Daiichi Sankyo taps CRO Syneos Health to help run ADC cancer drug work, including Enhertu

Daiichi Sankyo taps CRO Syneos Health to help run ADC cancer drug work, including Enhertu

Japanese pharma company Daiichi Sankyo has penned a new deal with Syneos Health to launch a “coalition” that sees the CRO work on its big-name antibody-drug conjugate (ADC) targets.

Under the deal, financial terms of which were not shared, Syneos will give out “both strategic and operational solutions” for three leading Daiichi ADCs: DS-1062, U3-1402 and DS-8201, now approved as Enhertu in breast cancer and the center of a multibillion-dollar tie-up with AstraZeneca.

The CRO and pharma, which have collaborated in separate areas in the past, will work together, but Syneos will lead “critical drug development decision-making from the start” while “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.”

Enhertu is a big drug for Daiichi and AstraZeneca, which paid nearly $7 billion to co-develop and co-sell the med. It’s also being tested in gastric cancers as well as in colorectal cancer and non-small cell lung cancer (NSCLC).

DS-1062, an investigational trophoblast cell-surface antigen 2-(TROP2)-targeting ADC, has completed a phase 1 in patients with unresectable advanced NSCLC, while U3-1402, an HER3-targeting ADC, has been tested in patients with metastatic, EGFR-mutated, TKI-resistant NSCLC, with data presented last year.

Syneos, recently rumored to be seeking a sale, is the result of the merger between INC Research and inVentiv, which came came together in a $7.4 billion merger and rebranded as Syneos Health a few years back.

“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 at 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.”

“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,” added Paul Colvin, president of 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.”

error: Content is protected !!