How are energy investors positioned?
SOUTH SAN FRANCISCO - Sutro Biopharma, Inc. (NASDAQ:STRO), a biotechnology company currently trading below its InvestingPro Fair Value with a market capitalization of $67.6 million, announced Tuesday it has entered into a collaboration with the U.S. Food and Drug Administration to develop reference materials for antibody drug conjugates (ADCs).
The partnership aims to improve regulatory standards and enhance analytical methods for ADC drug development, according to a company press release.
Under the collaboration, Sutro and the FDA’s Office of Pharmaceutical Quality will jointly lead the study design and selection of target antigens, payload-linkers, and drug conjugation sites representative of both approved ADCs and those in development.
The collaboration will utilize Sutro’s cell-free XpressCF technology to engineer ADCs with predefined attributes, while leveraging the FDA’s analytical capabilities to characterize these materials.
"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, Sutro’s Chief Scientific Officer.
Results from the collaboration will be published upon completion, with insights expected to enhance the FDA’s capacity for analytical characterization of ADCs to improve quality assessments.
ADCs represent a growing modality in biopharmaceutical development, combining the targeting precision of antibodies with the cell-killing ability of cytotoxic drugs.
Sutro Biopharma, headquartered in South San Francisco, focuses on developing cancer therapeutics using its proprietary technology platform.
In other recent news, Sutro Biopharma has been upgraded by Piper Sandler from Neutral to Overweight, with a set price target of $2.00. This upgrade follows Sutro’s announcement of plans to file three Investigational New Drug (IND) applications for next-generation antibody-drug conjugates (ADCs) over the next three years. The planned IND applications include STRO-004, expected in the second half of 2025, STRO-006, anticipated in mid-2026, and its first dual-payload ADC in 2027. Additionally, Sutro Biopharma has appointed Greg Chow as its new Chief Financial Officer. Chow brings over 20 years of experience in finance and operations within the biotech sector. His previous roles include significant positions at NodThera, Freenome Holdings, and Frontier Medicines, where he played key roles in business development and financing activities. These developments highlight Sutro Biopharma’s strategic focus on expanding its leadership team and advancing its drug development pipeline.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.