BPDCN

Menarini Group Announces New Data on ORSERDU® (elacestrant) at the 2023 San Antonio Breast Cancer Symposium and on ELZONRIS® (tagraxofusp-erzs) at the 65th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Monday, November 20, 2023

In September 2023 , ORSERDU was approved by the European Commission.

Key Points: 
  • In September 2023 , ORSERDU was approved by the European Commission.
  • Updated data, including a spotlight discussion on additional biomarker and clinical subgroup analyses from the Phase 3 EMERALD trial, along with new safety updates evaluating elacestrant in multiple combination settings, will be presented at the San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • Updated data, including an oral presentation of updated real-world results in treatment-naïve patients with BPDCN demonstrating durable outcomes and a manageable safety profile leading to prolonged survival, will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 9-12, 2023.
  • “The breadth of data on our novel oncology therapies, spanning solid tumors and hematologic malignancies, underscore our commitment to addressing significant unmet medical needs in difficult-to-treat cancers,” said Elcin Barker Ergun, CEO of the Menarini Group.

AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio

Retrieved on: 
Thursday, November 30, 2023

Under the terms of the transaction, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share in cash.

Key Points: 
  • Under the terms of the transaction, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share in cash.
  • "Together, AbbVie and ImmunoGen have the potential to transform the standard of care for people living with cancer."
  • As a fast-growing solid tumor therapy, ELAHERE provides AbbVie with a potential multi-billion-dollar on-market medicine with expansion opportunities in earlier lines of therapy and larger segments of the ovarian cancer market.
  • ImmunoGen's Phase 1 asset, IMGN-151, is a next-generation anti-FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications.

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023

ImmunoGen Inc. (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 September 30, 2023.

Key Points: 
  • ImmunoGen Inc. (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 September 30, 2023.
  • We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα.
  • Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022.
  • Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230830257431/en/
    BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline’s ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

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.

ImmunoGen Presents Updated Findings from CADENZA Trial of Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm at EHA 2023 Congress

Retrieved on: 
Friday, June 9, 2023

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • The data will be presented in an oral session on Sunday, June 11 at the European Hematology Association (EHA) 2023 Congress in Frankfurt, Germany.
  • The CADENZA trial is enrolling frontline BPDCN patients, including those with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM).
  • As of the May 19, 2023 data cutoff, data were available for 79 BPDCN patients (30 frontline, 49 R/R).

Mustang Bio Provides CAR T Cell Therapy Portfolio Updates and 2023 Anticipated Milestones

Retrieved on: 
Monday, December 19, 2022

WORCESTER, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced recent CAR T cell therapy portfolio updates and provided anticipated milestones for 2023.

Key Points: 
  • WORCESTER, Mass., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced recent CAR T cell therapy portfolio updates and provided anticipated milestones for 2023.
  • Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, “In 2022, Mustang successfully advanced our CAR T cell therapy portfolio which has laid the foundation for us to achieve multiple milestones in the coming year.
  • The combination leverages MB-108 to make cold tumors “hot,” thereby improving the efficacy of MB-101 CAR T cell therapy.
  • Additionally, Mustang plans to file an IND application for a multicenter Phase 1 clinical trial once a lead CAR construct has been identified.

ImmunoGen Announces Clinical Collaboration with Gilead to Evaluate Pivekimab Sunirine in Combination with Magrolimab in Relapsed/Refractory Acute Myeloid Leukemia

Retrieved on: 
Friday, December 9, 2022

Expected to initiate in 2023, the collaboration will be a new cohort in ImmunoGen's 802 study and will evaluate pivekimab in combination with magrolimab in up to 42 patients with R/R CD123-positive AML.

Key Points: 
  • Expected to initiate in 2023, the collaboration will be a new cohort in ImmunoGen's 802 study and will evaluate pivekimab in combination with magrolimab in up to 42 patients with R/R CD123-positive AML.
  • Pivekimab sunirine is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and other CD123+ hematologic malignancies.
  • Pivekimab is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza (azacitidine) and Venclexta (venetoclax) for patients with untreated and relapsed/refractory AML.
  • The European Medicines Agency (EMA) granted orphan drug designation to pivekimab for the treatment of BPDCN in June 2020.