Linkedin
RLS logo_header
Linkedin

Sutro Biopharma Announces Research Collaboration with the FDA to Advance Regulatory Standards for ADCs

“ADCs represent one of the most promising and fast-growing modalities for new biopharmaceuticals. We’re honored to be among a select group collaborating with the FDA to help shape regulatory standards for ADC development and quality control,” said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. “This collaboration underscores the precision and flexibility of our cell-free XpressCF® platform in advancing next-generation ADCs, and we look forward to the impact of this work across the industry, with regulators, and for the patient community. We thank the FDA for the opportunity to help define the future of ADC innovation.”

Read the full story on "Sutro Biopharma Announces Research Collaboration with the FDA to Advance Regulatory Standards for ADCs"

Share:

More News

FDA provides Feedback in Pre-IND Meeting Supporting Continued Development of MaaT034 in Solid Tumors

“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across

First Patient dosed in Ph 3 RASolve 308 Trial of Zoldonrasib + Pembrolizumab and Chemo in 1L Metastatic RAS G12D Non-Squamous NSCLC

“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed

Georgiamune and Menarini Group Enter Exclusive Global License and Collaboration Agreement for GIM-621

“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three

First Patients enrolled in Standard of Care Chemo Combination Cohorts of Global Ph 1/2 ASCEND Trial of CR-001

“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000