European Hematology Association

Kura Oncology Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023

ET –

Key Points: 
  • ET –
    SAN DIEGO, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported second quarter 2023 financial results and provided a corporate update.
  • Research and development expenses for the second quarter of 2023 were $28.2 million, compared to $24.3 million for the second quarter of 2022.
  • General and administrative expenses for the second quarter of 2023 were $11.8 million, compared to $11.1 million for the second quarter of 2022.
  • ET / 1:30 p.m. PT today, August 3, 2023, to discuss the financial results for the second quarter 2023 and to provide a corporate update.

Editas Medicine Announces Second Quarter 2023 Results and Business Updates

Retrieved on: 
Wednesday, August 2, 2023

CAMBRIDGE, Mass., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today reported financial results for the second quarter 2023 and business updates.

Key Points: 
  • Strengthened Executive Team with Appointments of Erick Lucera as Chief Financial Officer and Linda C. Burkly, Ph.D., as Chief Scientific Officer
    CAMBRIDGE, Mass., Aug. 02, 2023 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today reported financial results for the second quarter 2023 and business updates.
  • The Editas team is excited and continues driving execution towards our goals,” commented Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine.
  • ET to provide and discuss a corporate update and financial results for the second quarter of 2023.
  • To access the call, please dial 1-877-407-0989 (domestic) or 1-201-389-0921 (international) and ask for the Editas Medicine earnings call.

SpringWorks Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, August 2, 2023

STAMFORD, Conn., Aug. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported second quarter financial results for the period ended June 30, 2023 and provided an update on recent company developments.

Key Points: 
  • STAMFORD, Conn., Aug. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported second quarter financial results for the period ended June 30, 2023 and provided an update on recent company developments.
  • In May 2023, SpringWorks announced full enrollment of the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors.
  • SpringWorks expects to file an Investigational New Drug Application for SW-682 in the fourth quarter of 2023.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $77.9 million, or $1.25 per share, for the second quarter of 2023.

ImmunoGen Reports Recent Progress and Second Quarter 2023 Financial Results

Retrieved on: 
Monday, July 31, 2023

(Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.

Key Points: 
  • (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.
  • Research and development expenses were $50.1 million for the quarter ended June 30, 2023 compared to $51.4 million for the quarter ended June 30, 2022.
  • Selling, general and administrative expenses were $36.4 million for the quarter ended June 30, 2023 compared to $23.8 million for the quarter ended June 30, 2022.
  • Net loss for the second quarter of 2023 was $4.2 million, or $0.02 per share, compared to a net loss of $62.0 million, or $0.24 per share, for the second quarter of 2022.

Faron Updates Positive Clinical Data from Phase I/II BEXMAB Study of Bexmarilimab in Relapsed/Refractory AML and MDS BEXMAB Study Update

Retrieved on: 
Wednesday, July 19, 2023

The BEXMAB study (ClinicalTrials.gov: NCT05428969) investigates bexmarilimab, Faron's wholly owned immunotherapy asset, in combination with standard of care (SoC) in the aggressive hematological malignancies of relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

Key Points: 
  • The BEXMAB study (ClinicalTrials.gov: NCT05428969) investigates bexmarilimab, Faron's wholly owned immunotherapy asset, in combination with standard of care (SoC) in the aggressive hematological malignancies of relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
  • The data reported here builds on earlier positive results presented on June 9, 2023 at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • BEXMAB Phase I Study Update:
    In the three out of five patients in the 6 mg/kg + azacitidine doublet cohort, one patient also achieved a complete recovery of blood counts (CR).
  • “The data indicates bexmarilimab has the strong potential to tackle an unmet medical need in relapsed/refractory AML and MDS,” said Chief Medical Officer Dr. Marie-Louise Fjällskog.

Mustang Bio Announces Final Results from Follicular Lymphoma Cohort of Single-Institution Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy

Retrieved on: 
Thursday, June 15, 2023

WORCESTER, Mass., June 15, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that final data from the follicular lymphoma (“FL”) cohort of the single-institution Phase 1/2 clinical trial of MB-106 demonstrate treatment with the CD20-targeted, autologous CAR T-cell therapy resulted in high overall response (“ORR”) and complete response (“CR”) rates and CAR T persistence in FL patients. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”).

Key Points: 
  • The final FL cohort results from the Phase 1/2 clinical trial being conducted at Fred Hutch were presented by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington, at the 17th International Conference on Malignant Lymphoma (“17-ICML”).
  • Median age was 63 years (range: 44 – 81), and median prior lines of treatment was 4 (range: 1 – 12).
  • One patient, previously treated with a CD19-targeted CAR T-cell therapy, achieved a CR and remains in remission after 18 months.
  • We look forward to reporting initial data from our multicenter Phase 1/2 clinical trial of MB-106 shortly.”
    For more information on the multicenter clinical trial, please visit www.clinicaltrials.gov using the identifier NCT05360238 for the multicenter trial.

Six-Year Overall Survival Results Added to U.S. Prescribing Information for ADCETRIS® (brentuximab vedotin) as First-Line Treatment for Advanced Hodgkin Lymphoma

Retrieved on: 
Thursday, June 15, 2023

The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.

Key Points: 
  • The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.
  • ADCETRIS was approved for advanced Hodgkin lymphoma in 2018 based on an improvement in progression-free survival in combination with chemotherapy agents AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) in the ECHELON-1 trial.
  • Patients with advanced classical Hodgkin lymphoma are often young adults with their whole lives ahead of them,” said David Epstein, Chief Executive Officer, Seagen.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Seagen Announces ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 98% Overall Response Rate and 93% Complete Response Rate in Patients with Early-Stage Classical Hodgkin Lymphoma (cHL)

Retrieved on: 
Tuesday, June 13, 2023

Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.

Key Points: 
  • Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.
  • The study will be presented on June 17, 2023.
  • Immune-mediated AEs observed to date are consistent with the individual safety profile of nivolumab.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Mustang Bio Announces Updated Results from Waldenstrom Macroglobulinemia Cohort of Ongoing Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy

Retrieved on: 
Monday, June 12, 2023

WORCESTER, Mass., June 12, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia (“WM”), a rare form of blood cancer. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”).

Key Points: 
  • The updated results from the single-institution Phase 1/2 clinical trial were presented during a poster session at the European Hematology Association 2023 Hybrid Congress (“EHA2023”) by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington.
  • From a safety perspective, cytokine release syndrome (CRS) occurred in five patients: two patients with grade 1 and three patients with grade 2.
  • No grade 3 or 4 CRS or grade 2, 3 or 4 ICANS has been observed.
  • The MB-106 data from the Phase 1/2 clinical trial taking place at Fred Hutch continue to be encouraging for WM and other B-NHLs.

Salarius Pharmaceuticals Presents SP-3164 Targeted Protein Degrader Preclinical Data at the European Hematology Association 2023 Hybrid Congress

Retrieved on: 
Monday, June 12, 2023

SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment.

Key Points: 
  • SP-3164 does not negatively impact PBMC at clinically relevant concentrations up to 96 hours post-treatment.
  • In addition to having direct antitumor effects, SP-3164 also induces an anticancer immunomodulatory effect as demonstrated through the induction of cytokine secretion in human T cells following treatment.
  • We plan to begin a Phase 1 study in the second half of the year,” said David Arthur, president and chief executive officer of Salarius.
  • “Our first therapeutic target is blood cancer, and we are excited to embark on a potential new treatment option for these patients.”