I-Mab Accelerates Clinical Development of Anti-CD47 Monoclonal Antibody Lemzoparlimab in the US and China

SHANGHAI and GAITHERSBURG, Md., Dec. 4, 2020 /PRNewswire/ — I-Mab (the “Company”) (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced the advancement of clinical development of the highly differentiated anti-CD47 monoclonal antibody lemzoparlimab (also known as TJC4) in the US and China, achieving milestones as planned. The Company is progressing its US combination trial (NCT03934814), studying lemzoparlimab in combination with Rituxan® and Keytruda® in dose expansion cohorts in non-Hodgkin lymphoma (NHL) and advanced solid tumors, respectively. The combination study with Rituxan® will enroll NHL patients from both the US and China. Topline results from this study are expected next year.

I-MAB Logo (PRNewsfoto/I-Mab Biopharma)

“The results from early investigational studies support the notion that lemzoparlimab is a differentiated CD47 antibody therapy for cancers that remains among the most common causes of death around the world,” said Jordan Berlin

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Actinium Appoints Mary Mei Chen, M.D., Ph.D. as Vice President of Clinical Development

The MarketWatch News Department was not involved in the creation of this content.

NEW YORK, Dec. 1, 2020 /PRNewswire via COMTEX/ —
NEW YORK, Dec. 1, 2020 /PRNewswire/ — Actinium Pharmaceuticals, Inc.  (NYSE AMERICAN: ATNM) (“Actinium” or the “Company”) today announced the appointment of Mary Mei Chen, M.D., Ph.D. to the position of Vice President of Clinical Development, effective immediately. In this role, Dr. Chen will lead the clinical development of Actinium’s CD33 program including the Actimab-A plus CLAG-M and Actimab-A plus venetoclax combination trials in relapsed and refractory Acute Myeloid Leukemia (“R/R AML”). Dr. Chen joins Actinium from GlycoMimetics, where she played a leading role in multiple clinical trials including the global pivotal Phase 3 study of uproleselan (GMI-1271-301). In addition to working on Actimab-A development, Dr. Chen will also utilize her training in immunology and experience in translational medicine to identify areas of synergy between targeted radiotherapy with

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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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CMIC Supports Clinical Trials for Digital Therapeutics Using SUSMED’s Trial Management System

CMIC Co., Ltd. (henceforth “CMIC”)(TOKYO:2309) has launched services using SUSMED, Inc.’s (henceforth “SUSMED”) trial management system covering subject registration, software assignment and distribution for digital therapeutics (DTx).
The system is able to overcome the common challenges of DTx clinical trials, ensuring blinded assignment and preventing unauthorized access. By employing this system, CMIC will offer more efficient operations for DTx trials, such as for the assignment and delivery of software applications (apps) to trial participants, cutting development costs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201115005172/en/

*The system allows for seamless management of both intervention/sham app assignment and app distribution. (Graphic: Business Wire)

In a DTx clinical trial, the software app must be installed on a device, such as a smartphone. Additionally, a placebo app (sham) is often used as a control in comparison to the actual treatment app (intervention), so it is essential that each app is

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