Ipsen Adds Another Program To Its Preclinical Oncology R&D Pipeline Through Exclusive Global Collaboration With Accent Therapeutics, Targeting RNA Modifying Protein, METTL3

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  • Ipsen obtains an exclusive license to develop, manufacture and commercialize a program of METTL3 inhibitors in the preclinical phase

  • Building on Recent Announcements, Collaboration with Accent Therapeutics Strengthens Ipsen’s Expansion in Hematologic Malignancies, with Focus on Acute Myeloid Leukemia

PARIS – (BUSINESS WIRE) – Regulatory news:

Disclaimer: intended for international media and investors only

Ipsen (Euronext: IPN; ADR: IPSEY) and Accent Therapeutics (Accent) have signed an exclusive global collaboration agreement for the research, development, manufacture and commercialization of Accent’s preclinical METTL3 program.

Acute myeloid leukemia (AML) is a difficult-to-treat cancer of the blood and bone marrow, accounting for one-third of all new cases of leukemia in the United States each year.1 Globally, the incidence of LAM has increased year on year through the past 20 years.2 RNA modifying proteins (RMP) are an emerging target class that control multiple aspects of RNA biology and represent a novel approach to the potential treatment of various cancers. METTL3 is an RMP that has been preclinically validated as a novel therapeutic target for AML.1,3 This collaboration combines Accent’s expertise in therapies targeting RMP with Ipsen’s capabilities and proven track record in the development and commercialization of drugs in oncology.

Christelle Huguet, Senior Vice President, Head of Research, External Innovation and Early Development, Ipsen, said: “Oncology is a key focus area for Ipsen as we develop our pipeline. We are delighted to partner with Accent to advance the METTL3 program as we continue our expansion in hematologic oncology. Our teams are unwavering in our commitment to areas with high unmet medical need, including rare cancers. This collaboration is therefore strongly aligned with Ipsen’s mission and growth strategy.

Shakti Narayan, CEO of Accent Therapeutics, said, “This collaboration combines Ipsen’s commitment to develop and commercialize transformative oncology drugs with Accent’s leading expertise in RNA modification. . As we focus on developing our rich portfolio of novel RMP targeted therapies, we are pleased to entrust our METTL3 program to the innovative team at Ipsen to bring this new investigational therapy to patients in need.

As part of the deal, Ipsen will pay up to $ 446 million, comprising an upfront payment as well as pre-clinical, clinical, regulatory and sales-based milestone payments, as well as installment sales royalties ranging from a medium digit to a two digit low digit.

ENDS

METTL3 program

One of the most prevalent modifications in mRNA is the methylation of the adenine base at the N6 position, resulting in N6-methyladenosine (m6A). This modification is catalyzed by the enzyme complex methyltransferase METTL3 / METTL14. m6A is involved in several aspects of mRNA stability and turnover, controls the translation of oncogenes that confer growth advantage and migratory behavior, and has become a key mRNA modification implicated in hematologic cancers. METTL3 and / or METTL14 knockout promotes AML differentiation and apoptosis and has been shown to be important for both in vitro and in vivo growth of AML. Accent Therapeutic’s new investigational small molecule METTL3 inhibitors seek to treat specific AML subtypes with a high unmet medical need.

Ipsen

Ipsen is a mid-sized global biopharmaceutical company specializing in transformative drugs in oncology, rare diseases and neuroscience; it also has a well-established activity in the field of general public health. With total sales of more than 2.5 billion euros in fiscal year 2020, Ipsen sells more than 20 drugs in more than 115 countries, with a direct commercial presence in more than 30 countries. The Company’s research and development efforts are focused on its innovative and differentiated technological platforms located at the heart of the main biotechnology and life sciences centers: Paris-Saclay, France; Oxford, United Kingdom; Cambridge, United States; Shanghai, China. Ipsen has around 5,700 employees worldwide and is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt (ADR: IPSEY) program. For more information, visit ipsen.com.

Therapeutic focus

Accent Therapeutics is a biopharmaceutical company developing small molecule therapies focused on oncology in the emerging field of RNA modification. This area of ​​biology encompasses the post-transcriptional chemical modifications of RNA that provide cells with a unique mechanism for regulating proteins essential for cell growth and differentiation. By targeting cancer-linked RNA-modifying proteins (RMP) with precision therapies, the company is translating extraordinary science into life-changing therapies. For more information, please visit accenttx.com.

Ipsen forward-looking statements

The forward-looking statements, objectives and targets contained in this document are based on Ipsen’s management strategy, its current opinions and assumptions. Such statements involve known and unknown risks and uncertainties which may cause actual results, performance or events to differ materially from those anticipated in this document. All of the above risks could affect Ipsen’s future ability to meet its financial goals, which have been set assuming reasonable macroeconomic conditions based on information available today. The use of the words “believes”, “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including filings and regulatory decisions. . In addition, the objectives described in this document were established without taking into account assumptions of external growth and possible future acquisitions, likely to modify these parameters. These objectives are based on data and assumptions considered reasonable by Ipsen. These targets depend on conditions or facts that may occur in the future, and not exclusively on historical data. Actual results may deviate significantly from these objectives given the occurrence of certain risks and uncertainties, including the fact that a promising product in early development or clinical trial phase may end up never being marketed. or achieve its business objectives, in particular for regulatory or competition reasons. Ipsen faces or could face competition from generic products which may result in a loss of market share. In addition, the Research and Development process comprises several stages, each of which carries the significant risk that Ipsen will not be able to achieve its objectives and be forced to abandon its efforts on a product in which it has invested large sums. Therefore, Ipsen cannot be certain that the favorable results obtained in the preclinical trials will be confirmed subsequently in the clinical trials, or that the results of the clinical trials will be sufficient to demonstrate the safety and efficacy of the product concerned. There can be no guarantee that a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If the underlying assumptions prove to be incorrect or if risks or uncertainties materialize, actual results may differ materially from those stated in forward-looking statements. Other risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including fluctuations in interest rates and exchange rates; the impact of pharmaceutical industry regulation and health care legislation; global trends towards containing health care costs; technological advances, new products and patents obtained by competitors; challenges inherent in developing new products, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative products; and exposure to litigation, including patent litigation, and / or regulatory actions. Ipsen also depends on third parties to develop and market some of its products which may generate substantial royalties; these partners could behave in a way that is detrimental to Ipsen’s business and financial results. Ipsen cannot be certain that its partners will fulfill their obligations. She may not be able to derive any benefit from these agreements. Failure of one of Ipsen’s partners could generate lower than expected revenues. Such situations could have a negative impact on Ipsen’s business, financial situation or performance. Ipsen expressly disclaims any obligation or commitment to update or revise any forward-looking statements, objectives or estimates contained in this press release to reflect any change in the events, conditions, assumptions or circumstances upon which such statements are made. based, unless required by law. Ipsen’s business is subject to the risk factors described in its reference documents filed with the Autorité des Marchés Financiers. The risks and uncertainties mentioned are not exhaustive and the reader is invited to refer to the Ipsen 2020 Registration Document, available on ipsen.com.

The references

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1 American Cancer Society. Key statistics for acute myeloid leukemia. https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html

2 Yin Dong, Oumin Shi, Quanxiang Zeng, Xiaoquin Lu, Wei Wang, Yong Li, Qi Wang, Yong Li and Qi Wang, Trends in the incidence of leukemia at global, regional and national levels between 1990 and 2017. Hematology and experimental oncology 9, Article number 14. 2020

3 Shane M Buker, Zachary A Gurard-Levin, Benjamin D Wheeler, Michael D Scholle, April W Case, Jeffrey L Hirsch, Scott Ribich, Robert A Copeland, P Ann Boriack-Sjodin. A mass spectrometry assay of the METTL3 / METTL14 methyltransferase activity. SLAS Discov. April 2020; 25 (4): 361-371. Published online 4 Oct 2019

Ipsen contacts

Investors

Craig marks

Vice-President, Investor Relations

+44 7584 349 193

Adrien Dupin de Saint-Cyr

Investor Relations Manager

+33 6 64 26 17 49

Media

Jess smith

Senior Director, Head of Global Communications R&D and Business Development

+44 7557 267 634

Accent Therapeutics contacts

Media

Jennifer gordon

Spectrum science communications

[email protected]

+001 202 587 2580

Source: Ipsen

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