Daiichi Sankyo and Syneos Health® Form Strategic Coalition for Development of Daiichi Sankyo’s ADC Oncology Pipeline

On May 28, 2020 Daiichi Sankyo, Inc. (hereafter, Daiichi Sankyo) reported that it has entered into a strategic agreement with Syneos Health (Nasdaq:SYNH) (Press release, Daiichi Sankyo, MAY 28, 2020, https://www.businesswire.com/news/home/20200528005466/en/Daiichi-Sankyo-Syneos-Health%C2%AE-Form-Strategic-Coalition [SID1234558637]). The companies are coming together to form a coalition to accomplish their shared goal of bringing promising cancer therapies to patients as safely, effectively and efficiently as possible .

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Under the agreement, Syneos Health will provide both strategic and operational solutions for three lead Daiichi Sankyo DXd antibody drug conjugates (ADC): DS-1062, U3-1402 and DS-8201 (known as ENHERTU). The coalition expands a strong, pre-existing relationship between the two companies, further leveraging Syneos Health’s insights-driven Syneos One product development model to de-risk and accelerate development.

The coalition will enable early strategic engagement of Syneos Health teams to inform critical drug development decision making from the start. Cross-functional teams from both companies will share therapeutic expertise and product development insights to shape optimal study designs and create a consistent quality clinical delivery process across a portfolio of studies. Adding to the world-class scientific and technological expertise at Daiichi Sankyo, Syneos Health brings strong clinical site-level relationships and field experts located across the globe who can engage more closely and effectively with investigator teams.

"We quickly recognized that our three flagship ADCs have transformative potential that our in-house structure and current CRO engagements could not deliver as fast as we feel obligated to for patients," said Marielle Cohard Radice, Global Head of Development Operations, Daiichi Sankyo. "The ‘one-team and patient-first’ philosophy we have built with Syneos Health will enable evaluation of our development candidates in more therapeutic settings, more swiftly and more effectively."

The combined end-to-end knowledge from the Daiichi Sankyo and Syneos Health teams will provide a robust understanding of how patients are cared for, which workflows exist, and how cutting-edge clinical investigation can best be embedded in the clinic setting. Shared insights will also enable optimized site selection and engagement to best address patient needs. By leveraging this coalition approach, Daiichi Sankyo expects deeper synergies, particularly at the clinical site level, across projects with common indications and patient populations.

"High unmet patient need and rapid scientific discovery in the oncology space are driving the need for a faster and more predictable approach to clinical development," said Paul Colvin, President, Syneos Health Clinical Solutions. "We’re pleased to collaborate with an innovative company like Daiichi Sankyo, using our unique outsourced product development model to improve clinical trial performance for their advanced oncology portfolio."