Mirvetuximab soravtansine

Ovarian Cancer Opportunity Assessment and Forecast Report 2024: Sales of ImmunoGen's Elahere Represent the Most Impactful Driver of Growth - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 10, 2024
Genetics, Health, Oncology, Cancer, Ovarian cancer, Taxane, PBF, Risk, PARP, Recurrence, Bevacizumab, Gemcitabine, ICIS, Therapy, Patent, Patient, WMH, ImmunoGen, Mirvetuximab soravtansine, VEGF, Growth, Pharmaceutical industry

This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 7MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for Ovarian Cancer.

Key Points: 
  • This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 7MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for Ovarian Cancer.
  • Ovarian cancer patients generally respond well to platinum-based chemotherapy and achieve complete remission in the initial setting.
  • Major drivers of growth in the Ovarian Cancer market across the 7MM over the forecast period include the following:
    The sales of ImmunoGen's Elahere represent the most impactful driver of growth for the ovarian cancer market.
  • Voluntary withdrawals and generic erosion upon the patent expiries of the PARP inhibitors will temper sales growth during the forecast period in the ovarian cancer market.

Allarity Therapeutics Makes Strategic Pivot to Focus Solely on Accelerating Stenoparib Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer

Retrieved on: 
Wednesday, March 27, 2024
Toxicity, Ovarian cancer, BRCA, Mirvetuximab soravtansine, Partnership, Patient, Neoplasm, Cancer, Merck, Doctor of Philosophy, Olaparib, WNT, Niraparib, Jiangsu Hengrui Medicine, PARP, Therapy, Safety, Platinum, Interim, Rucaparib, Pharmaceutical industry

This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.

Key Points: 
  • This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.
  • In addition, stenoparib is unique in its mechanism of action, inhibiting PARP as well as the novel cancer target, tankyrase.
  • Tankyrase inhibition would restrain the WNT pathway, which is commonly upregulated not only in ovarian cancers but in many other solid cancers.
  • Given the unique, dual mechanism of action for stenoparib—coupled with its favorable safety profile—stenoparib may represent the next-generation alternative in the evolving market for advanced ovarian cancer patients.

U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients

Retrieved on: 
Friday, March 22, 2024
AbbVie, Ovarian cancer, Survival, ImmunoGen, Progression-free survival, Patient, Neoplasm, ABBV, Malignancy, University, Mirvetuximab soravtansine, PROC, Cancer, PFS, ADC, Food, FDA, Medicine, Pharmaceutical industry

NORTH CHICAGO, Ill., March 22, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE.  

Key Points: 
  • Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy.
  • They may become resistant to this treatment and require another therapy, such as ELAHERE.
  • "The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team.
  • "As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors.

Labcorp Presents New Research Demonstrating Clinical Impact of Precision Diagnostics in Guiding Biomarker-targeted Therapies for Patients with Epithelial Ovarian Cancer

Retrieved on: 
Saturday, March 16, 2024
Diagnosis, Ovarian cancer, MIRV, Mutation, Health, BRCA, Science, Disease, Partnership, Patient, Education, Glomus tumor, Roche, Biomarker, Neoplasm, Research, Cancer, EOC, Recombinant DNA, Woman, HRP, PARP, TTD, Fibroadenoma, HRD, Mirvetuximab soravtansine, BRCA2, Recurrence, LH, BRCA1, ADP, Pharmaceutical industry

BURLINGTON, N.C., March 16, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today presented the results from two studies at the 2024 SGO Annual Meeting on Women's Cancer. The studies demonstrate the value of biomarker testing in closing testing gaps and guiding targeted therapies for patients with epithelial ovarian cancer (EOC).

Key Points: 
  • The studies demonstrate the value of biomarker testing in closing testing gaps and guiding targeted therapies for patients with epithelial ovarian cancer (EOC).
  • Labcorp researchers conducted two studies to generate further evidence of the value of comprehensive genomic profiling to drive guideline-compliant testing that enables increased patient access to targeted therapies for improved outcomes.
  • When combined, the results of BRCA and HRD testing can determine which patients are most likely to benefit from treatment with poly-ADP ribose polymerase (PARP) inhibitors.
  • "This research emphasizes the power of comprehensive biomarker testing in advancing the treatment of ovarian cancer.

Shattuck Labs Reports Fourth Quarter and Full-Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, February 29, 2024
Research, Autoimmune disease, Anemia, Investment, Lung cancer, Patient, Mirvetuximab soravtansine, PLD, Cancer cell, AZA, Azacitidine, Neoplasm, Clinical trial, TP53, Fusion, Autoimmunity, G&A, Cancer research, NSCLC, AML, ASH, Inflammation, Conference, Safety, Collaboration, Pharmacokinetics, Insurance, Messenger, Research and development, Society, Event, Administration, Citigroup, Publication, Cancer, Pharmaceutical industry

Initial combination data from the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024.

Key Points: 
  • Initial combination data from the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024.
  • Shattuck Closes Financing: On December 21, 2023, Shattuck announced a $50 million public offering of common stock and concurrent private placement of pre-funded warrants.
  • Research and Development (R&D) Expenses: R&D expenses for the quarter ended December 31, 2023, were $15.2 million, as compared to $21.9 million for the quarter ended December 31, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses for the quarter ended December 31, 2023 were $4.4 million, as compared to $4.8 million for the quarter ended December 31, 2022.

Shattuck Labs Provides Corporate Update and Highlights Upcoming Key Milestones in 2024

Retrieved on: 
Monday, January 8, 2024
Autoimmune disease, Completeness, Ovarian cancer, PROC, AZA, TP53, Anemia, Society, Clinical trial, Cancer, Event, Azacitidine, Investment, Webcast, Patient, Safety, PLD, Acceleration, AML, Mirvetuximab soravtansine, Pharmaceutical industry

AUSTIN, TX and DURHAM, NC, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today provided a corporate update and highlighted upcoming key milestones anticipated in 2024.

Key Points: 
  • AUSTIN, TX and DURHAM, NC, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today provided a corporate update and highlighted upcoming key milestones anticipated in 2024.
  • “In 2023, we delivered key safety and efficacy data across our clinical development program for SL-172154 and further strengthened our financial resources, which we believe will carry us beyond upcoming milestones in the year ahead,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck Labs.
  • On December 21, 2023, Shattuck announced a $50 million registered offering of common stock and concurrent private placement of pre-funded warrants.
  • Initial combination data from the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected mid-year 2024.

FDA Grants Priority Review of ImmunoGen’s Supplemental Biologics License Application for ELAHERE® (mirvetuximab soravtansine-gynx) in Platinum-Resistant Ovarian Cancer

Retrieved on: 
Tuesday, December 5, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, National Medical Products Administration, Priority review, Annual general meeting, Food, European Medicines Agency, Spacecraft, Progression-free survival, US Foods, ADC, Patient, IMGN, ASCO, New Drug Application, Medical Affairs Bureau, ImmunoGen, MD, Cancer, Mirvetuximab soravtansine, Society, PDUFA, Pharmaceutical industry, Research

The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.

Key Points: 
  • The application has been granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) action date of April 5, 2024.
  • We look forward to collaborating closely with the FDA throughout the review process."
  • The confirmatory Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer forms the basis of the sBLA.
  • ELAHERE was granted accelerated approval by the FDA in November 2022 based on data from the pivotal SORAYA trial.

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

Retrieved on: 
Thursday, November 30, 2023
Medicine, Food and Drug Administration, Bone marrow, Acquisition, NYSE, Food, Ovarian cancer, ADC, MAA, Patient, IMGN, ImmunoGen, European, EPS, FDA, Goldman Sachs, Morgan Stanley, AbbVie, Ropes & Gray, Cancer, Mirvetuximab soravtansine, Death, Survival, BPDCN, ABBV, PROC, Biologics license application, Lazard, Vaccine, Bank, Pharmaceutical industry, Financial adviser, Spacecraft

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.

Shattuck Labs Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, November 9, 2023
Bevacizumab, Patient, Neoplasm, Headache, Acute myeloid leukemia, Optimism, Mirvetuximab soravtansine, Clinical trial, PROC, Fatigue, Embolism, IRR, TP53, Thrombocytopenia, Macrophage, Conference, PLD, Nausea, Society, ASH, Pharmacokinetics, Pfizer, Autoimmune disease, AZA, Platinum, Anemia, Safety, Cancer, Conference call, Neutropenia, AML, Pharmaceutical industry, Azacitidine

AUSTIN, TX and DURHAM, NC, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended September 30, 2023, and provided recent business highlights.

Key Points: 
  • ET –
    AUSTIN, TX and DURHAM, NC, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended September 30, 2023, and provided recent business highlights.
  • Shattuck remains on track to share initial data in the fourth quarter of 2023 from the frontline expansion cohorts in TP53 mutant AML and HR-MDS.
  • ET today to review third quarter 2023 financial results and provide a general business overview.
  • General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the quarter ended September 30, 2023, as compared to $6.6 million for the quarter ended September 30, 2022.

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Novartis Institute for Tropical Diseases, Research, NSCLC, Acute myeloid leukemia, IMGN, Food, PIN, Biomedical Research, ImmunoGen, European Medicines Agency, Doctor of Philosophy, Medicine, Capital expenditure, New Drug Application, Takeda Pharmaceutical Company, Marketing, BPDCN, ESGO, US Foods, Azacitidine, European Society of Gynaecological Oncology, EMA, ORR, NDA, Safety, Cancer, György Enyedi (geographer), Patient, National Medical Products Administration, Eli Lilly and Company, MAA, Congress, Mirvetuximab soravtansine, Blastic plasmacytoid dendritic cell neoplasm, ASH, Growth, ADC, Spacecraft, FDA, NMPA, PROC, University Clinical Centre in Gdańsk, Society, Senior, Inc., Huadong Medicine, AML, PARP, Vaccine, Pharmaceutical industry, Dietary supplement, Takeda

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.