CLINICAL AND REGULATORY
Yescarta received FDA approval as first CAR-T for initial treatment of large B cell lymphoma
Kite, a Gilead company, announced the U.S. FDA has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause.
Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC. Yescarta is also being reviewed by global regulatory authorities for additional indications inclusive of ZUMA-7 patient population. ZUMA-7 is considered a landmark trial for being the first and largest trial of its kind, with the longest follow-up.
Nkarta announced positive preliminary dose finding data for two lead NK cell programs
Nkarta announced positive preliminary Phase 1 data from independent dose finding studies of its two lead CAR NK cell therapy candidates, NKX101 and NKX019, in two distinct groups of hematologic malignancies. In the first trial, evaluating NKX101, in relapsed or refractory AML and MDS, three of five patients with heavily pre-treated AML who received the higher dose level in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (minimal residual disease) negative.
There is currently no standard of care for these patients. In the second trial, evaluating NKX019, in B cell malignancies, three of six patients treated at the higher dose level in a three-dose regimen showed a complete response (50% CR), including one patient with aggressive DLBCL and one patient with MCL. In both trials, no dose limiting toxicity was observed and there were no CAR T like adverse events of any grade. Nkarta continues to enroll patients in three-dose regimens of 1.5 billion NK cells per dose in the dose finding portions of the NKX101 and NKX019 trials.
Affimed presented updated Phase 1/2 data of AFM13 at AACR
Affimed provided a data update from the ongoing study of its lead innate cell engager AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells. AFM13 is currently being investigated at The University of Texas MD Anderson Cancer Center in a phase 1/2 study in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas. The study shows a 100% ORR and an improvement of CR rate to 62% at the recommended phase 2 dose in 13 patients after 2 cycles of therapy.
As of the cut-off date, the study had enrolled 22 patients with relapsed or refractory CD30+ Hodgkin and non-Hodgkin lymphoma having received a median of seven prior lines of therapy, of whom 19 were evaluable for response. Thirteen response-evaluable patients were treated at the RP2D, including 12 patients with Hodgkin Lymphoma and one patient with non-Hodgkin Lymphoma. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with AFM13.
DEALS AND FINANCING
Pregene enteres into innovative partnership with CellPoint to develop anti-BCMA CAR-T
Shenzhen Pregene Biopharma and CellPoint announced exclusive license agreement for the development and commercialization of PRG-1801, Pregene's single domain antibody-based anti-BCMA CAR-T program, for the treatment of hematological indications in Europe and US. PRG-1801 has demonstrated strong signs of efficacy and an excellent safety profile in its initial investigator-initiated trial and Phase 1/2 trials.
Pregene will receive over €20 million of upfront and near-term consideration and is eligible to receive additional milestone and royalty payments. CellPoint will be responsible for the development and commercialization of the anti-BCMA CAR-T therapy in Europe and the US.
Nkarta closed upsized public offering raising $200 million
Nkarta priced an upsized follow-on offering of 13.3 million shares at $15 per share to raise $200 million. The deal price is a 20% discount to Nkarta’s close of $18.72, before the company proposed the offering. Cowen, SVB, Evercore and Stifel acted as joint book-running managers for the offering.