Cue Biopharma Extends Research Collaboration for the Development of Immuno-STAT Biologics for the Treatment of Defined Autoimmune Diseases with Merck

CAMBRIDGE, Mass., Nov. 19, 2020 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, announced today that the company has extended the term of the research program under its existing 2017 research collaboration and license agreement with Merck toward developing a clinical candidate for the treatment of type 1 diabetes and an additional undisclosed autoimmune disease.

“We are very pleased with the progress to date in our ongoing strategic collaboration with Merck,” said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. “Extending the research term of our agreement based on promising preclinical data with a goal of identifying a clinical candidate underscores the significant potential of our therapeutic Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform and CUE-300 series in the treatment of debilitating

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Rigel Finalizes the Study Design of its Ongoing Phase 3 Clinical Trial of Fostamatinib in Warm Autoimmune Hemolytic Anemia

FDA agrees to the proposed primary efficacy endpoint and additional secondary endpoints

SOUTH SAN FRANCISCO, Calif., Nov. 17, 2020 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the final design of its FORWARD study, a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic anemia (AIHA). The FDA agreed to Rigel’s proposed durable response measure for the primary efficacy endpoint as well as the inclusion of additional secondary endpoints.  

The Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study of approximately 90 patients with primary or secondary warm AIHA who have failed at least one prior treatment. The primary efficacy endpoint for the trial is a durable response defined as a hemoglobin level ≥ 10 g/dl with an increase from baseline of ≥ 2 g/dl on three consecutive

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