Ipsen and Sutro Biopharma announce unique world licensing settlement for an ADC focusing on stable tumors

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• Ipsen secures unique world rights for growth and commercialization of STRO-003, an antibody-drug conjugate, finishing the ultimate phases of pre-clinical growth
• STRO-003 targets ROR1, a clinically validated antibody drug conjugate (ADC) goal
• STRO-003 has proven sturdy monotherapy efficacy and potential for a differentiated security profile in preclinical growth in stable tumors and hematological malignancies¹

PARIS, FRANCE; SAN FRANCISCO, U.S., 02 April 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) and Sutro Biopharma (NASDAQ: STRO, “Sutro”, “the Firm”) as we speak introduced an unique world licensing settlement for STRO-003. STRO-003, an antibody-drug conjugate (ADC) within the closing phases of pre-clinical growth, targets the ROR1 tumor antigen which is understood to be overexpressed in many various most cancers varieties together with stable tumors and hematological malignancies.¹ The settlement provides Ipsen unique worldwide rights to develop and commercialize STRO-003 and would be the first ADC candidate becoming a member of Ipsen’s increasing portfolio.

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“The potential for ADCs in oncology is well-documented and we’re excited by the addition of STRO-003, Ipsen’s first ADC candidate with best-in-class potential.” mentioned Mary Jane Hinrichs, SVP and Head of Early Improvement at Ipsen. “STRO-003 is a next-generation ROR1 ADC, leveraging Sutro’s site-specific know-how to generate a extremely secure conjugate, coupled with exatecan payloads, which have proven important potential in stable tumors. That is our focus as we put together to enter Section I, harnessing Ipsen’s world experience in oncology growth, whereas additionally reinforcing our dedication to bringing new medicines to sufferers with few therapy choices.”

“We’re excited to accomplice STRO-003 with Ipsen to assist us attain extra sufferers sooner whereas retaining important downstream participation in a drugs through which we imagine,” mentioned Jane Chung, President and Chief Working Officer at Sutro. “Sutro’s analysis innovation represented in STRO-003 illustrates our management in ADC design. We sit up for collaborating with Ipsen’s spectacular oncology growth workforce to deliver a differentiated ROR1-targeted ADC to sufferers.”

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ADCs are comprised of three major elements: the antibody, payload and linker. The antibody selectively targets an recognized tumor antigen, similar to ROR1. Payloads are the pharmaceutically lively part to deal with the most cancers, connected to the antibody through a chemical linker. The linker connects the antibody and the payload and reduces the quantity of payload that reaches non-tumor tissue.²

Underneath the phrases of the settlement, Ipsen will assume duty for Section I preparation actions, together with submission of the Investigational New Drug (IND) software, and all subsequent clinical-development actions and world commercialization actions. Sutro Biopharma is eligible to obtain as much as $900m in potential upfront, growth, regulatory and business milestone funds together with roughly $90m in near-term funds, together with an fairness funding, and tiered royalties on world gross sales, contingent upon profitable growth and commercialization.

ENDS

About Ipsen

We’re a worldwide biopharmaceutical firm with a deal with bringing transformative medicines to sufferers in three therapeutic areas: Oncology, Uncommon Illness and Neuroscience.

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Our pipeline is fueled by exterior innovation and supported by almost 100 years of growth expertise and world hubs within the U.S., France and the U.Okay. Our groups in additional than 40 international locations and our partnerships world wide allow us to deliver medicines to sufferers in additional than 80 international locations.

Ipsen is listed in Paris (Euronext: IPN) and within the U.S. by a Sponsored Degree I American Depositary Receipt program (ADR: IPSEY). For extra data, go to ipsen.com.

About Sutro Biopharma

Sutro Biopharma, Inc., is a clinical-stage firm relentlessly targeted on the invention and growth of exactly designed most cancers therapeutics, reworking what science can do for sufferers. Sutro’s fit-for-purpose know-how, together with cell-free XpressCF®, offers the chance for broader affected person profit and an improved affected person expertise. Sutro has a number of scientific stage candidates, together with luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in scientific research. A strong pipeline, coupled with high-value collaborations and trade partnerships, validates our steady product innovation. Sutro is headquartered in South San Francisco. For extra data, comply with Sutro on social media @Sutrobio, or go to www.sutrobio.com.

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Ipsen contacts

E mail:
company.communications@ipsen.com

Buyers

Craig Marks | + 44 7584 349 193

Nicolas Bogler | +33 (0) 6 52 19 98 92

Media

Amy Wolf | +41 7 95 76 07 23

Jess Smith | + 44 7557 267 634

Sutro Biopharma contacts

Emily White | 1-650-823-7681
E mail: ewhite@sutrobio.com

Ipsen Disclaimers and/or Ahead-Wanting Statements

The forward-looking statements, targets and targets contained herein are based mostly on Ipsen’s administration technique, present views and assumptions. Such statements contain identified and unknown dangers and uncertainties which will trigger precise outcomes, efficiency or occasions to vary materially from these anticipated herein. All the above dangers might have an effect on Ipsen’s future skill to attain its monetary targets, which had been set assuming affordable macroeconomic circumstances based mostly on the data out there as we speak. Use of the phrases ‘believes’, ‘anticipates’ and ‘expects’ and related expressions are meant to establish forward-looking statements, together with Ipsen’s expectations relating to future occasions, together with regulatory filings and determinations. Furthermore, the targets described on this doc had been ready with out considering external-growth assumptions and potential future acquisitions, which can alter these parameters. These targets are based mostly on information and assumptions considered affordable by Ipsen. These targets rely upon circumstances or information more likely to occur sooner or later, and never solely on historic information. Precise outcomes could depart considerably from these targets given the incidence of sure dangers and uncertainties, notably the truth that a promising drugs in early growth section or scientific trial could find yourself by no means being launched in the marketplace or reaching its business targets, notably for regulatory or competitors causes. Ipsen should face or may face competitors from generic drugs that may translate right into a lack of market share. Moreover, the analysis and growth course of includes a number of phases every of which includes the substantial danger that Ipsen could fail to attain its targets and be compelled to desert its efforts as regards to a drugs through which it has invested important sums. Subsequently, Ipsen can’t be sure that favorable outcomes obtained throughout preclinical trials might be confirmed subsequently throughout scientific trials, or that the outcomes of scientific trials might be adequate to display the protected and efficient nature of the medication involved. There will be no ensures a drugs will obtain the required regulatory approvals or that the medication will show to be commercially profitable. If underlying assumptions show inaccurate or dangers or uncertainties materialize, precise outcomes could differ materially from these set forth within the forward-looking statements. Different dangers and uncertainties embody however usually are not restricted to, basic trade circumstances and competitors; basic financial elements, together with rate of interest and foreign money trade price fluctuations; the impression of pharmaceutical trade regulation and healthcare laws; world tendencies towards healthcare value containment; technological advances, new drugs and patents attained by opponents; challenges inherent in new-medicine growth, together with acquiring regulatory approval; Ipsen’s skill to precisely predict future market circumstances; manufacturing difficulties or delays; monetary instability of worldwide economies and sovereign danger; dependence on the effectiveness of Ipsen’s patents and different protections for modern medicines; and the publicity to litigation, together with patent litigation, and/or regulatory actions. Ipsen additionally depends upon third events to develop and market a few of its medicines which might probably generate substantial royalties; these companions might behave in such methods which might trigger injury to Ipsen’s actions and monetary outcomes. Ipsen can’t be sure that its companions will fulfil their obligations. It is perhaps unable to acquire any profit from these agreements. A default by any of Ipsen’s companions might generate decrease revenues than anticipated. Such conditions might have a unfavourable impression on Ipsen’s enterprise, monetary place or efficiency. Ipsen expressly disclaims any obligation or enterprise to replace or revise any forward-looking statements, targets or estimates contained on this press launch to replicate any change in occasions, circumstances, assumptions or circumstances on which any such statements are based mostly, except so required by relevant legislation. Ipsen’s enterprise is topic to the chance elements outlined in its registration paperwork filed with the French Autorité des Marchés Financiers. The dangers and uncertainties set out usually are not exhaustive and the reader is suggested to consult with Ipsen’s newest Common Registration Doc, out there on ipsen.com.

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Sutro Ahead-Wanting Statements

This press launch incorporates forward-looking statements inside the that means of the “protected harbor” provisions of the Personal Securities Litigation Reform Act of 1995, together with, however not restricted to, the Firm’s entry into the unique world licensing settlement with Ipsen and potential advantages of such settlement, together with potential future funds thereunder, anticipated preclinical and scientific growth actions, potential advantages of luvelta and the Firm’s different product candidates and platform; potential growth into different indications and mixtures, together with the timing and growth actions associated to such growth; and potential market alternatives for luvelta and the Firm’s different product candidates. All statements aside from statements of historic truth are statements that could possibly be deemed forward-looking statements. Though the Firm believes that the expectations mirrored in such forward-looking statements are affordable, the Firm can not assure future occasions, outcomes, actions, ranges of exercise, efficiency or achievements, and the timing and outcomes of biotechnology growth and potential regulatory approval is inherently unsure. Ahead-looking statements are topic to dangers and uncertainties which will trigger the Firm’s precise actions or outcomes to vary considerably from these expressed in any forward-looking assertion, together with dangers and uncertainties associated to the Firm’s skill to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates and the Firm’s skill to efficiently leverage Quick Monitor designation, the market dimension for the Firm’s product candidates to be smaller than anticipated, scientific trial websites, provide chain and manufacturing services, the Firm’s skill to keep up and acknowledge the advantages of sure designations obtained by product candidates, the timing and outcomes of preclinical and scientific trials, the Firm’s skill to fund growth actions and obtain growth objectives, the Firm’s skill to guard mental property, the worth of the Firm’s holdings of Vaxcyte frequent inventory, and the Firm’s business collaborations with third events and different dangers and uncertainties described below the heading “Threat Components” in paperwork the Firm recordsdata occasionally with the Securities and Alternate Fee. These forward-looking statements communicate solely as of the date of this press launch, and the Firm undertakes no obligation to revise or replace any forward-looking statements to replicate occasions or circumstances after the date hereof.

References

¹ Preclinical growth of STRO-003, a ROR1 focused antibody-drug conjugate. 14^th Annual WADS ADC. San Diego 2023. Obtainable right here: https://www.sutrobio.com/wp-content/uploads/2023/10/WADC_SD_2023_HKiefel.pdf
² E. Jabbour, S. Paul, H. Kantarjian. The scientific growth of antibody-drug conjugates – classes from leukemia. Nature Critiques Scientific Onoclogy. 2021. 18: 418-433. Obtainable right here: https://www.nature.com/articles/s41571-021-00484-2

Attachment

• Ipsen PR_ Sutro Biopharma licensing agreement_02042024

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