, Harbour Therapeutics has granted the regional out-licensing of HBM7008 in the U.S. to Cullinan Oncology, and HBM7022/AZD5863, which was licensed to AstraZeneca in 2022, has entered into clinical stage. Meanwhile, the three assets which have been licensed the Greater China Rights to Hualan Genetic obtained IND approvals from NMPA to initiate clinical study in China. In addition, HBM9378, which was developed in collaboration with Kelun-Biotech, completed its phase I clinical trial. With these multiple collaborations based on the assets generated from HBICE®, Harbour Therapeutics has shown its strength and unique advantages in building a comprehensive portfolio in immune cell engagers. And the co-development and collaboration of the pipeline is not only the recognition of the industry partners for the Company's products and technology platforms, but will also help the Company to improve the efficiency of portfolio advancement, spread the costs and risks, and make the development of the Company more robust. Multiple Collaborations of Nona Biosciences In addition to collaboration through the molecules and pipeline generated from the platforms, the Company is also focusing the vision on more original and innovative collaborations on early stages. By integrating the industry leading Harbour Mice® and HCAb PlusTM platforms with an experienced therapeutic antibody discovery team, Nona Biosciences provides a one-stop solution for therapeutic antibody discovery, engineering and development from I to ITM (Idea to IND) with flexible business models. From the end of 2022, Nona Biosciences achieved big success in its launch as it has landed several international collaborations in multiple innovative formats. It is worth mentioning that Nona Biosciences has granted the global out-licensing of HBM9033, a potential best-in-class MSLN-targeted ADC, to Pfizer. Until now, Harbour Mice® platforms have been validated by over 50 industry and academic partners. Nona Biosciences has established four leading technology units based on HCAb, including protein engineering, conjugation technology, delivery technology and cell therapy to empower the next-generation therapies. With the multiple collaborations based on the assets generated from HCAb PlusTM, Nona Biosciences has demonstrated its robust capabilities in antibody discovery and development, exploring a new path to expand the collaboration network and maximize the value of the platforms. Incubation on Cutting-Edge Collaborations To give full play to the value of the unique platform technologies, the Company has continued to explore the expandability of platform technology application scenarios which generate impactful values and bring us new value growth points with minimal marginal investment. Representative projects include HBM Alpha Therapeutics, in partnership with Boston Children's Hospital, and Shanghai NK Cell Technology Limited. 2024 OUTLOOK: EXTENSIVE GLOBALIZATION AND BREAKTHROUGH INNOVATION Looking to the future, Harbour BioMed will keep driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences. The former will advance multiple clinical trials of the internal pipeline to fully advance the global clinical development project, and the latter will keep providing integrated discovery solutions for biotechnology and pharmaceutical companies and ultimately create an innovation ecosystem to promote biological advancement. A range of products based on the technology platform and generated from the concept of T-cell engager and NK cell engager, will be pushed forward to clinical stage in the following years. With a combination of in-house development and business collaborations, the Company will continuously form a portfolio of products with a differentiated competitive advantage in immuno-oncology. The platform-valued-maximized business collaborations, driven by Nona Biosciences, will further walk the Company down the path of global development. Positive outcomes have been attained through platform-based collaborations with top institutions around the world and more extensive global collaborations are expected in 2024 as our preclinical products become increasingly mature. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions. The proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please refer to . SOURCE Harbour BioMed