CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, March 24, 2022 /PRNewswire/ — Harbour BioMed (“HBM” or the “Firm”; HKEX: 02142), a world biopharmaceutical firm dedicated to the invention, improvement and commercialization of novel antibody therapeutics specializing in oncology and immunology, at this time reported full yr 2021 annual outcomes. In the course of the reporting interval, the Firm’s product improvement continued to make excellent breakthroughs, unleashing the ability of progressive know-how platforms and globalization benefits.
“2021 was a yr of sturdy momentum for Harbour BioMed. The corporate has been making vital progress with respect to our extremely differentiated pipeline merchandise and enterprise operations,” mentioned Jingsong Wang, Founder, Chairman and Chief Govt Officer. “Our 10 scientific trials are ongoing whereas two of them, Batoclimab and Tanfanercept, are in pivotal section III trials and are progressing in the direction of BLA (Biologics License Software) submission. We have seen encouraging information of the worldwide scientific trials of HBM4003 and strong progress of a number of belongings by pre-clinical improvement. The worth of our platforms has been additional validated with greater than 50 main companions round world.
Transferring ahead in 2022, we are going to proceed to discover extra differentiated novel therapeutics on a world foundation, leveraging in-house know-how platforms and robust analysis and improvement capabilities. I imagine that every of our progressive merchandise empowered by our distinctive platforms has the potential to profit the sufferers globally, accelerating our mission to guide a wholesome life with breakthrough medicines globally.”
Continued development throughout broad pipeline of core belongings —
- 10 scientific trials are ongoing.
- 2 merchandise, Batoclimab (HBM9161 for sufferers with myasthenia gravis) and Tanfanercept (HBM9036 for sufferers with dry eye illness), are in pivotal section III trials and are progressing in the direction of BLA submission.
- International scientific trials of HBM4003 in each monotherapy and mixture remedy are additionally quickly advancing at full tempo, with encouraging information and promising outcomes thus far.
A number of belongings are progressing by pre-clinical improvement —
- 6 progressive and differentiated merchandise are nearing scientific phases of improvement.
- HBM7008 was accredited for section I scientific trial in Australia and HBM9378 was accredited for section I scientific trial in China.
- HBM1020, HBM1022, HBM1007, and HBM7020 are all advancing in the direction of scientific purposes.
- One other 7 INDs are accredited. This portfolio of progressive and differentiated merchandise getting into the scientific stage demonstrates the worth of the Firm’s know-how platforms.
The Firm is actively exploring new scientific discoveries in novel therapeutic areas to deal with unmet medical wants —
- Leveraging in-house know-how platforms, the Firm is incubating NK cell remedy, bispecific NK cell engager and creating progressive antibody drug conjugate (ADC) merchandise.
The Firm’s scientific analysis crew strives to scale new heights in science with its sturdy analysis and improvement capabilities —
- Within the interval, 65 patents have been filed.
- The Firm additionally participated in a number of educational conferences, presenting scientific achievements whereas highlighting its sturdy innovation capabilities.
Additional superior its international technique by a number of collaborations —
- Entered right into a analysis collaboration settlement with the Dana-Farber Most cancers Institute of the Affiliated Hospital of Harvard Medical College.
- Reached a strategic collaboration on synthetic intelligence with BioMap, integrating the Firm’s AI know-how benefits into the Harbour Mice® platform.
- Additional expanded a tutorial collaboration with the Icahn College of Drugs at Mount Sinai.
- Superior the strategic collaboration with Hualan Bio, and several other belongings are anticipated to enter the scientific stage this yr.
- The worth of the Firm’s platforms is additional validated with greater than 50 main companions around the globe.
Driving antibody drug improvement by innovation
The Firm stays dedicated to the invention and improvement of differentiated antibody therapeutics specializing in oncology and immunology. Powered by Harbour BioMed’s distinctive know-how platforms, it has developed a differentiated portfolio and innovation engine for sustained long-term growth and development of its self-developed pipeline.
Harbour BioMed is on the forefront of creating subsequent technology immuno-oncology therapeutics, together with progressive immune cell engager bispecific antibodies, distinctive Treg depletion mechanism, and novel immune escape pathway. Most cancers remedy market unfolds huge alternatives, and the Firm seeks to develop oncology therapeutics that tackle conditions the place 70%-80% of sufferers don’t reply to or are proof against PD1/PD-L1, in its pursuit of next-generation immuno-oncology therapeutics which faucet the potential worth of this $100 billion market.
With the R&D benefits of HBM’s distinctive and extremely environment friendly antibody discovery platforms underneath one organizational umbrella, the Firm developed a lot of first-in-class scientific and preclinical merchandise. Amongst them, the bispecific antibody HBM7008 (B7H4/4-1BB) and the monoclonal antibody HBM1020 (B7H7) which represents the following technology of immune checkpoint inhibitors with vital differentiated benefits. As well as, the monoclonal antibody HBM1022 targets the Treg cell protein CCR8. CCR8 is acknowledged globally as a difficult goal however one which is garnering elevated consideration in immuno-oncology. The Firm’s use of mRNA immunization know-how mixed with its proprietary antibody platforms permit for a collection of options of G protein-coupled receptor (GPCR) antibody discovery. These famous merchandise have been all developed by the Firm and indicative of the encouraging progress HBM has made in overcoming the challenges confronted throughout the aggressive panorama. The Firm seems to be ahead to persevering with this success with promising scientific outcomes as these and different packages transfer ahead of their improvement lifecycles.
The speedy development of HBM’s scientific pipeline has continued into 2022, with a number of milestones reported within the first quarter. In February, the totally human monoclonal antibody HBM9378 (or SKB378) generated from the Firm’s H2L2 platform was accredited for an investigational new drug (“IND”) scientific trial software for the remedy of average to extreme bronchial asthma; in the identical month, HBM7008 (B7H4/4-1BB), the world’s first-in-class product from the HBICE® bispecific antibody platform, was formally accredited by the Impartial Assessment Board (IRB) in Australia and will probably present improved efficacy with higher security as in comparison with conventional monoclonal antibody therapies. The Firm expects 4-6 merchandise to enter the scientific stage this yr and to quickly push ahead progressive merchandise with blockbuster potential, laying a strong basis for constructing a world aggressive benefit.
HBM’s cutting-edge totally human antibody platforms allow distinctive innovation and differentiation
HBM’s antibody discovery platforms are the engine of its portfolio innovation: HBICE® – a completely human bispecific antibody platform for immune cell engagers, a completely human heavy-chain-only antibody HCAb platform for monoclonal antibodies, and a completely human heavy and lightweight chain antibody H2L2 platform with international patent safety. These sturdy know-how platforms drive the Firm to repeatedly advance antibody drug improvement whereas transfer in the direction of extra novel and difficult targets to deal with unmet medical wants, offering the momentum for sustained therapeutics innovation worldwide.
It’s value noting that, within the discipline of bispecific antibodies improvement, the Firm’s totally human HBICE® bispecific platform for immune cell engagers, the extremely differentiated bispecific antibody know-how platform globally, is constructed upon the totally human HCAb primarily based codecs for immune cell engagers, which can also be a patented achievement independently developed by the Firm. The HBICE® platform focuses on immune cell engagers, which might flexibly generate a number of molecular buildings adapting to completely different organic mechanisms of motion and successfully fixing the issue of heavy and lightweight chain mismatch in antibody engineering. The know-how platform connects tumor cells with immune cells, prompts immune cells, and kills tumor cells particularly, which might enhance the effectiveness of remedy and scale back the chance of cytokine storm, avoiding the toxicity danger of systemic activation. Thus, security is considerably improved, which is conducive to creating extra progressive, differentiated, and protected merchandise.
HBM is actively strengthening globalization presence to empowering its long-term improvement objectives
As innovation and improvement throughout the biopharmaceutical business continues to turn into extra international, the Firm is thriving on its three international innovation analysis facilities and 4 main scientific websites, which displays the Firm’s international ambition and continued funding into its R&D capabilities. By integrating R&D facilities established within the US, the Netherlands and China, the Firm is succesful to consolidate main international scientific and technological innovation assets. By maximizing regional innovation success, useful resource utilization is improved and translational scientific analysis outcomes are superior, accelerating bringing about differentiated progressive therapeutics, facilitating cooperation inside the business for the advantage of sufferers. On the identical time, following the technique of worldwide analysis and improvement, HBM arrange with 4 scientific websites in China, the US, Australia, and Europe to hurry up the worldwide improvement of its self-developed merchandise.
Importantly, progressive options form the worldwide biopharmaceutical business. The Firm is collectively creating the following technology of progressive therapeutics by its proprietary know-how platforms and international innovation community; an strategy that has been validated by over 50 business and academia companions with greater than 10 merchandise having entered the scientific stage. Exterior collaborations embody these with Eli Lilly, AbbVie, Pfizer, BeiGene, Innovent, Dana-Farber Hospital of Harvard Medical College, and Icahn College of Drugs of Mount Sinai Medical System in New York. Our international footprint permits the worth proposition the Firm’s antibody know-how platforms, which may be repeatedly tapped into and rising the industrial earnings producing potential of its R&D capabilities.
As well as, the Firm beforehand introduced that it’s going to provoke exploration of NK cell and ADC therapeutics. The Firm hopes to leverage its novel know-how throughout these frontier therapeutic areas, develop the applying of its know-how platforms, and lead subsequent drug improvement packages to deal with areas of great unmet scientific wants.
Accelerating scientific improvement to unlock potential worth
As of now, the Firm has independently developed greater than ten extremely differentiated merchandise, two of that are in pivotal scientific section III trials and are shifting in the direction of Biologics License Software (BLA) submission – particularly Batoclimab (HBM9161), which has obtained the nationwide Breakthrough Therapeutics Designation for myasthenia gravis, and Tanfanercept (HBM9036), the primary globally progressive organic drug for dry eye illness in China.
Particularly, Batoclimab is a subsequent technology totally human monoclonal antibody that selectively binds to and inhibits the neonatal crystal fragment receptor (FcRn) and has the potential for breakthrough remedy of varied autoimmune illnesses. Tanfanercept is essentially the most superior product candidate presently being developed by the Firm for the remedy of moderate-to-severe dry eye illness, which has a shiny market potential within the rising dry eye drug market in China. These two merchandise are extremely differentiated and have giant potential market alternatives.
As folks start to emerge from the worldwide pandemic, good well being is much more in focus now. Within the more and more aggressive biopharmaceutical market, innovation is little doubt the core commodity. Harbour BioMed has constructed a broad moat with its innovation engine and differentiated pipeline, leveraging its distinctive and sturdy antibody know-how platforms, regional international innovation ecosystem, and accelerated scientific operations of its core merchandise.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a world biopharmaceutical firm dedicated to the invention, improvement and commercialization of novel antibody therapeutics specializing in immunology and oncology. The Firm is constructing its sturdy portfolio and differentiated pipeline by inside R&D functionality, collaborations with co-discovery and co-development companions and choose acquisitions.
The Firm’s proprietary antibody know-how platforms Harbour Mice® generate totally human monoclonal antibodies in two heavy and two mild chain (H2L2) format, in addition to heavy chain solely (HCAb) format. Constructing upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) are able to delivering tumor killing results unachievable by conventional mixture therapies. Integrating Harbour Mice® with single B cell cloning platform, our antibody discovery engine is very distinctive and environment friendly for improvement of subsequent technology therapeutic antibodies.
SOURCE Harbour BioMed