Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed R/R Multiple Myeloma

“Our continued focus on bringing Abecma into earlier lines of treatment demonstrates our commitment to increasing treatment options and improving outcomes for patients living with multiple myeloma,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “This FDA acceptance marks another step forward in our mission by bringing us closer to offering this potentially transformative, one-time CAR T treatment option to more patients.”
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“The start of patient dosing represents a huge milestone for Moleculin and importantly, the AML community,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Our team remains focused on bringing clinical sites online in the U.S., Europe and Middle East and enrolling patients to build on this momentum.
“Enrollment of the first patient with HPV+ head and neck cancer in the Phase 1 ACESOT-1051 trial is an important step and is in line with our goal of identifying patient populations most likely to benefit from WEE1 inhibition,” said Philippe Pultar MD., Senior Medical Advisor and Lead WEE1 Clinical
“We are thrilled to partner with Aurigene Oncology’s exceptional team, whose deep expertise in oncology development and cell therapy manufacturing is unparalleled,” said Michal Golan Mashiach, CEO of Edity Therapeutics. “This collaboration is a pivotal step in advancing our mission to deliver transformative, curative medicines to cancer patients.”
“We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to cancer patients worldwide,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors