CLINICAL AND REGULATORY

Gracell gains on recent positive FastCAR data in B cell NHL

At ASCO meeting, the company reported that GCO12F led to a 93% ORR and an 83% complete response rate in 29 Chinese multiple myeloma patients in an investigator-initiated trial. On June 10 at the EHA Congress, it reported that the same rapidly manufactured therapy led to a 100% ORR and a 66.7% six-month CR in nine diffuse large B cell lymphoma patients in China. Gracell has been cleared to start Phase 1b/2 multiple myeloma studies in the US and China.

Latest Nkarta update on NKX101 disappointed the market

Shares of Nkarta lost more than a third of their value after the company reported the latest data from a Phase 1 trial of NKX101, its allogeneic CAR NK cell therapy. Although the therapy plus lymphodepletion led to complete responses in four of six patients with acute myelogenous leukemia, with two responders showing minimal residual disease and one response deepening with exposure to more cycles, the company also reported data showing that among 13 new patients receiving lymphodepletion and NKX101, only one had a complete response.

2seventy bio slips after patient death in Phase 1 study

2seventy bio announced a Phase 1 study of SC-DARIC33 conducted by Seattle Children’s will be paused after a pediatric patient with acute myelogenous leukemia died following treatment at the trial’s second dose level. The cause is under investigation. SC-DARIC33 uses 2seventy’s DARIC technology, an on-off switch to regulate the CAR T cell’s activity as it targets CD33; the platform is designed to confer a safety advantage by allowing myeloid recovery or reactivation.

FDA placed a clinical hold on CAR-T therapy from Arcellx following patient death

Arcellx said it believes that limitations on bridging therapy could have contributed to the death of a patient in the company’s iMMagine-1 Phase 2 clinical trial of CART-ddBCMA to treat relapsed or refractory multiple myeloma, a study on which FDA has placed a clinical hold. The company added that it was working with the agency to amend the study protocol to expand options for patients that are consistent with current clinical practice, and that FDA had cleared Arcellx to dose patients who have undergone lymphodepletion.

DEALS AND FINANCING

Antibody-cell conjugate company Acepodia raises $100 million Series D

Acepodia will use its $100 million series D financing to advance its pipeline of allogeneic T cell therapies against both solid and hematologic cancers. The company’s programs link ɣδ2 T cell therapies to tumor-targeting antibodies to increase tumor binding. The new funding will support Phase 1 testing of lead program ACE1831, an anti-CD20-armed ɣδ2 T cell therapy for non-Hodgkin lymphoma, and preclinical development of ACE2016, an allogeneic ɣδ2 T cell therapy targeting EGFR-expressing solid tumors.

Lion takes TCR therapy to Phase 1b/2 with $40 million financing

Guangzhou Industrial Investment and Capital Operation Holding Group led a $40 million B2 round for Singapore- and Guangzhou-based Lion TCR, which said the money would be primarily used to support clinical trials of its TCR T cell therapy to treat hepatitis B-related HCC and construct a GMP facility in China.  Lion added that FDA’s filing of an IND for its international, multi-center Phase 1b2I trial is the agency’s first for a TCR T cell therapy in the indication. Guangzhou Guoju Investment and CSPC NARD Capital Fund participated in the financing.

TCR company Anocca raises $37 million to move into clinics

Sweden-based Anocca AB believes its new SEK400 million ($37 million) round of funding will allow it to begin clinical work next year on the first treatments from its pipeline of T cell receptor therapies. Lead investors Mellby Gård and AMF joined Michano, Swedbank Robur, Ramsbury, Nidoco, family offices and individuals in the round. The nine-year-old company has raised SEK1.3 billion to date.