GenScript ProBio and AbTis Enter into an Exclusive Worldwide License Agreement for ADC Targeting Claudin 18.2
On December 8th, 2021, GenScript ProBio entered into a partnership with AbTis, a Korean biotechnology company dedicated to the development of antibody drug conjugate (“ADC”), to grant AbTis an exclusive, worldwide license of GenScript ProBio’s anti-Claudin 18.2 monoclonal antibody (“Licensed Antibody”), to develop and commercialize the ADC. AbTis and GenScript ProBio will enter into an exclusive CDMO collaboration for the preclinical CMC development as well as clinical and commercial production of the antibodies for ADC product.
Claudin-18 is an important member of Claudin protein family, and Claudin18.2 is mainly expressed in gastric epithelial cells and highly expressed in primary malignant tumors, such as gastric, pancreatic, breast, colon and liver cancers. Claudin18.2 is now one of the most popular targets for pharmaceutical companies, especially those engaged in ADC development. GenScript ProBio team has completed antibody discovery, functional validation and cell line development for this Licensed Antibody. AbTis will continue to develop and commercialize ADC products based on the Licensed Antibody. Financial terms of the License Agreement were not disclosed.
About AbTis Antibody Technology
AbTis is a biotechnology company that specializes in antibody-drug conjugates (ADC) platform technology with its own proprietary patents and its own pipelines in developments in oncology areas.
More information: https://www.abtis.co.kr
About GenScript ProBio
GenScript ProBio is the biologics CDMO segment of GenScript Biotech, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.
More information: https://www.genscriptprobio.com
Peptron, Inc. ("Peptron"), a South Korea-based biotech company, and
Qilu Pharmaceutical ("Qilu"), a leading vertically integrated pharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative medicines announced todaythat the companies have entered into an exclusive licensing agreement for the manufacturing, development and commercialization of Peptron's PAb001-ADC, the antibody-drug conjugate (the "ADC") product containing the anti-MUC1 monoclonal antibody PAb001 as effective of March 26, 2021.
Under the terms of the agreement, Peptron grants Qilu an exclusive global right and license to develop, manufacture, sell, and commercialize PAb001-ADC for the treatment of cancers.
PAb001-ADC is a pre-clinical ADC entering into Investigational New Drug ("IND") enabling studies. It targets MUC1, a high-potential ADC target for multiple solid and hematological malignancies. MUC1 is overexpressed in many cancers and is recognized as a promising molecular target for therapeutic development for various types of cancers.
“I believe that it was Kairos' professional consulting and BD activities that led to the success of our LO deal with Qilu. With Kairos' extensive experience and expertise, I have no doubt that we will make successful history again.”
Jin G. Jung, Associate Director of Business Development at Peptron
For more information about Peptron Inc., please visit www.peptron.com.
For more information about Qilu Pharmaceutical Co., Ltd., please visit http://en.qilu-pharma.com.
license agreement HL 161, anti-FcRn monoclonal antibody
HanAll Biopharma has signed again a large-scale technology transfer agreement. In September, following the Chinese Harbour BioMed, this time is the Swiss pharmaceutical company, Roivant Sciences. This contract on HL 161, autoimmune antibody, is worth up to 500 million dollars.
HanAll Biopharma announced on Tuesday that they have transferred technology for the treatment of autoimmune disease antibody to Roivant Sciences. Under the terms of agreement, Roivant Sciences will now have exclusive rights to clinical development, production, and product licensing in North America, Latin America, the EU, the UK, Switzerland, the Middle East and North Africa.
The fixed-term technology fee is a total of $502.5 million, with $30 million in non-refundable contracts, research fees limited to $20 million, (five-year split), and $452.5 million dollars in each milestones. It is also a condition to receive the ordinary technical fee separately.
Swiss pharmaceutical company Roivant Sciences is also well known as a company that has received investment $1.1 billion, the largest ever in the biotechnology and pharmaceutical industry, from Vision fund led by Softbank in August.
Roivant has a model to develop and commercialize by taking over the late clinical pipeline through its subsidiary company.
The technology transferred this time is HL 161, which is being developed as an autoimmune disease antibody drug. Technology of this substance was transferred at a total of $81 million (including substance HL036), including $4 million contracts fee, to Chinese Harbour Biomed in September.
HL161 is a human antibody derived from a transgenic model. It has a mechanism of inhibiting FcRn receptor that keeps autoimmune antibody staying in our body, entering the cells and degraded in lysosome.
While most of drugs are targeting the factors associated antibodies producing b-cells, this new substance is targeting FcRn receptor as a ‘first-in-class’ drug. HanAll Biopharma targets optic neuropathy, a rare neurological disorder, and plans to expand its indications to other rare diseases such as myasthenia gravis and pemphigus vulgaris.
HanAll Biopharma has recently received phase 1 approval from the Austrailian FDA for clinical trials for HL 161 autoimmune disease therapeutic antibody drug and started phase 1 clinical trial. Phase 1 clinical trial is processed under Quintiles, a global CRO, and to be completed by third quarter of 2018.
HanAll Biopharma and Harbour BioMed Sign Collaboration and License Agreement to Develop Two Novel Biologic Therapies in Greater China
HanAll Biopharma Co., Ltd. (009420.KS) and Harbour BioMed announced today that they have entered into a strategic collaboration and license agreement to develop, manufacture and commercialize in Greater China (including Hong Kong, Macau and Taiwan) HanAll's two novel biologics, the anti-FcRn monoclonal antibody, HL161, for the treatment of pathogenic IgG-mediated autoimmune diseases, and the anti-TNF ophthalmic solution, HL036, for dry eye and other inflammatory diseases.
HanAll Biopharma will receive up to $81 million in total upfront, development, registration, and sales milestones, as well as royalties on net sales. The rights outside of Greater China are reserved for HanAll. Additional terms were not disclosed.
"We are delighted to be able to work with Harbor BioMed's team who have demonstrated outstanding capability in the discovery and development and commercialization of novel antibody therapeutics within the immunology field and deep expertise in China," said Seung Kook Park, PhD, MBA, CEO of HanAll Biopharma. "This collaboration will enable us to accelerate the development and commercialization of our pipeline products in other countries too, especially in the US and European countries."
"There are great unmet medical needs that these two innovative compounds can address for Chinese patients," said Jingsong Wang, MD, PhD, CEO of Harbour BioMed. "We are looking forward to collaborating with HanAll Biopharma to develop them in Greater China. This collaboration is aligned with our strategy to leverage our global and regional clinical development expertise by in-licensing clinical stage compounds that are complementary to the internal portfolio we are building through our industry leading, transgenic mouse platforms for generating fully human antibodies."
HL161 is a fully human monoclonal antibody targeting neonatal Fc receptor (FcRn). The FcRn rescues IgGs from intracellular degradation and maintains the high serum levels, even pathogenic auto-IgGs. Blocking the FcRn-IgG interaction accelerates the degradation of autoantibodies and alleviates the flare-up in wide array of pathogenic IgG-mediated autoimmune diseases such as myasthenia gravis, pemphigus, immune thrombocytopenia purpura, neuromyelitis optica, and etc. HanAll discovered HL161 by using transgenic animal producing fully human monoclonal antibodies. The company is planning a Phase I clinical study of HL161 in late 2017 as a subcutaneous injectable formulation that differentiates it from the competitors' intravenous formulations.
HL036 is a TNF receptor fragment which has been molecularly engineered to enhance tissue penetration efficiency and TNF-neutralizing potency for the best topical anti-TNF peptide. HanAll has developed the HL036 eye drop for the treatment of dry eye disease (DED) and other inflammatory ocular diseases. The HL036 eye drop shows no drug-related adverse effects and systemic exposure from Phase I studies in healthy volunteers. HanAll submitted an Investigational New Drug (IND) application for HL036 to initiate the Phase II clinical study for dry eye disease in November 2017 in collaboration with Ora Inc in the US. In addition to DED, HanAll is developing a new HL036 formulation for the inflammatory ocular diseases in posterior regions such as diabetic retinopathy and wet age-related macular degeneration, in collaboration with an undisclosed Japanese company.
About HanAll Biopharma
HanAll BioPharma Co., Ltd. (009420.KS), a subsidiary of Daewoong Pharmaceutical Co., Ltd., is a fully integrated biopharmaceutical company based in South Korea focusing on the discovery and development of innovative biological therapeutics in the areas of autoimmune diseases and immuno-oncology. HanAll's lead pipeline assets are 1) HL161, a fully human monoclonal antibody targeting neonatal Fc Receptor (FcRn) for the treatment of pathogenic-IgG mediated autoimmune diseases, 2) HL036, anti-TNF ophthalmic solution for the treatment of dry eye diseases, and 3) two novel immuno-oncologic projects. HanAll's ambition is to be a leader in the area of immunology providing new therapeutics to patients with severe immune disorders in cooperation with specialized groups in each research field and through open innovation.
Learn more at: http://en.hanall.co.kr
About Harbour BioMed
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer, with a focus on immuno-oncology, and immunological diseases. The company's discovery and development programs are built around its two patented transgenic mouse platforms (Harbour Mice) for human antibody discovery. The company is building its proprietary pipeline through its innovative internal discovery programs, and through in-licensing clinical stage assets that strategically fit its internal portfolio. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.