After gaining U.S. FDA priority approval for the first gene therapy to treat hemophilia B, CSL Ltd. reported long-term data from the pivotal HOPE-B trial that showed a single infusion of Hemgenix (etranacogene dezaparvovec-drlb) generated elevated and sustained mean factor IX levels and reduced the rate of annual bleeding. Presented at the American Society of Hematology (ASH) annual meeting on Dec. 10, data showed 24-month results reinforced the safety of treatment, with no serious treatment-related adverse effects.
Affimed NV said the latest data with its lead innate cell engager (ICE) known as AFM-13, disclosed at the American Society of Hematology (ASH) meeting, have caused the focus to shift from monotherapy to combination regimens.
New and updated clinical data presented by biopharma firms at the San Antonio Breast Cancer Symposium, including: Ambrx, Astrazeneca, Celcuity, Treadwell, Zymeworks.
Arcellx Inc. signed a deal that could be worth almost $4 billion with Gilead Sciences Inc.’s unit Kite Pharma Inc. to push forward Arcellx's lead late-stage candidate CART-ddBCMA for relapsed or refractory multiple myeloma. The arrangement brings $225 million up front plus an equity investment of $100 million, along with as much as $3.9 billion in milestone payments. Arcellx CEO Rami Elghandour said the firm sorted through a number of suitors interested in the program. Data at the American Society of Clinical Oncology meeting “catalyzed a number of discussions and a broad set of interests. We felt of the possibilities out there, [Kite/Gilead is] the partner of choice in this space.”
New and updated clinical data presented by biopharma firms at the San Antonio Breast Cancer Symposium, including: Astrazeneca, Context, Dantari, Exelixis, G1, Intensity.
At the ESMO Immuno-Oncology Congress 2022, Compugen Inc. shared phase I data for COM-701 in dual and triple combination with Bristol Meyers Squibb Co.’s Opdivo (nivolumab) and with or without BMS-986207. Compugen’s candidate demonstrated preliminary durable antitumor activity and immune activation in patients with platinum resistant ovarian cancer with a favorable safety and toxicity profile.
New and updated clinical data presented by biopharma firms at the ESMO Immuno-Oncology Congress 2022, including: Immunocore, Jounce, NGM, Promontory, Rapt.
Vega Therapeutics Inc. emerged from stealth in advance of a podium presentation at this year’s American Society of Hematology meeting in New Orleans. The company, a spin-out from Star Therapeutics Inc., will disclose preclinical data on its lead drug candidate VGA-039, a first-in-class antibody in development for von Willebrand disease.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.