PHARMACY MARKET

Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma.

HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech, the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate.

Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs, HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators.

"HBM9378/SKB378, a next-gen fully human monoclonal antibody, is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine, we are highly confident and determined to defeat intractable diseases across the world." 

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed


About HBM9378/SKB378
HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP 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.

About Asthma
Asthma is a heterogeneous disease defined by the history of respiratory symptoms that vary over time and in intensity, together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA), currently available biologic therapies and oral corticosteroids (OCS), many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia, sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO).

Severe asthma patients experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore, there are still significant unmet needs to develop safer and broader therapies for severe asthma.

About Harbour BioMed
Harbour BioMed 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.

Spotlight

The future is arriving fast for the life science industry. Convergence is happening along the entirety of the industry value chain, blurring the boundaries between pharma, biotech, generics, devices and broader healthcare companies. Advanced technologies and materials, once the realm of science fiction, are now starting to emerge and can be expected to play a much greater role in the research efforts of life science companies in the future. Emerging market companies are expanding and edging their way to the top table as innovator drug companies.

Spotlight

The future is arriving fast for the life science industry. Convergence is happening along the entirety of the industry value chain, blurring the boundaries between pharma, biotech, generics, devices and broader healthcare companies. Advanced technologies and materials, once the realm of science fiction, are now starting to emerge and can be expected to play a much greater role in the research efforts of life science companies in the future. Emerging market companies are expanding and edging their way to the top table as innovator drug companies.

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BUSINESS INSIGHTS

MediPharm Labs Enters into $6.2M Purchase Agreement for the Sale of Australian Facility

MediPharm Labs Corp. | July 12, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, has entered into a Share Purchase Agreement with OneLife Botanicals PTY for the sale of MediPharm Labs Australia Pty Ltd a wholly-owned subsidiary of the Company, for a minimum value of $6.9M AUD. The Agreement is subject to routine conditions and is anticipated to close within 90 days. The Agreement includes the assets of MPLA, specialized licensing, operational knowledge, and Australian and New Zealand customers currently served from that facility. All international contracts outside of Australia and New Zealand will remain with MediPharm Labs and be serviced from our Barrie GMP facility. In July 2021, MediPharm Labs was the first purpose-built cannabis facility to receive a pharmaceutical Drug Establishment License. Awarded by Health Canada, this license is recognized in over 50 countries as part of the Pharmaceutical Inspection Co-operation Scheme. At this time, the Company has completed a review of its international manufacturing platform and identified significant potential savings in moving all domestic and international manufacturing to the Canadian facility. After an extensive sale process, the Agreement with OneLife Botanicals was identified as a strategic fit for both parties. OneLife Botanicals is an emerging leader in Australia region for cannabis-based wellness and medical products, with plans to launch OTC CBD products across Australia. Purchasing the MPLA facility expedites OneLife Botanicals' timing to commercialization. The Company and OneLife Botanicals will also enter into a transition services agreement to allow for the two companies to smoothly transition products and services produced in the facility, and to work together on future commercial opportunities. David Pidduck, CEO of MediPharm Labs commented, "This sale represents a major milestone for MediPharm Labs as it continues to focus on rightsizing the business to achieve profitability. As we look to maintain our strong cash balance, this transaction paired with corporate restructuring completed in June 2022 should allow us to reduce our quarterly burn rate as we improve sales. I want to personally thank our Australian team. This group of professionals are trailblazers in the Australian and international medical cannabis market, achieving major milestones such as multiple customer product launches and our first deliveries to Germany. OneLife Botanicals is gaining one of the most capable medical cannabis manufacturing teams in Australia." "This purchase aligns and expedites the strategic aim of our organization to produce high quality medicinal cannabis products by integrating manufacturing into the end-to-end supply chain. The integration of a fully operational facility brings forward our objectives to take our products and brand to the market. OneLife Botanicals CEO Andrew Grant Our company undertook extensive research in considering this important acquisition and is highly confident about the capabilities and capacity of the operation to manufacture products in accordance with all compliance and quality standards. The integration of this business with our existing cultivation facility facilitates savings in capital investment, access to operational efficiencies and establishes us as a significant supplier in the Australian medicinal cannabis industry. We intend to build on the existing customer base and develop additional product distribution opportunities to become a formidable participant in the market." About MediPharm Labs Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment Licence from Health Canada, becoming the only company in North America to hold a domestic Good Manufacturing Licence for the extraction of natural cannabinoids. The Company carries out its operations in compliance with all applicable laws in the countries in which it operates. About OneLife Botanicals Onelife Botanicals is a niche producer of medicinal cannabis in Melbourne, Australia. The company has a passion for developing and producing products that provide a range of health benefits and assist in treating a range of specific health conditions. The company operates an existing cultivation site with extensive Infrastructure, including fit for purpose glasshouses for growing Medicinal Cannabis in a controlled environment. The glasshouses facilitate the optimum growing environment through temperature and climate control, allowing natural sunlight to be maximized in a protected and secure environment. The Directors and stakeholders are focused on identifying and exploring market opportunities, along with embracing innovation in the production processes. The success of the business is able to be achieved with an extensive Research and Development program, aimed at staying ahead of changes in growing methods, technological solutions and product applications, along with advanced automation ensuring that we minimize operating expenditure and maximise quality control.

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EditForce and Mitsubishi Tanabe Pharma Enter into License Agreement

EditForce, Inc. | July 06, 2022

EditForce, Inc. has entered into a License Agreement with Mitsubishi Tanabe Pharma Corporation to research, develop and commercialize potential gene therapy products for a specific target disease in the field of CNS by utilizing EditForce's proprietary PPR protein platform technology. In this alliance, MTPC and EditForce aim to create potential novel pharmaceuticals for the specific CNS disease by utilizing the drug R&D know-how and global business experience of MTPC and the novel biotechnology of EditForce. MTPC will acquire the exclusive right to conduct the selection of drug candidate molecules, preclinical and clinical development, manufacturing, and commercialization worldwide. Under the terms of the Agreement, EditForce will receive an upfront payment and milestone payments amounting to over 20 billion yen depending on the development stage and commercialization progress, and royalties based on worldwide sales after the launch. "I am so delighted to reach the agreement with MTPC, which has an interest in our proprietary PPR protein platform technology. We look forward to working closely with MTPC to develop and deliver breakthrough pharmaceutical products with our technology to patients suffering from diseases." Takashi Ono, President and CEO of EditForce About EditForce, Inc. EditForce, Inc., a Kyushu University-originated venture company developing a unique DNA/RNA editing technology (PPR platform technology (*)), was established in May 2015 by KISCO Ltd. and Prof. Takahiro Nakamura of Kyushu University (former president of EditForce and currently its scientific advisor) and funded by companies and funds that have track records of investing in life sciences and biotechnology. EditForce aims for drug discovery that applies the PPR technology through joint research with universities and private companies. Pentatricopeptide repeat protein platform technology PPR is a protein discovered in plants that regulates gene expression by binding to DNA and RNA in a sequence-specific manner. The PPR proteins are also found in humans and yeasts, and they have similar functions. Prof. Takahiro Nakamura and Dr. Yusuke Yagi, CTO of EditForce, have focused on the PPR proteins and elucidated the mechanism that determines sequence specificity, and established a technology for creating various PPR proteins, each of which binds to a specific target DNA or RNA sequence. Furthermore, it is possible to manipulate and modify the target genome and RNA both inside and outside the cell by fusion with effector proteins. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation the pharma arm of Mitsubishi Chemical Group is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future." MTPC sets the MISSION of "Creating hope for all facing illness." To that end, MTPC is prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of the central nervous system and immuno-inflammation. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis.

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On Demand Pharmaceuticals Announces Preferred Supplier Relationship with Azzur Group

On Demand Pharmaceuticals, Azzur Group | June 02, 2022

On Demand Pharmaceuticals, Inc. an innovative technology company transforming the way medicines are made, announced that it has signed a Preferred Supplier agreement with Azzur Group through 2024. The transformation of ODP's Rockville Headquarters into a State-of-the-Art cGMP Medicine Manufacturing facility began with Azzur in the fall of 2020. Azzur collaborated in designing ODP's GMP Roadmap and helped develop the strategy and execution plan for ushering in this latest addition to Maryland's Biotech Hub. Building on the strategy, Azzur worked alongside ODP to initiate a Managed Services approach to execution, providing a single source for Commissioning services, Equipment rentals, Technology subscriptions, and a series of outsourced packages covering Environmental Monitoring, Training, and Documentation. "The flexibility Azzur demonstrated to accommodate the fluid nature of a startup and the challenges we all faced during the COVID-19 pandemic was remarkable. Having the ability to pull on a variety of resources and expertise, when we needed it, is the reason we entered this relationship." Dr. John Lewin, ODP's Chief Medical Officer Tita Tavares, the Director of Azzur Washington, D.C., said "Enabling ODP to implement their innovative approaches required beginning with compliance in mind. Our unique approach to the Compliance Services world parallels ODP's strengths for innovation and delivering value to customers. At Azzur Group, we deliver the cGMP solutions required to address the greatest challenges life science companies face at every stage of their life cycle. ODP is on their way to filing their first regulatory submission and we look forward to our future efforts together." About On Demand Pharmaceuticals On Demand Pharmaceuticals™ is an innovative technology company transforming how medicines are made so they can be produced on demand—whenever and wherever medicines are needed. Our breakthrough manufacturing technology platform, Pharmacy on Demand (PoD)™, can be quickly customized to produce anything from key starting materials to active pharmaceutical ingredients (API) and final formulated drugs and was recently named by the World Economic Forum and published in Scientific American as one of the top 10 emerging technologies of 2021. With this technology, we're on a mission to provide an adequate, safe, and reliable supply of medicines to every community across the world. About Azzur Group From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers, and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

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