Harbour BioMed Reports 2021 Interim Results

CAMBRIDGE, Mass.and SUZHOU, China and ROTTERDAM, Netherlands, Aug. 31, 2021 /PRNewswire/ -- Harbour BioMed ("HBM", or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported its interim results for the six months ended June 30, 2021, and provided key business updates.

Corporate Highlights

• Critical milestones of core clinical assets have been achieved: Batoclimab HBM9161 proceeds into full clinical stage development across the first group of indications with positive trial results reported, preparations being made for the second group of indications. Phase III trial of Tanfanercept HBM9036 are advancing at full speed. Significant progress has been made in HBM4003's global development plan, and data readout of the clinical trial results will be released at ESMO (the European Society of Medical Oncology) in September 2021.
• Multiple research programs are developing at an accelerated pace, including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1029 and HBM1007.
• Scientific team has put forth a strong R&D contribution: within reporting period, the Company has applied for 28 patents with 4 patents issued including 1US and 3HK applications, while presenting research results at multiple medical and academic conferences.
• Strengthened global partnerships continuously unlock value of HBM's integrated antibody discovery platforms through entering into research cooperation agreement with the Dana-Farber Cancer Institute, Affiliated Hospital of Harvard Medical School; reaching a strategic collaboration agreement with BioMap, an AI driven research and development platform focusing on precision medicine; and further advancing academic cooperation with the Icahn School of Medicine at Mount Sinai.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, "Harbour BioMed remains committed to developing innovative therapeutics for patients worldwide, becoming the leader in next generation antibody therapeutics with a strategic focus on immunology and oncology. In the first half of 2021, we further accelerated our product pipeline, advancing multiple clinical trials of the core products: Batoclimab and Tanfanercept are in preparation of expected commercial launches. We will continue to invest in HBM4003, and other numerous candidates generated from our discovery engine, while exploring innovative molecules with new targets as well as known targets. The remarkable business progress and growth momentum achieved in the first half of 2021 give us full confidence in securing the Company's future. As such, the Company will continue to successfully navigate the complex market environment and provide innovative treatments for patients around the world."

Core clinical assets are advancing, further developing HBM's product portfolio and pipeline

Since 2021, China's healthcare reform has been further deepened, and reform of the pharmaceutical industry has gradually matured amidst policy and market changes. Adjustments made to the medical insurance catalog, price negotiation of medical insurance and a new round of volume procurement bring continuous challenges to drug pricing, especially pricing of products with weak differentiators. At the same time, the exploration of medical insurance reform has pushed the industry to pay more attention to drug pricing. The Company is committed to bringing benefits and value to patients, and value-based healthcare approach is adopted in its unique and differentiated portfolio planning as well as the clinical assets' development.

Batoclimab HBM9161

A fully human monoclonal antibodies that can selectively bind to and inhibit the neonatal crystal fragment receptor (FcRn) and have the potential to treat a variety of autoimmune diseases. During the reporting period, the Company announced the positive results of its phase II clinical trial for Chinese patients with generalized myasthenia gravis (gMG), which is also the first clinical evidence of anti-FcRn therapy in Chinese patients. Batoclimab has entered full clinical stage development in:

Myasthenia Gravis (MG) 

• Obtained Breakthrough Therapy Designation (BTD) for MG treatment from China Center for Drug Evaluation (CDE) in January 2021.
• Announced positive topline results from phase II clinical trial for MG in July 2021, as the first clinical evidence of anti-FcRn therapies among Chinese patients, which showed a statistically and clinically meaningful efficacy of Batoclimab over placebo, as well as a favorable safety and tolerability profile.
• Held a "Phase II Ending" meeting with Center for Drug Evaluation, People's Republic of China's National Medical Products Administration (NMPA) and obtained their full support on proceeding to the phase III clinical trial.
• The phase III study of MG will be initiated in the second half of 2021 and submission of a BLA application is expected to occur in 2022.

Neuromyelitis Optica Spectrum Disorder (NMOSD)

• Completed the patient enrollment of NMOSD phase Ib/IIa clinical trials in July 2021.
• Data analysis of phase Ib/IIa clinical trials is expected in the second half of 2021, and regulatory communication for key trials is anticipated at the end of 2021.
• Expects to submit a BLA application in 2022.

Immune Thrombocytopenia (ITP)

• Completed phase II clinical trials in the first half of 2021 and plans to conduct data analysis in the second half of 2021.
• Obtained the NMPA's approval for the new dosage regimen for ITP patients in February 2021.
• Expects to submit a BLA application in 2023.

Graves Ophthalmopathy (GO)

• Expects to initiate GO phase II/III registration trials in the second half of 2021 and submit a BLA application in 2023.

Other Indications

• Submitted an IND application for chronic inflammatory demyelinating polyneuropathy (CIDP) indication to NMPA in May 2021.
• Submitted an IND application for pemphigus vulgaris (PV) indication to NMPA in August 2021.

Tanfanercept HBM9036

Tanfanercept is the Company's lead candidate product for the treatment of moderate to severe dry eye disease (DED), which is expected to meet the huge clinical needs of the Chinese patients.

• Completed the first patient dosing in ongoing phase III clinical trial in China in March 2021.
• Expects to submit a BLA application in 2022.

HBM4003

HBM4003 is a next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from HBM's HCAb platform. It is also the world's first fully human heavy chain only antibody to enter clinical development. In 2021, we have implemented the global development plan of multiple types of solid tumors utilizing HBM4003.

• Obtained IND approvals of combination therapy with PD-1/chemotherapy for advanced non-small cell lung cancer (NSCLC) and other advanced solid tumors from NMPA in February 2021.
• Achieved the first data readout of a phase I clinical trial of monotherapy in Australia with positive results. The abstract has been accepted by the ESMO and will be published at its annual conference in September 2021.
• Accomplished the first dosing of part 2/dose expansion cohort of the phase I monotherapy clinical trial in May 2021.
• Accomplished the first dosing in a phase I clinical trial for combination therapy with PD-1 for advanced melanoma and other advanced solid tumors in China in March 2021.
• Accomplished the first dosing in a phase I clinical trial for combination therapy with PD-1/chemotherapy for advanced NSCLC and other advanced solid tumors in China in June 2021.
• Submitted 2 IND applications for new indications, hepatocellular carcinoma (HCC) and neuroendocrine neoplasm (NEN), with PD-1 combination therapy in June 2021. We anticipate the approvals in the second half of 2021, and the Company plans to start patient dosing in early 2022.

Multiple potential preclinical assets approach clinical stage

In addition to the above-mentioned clinical assets, multiple potential products are also in full-speed preclinical development including: HBM7008, HBM9378, HBM1022, HBM1020, HBM7020, HBM7015, HBM1007, HBM1029, etc. – which are all approaching clinical stages. In the near future, the Company will continuously submit more IND applications through its efficient drug discovery engine.

HBM7008

HBM7008 is a bispecific antibody targeting Tumor Associated Antigen (B7H4)x4-1BB. It is discovered from Company's heavy-chain antibody immune cell engager HBICE^® and is currently the only bispecific antibody against these two targets worldwide. It is expected to file a CTA/IRB submission in the second half of 2021.

HBM9378

HBM9378 is a fully human monoclonal antibody generated from HBM's H2L2 platform, which has less immunogenicity risk and better bioavailability comparing to the other TSLP target competitors. The long half-life optimization and outstanding biophysical properties support its favorable dosing and formulation advantages. It is expected that an IND application will be submitted in the second half of 2021.

HBM1022

HBM1022 is a CCR8 antibody developed by HBM, which cross-reacts with the CCR8 target of cynomolgus monkeys, and has demonstrated its significant tumor growth inhibitory effect in mouse tumor models. As an innovative target, CCR8-targeted drugs have not yet entered the clinical development stage globally. It is expected that an IND application will be submitted in 2022.

HBM1020

HBM1020 is a fully human monoclonal antibody generated from HBM's H2L2 platform. The antibody is directed against a brand-new target in the B7 family and can enhance the anti-tumor immunity by blocking the immune checkpoint target. Preclinical data has demonstrated its immune activation and anti-tumor functional activities. It is expected to file an IND in 2022.

HBM1007

HBM1007 is a fully human monoclonal antibody against CD73 generated from HBM's H2L2 platform. It is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. HBM1007 is being studied in preclinical setting and an IND application is expected to be submitted in 2022.

HBM7020, HBM1029 and HBM7015

HBM7020 is a BCMAxCD3 bispecific antibody equipped with HBM's HBICE^® technology. HBM1029 is a fully human monoclonal antibody developed from the Company's H2L2 platform with higher CLDN18.2 binding affinity and stronger ADCC and CDC anti-tumor activities. HBM7015 is a bifunctional fusion protein generated from the H2L2 platform that demonstrated better PD-L1 binding activity than competitor drugs.

In 2020, the Company licensed-out the Greater China rights and interests of three preclinical products (HBM7020, HBM1029 and HBM7015) developed from its own technology platform to Hualan Genetic, a Chinese biopharmaceutical corporation. After completing the technology transfer, the two companies have jointly worked on the development of these three innovative products. It is expected that IND applications for these products will be submitted in 2022.

Build a global innovation hub with strong R&D capabilities and expertise

HBM focuses on a new generation of innovative therapies in the field of immunology and oncology. The drug discovery and preclinical research team has conducted drug discovery, formulation development, process development and preclinical research on new drug candidates. At the same time, the Company has a professional team of scientists to optimize, upgrade and re-develop our technology platform.

During the reporting period, the Company's main progress in drug discovery, technology platform and patents are as follows:

• Applied for 28 patents, 4 patents got issued including 1 US and 3 HK applications. These patent applications have further strengthened the intellectual property protection of the Company's core products and technology platforms.
• Developed and presented a newly discovered fully human anti-B7H7 monoclonal antibody HBM1020 at the American Association for Cancer Research (AACR) Annual Meeting in April 2021.
• Developed and presented a novel bispecific antibody HBM7022 (CLDN18.2xCD3) at the Antibody Engineering and Therapeutics (AET) Conference in June 2021.

HBM has established a robust antibody discovery platform and GPCR drug development platform. Based on these technology platforms, the Company is expected to move towards more novel and challenging drug targets worldwide.

Strengthened R&D collaborations worldwide

During the reporting period, HBM continued to expand collaborations with leading global academic institutions and selected industry partners focused on innovation and efficiency. HBM's flexible business models built around our proprietary technologies and our strong internal discovery capabilities can and will maximize our platform value by leveraging complementary advantages from the Company and our collaborators.

• In May 2021, it reached a strategic cooperation agreement with BioMap, committed to the scientific research, development and transformation of new antibodies products, and integrated BioMap's artificial intelligence technology advantages into the Harbour Mice^® platform.
• In June 2021, it entered into a multi-year and multifaceted research cooperation agreement with Dana-Farber Cancer Institute ("Dana-Farber"), an affiliated hospital of Harvard Medical School, to jointly develop new biological therapies in cancer treatment. Company scientists and Dana-Farber researchers will jointly develop novel biotherapies in cancer treatment, including bispecific antibodies, CAR-T cell products, etc.
• Further advanced academic cooperation with Icahn School of Medicine at Mount Sinai ("Mount Sinai") in connection with an exclusive license agreement between Mount Sinai and a third party over a collection of antibodies having SARS-CoV-2 (COVID-19) neutralizing assets generated from Harbour Mice^® platform.

Build internal manufacturing and commercialization capability to support clinical development and product launches

With the maturity of our pre-clinical products, we planned to build internal manufacturing and commercialization capability in due course.

• In 2021, the Company initiated the clinical supply manufacturing facility project to support the clinical development of its pipeline products. The pilot facility is located in Suzhou, Jiangsu Province. The facility's floor area is of around 8,500 square meters and the designed production capability scales up to 4000 liters. With the initiation and rapid formation of the Company's CMC team, it is expected that the facility will be ready for manufacturing in 2022.
• The Company has begun to build a commercial team with in-depth knowledge, experience and expertise in sales, marketing, and market access strategies, who will be involved in launches across several therapeutic areas. During the reporting period, the commercial team has initiated preparation for the launch of leading products, future academic promotion and pipeline expansion.

Financial Summary of First Half of 2021

For the half-year ended June 30, 2021, the Company recorded a revenue of US$2.2 million, mainly from molecule license fee.

For the half-year ended June 30, 2021, the Company's other income and gains were US$2.7 million, mainly attributable to the increase of bank deposit interest, as well as increase of government subsidy and grants.

For the half-year ended June 30, 2021, the Company's R&D expenses were US$41.2 million, increased investment in key clinical programs, discovery and pre-clinical programs; increased employee costs, mainly research scientists and development clinician headcounts, as well as share-based compensation expenses.

About HBM4003

HBM4003 is the next-generation, fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from Harbour Mice^®. It is the first molecule generated through our in-house efforts and has entered clinical trial since first being discovered as a drug candidate only 3 years ago. HBM4003 is the world's first fully human heavy chain only anti CTLA-4 antibody entered into clinical development. It shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

About Tanfanercept (HBM9036)

Tanfanercept (HBM9036) is at the forefront of the Company's R&D pipeline, it is a modified 19 kDa TNF receptor 1 fragment and is for the treatment of moderate to severe Dry Eye Disease. Tanfanercept has the potential to seize a majority market share in a fast-growing DED drug market.

About Batoclimab (HBM9161)

Batoclimab (HBM9161) is a novel, fully human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor (FcRn). As the first in class FcRn inhibitor being developed in Greater China, it is expected to become a breakthrough therapy to patients with autoimmune disease conditions.

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.

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