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Phase 3 data of CD-19 targeting CAR-Tliso-cel show significant improvement in DLBCL

SOTIO Biotech

17/1/2022 | 4 minuty čtení

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Liso-cel significantly improves outcomes in second-line DLBCL

BMS announced the first disclosure of results from a prespecified interim analysis of the pivotal TRANSFORM study, a global randomized Phase 3 trial evaluating Breyanzi(liso-cel), a CD19-directed CAR-T cell therapy as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma.

It compared the outcomes to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant.

Results show, at a median follow up of 6.2 months, Breyanzi significantly improved event-free survival (EFS) compared to standard of care, the study’s primary endpoint, with a median EFS of 10.1 months for Breyanzi and 2.3 months for standard of care, representing a 65% reduction in risk of EFS events with Breyanzi. The data were presented in an oral session during the 63rd ASH Meeting.

New cita-cel data show greater clinical benefit in heavily pretreated myeloma patients

Janssen announced longer-term results from the Phase 1b/2 CARTITUDE-1 study evaluating the efficacy and safety of ciltacabtageneautoleucel (cilta-cel), an investigational BCMA-directed CAR-T therapy administered as a single infusion, in the treatment of patients with relapsed or refractory multiple myeloma. The data, featured as an oral presentation at ASH Meeting, show that patients receiving cilta-cel continue to demonstrate deep and durable responses, with a very high ORR of 98%. Responses in the 97 patients treated with cilta-cel deepened over time, with 83% of patients achieving a stringent CR at median 22-month follow-up, an increase from 80% at the 18-month median follow-up data presented at the 2021 ASCO Meeting, and from 67% at the 12.4-month median follow-up data presented at ASH 2020. At median follow-up of 22- months, median PFS and median OS were not reached, suggesting long-term durability of responses and survival for patients. Two-year PFS and OS rates were 61% and 74%, respectively. Among 61 minimal residual disease (MRD) evaluable patients, 92% of patients achieved MRD negativity at 10-5.1 The two-year PFS rates in patients who achieved MRD negativity for ≥6 and ≥12 months were 91%.

Yescarta Is First CAR T-cell Therapy to Report Five-Year Survival Data From Pivotal Study

Kite Pharma announced five-year follow-up data from the pivotal ZUMA-1 trial of Yescarta in adult patients with refractory large B-cell lymphoma. Among all patients treated with Yescarta, the five-year OS rate was 42.6%. Among patients who had a CR, the five-year OS rate was 64.4% and median survival time has yet to be reached. Among treated patients alive at five years, 92% have received no additional treatment since their one-time infusion of Yescarta, suggestive of a cure for these patients. The data were presented today at the ASH Meeting. At five years, these data demonstrate impressive and durable survival benefit with axicabtageneciloleucel in patients with refractory LBCL. Nearly half of patients in the ZUMA-1 trial are still alive at five years a group that previously had an average life expectancy of only six months. These results are a truly transformative shift in the standard of care for this disease.


Italian Genenta closed its upsized IPO on NASDAQ raising $36 million

Genenta Science closed its upsized IPO of 2.4 million American Depositary Shares at a public offering price of $11.50 per ADS. Genenta also sold 720,114 ordinary shares reserved for subscription by its existing shareholders at a price of $11.50 per share. The gross proceeds from the offering, including ordinary shares, were approximately $36 million. The company is a clinical-stage biotech pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for solid tumors, including the lead product candidate, Temferon. Roth Capital Partners acted as sole book-running manager of the offering. Maxim Group LLC acted as lead manager of the offering. Genenta has granted the underwriters an option for a period of 30 days from the date of the final prospectus to purchase an additional 360,000 ADSs, which, if exercised, the gross proceeds from the offering will be approximately $40 million.

Exuma Biotech completed Series B2 to advance novel cell and gene therapies

Exuma Biotech completed a $41 million Series B2 financing. The Series B2 brings the total capital raised since its inception to approximately $130 million.Proceeds will be used to support further development of EXUMA’s autologous rPOC CAR-TaNK (T- and NK-like) platform for hematologic and solid tumors and continued clinical investigation of its Tumor Metabolism Regulated CAR technology targeting solid tumors. New investors in the Series B2 financing included Americo Life, in addition to existing investors.

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