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Ono Enters into a Drug Discovery Collaboration and Option Agreement with Shattuck Labs to Generate Bifunctional Fusion Proteins

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Ono Pharmaceutical Co., Ltd. announced a drug discovery collaboration and option agreement with Shattuck Labs, Inc. to develop bifunctional fusion proteins for autoimmune and inflammatory diseases. Shattuck will generate fusion proteins for targets using its technology, with Ono having the option to develop and commercialize resulting drug candidates worldwide. The agreement includes research funding, an upfront payment, milestones, and royalties up to $227 million. Pre-clinical studies showed promising immunoregulatory effects of the fusion proteins.
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The collaboration between Ono Pharmaceutical and Shattuck Labs represents a strategic move to expand Ono's biologics portfolio, specifically targeting autoimmune and inflammatory diseases. The financial commitment of up to $227 million, inclusive of research funding, an up-front payment and milestone payments, is indicative of the high potential value Ono sees in Shattuck's bifunctional fusion proteins. These proteins have shown promise in pre-clinical studies, suggesting potential as a novel therapeutic approach.

From an investor's perspective, the tiered royalties based on net sales highlight the long-term financial interest Ono has in the commercial success of the drug candidates. This deal could have significant implications for Ono's revenue streams and market share in the biologics sector if the drug candidates reach commercialization. However, it is important to note that the development process for biologics is lengthy and complex and there are inherent risks involved in drug discovery and clinical trials.

Bifunctional fusion proteins are an emerging class of therapeutics that can simultaneously target multiple pathways, which is particularly beneficial in treating complex diseases like autoimmune and inflammatory conditions. The technology that Shattuck Labs brings to the table could represent a breakthrough in this field. The ability to modulate two targets with a single molecule could lead to more effective and potentially safer treatments compared to current therapies that may only address one aspect of the disease mechanism.

For stakeholders, the success of this collaboration could mean access to a new class of medicines that address unmet medical needs. However, the path from pre-clinical studies to market approval is fraught with challenges, including demonstrating safety and efficacy in humans, which is a significant hurdle that many drug candidates fail to overcome.

Autoimmune and inflammatory diseases represent a substantial market with a growing patient population. Innovative treatments, like the bifunctional fusion proteins being developed by Ono and Shattuck, could capture a significant share of this market if proven effective. The collaboration leverages Shattuck's proprietary protein engineering technology, which could give Ono a competitive edge in a crowded marketplace.

Assuming successful development and commercialization, Ono could see an increase in its market valuation and investor confidence. However, the market for biologics is highly competitive and the success of these drug candidates will depend on their clinical differentiation from existing therapies and their ability to secure market access and reimbursement.

OSAKA, Japan, Feb. 14, 2024 /PRNewswire/ -- Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and CEO: Gyo Sagara; "Ono") today announced that it has entered into a drug discovery collaboration and option agreement with Shattuck Labs, Inc. (Austin, Texas, USA; CEO: Taylor Schreiber; "Shattuck") to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases.

Under the terms of the agreement, Shattuck will generate fusion proteins for certain targets using its proprietary protein engineering technology and provide Ono with drug candidates for further optimization and clinical development. Ono will have an exclusive option right to develop and commercialize multiple potential drug candidates to be created through this collaboration worldwide. Ono will pay to Shattuck research funding, an up-front payment, milestones on the progress of research and development and commercialization, up to a total of $227 million, as well as tiered royalties based on net sales.

These fusion proteins are designed to modulate two targets associated with autoimmune and inflammatory diseases. In pre-clinical studies conducted by Shattuck, the bifunctional fusion proteins demonstrated immunoregulatory effects and may show efficacy on a broad range of immune and inflammatory diseases.

"We are actively working to create biologics in order to address unmet medical needs for a wide range of diseases. We appreciate Shattuck's proprietary research and development capabilities and expertise in protein engineering enabling the generation of functional biologics against therapeutic targets that have been difficult through conventional technologies, and are excited to work with Shattuck's team through this collaboration agreement," said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono Pharmaceutical. "We hope to add bifunctional fusion proteins discovered and developed by Shattuck into our portfolio to bring innovative drugs for patients suffering from autoimmune and inflammatory diseases as soon as possible."

"We are excited to embark upon this collaboration with Ono Pharmaceutical, a leading Japanese pharmaceutical company with a track record of scientific innovation, which was enabled by Shattuck's protein engineering and development expertise with complex fusion proteins," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck Labs. "We have prioritized autoimmune and inflammatory diseases for a select group of preclinical pipeline candidates as we continue to expand into areas of high unmet need. This collaboration aligns with our strategy to unlock further value from our bifunctional fusion protein platform and scientific expertise."

About Shattuck Labs, Inc.

Shattuck Labs, Inc. (NASDAQ: STTK) is a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck's proprietary Agonist Redirected Checkpoint (ARC®) platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company's lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com.

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SOURCE Ono Pharmaceutical co., ltd.

Ono Pharmaceutical announced a drug discovery collaboration and option agreement with Shattuck Labs, Inc. to develop bifunctional fusion proteins for autoimmune and inflammatory diseases.

Shattuck Labs will generate fusion proteins for certain targets using its proprietary protein engineering technology and provide Ono with drug candidates for further optimization and clinical development.

Ono Pharmaceutical will provide research funding, an upfront payment, milestones on research and development progress, and commercialization, up to a total of $227 million.

In pre-clinical studies, the bifunctional fusion proteins demonstrated immunoregulatory effects and potential efficacy on a broad range of immune and inflammatory diseases.

The CEO of Shattuck Labs, Inc. is Taylor Schreiber.
Shattuck Labs Inc

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shattuck is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. compounds derived from shattuck’s proprietary agonist redirected checkpoint, arc®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. the company’s lead wholly owned program, sl-172154 (sirpα-fc-cd40l), which is designed to block the cd47 immune checkpoint and simultaneously agonize the cd40 pathway, is being evaluated in a phase 1 trial. a second compound, sl-279252 (pd1-fc-ox40l), is being evaluated in a phase 1 trial in collaboration with takeda pharmaceuticals. additionally, the company is advancing a proprietary gamma delta t cell engager, gadlen™, platform, which is designed to bridge gamma delta t cells to tumor antigens for the treatment of patients with cancer. shattuck has offices in both austin, tex