EMA has granted conditional marketing authorization to Abecma idecabtagene vicleucel by BMS to treat relapsed and refractory multiple myeloma in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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EMA approved Abecma CAR-T therapy for treatment of advanced multiple myeloma
Abecma is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells. BMS, which holds the rights to manufacture and commercialize outside the US, is adding a manufacturing facility in Leiden, the Netherlands, making Abecma available to patients in the EU.
CLINICAL
CARsgen has dosed first patient in its Phase 2 trial of BCMA CAR-T
CARsgen Therapeutics gained 12 % to HK$35.20 after dosing the first subject in its North American Phase 2 LUMMICAR trial of CT053, an autologous BCMA CAR T therapy to treat refractory and/or relapsed multiple myeloma. The company plans to make regulatory submissions for marketing approval to NMPA and FDA in 1H22 and 1H23, respectively.
Kymriah missed its primary endpoint of event-free survival in Phase 3
Novartis announced that its CD19 CAR-T therapy Kymriah tisagenlecleucel missed the primary endpoint of event-free survival in the Phase 3 BELINDA trial to treat relapsed or refractory second-line B cell non-Hodgkin’s lymphoma compared to standard of care. In June, CD19 CAR-T competitors Yescarta axicabtagene ciloleucel from Gilead Sciences and Breyanzi lisocabtagene maraleucel from BMS both showed statistically significant outcomes on event-free survival in Phase 3 trials of the same setting.
Poseida gains proof of concept for its solid tumor CAR-T P-PSMA-101
At the CAR-TCR Summit, Poseida Therapeutics presented preliminary Phase 1 data for P-PSMA-101 in mCPRC showing that the PSMA-targeting CAR T cell therapy led to complete tumor elimination in one of the nine treated patients and measurable declines in PSA levels in four others. Three of the heavily pretreated patients, who received a median of six prior therapies, achieved more than a 50% reduction in PSA levels with concordant improvements on PSMA-PET imaging. Investors were hoping for more. Over half of the patients in the study achieved some level of PSA decline, however the data failed to impress the investors, which led to 19% share price drop during the day of data presentation.
DEALS AND FINANCING
Kite and Appia Bio announce collaboration to develop allogeneic cell therapies for cancer
Three months after emerging from stealth mode, Appia Bio has clinched a deal with the Kite Pharma cell therapy division of Gilead Sciences to jointly develop CAR-engineered invariant natural killer T (CAR-iNKT) cell therapies for oncology. Appia Bio will receive an upfront, equity investment, and milestone payments for a total value of up to $875 million as well as tiered royalties. Appia Bio will be responsible for preclinical and early clinical research of two HSC-derived CAR-iNKT product candidates engineered with CARs provided by Kite. Kite is responsible for development, manufacturing, and commercialization of the product candidates identified through the collaboration.
Sonoma Bio raised $265 million in Series B to advance its Treg therapies
Sonoma Bio has raised $265 million in an oversubscribed Series B financing. Proceeds from the financing will be used to advance Sonoma Bio’s Treg cell therapy platform and a novel Teff conditioning biologic into the clinic to treat multiple, severe autoimmune and inflammatory diseases and to further invest in and scale up manufacturing operations in order to support supply for initial clinical studies. Sonoma Bio has not disclosed the target antigen for lead CAR T cell therapy SB-77-7101.
Lilly Asia Ventures leads $40 million angel round for Richard Wang’s newco
A $40 million angel financing led by Lilly Asia Ventures will enable Shanghai-based Neukio Biotherapeutics to create a research facility and develop off-the-shelf immune cell technology platforms and therapies. The company is led by founder, Chairman and CEO Richard Wang, who was founding CEO of Fosun Kite, the JV between Fosun Pharma and Kite Pharma. IDG Capital and Sherpa Investments also participated.
