Category: AML

Ipsen Signs an Exclusive WW Collaboration with Accent to Develop and Commercialize METTL3 Program

Shots: Accent to receive ~$446M including up front, pre-clinical, clinical, regulatory, and sales-based milestone along with royalties Ipsen obtains an exclusive license to develop, manufacture and commercialize a pre-clinical stage METTL3-inhibitor program The collaboration combines Accent’s expertise in RMP-targeting therapeutics with Ipsen’s capabilities to develop and commercialize transformative oncology medicines for the treatment of AML […]

Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis

Shots: EMA’s COMP has granted ODD to SLS-005 for the treatment of amyotrophic lateral sclerosis Under ODD, Seelos will get benefit from several incentives such as protocol assistance, reduced regulatory fees and market exclusivity Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the BBB, stabilizes proteins and activates autophagy and has received […]

AbbVie’s Venclyxto Receives the EC’s Approval for Patients with Newly Diagnosed Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy

Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed AML who were ineligible for intensive CT and demonstrated OS (14.7mos. vs 9.6mos.), CCCR (66.4% vs 28.3%), CR (36.7% vs 17.9%) The P-Ib M14-358 trial involves assessing in Venclyxto + […]

Cellectis Collaborates with Sanofi for Alemtuzumab to be Utilized in CART-Cell Trials

Shots: The companies enter into a supply agreement for Alemtuzumab to be used in Cellectis’ trials as a lymphodepleting regimen for UCART22 in the BALLI-01 clinical trial to treat r/r ALL, and for UCART123 in AMELI-01 clinical trial to treat r/r AML but not for UCARTCS1 due to self-lymphodepleting activity Sanofi will provide alemtuzumab for […]

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

Shots: The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 trial that met its 1EPs of OS The opinion for Onureg is based P-III QUAZAR AML-001 study assessing Onureg (300mg, qd) vs PBO in 472 patients in a ratio (1:1) […]

FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. But accelerated approval is only a temporary measure and […]