Abecma from BMS more than triples PFS in triple-class multiple myeloma

CLINICAL AND REGULATORY

Yescarta crosses the blockbuster line reaching sales of $1.16 billion

The commercial growth of Yescarta axicabtagene ciloleucel was partly propelled by expansion of its FDA label in April 2022 to include second-line treatment of large B cell lymphoma. 

BMS’s Abecma more than triples PFS in triple-class multiple myeloma

BMS and 2seventy bio said cell therapy Abecma idecabtagene vicleucel more than tripled PFS in patients with triple-class exposed multiple myeloma, demonstrating a benefit of 13.3 months compared with 4.4 months (HR:0.49; p<0.0001) for standard regimens in the Phase 3 KarMMa-3 study. Abecma gained FDA approval last year to treat multiple myeloma patients who have received at least four prior treatments; KarMMa-3 enrolled adults who have received two to four lines of therapy. The anti-BCMA CAR T therapy also met the secondary endpoint of overall survival, with 71% of patients receiving a response compared with 41% who received standard regimes. Data will be included in an sBLA submission this year.

China to prohibit the export of gene and cell technologies

China is working to revise its “Catalog of Technologies Prohibited or Restricted from Export,” last published in 2020. The latest version adds new technologies related to gene editing including CRISPR, cell cloning, and synthetic biology, among other life science items. The Ministry of Commerce and the Ministry of Science and Technology of China made the draft proposal public at the end of 2022. The new catalog is under final official review after a public comment phase ended in January.

Personalized CAR T cell stimulation, plus platforms from Flashpoint, AbSeek and TBG

A team lead by Harvard University shared in Nature Communications a system for patient-specific optimization of T cell stimulation during CAR T cell manufacturing to improve cell therapy functionality. The technology has been licensed to Lyell Immunopharma. The authors used artificial antigen-presenting cell mimetic scaffolds (aAPC-ms) to deliver specific densities of anti-CD3/anti-CD28 T cell stimulatory ligands during T cell culture. The team developed a computational model that predicts the optimal stimulation dose for an individual patient’s cells based on a clustering analysis of his or her immune cell phenotypes.

DEALS AND FINANCING

Replay launches Syena to merge NK and TCR technologies

The latest company launched under the Replay Holdings umbrella has a new take on NK cell therapies that could expand the target space to treat solid tumors. Replay Holdings and The University of Texas MD Anderson Cancer Center launched Syena to develop targeted, engineered NK cells that express a TCR, rather than a CAR. Though many companies are developing T cell therapies that are re-targeted to tumors with engineered TCRs, and many companies are developing NK or T cell therapies that use CARs, the Replay team believes this is the first to develop a TCR NK cell. Replay was formed last year around a toolkit of genetic therapy platform technologies. The company’s model involves forming discrete, asset-centric companies to develop specific programs, with sublicenses to the platform technologies. Syena is the fourth product company to launch, and the first in the cell therapy space. It follows a trio of gene therapy plays that take advantage of Replay’s large payload HSV gene therapy vectors. The Replay companies have separate founders but operate under the Replay management team using the parent company’s $55 million series A round led by KKR and OMX Ventures.

Oricell completes Series B1 round raising $45 million to help Oricell build out US presence

Oricell Therapeutics (Shanghai) will use proceeds from a $45 million series B1 round to fund the US-based clinical development of OriCAR-017, a GPRC5D CAR T therapeutic to treat relapsed and refractory multiple myeloma, which is at the IND enabling stage in the US and China. The financing was led by RTW Investments and Qatar Investment Authority, with participation from existing investors including Qiming Venture Partners and C&D Emerging Industry Equity Investment and follows a $125 million series B raise in July 2022.