Ipsen Inks $1.03B Deal for Second ADC of the Year: Preclinical First-in-Class Candidate FS001 Targeting Novel Tumor Antigen
Ipsen
Biopharmaceutical Manufacturer
丨Medicine Hunter Club Research Team
Under the terms of the agreement, Ipsen will be responsible for the preparation activities of Phase I clinical trials for the drug, including the submission of the Investigational New Drug (IND) application, as well as all subsequent clinical development, manufacturing, and global commercialization activities.
As the consideration,Foreseen Biotechnology is eligible to receive up to $1.03 billion in upfront, development, regulatory, and commercial milestone payments, as well as tiered royalties on global sales., the specific amount depends on successful development and regulatory approval.
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Founded in 1929, Ipsen has nearly a century of history. As one of the well-known pharmaceutical companies in France, Ipsen's most widely recognized drug is Smectite Powder.With the development of its business, in 2022 Ipsen officially divested its CHC (Consumer Healthcare) business through a strategic transformation.Focusing on three therapeutic areas: oncology, rare diseases, and neuroscience。
March 2023,Ipsen Acquires Albireo, a Leading Innovator in Bile Acid Modulators for the Treatment of Cholestatic Liver Diseases in Children and Adults, for $952 Million, Further Expanding Its Rare Disease Portfolio and R&D PipelineThe main focus of the deal is Bylvay, an effective oral, non-systemic ileal bile acid transporter inhibitor (IBATi) taken once daily. In 2021, Bylvay was approved in the U.S. for the treatment of pruritus in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), and in the EU for PFIC treatment in patients six months and older. Pruritus is one of the most prominent and problematic manifestations of the disease, often leading to a significant decline in quality of life. Bylvay holds orphan exclusivity for its approved indications in PFIC in both the U.S. and EU.
Under the dual strategies of in-house R&D and acquisitions, Ipsen achieved double-digit growth in 2023. Sales of Cabometyx and Dysport increased by 22.9% and 14.5%, respectively. Newly launched drugs Bylvay® (odevixibat), Sohonos® (palovarotene), and Tazverik® (tazemetostat) also contributed to sales growth. Meanwhile, sales of Somatuline® (lanreotide) continued to decline gradually (-10.4%), accounting for only 34% of total sales (FY 2022: 40%).
Ipsen has increased its investment in innovative technologies this year, and so farThe company has invested $4.93 billion in heavy-hitting layouts for ADC, small-molecule drugs targeting RNA, and multispecific antibodies:
On April 2, Ipsen acquired a product from Sutro Biopharma for a total amount of $900 million.Preclinical ROR1 ADC Drug STRO-003This agreement grants Ipsen the global exclusive rights to develop and commercialize STRO-003, which is the first ADC candidate in Ipsen's continuously expanding R&D pipeline.
On April 22, Ipsen partnered with Skyhawk Therapeutics in a collaboration worth up to $1.8 billion to jointly discover and develop treatments that modulate rare neurological disorders.Novel Small Molecule Drugs for RNA. This agreement includes an option, under which Ipsen will obtain the exclusive license to develop successful candidate drugs worldwide.
On June 11, Ipsen and Marengo Therapeutics announced the expansion of their ongoing early-stage oncology research collaboration, which includes the addition of two further collaborative pipelines.Using Marengo's Next-Generation Precision T Cell Engager (TCE) Technology TriSTAR Platform, with a potential total transaction value of up to 1.2 billion US dollars.
Today's collaboration with Foreseen Biotechnology further expands Ipsen's ADC pipeline.
In the past 20 years, Ipsen has completed 27 licensing deals as the licensee, with a total amount reaching $12.7288 billion.
Ipsen Group entered China in 1992 and established an innovation center in Shanghai in 2019, which is one of the four global research and development centers. Ipsen set up its China headquarters in Shanghai in 2021, and in 2022, in line with the group's business changes, simultaneously divested its diversified health business to focus on specialty care. Targeting three major disease areas (oncology, rare diseases, neuroscience) and six indications, Ipsen collaborates with the Innovation Center to continuously introduce innovative treatment solutions to meet the urgent treatment needs of Chinese patients.
A Rising Star in Proteomics Research and Development
Foreseen-Biotechnology (Yuyan Biotech) was founded in 2021 by Professor Huang Chaolan, incubated by Nest.Bio, with the support of Sequoia, Source Code, and CMB International. The founding executive team includes several returned overseas Ph.D.s with R&D experience in multinational pharmaceutical companies. Yuyan Biotech is developing rapidly and currently has research centers in Beijing, Shanghai, and Wuxi.Beijing's headquarters, spanning over a thousand square meters, operates multiple high-precision mass spectrometers for proteome acquisition of clinical large-cohort samples and target screening using the integrated omics system PrOmics®.；Shanghai R&D CenterLocated in the core area of Zhangjiang Pharm Valley in Shanghai, a team led by several returned PhDs with rich experience in innovative project R&D at multinational pharmaceutical companies.Focus on clinical proteomics data mining and the transformation of downstream products, with a series of top-tier translational medicine capabilities including drug target selection, target validation, antibody screening, antibody validation, biomarker detection kit development, and early therapeutic drug development.; Wuxi R&D Center is dedicated to the late-stage clinical transformation development and clinical approval of diagnostic products for psychiatric and neurological diseases.
As the transferor of this transaction, Yuyan Technology utilized cutting-edge proteomics technology and an artificial intelligence screening platform, through which the company's research and development team made discoveries.A Novel and Clinically Significant Target, it can unlock the potential of ADC for more people suffering from difficult-to-treat cancers.
The ADC drug molecule FS001, which is the focus of this collaboration between the two parties, shows significant therapeutic potential and market prospects in difficult-to-treat cancer types such as colorectal cancer, cholangiocarcinoma, and squamous cell carcinoma of the lung. FS001 will become an ADC therapeutic agent in the global new drug target field, possessing both First-in-class and Best-in-class attributes.
In November 2023, Yuyan Biotech also reached a product development cooperation agreement for FS001 with Shijian Biotech: The two parties will jointly develop an ADC based on Shijian Biotech's linker-payload technology EZWi-Fit® and the First-in-class target and antibody discovered by Yuyan Biotech. It is estimated that the current value of this cooperative project exceeds 5 billion yuan.
In March this year, Yuyan Technology reached a strategic cooperation with ALS fighter Cai Lei and the ALS Foundation,Jointly establish the Cai Lei-Yuyan Technology ALS Proteomics Functional Target Research Laboratory.Professor Huang Chaolan, Chairman of Yuyan Technology, stated: Yuyan Technology has a strong background in biomedicine and neuroscience, as well as extensive experience and successful cases in the field of translational medicine. This professional background and deep understanding of the field enable Yuyan Technology to be more targeted in the research and development of functional targets for ALS, thereby achieving better R&D results.With the clinical translation experience accumulated by Yuyan Technology in the cancer field, a solid foundation can be provided for the faster application of ALS functional target research results to actual treatment, thereby offering the possibility of better treatment options for ALS patients.
Source:
3.Medicine Cube
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