Monthly Archives: March 2022

MONROVIA, Calif. & TOA BAJA, Puerto Rico--(BUSINESS WIRE)--CytoImmune Therapeutics, a clinical-stage immunotherapy company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, today announced the opening of the Companys clinical cell manufacturing facility in Toa Baja, which was celebrated with a visit from the Governor of Puerto Rico, Pedro R. Pierluisi. The Secretary of Economic Development and Commerce, Manuel Cidre, and the Mayor of the municipality, Bernardo Betito'' Mrquez, were also in attendance during the opening of the facility.

In Puerto Rico we have the talent, the resources and the potential for this type of biotechnology company to successfully establish operations here. The opening of this new facility shows our commitment to this investment which has a direct effect on job creation and economic development. This investment impacts all of Puerto Rico and the patients in the trials, said Governor Pedro R. Pierluisi.

We chose Puerto Rico to develop and manufacture these innovative cancer treatments based on the significant scientific capabilities of our local talent and the decades of experience on the island in biopharmaceutical manufacturing. Our goal is to create cellular immunotherapies for patients to recognize and kill cancer cells. The work by the Company here holds the potential to positively impact patients around the world," said Jos Eduardo Vidal, Ph.D., Chief Operating Officer of the company.

CytoImmune is leveraging proprietary, robust and well characterized natural killer (NK) cell expansion and engineering technologies to advance its tumor-reactive NK (TRACK-NK) cell therapies for patients with cancer. The cells are engineered to directly attack cancer cells and broadly stimulate both the innate and adaptive arms of the human immune system through the potent release of interleukin 15, enabling robust and specific tumor killing. The CytoImmune clinical cell manufacturing facility in Toa Baja is custom designed to support all manufacturing needs for the Companys cell therapies, allowing the Company to accelerate the research and development efforts.

The early investment in our manufacturing capabilities will accelerate our clinical trials with collaboration between our clinical teams and the supply chain management. Further, developing this internal expertise in manufacturing also shortens the time needed to advance our newest innovations from the laboratory bench to patients, explained Christina Coughlin M.D., Ph.D., CEO of CytoImmune Therapeutics, Inc.

Just over a year ago we announced the establishment of Cytolmmune Therapeutics Puerto Rico and today we are glad to be witnesses of its opening in Toa Baja. This operation will be the first on the Island whose purpose is to conduct research, development and manufacturing in the 37,000 square-foot facility. A main part of our economic development strategy relies on innovation in the biopharmaceutical sector, where research and development are in the front line. Thank you for being part of Puerto Ricos transformation and for trusting our capable workforce, expressed Manuel Cidre, secretary of the Department of Economic Development and Commerce.

About CytoImmune Therapeutics:

CytoImmune Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to utilize the power of the engineered cells to activate the patients immune system to eliminate cancer cells. The company is advancing a differentiated pipeline of off-the-shelf NK cell therapies, using proprietary, robust and well characterized NK cell expansion and engineering technologies that are designed to provide effector cell therapy with broad immune stimulation, to enable effective tumor killing in both solid tumors and hematologic malignancies. For more information, please visit Cytoimmune.com

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CytoImmune Therapeutics, Inc. Opens the Company's Clinical Cell Manufacturing Facility in Toa Baja - Business Wire

Natural killer (NK) cells are a viable cancer immunotherapy alternative to T cells. Clinical studies were being conducted to test adoptive therapeutics using allogeneic, cytokine-activated NK cells. The appropriate cytokine support following adoptive transfer to increase NK cell growth and persistence, on the other hand, was unknown. Correlative studies from two independent clinical trial cohorts treated with major histocompatibility complex-haploidentical NK cell therapy for relapsed/refractory acute myeloid leukemia revealed systemic interleukin-15 (IL-15; N-803) cytokine support resulted in lower clinical activity compared to IL-2.

Researchers postulated that the mechanism was IL-15/N-803 activating recipient CD8 T-cells, which increased donor NK cell rejection. The hypothesis was validated by higher proliferating CD8+ T-cell counts in patients treated with IL-15/N-803 versus IL-2. Furthermore, in mixed lymphocyte responses, IL-15/N-803 increased responder CD8 T-cell activation and proliferation when compared to IL-2 alone. Furthermore, IL-15/N-803 increased the capacity of responder T cells to eliminate stimulator-derived memory-like NK cells, suggesting that more IL-15 could speed up donor NK cell removal.

As a result, using systemic IL-15 to assist allogeneic cell treatment might paradoxically reduce their therapeutic window of opportunity and clinical efficacy. The study suggested that inducing patient CD8 T-cell allo-rejection responses might severely restrict allogeneic cellular treatment with IL-15.

Reference:ashpublications.org/blood/article-abstract/139/8/1177/482704/Systemic-IL-15-promotes-allogeneic-cell-rejection?redirectedFrom=fulltext

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Systemic IL-15 Induces Allogeneic Cell Rejection in Patients - Physician's Weekly

SOMERSET, N.J.--(BUSINESS WIRE)--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, was named Newcomer of the Year at the tenth annual Foreign Investment Trophy ceremony hosted by Flanders Investment & Trade (FIT).

Flanders Investment and Trade is a Flemish government organization that facilitates investment projects in Flanders, a northern region of Belgium, and supports Flemish companies. The Foreign Investment Trophy recognizes international firms with investment projects in Flanders, and FITs Newcomer of the Year award is conferred upon organizations who have recently embarked on substantial investment projects in the region.

Legend Biotech earned the honor for its joint investment in a state-of-the-art manufacturing facility in Flanders with Janssen Pharmaceutica N.V. (Janssen). The cell therapy facility is the first-ever cell therapy manufacturing site located in Flanders, and it will serve as a regional hub for the companies cell therapy production for patients in Europe, the Middle East and Africa.

The 26,000-square-meter manufacturing hub is part of Legends collaboration with Janssen to advance the manufacturing of ciltacabtagene autoleucel (cilta-cel), a B cell maturation antigen-directed CAR-T treatment being evaluated for the treatment of relapsed or refractory multiple myeloma by the European Medicines Agency. In April 2019, cilta-cel was granted PRIME (Priority Medicines) designation. PRIME offers enhanced interaction and early dialogue with the developers of promising medicines to optimize drug development plans and speed up the evaluation of cutting-edge, scientific advances that target a high unmet medical need.

The European manufacturing hub is anticipated to come on-line in 2023 and will be managed by Legend Biotech.

As he accepted the award in Belgium, Ying Huang, PhD, CEO and CFO of Legend Biotech, said: This award is special recognition of our investment in Flanders, one of Europes most exciting biotechnology hubs. The Newcomer of the Year award marks how far weve come in since Legend was established to apply cell therapy to rare and uncommon diseases. We look forward to advancing that goal and to playing a meaningful role in the Ghent ecosystem for years to come.

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Learn more at http://www.legendbiotech.com and follow us on Twitter and LinkedIn.

About Flanders Investment & Trade

Flanders Investment & Trade (FIT) actively promotes sustainable international business in Flanders as a key element of the regions socio-economic development. FIT accomplishes this by supporting Flanders-based companies in their international business ventures and by attracting foreign investors. FIT assists businesses across Flanders in their international endeavors and provides custom advice and support. Companies can call on the agencys local and international networks of contacts, while FIT also offers financial support and information about the financial incentives available.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotechs strategies and objectives; statements relating to CARVYKTI, including Legend Biotechs expectations for CARVYKTI, such as Legend Biotechs manufacturing and commercialization expectations for CARVYKTI and the potential effect of treatment with CARVYKTI; statements about submissions for cilta-cel to, and the progress of such submissions with, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Chinese Center for Drug Evaluation of National Medical Products Administration (CDE) and other regulatory authorities; the anticipated timing of, and ability to progress, clinical trials, including patient enrollment; the submission of Investigational New Drug (IND) applications to, and maintenance of such applications with, regulatory authorities; the ability to generate, analyze and present data from clinical trials; and the potential benefits of Legend Biotechs product candidates. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotechs expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotechs patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the Risk Factors section of the Legend Biotechs Annual Report filed with the Securities and Exchange Commission on April 2, 2021. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Flanders Investment and Trade Names Legend Biotech Newcomer of the Year - Business Wire

DUBLIN, March 21, 2022 /PRNewswire/ -- The "Cell and Gene Therapy Bioassay Services Market by Type of Therapy, Therapeutic Area, Scale of Operation and Geography: Industry Trends and Global Forecasts, 2021-2030" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the current landscape and the likely future potential of cell and gene therapy bioassay service providers, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field.

Given the various advantages of cell and gene therapies and their ability to address the underlying causes of serious clinical conditions, the preference for such therapeutic modalities has increased over the years. As a result, several cell and gene therapies have been developed and approved for the treatment of a wide range of disease indications. In fact, at the time of this report's publication, more than 30 such therapies had been approved and over 1,200 therapeutic leads are under evaluation in different stages.

Owing to their rising popularity, these upcoming advanced therapeutic products are on the verge of becoming one of the highest valued therapeutic segments within the biopharmaceutical industry. Having said that, as is the case for all biological products, the development of cell and gene therapies is a complex, challenging and cost intensive process. Outsourcing is, therefore, a preferred operational model, with cell and gene therapy innovators relying heavily on specialty contract service providers to handle various aspects of their product development and manufacturing operations. In fact, over three quarters of the biopharmaceutical companies prefer to outsource their operations to the contract service providers and a large part of their expenditure goes to outsourcing services.

Amongst the various operations, the outsourcing of analytical testing services, including environment testing, bioanalytical testing, analytical testing, chemistry and stability testing, method development and validation, and product characterization, has witnessed significant rise in recent years.

The rising demand for outsourcing bioanalytical services has prompted the emergence of several contract research organizations that claim to offer bioassay services for cell and gene therapies. These companies usually have relatively more experience and are well equipped with the instruments and technological platforms to offer both pre-developed and customized bioassays.

In fact, these companies assist in bringing out the maximum efficiency of study design by offering several cost benefits and reducing the associated timelines. Given the benefits of outsourcing the bioassay services and the ongoing efforts of service providers to further improve / expand their respective offerings, we believe that the cell and gene therapy bioassay services market is likely to evolve at a steady pace, till 2030.

In addition to other elements, the study includes:

Key Questions Answered

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE

5. COMPANY COMPETITIVENESS ANALYSIS5.1. Chapter Overview5.2. Methodology5.3. Key Parameters5.4. Competitiveness Analysis: Companies Offering Cell and Gene Therapy Bioassay Services in North America5.5. Competitiveness Analysis: Companies Offering Cell and Gene Therapy Bioassay Services in Europe and Asia-Pacific

6. CELL AND GENE THERAPY BIOASSAY SERVICE PROVIDERS IN NORTH AMERICA: COMPANY PROFILES6.1. Chapter Overview6.2. CCRM6.2.1. Company Overview6.2.2. Cell and Gene Therapy Bioassay Service Portfolio6.2.3. Recent Developments and Future Outlook6.3. Nexelis6.3.1. Company Overview6.3.2. Cell and Gene Therapy Bioassay Service Portfolio6.3.3. Recent Developments and Future Outlook6.4. Pacific BioLabs6.4.1. Company Overview6.4.2. Cell and Gene Therapy Bioassay Service Portfolio6.4.3. Recent Developments and Future Outlook6.5. PPD Laboratories6.5.1. Company Overview6.5.2. Cell and Gene Therapy Bioassay Service Portfolio6.5.3. Recent Developments and Future Outlook6.6. WuXi Advanced Therapies6.6.1. Company Overview6.6.2. Cell and Gene Therapy Bioassay Service Portfolio6.6.3. Recent Developments and Future Outlook

7. CELL AND GENE THERAPY BIOASSAY SERVICE PROVIDERS IN EUROPE AND ASIA-PACIFIC: COMPANY PROFILES7.1. Chapter Overview7.2. AnaBioTec7.2.1. Company Overview7.2.2. Cell and Gene Therapy Bioassay Service Portfolio7.2.3. Recent Developments and Future Outlook7.3. Intertek Pharmaceutical Services7.3.1. Company Overview7.3.2. Cell and Gene Therapy Bioassay Service Portfolio7.3.3. Recent Developments and Future Outlook7.4. Lonza7.4.1. Company Overview7.4.2. Cell and Gene Therapy Bioassay Service Portfolio7.4.3. Recent Developments and Future Outlook7.5. Porton Bio7.5.1. Company Overview7.5.2. Cell and Gene Therapy Bioassay Service Portfolio7.5.3. Recent Developments and Future Outlook

8. MARKET TREND ANALYSIS

9. GLOBAL EVENT AND STRATEGIC INITIATIVE ANALYSIS

10. CASE STUDY: MARKET LANDSCAPE OF CELL AND GENE THERAPIES10.1. Chapter Overview10.2. Cell Therapy Market10.2.1. T-Cell Immunotherapies: Development Pipeline10.2.1.1. Analysis by Type of Product10.2.2. CAR-T Cell Therapies: Development Pipeline10.2.2.1. Analysis by Phase of Development10.2.2.2. Analysis by Therapeutic Area10.2.2.3. Analysis by Type of Developer10.2.2.4. Key Industry Players: Analysis by Number of CAR-T Cell Therapies in Development10.2.3. TCR-based Therapies: Development Pipeline10.2.3.1. Analysis by Phase of Development10.2.3.2. Analysis by Therapeutic Area10.2.3.3. Analysis by Type of Developer10.2.3.4. Key Industry Players: Analysis by Number of TCR-based Therapies in Development10.2.4. TIL-based Therapies: Development Pipeline10.2.4.1. Analysis by Phase of Development10.2.4.2. Analysis by Therapeutic Area10.2.4.3. Analysis by Type of Developer10.2.4.4. Key Industry Players: Analysis by Number of TIL-based Therapies in Development10.3. Gene Therapy Market10.3.1. Gene Therapy Market: Clinical and Commercial Pipeline10.3.1.1. Analysis by Phase of Development10.3.1.2. Analysis by Therapeutic Area10.3.2. Gene Therapy Market: Development Pipeline10.3.2.1. Analysis by Phase of Development10.3.2.2. Analysis by Therapeutic Area

11. LIKELY PARTNERS FOR CELL THERAPY BIOASSAY SERVICE PROVIDERS11.1. Chapter Overview11.2. Scope and Methodology11.3. Potential Strategic Partners for Cell Therapy Bioassay Service Providers11.3.1. Likely Partner Opportunities for Stem Cell Therapy Bioassay Service Providers11.3.2. Likely Partner Opportunities for CAR-T Therapy Bioassay Service Providers11.3.3. Likely Partner Opportunities for Dendritic Cell Therapy Bioassay Service Providers11.3.4. Likely Partner Opportunities for Tumor Cell Therapy Bioassay Service Providers11.3.5. Likely Partner Opportunities for NK Cell Therapy Bioassay Service Providers

12. LIKELY PARTNERS FOR GENE THERAPY BIOASSAY SERVICE PROVIDERS12.1. Chapter Overview12.2. Scope and Methodology12.3. Potential Strategic Partners for Gene Therapy Bioassay Service Providers12.3.1. Likely Partner Opportunities in North America12.3.2. Likely Partner Opportunities in Europe12.3.3. Likely Partner Opportunities in Asia-Pacific

13. MARKET FORECAST AND OPPORTUNITY ANALYSIS

14. CONCLUSION

15. EXECUTIVE INSIGHTS

16. APPENDIX 1: TABULATED DATA

17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/5d7pa0

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

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Global Cell and Gene Therapy Bioassay Services Market to 2030 - by Type of Therapy, Therapeutic Area, Scale of Operation and Geography - PR Newswire

Phase 1 trials increased by 32% in 2021, representing a considerable transition of advanced therapies into first-in-human trials, said the CGT Catapult as it released its 2021 Advanced Therapy Medicinal Product (ATMP) clinical trials database and report.

Moreover, commercially sponsored trials now represent nearly 80% of all UK ATMP clinical trials, demonstrating the attractiveness of the UKs ecosystem, said the organization.

Matthew Durdy, CEO of CGT Catapult, said that the rising and sustained commercial investment in these trials showcases the incredible strength and dynamism of the UK ATMP industry and "isa testament to the ongoing support of the UK government and the industry.

Fewer ATMP trials were reported as completed in 2021 compared to 2020, however, and this is likely due to the ongoing COVID-19 pandemic, which has resulted in trial delays, said the organization.

The MHRA does not need to be notified of interruptions to trials due to COVID-19, therefore the true impact of the pandemic on all stages of clinical trials is not yet completely understood.

The division of therapeutic indications among the ongoing ATMP trials remains largely unchanged from previous years. Oncology, which includes hematological malignancies and solid tumors, remains the dominant therapeutic area accounting for 37% of ATMP clinical trials, followed by ophthalmology (12%) and hematological (11%).

Again, little difference in the cell types investigated in ATMP clinical trials last year: T cells continue to be the dominant cell type, accounting for 47% of UK ATMP clinical trials. This is as expected since research into oncology, the largest therapeutic area, is largely T cell focused and is consistent with previous years.

The majority of the 168 ATMP clinical trials ongoing in the UK in 2021 were gene therapies (72%) followed by somatic-cell therapies (19%). Tissue engineered therapies accounted for approximately 9% of the ongoing clinical trials, noted the publication.

Of the ongoing gene therapy clinical trials, similar numbers of ex vivo (46%), which includes CAR-T, and in vivo (54%) genetic modifications were investigated.

For in vivo gene therapy clinical trials, AAV based vectors remain the main vector of choice (72%), followed by oncolytic viruses (17%).

Overall, the majority of the UK ATMP clinical trials ongoing in 2021 are currently recruiting (45%) or in follow- up (29%), indicated the report.

There has been an increase in the overall number of ATMP clinical trials for both autologous and allogeneic therapies since 2016, but the proportion of autologous to allogeneic products has remained fairly consistent, with approximately 70% being autologous and 30% allogeneic, it also noted.

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'Rising and sustained' commercial investment in advanced therapy trials in UK - BioPharma-Reporter.com

CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, March 24, 2022 /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 reported full year 2021 annual results. During the reporting period, the Company's product development continued to make outstanding breakthroughs, unleashing the power of innovative technology platforms and globalization advantages.

Logo (PRNewsfoto/Harbour BioMed)

"2021 was a year of strong momentum for Harbour BioMed. The company has been making significant progress with respect to our highly differentiated pipeline products and business operations," said Jingsong Wang, Founder, Chairman and Chief Executive Officer. "Our 10 clinical trials are ongoing while two of them, Batoclimab and Tanfanercept, are in pivotal phase III trials and are progressing towards BLA (Biologics License Application) submission. We've seen encouraging data of the global clinical trials of HBM4003 and solid progress of multiple assets through pre-clinical development. The value of our platforms has been further validated with more than 50 leading partners around world.

Moving forward in 2022, we will continue to explore more differentiated novel therapeutics on a global basis, leveraging in-house technology platforms and strong research and development capabilities. I believe that each of our innovative products empowered by our unique platforms has the potential to benefit the patients globally, accelerating our mission to lead a healthy life with breakthrough medicines globally."

Recent Highlights:

Continued advancement across broad pipeline of core assets

10 clinical trials are ongoing.

2 products, Batoclimab (HBM9161 for patients with myasthenia gravis) and Tanfanercept (HBM9036 for patients with dry eye disease), are in pivotal phase III trials and are progressing towards BLA submission.

Global clinical trials of HBM4003 in both monotherapy and combination therapy are also rapidly advancing at full pace, with encouraging data and promising results to date.

Story continues

Multiple assets are progressing through pre-clinical development

6 innovative and differentiated products are nearing clinical stages of development.

Another 7 INDs are approved. This portfolio of innovative and differentiated products entering the clinical stage demonstrates the value of the Company's technology platforms.

The Company is actively exploring new scientific discoveries in novel therapeutic areas to address unmet medical needs

Leveraging in-house technology platforms, the Company is incubating NK cell therapy, bispecific NK cell engager and developing innovative antibody drug conjugate (ADC) products.

The Company's scientific research team strives to scale new heights in science with its strong research and development capabilities

In the period, 65 patents were filed.

The Company also participated in multiple academic conferences, presenting scientific achievements while highlighting its strong innovation capabilities.

Further advanced its global strategy through multiple collaborations

Entered into a research collaboration agreement with the Dana-Farber Cancer Institute of the Affiliated Hospital of Harvard Medical School.

Reached a strategic collaboration on artificial intelligence with BioMap, integrating the Company's AI technology advantages into the Harbour Mice platform.

Further expanded an academic collaboration with the Icahn School of Medicine at Mount Sinai.

Advanced the strategic collaboration with Hualan Bio, and several assets are expected to enter the clinical stage this year.

The value of the Company's platforms is further validated with more than 50 leading partners around the world.

Driving antibody drug development through innovation

The Company remains committed to the discovery and development of differentiated antibody therapeutics focusing on oncology and immunology. Powered by Harbour BioMed's unique technology platforms, it has developed a differentiated portfolio and innovation engine for sustained long-term expansion and growth of its self-developed pipeline.

Harbour BioMed is at the forefront of developing next generation immuno-oncology therapeutics, including innovative immune cell engager bispecific antibodies, unique Treg depletion mechanism, and novel immune escape pathway. Cancer treatment market unfolds vast opportunities, and the Company seeks to develop oncology therapeutics that address situations where 70%-80% of patients do not respond to or are resistant to PD1/PD-L1, in its pursuit of next-generation immuno-oncology therapeutics which tap the potential value of this $100 billion market.

With the R&D advantages of HBM's unique and highly efficient antibody discovery platforms under one organizational umbrella, the Company developed a number of first-in-class clinical and preclinical products. Among them, the bispecific antibody HBM7008 (B7H4/4-1BB) and the monoclonal antibody HBM1020 (B7H7) which represents the next generation of immune checkpoint inhibitors with significant differentiated advantages. In addition, the monoclonal antibody HBM1022 targets the Treg cell protein CCR8. CCR8 is recognized globally as a challenging target but one which is garnering increased attention in immuno-oncology. The Company's use of mRNA immunization technology combined with its proprietary antibody platforms allow for a suite of solutions of G protein-coupled receptor (GPCR) antibody discovery. These noted products were all developed by the Company and indicative of the encouraging progress HBM has made in overcoming the challenges faced across the competitive landscape. The Company looks forward to continuing this success with promising clinical results as these and other programs move forward in their development lifecycles.

The rapid advancement of HBM's clinical pipeline has continued into 2022, with multiple milestones reported in the first quarter. In February, the fully human monoclonal antibody HBM9378 (or SKB378) generated from the Company's H2L2 platform was approved for an investigational new drug ("IND") clinical trial application for the treatment of moderate to severe asthma; in the same month, HBM7008 (B7H4/4-1BB), the world's first-in-class product from the HBICE bispecific antibody platform, was officially approved by the Independent Review Board (IRB) in Australia and could potentially provide improved efficacy with better safety as compared to traditional monoclonal antibody therapies. The Company expects 4-6 products to enter the clinical stage this year and to rapidly push forward innovative products with blockbuster potential, laying a solid foundation for building a global competitive advantage.

HBM's cutting-edge fully human antibody platforms enable unique innovation and differentiation

HBM's antibody discovery platforms are the engine of its portfolio innovation: HBICE - a fully human bispecific antibody platform for immune cell engagers, a fully human heavy-chain-only antibody HCAb platform for monoclonal antibodies, and a fully human heavy and light chain antibody H2L2 platform with global patent protection. These robust technology platforms drive the Company to continuously advance antibody drug development while move towards more novel and challenging targets to address unmet medical needs, providing the momentum for sustained therapeutics innovation worldwide.

It is worth noting that, in the field of bispecific antibodies development, the Company's fully human HBICE bispecific platform for immune cell engagers, the highly differentiated bispecific antibody technology platform globally, is built upon the fully human HCAb based formats for immune cell engagers, which is also a patented achievement independently developed by the Company. The HBICE platform focuses on immune cell engagers, which can flexibly generate multiple molecular structures adapting to different biological mechanisms of action and effectively solving the problem of heavy and light chain mismatch in antibody engineering. The technology platform connects tumor cells with immune cells, activates immune cells, and kills tumor cells specifically, which can improve the effectiveness of treatment and reduce the risk of cytokine storm, avoiding the toxicity risk of systemic activation. Thus, safety is significantly improved, which is conducive to creating more innovative, differentiated, and safe products.

HBM is actively strengthening globalization presence to empowering its long-term development goals

As innovation and development across the biopharmaceutical industry continues to become more global, the Company is thriving on its three global innovation research centers and four major clinical sites, which reflects the Company's global ambition and continued investment into its R&D capabilities. By integrating R&D centers established in the US, the Netherlands and China, the Company is capable to consolidate leading global scientific and technological innovation resources. By maximizing regional innovation success, resource utilization is improved and translational clinical research results are advanced, accelerating bringing about differentiated innovative therapeutics, facilitating cooperation within the industry for the benefit of patients. At the same time, following the strategy of international research and development, HBM set up with four clinical sites in China, the US, Australia, and Europe to speed up the global development of its self-developed products.

Importantly, innovative solutions shape the global biopharmaceutical industry. The Company is jointly developing the next generation of innovative therapeutics through its proprietary technology platforms and global innovation network; an approach that has been validated by over 50 industry and academia partners with more than 10 products having entered the clinical stage. External collaborations include those with Eli Lilly, AbbVie, Pfizer, BeiGene, Innovent, Dana-Farber Hospital of Harvard Medical School, and Icahn School of Medicine of Mount Sinai Medical System in New York. Our global footprint enables the value proposition the Company's antibody technology platforms, which can be continuously tapped into and increasing the commercial income generating potential of its R&D capabilities.

In addition, the Company previously announced that it will initiate exploration of NK cell and ADC therapeutics. The Company hopes to leverage its novel technology across these frontier therapeutic areas, expand the application of its technology platforms, and lead next drug development programs to address areas of significant unmet clinical needs.

Accelerating clinical development to unlock potential value

As of now, the Company has independently developed more than ten highly differentiated products, two of which are in pivotal clinical phase III trials and are moving towards Biologics License Application (BLA) submission namely Batoclimab (HBM9161), which has obtained the national Breakthrough Therapeutics Designation for myasthenia gravis, and Tanfanercept (HBM9036), the first globally innovative biological drug for dry eye disease in China.

Specifically, Batoclimab is a next generation fully human monoclonal antibody that selectively binds to and inhibits the neonatal crystal fragment receptor (FcRn) and has the potential for breakthrough treatment of various autoimmune diseases. Tanfanercept is the most advanced product candidate currently being developed by the Company for the treatment of moderate-to-severe dry eye disease, which has a bright market potential in the emerging dry eye drug market in China. These two products are highly differentiated and have large potential market opportunities.

As people begin to emerge from the global pandemic, good health is even more in focus now. In the increasingly competitive biopharmaceutical market, innovation is no doubt the core commodity. Harbour BioMed has built a broad moat with its innovation engine and differentiated pipeline, leveraging its unique and robust antibody technology platforms, regional global innovation ecosystem, and accelerated clinical operations of its core products.

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 Company's proprietary antibody technology platforms Harbour Mice generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies.

Cision

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Harbour BioMed Reports Full Year 2021 Financial Results: Empower Value Creation with Global Innovation Capabilities - Yahoo Finance