HER4

Spectrum Pharmaceuticals Provides Update on Poziotinib Following FDA Oncologic Drugs Advisory Committee Meeting

Retrieved on: 
Thursday, September 22, 2022
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The committee makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.

Key Points: 
  • The committee makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.
  • Spectrum Pharmaceuticals holds an exclusive license from Hanmi Pharmaceutical (Hamni) to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China.
  • SPECTRUM PHARMACEUTICALS, INC. is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate.
  • REDEFINING CANCER CARE and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

Spectrum Pharmaceuticals Announces Data from Poster Presentation for Poziotinib in NSCLC Patients with G778_P780dup HER2 Exon 20 Mutations at ESMO Congress 2022

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Saturday, September 10, 2022
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The data show that poziotinib is highly active in G778 mutations in both treatment nave and previously treated patients with NSCLC.

Key Points: 
  • The data show that poziotinib is highly active in G778 mutations in both treatment nave and previously treated patients with NSCLC.
  • A poster with the data is available to registered participants at the European Society for Medical Oncology Congress (ESMO) 2022 taking place in Paris from September 9-13, 2022.
  • The G778 mutation is one of the frequent HER2 exon 20 insertion mutations and patients with these tumors have a poor prognosis, said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals.
  • There is no approved therapy specifically for either treatment-nave or previously treated NSCLC with HER2 exon 20 insertion mutations.

Spectrum Pharmaceuticals Announces Poster Presentation for Poziotinib in NSCLC Patients with G778_P780dup HER2 Exon 20 Mutations at the Upcoming ESMO Congress 2022

Retrieved on: 
Monday, September 5, 2022
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The poster will be presented at the upcoming European Society for Medical Oncology Congress (ESMO) 2022 that will take place in Paris from September 9-13, 2022.

Key Points: 
  • The poster will be presented at the upcoming European Society for Medical Oncology Congress (ESMO) 2022 that will take place in Paris from September 9-13, 2022.
  • HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC.
  • There is no approved therapy specifically for either treatment-nave or previously treated NSCLC with HER2 exon 20 insertion mutations.
  • REDEFINING CANCER CARE and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

Spectrum Pharmaceuticals to Present Data at 2022 ASCO Highlighting the Potential Predictive Capabilities of ctDNA as a Biomarker for Poziotinib Treatment Response

Retrieved on: 
Thursday, May 26, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Hanmi, Cancer, PDUFA, Poziotinib, HER2, Regulation of tobacco by the U.S. Food and Drug Administration, Food, U.S. Securities and Exchange Commission, Breast cancer, Progression-free survival, Nasdaq, Patient, Poster, RECIST, Review, ORR, Society, Stomach, American Society of Clinical Oncology, Hanmi Pharmaceutical, FDA, Spectrum Pharmaceuticals, Medication, Broadcast license, Safety, HIV disease progression rates, ASCO, SPPI, Large-cell lung carcinoma, EGFR, Quality control, Fast Track, Security (finance), Neoplasm, HER4, Pharmaceutical industry, Spectrum, NSCLC

This early data suggests that a reduction in ctDNA may be a predictor of response to treatment with poziotinib, said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals.

Key Points: 
  • This early data suggests that a reduction in ctDNA may be a predictor of response to treatment with poziotinib, said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals.
  • We are encouraged by these findings and look forward to further investigate ctDNA as a potential predictive biomarker of poziotinib treatment response.
  • SPECTRUM PHARMACEUTICALS, INC. is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate.
  • REDEFINING CANCER CARE and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

Elevation Oncology to Present Initial Seribantumab Proof-of-Concept Data from Phase 2 CRESTONE Study in Patients with Tumors Harboring NRG1 Fusions at ASCO 2022

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Thursday, May 26, 2022
Disease, Key finding attacks, NEW, Food, U.S. Securities and Exchange Commission, Webcast, Trial of the century, HER3, Cell, Cohort, Cholangiocarcinoma, Lung, Private Securities Litigation Reform Act, Cancer, Risk, HER2, Doctor of Pharmacy, Annual general meeting, Clinical trial, Pharmacist, COVID-19, American Society of Clinical Oncology, NSCLC, Erosion (morphology), RNA, Sarcoma, EGFR, Fast Track, Growth, NRG1, HER4, Breast, Company, Doctor of Philosophy, Goal, Patient, RECIST, Fusion, PRS, FDA, Biotechnology, ASCO, Therapy, Security (finance), CRS, Population, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nasdaq, Neuregulin 1, Society, Gallbladder, Forward-looking statement, Safety, Immunoglobulin G, Medical imaging, Pharmaceutical industry, Neoplasm, Seribantumab, MD

NEW YORK, May 26, 2022 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced positive initial clinical proof-of-concept data from its ongoing Phase 2 CRESTONE study evaluating the safety and efficacy of seribantumab in patients with advanced solid tumors that harbor NRG1 gene fusions. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago from June 3-7, 2022.

Key Points: 
  • These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago from June 3-7, 2022.
  • We look forward to continuing to advance seribantumab to address the significant unmet needs of patients with NRG1 fusions."
  • We look forward to sharing the data with the medical and scientific community at ASCO in June."
  • The full presentation can be accessed on the Elevation Oncology website at elevationoncology.com/resources/publications/following completion of the live presentation at ASCO.

Elevation Oncology Announces FDA Fast Track Designation Granted to Seribantumab for the Tumor-Agnostic Treatment of Solid Tumors Harboring NRG1 Gene Fusions

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Wednesday, May 25, 2022
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A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.

Key Points: 
  • A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug's development, review and potential approval.
  • The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins".
  • NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas.
  • Seribantumab was granted Fast Track designation from the FDA for the tumor-agnostic treatment of patients whose solid tumors harbor NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

Salubris Biotherapeutics Announces New Pipeline Advancements and Appointment of Chief Medical Officer

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Monday, May 23, 2022
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The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.

Key Points: 
  • The Company also announced the submission of the first clinical trial application (CTA) in Europe for its lead oncology program, JK08, and the appointment of Arian Pano, M.D., as Chief Medical Officer.
  • We have made considerable progress this year across our pipeline and remain laser-focused on advancing these important programs to bring differentiated complex biologics to patients with unmet needs, concluded Murphy.
  • In addition, dose-dependent increases in biomarker surrogates of target engagement have been observed across the two completed cohorts.
  • SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular, oncology, and neurodegenerative diseases.

Elevation Oncology Announces Initial Data from Phase 2 CRESTONE Study of Seribantumab Selected for Oral Presentation at ASCO 2022

Retrieved on: 
Wednesday, April 27, 2022
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Details for the ASCO 2022 oral presentation are as follows:

Key Points: 
  • Details for the ASCO 2022 oral presentation are as follows:
    The abstract will be published by ASCO on May 26, 2022 at 5:00 pm ET.
  • The abstract and a broadcast of the oral presentation can be accessed on the ASCO 2022 website at conferences.asco.org/am .
  • Copies of these materials will also be available on the Elevation Oncology website at elevationoncology.com/resources/publications following completion of the live presentation.
  • Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

Cogent Biosciences Presents Nonclinical Data at AACR Annual Meeting and Provides Updates on Portfolio Expansion at R&D Investor Event

Retrieved on: 
Monday, April 11, 2022
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CAMBRIDGE, Mass. and BOULDER, Colo., April 11, 2022 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, presented two poster presentations at the American Association of Cancer Research (AACR) annual meeting taking place April 8-13, 2022. The first included updated nonclinical bezuclastinib data reinforcing its potential to be a differentiated, best-in-class KIT mutant inhibitor. The second focused on nonclinical data from Cogent’s next-generation fibroblast growth factor receptor 2 (FGFR2) research program, designed to spare FGFR1 while potently covering all gatekeeper and molecular brake mutations. Finally, the company shared additional details at an R&D Investor Event, on its portfolio expansion plans by highlighting its early efforts to develop an ErbB2 mutant selective inhibitor for patients with non-exon 20 mutations.

Key Points: 
  • The first included updated nonclinical bezuclastinib data reinforcing its potential to be a differentiated, best-in-class KIT mutant inhibitor.
  • Separately, we introduced two novel programs from the Cogent Research Team which highlighted our growing portfolio of novel, small-molecule targeted therapies for patients fighting genetically driven diseases.
  • Bezuclastinib is a tyrosine kinase inhibitor that is active against KIT mutations relevant to both systemic mastocytosis (SM) and gastrointestinal stromal tumors (GIST).
  • These data support that bezuclastinib inhibits KIT downstream signaling and is able to drive tumor regressions at clinically achievable doses.

Salubris Biotherapeutics Announces $32 Million Financing to Advance Novel Complex Biologics for Cardiovascular, Oncology, and Neurodegenerative Diseases

Retrieved on: 
Monday, March 7, 2022
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Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd.

Key Points: 
  • Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd.
  • We are focused on advancing our programs and securing additional funding to progress the development of our portfolio of antibody fusion proteins and other complex biologics.
  • Since its inception, SalubrisBio has built a drug discovery and development platform to address significant unmet medical needs in cardiovascular diseases, cancer and neurodegenerative diseases.
  • SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular, oncology, and neurodegenerative diseases.