Innocare Pharma Ltd. has received IND approval from China's National Medical Products Administration (NMPA) to begin clinical trials of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248.
Galapagos NV is making a decisive shift away from its small-molecule roots, sealing the simultaneous acquisition of CAR T-cell therapy specialist Cellpoint BV and fully-human antibody company Aboundbio Inc. The Cellpoint deal is by far the largest, with Galapagos paying €125 million (US$132 million) cash up front, with a further €100 million to come in milestones. The price for Aboundbio of Pittsburgh, is $14 million.
Analysts have already started tagging Cogent Biosciences Inc.’s bezuclastinib as potentially best in class, after the company presented impressive, though early stage, data at the European Hematology Association Congress in Vienna demonstrating promising efficacy and a possibly differentiating safety profile for the selective KIT D816V inhibitor in advanced systemic mastocytosis.
After rolling out positive, preliminary phase I CAR natural killer cell data, Nkarta Inc. saw its stock (NASDAQ:NKTX) soar to $18.72, up $10.95, or 140.9%, as Wall Street made known its pleasure in results from the small, independent dose-finding studies with Nkarta’s two off-the-shelf lead candidates, NKX-101 and NKX-019, in two groups of blood cancer patients: those with relapsed/refractory (r/r) acute myeloid leukemia (AML) and with r/r non-Hodgkin lymphoma (NHL), respectively.
Oncology specialist Affimed NV is pushing forward with clinical development of technology that encourages natural killer cells to attack solid tumors. The move, supported by data the company presented at the annual meeting of the American Association for Cancer Research (AACR), is backing its creation of “innate cell engager” molecules.
Shares of TG Therapeutics Inc. fell 40% Jan. 27 after the firm disclosed in a U.S. SEC filing that the FDA had put a partial clinical hold on certain studies testing Ukoniq (umbralisib) and ublituximab, or the combination, for chronic lymphocytic leukemia and non-Hodgkin lymphoma.
Cell therapy developer Cellular Biomedicine Group Inc. (CBMG) completed a $120 million series A financing, its first since becoming a private company. The funds will benefit the U.S. and China-based firm’s CAR T pipeline, and the round was jointly led by Astrazeneca-CICC Fund, Sequoia Capital China and Yunfeng Capital. Existing investors including GIC Private Ltd. (formerly Government of Singapore Investment Corp.) and TF Capital also took part.
Foresight Diagnostics Inc. has developed a circulating tumor DNA (ctDNA) detection platform for detecting minimal residual disease (MRD) in B-cell lymphomas, a form of non-Hodgkin lymphoma and the most common lymphoma in the U.S., accounting for about 85% of all cases. Now, it has published data showing its phased variant enrichment detection sequencing (PhasED-Seq) nearly doubled the identification of patients with aggressive lymphoma who were not cured by standard therapy and need new treatment options.
A collection of CAR T-cell programs originally licensed by Precision Biosciences Inc. to Baxalta Inc. in a $1.6 billion deal are, after handoffs to Shire and Servier SAS, back where they began. Precision said April 15 it would reacquire all development and commercial rights to the programs, including two clinical-stage CD19-targeting allogeneic CAR T candidates, from Servier for $1.25 million in cash, plus the waiver of earned but as-yet unpaid milestones totaling $18.75 million.
While it’s too late to save the contingent value rights connected with the acquisition of Celgene Inc., Bristol Myers Squibb Co.’s CD19-targeted CAR T therapy, lisocabtagene maraleucel, for treating certain types of relapsed or refractory large B-cell lymphoma patients who have received at least two prior therapies, won FDA approval.
