SERD

Natera Announces Randomized, Phase III TREAT ctDNA Trial in Early-Stage Breast Cancer

Retrieved on: 
Wednesday, November 8, 2023

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be used in a new breast cancer study called TREAT ctDNA (EORTC 2129-BCG).

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be used in a new breast cancer study called TREAT ctDNA (EORTC 2129-BCG).
  • This international, multi-center, randomized, phase III clinical trial is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer Group in collaboration with Natera and Menarini Group (Menarini), a leading international pharmaceutical and diagnostics company.
  • “We are excited to offer to our high-risk, ctDNA positive, ER+/HER2- early-stage breast cancer patients the possibility to participate in the TREAT ctDNA trial.
  • “Collaborations with leading clinical trial organizations like EORTC are needed as we seek to demonstrate the power of treatment on molecular recurrence across cancer indications.

EvolveImmune Therapeutics Presents New Preclinical and Translational Data on Novel CD2 Costimulatory T Cell Engager Platform at 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Monday, November 6, 2023

In addition, presented data highlighted the robust anti-tumor efficacy exhibited by lead molecules for the EV-104 and EV-106 programs in patient-derived solid tumor models.

Key Points: 
  • In addition, presented data highlighted the robust anti-tumor efficacy exhibited by lead molecules for the EV-104 and EV-106 programs in patient-derived solid tumor models.
  • The EVOLVE platform uniquely unleashes potent, selective and integrated T cell costimulation, which amplifies and sustains the tumor killing capacity of these T cells.
  • The platform also takes advantage the company’s understanding of specific tumor cell characteristics to guide tumor antigen prioritization and program differentiation.
  • In a poster presentation at SITC, EvolveImmune spotlighted advances to the company’s first-in-class EV-104 program, a novel multi-functional T cell engager with integrated CD2 costimulation which conditionally targets ULBP2.

Olema Oncology Announces Positive Phase 2 Monotherapy Clinical Study Results for Palazestrant

Retrieved on: 
Sunday, October 22, 2023

These results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023.

Key Points: 
  • These results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023.
  • “These Phase 2 monotherapy study results demonstrate that palazestrant (OP-1250) has the potential to become a best-in-class endocrine therapy and improve upon current standard of care treatments for women living with metastatic breast cancer.
  • In addition to being well-tolerated, palazestrant has demonstrated compelling progression-free survival as monotherapy in a heavily pretreated patient population,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology.
  • A copy of the oral presentation is available on Olema’s website under the Science section of the Olema website.

Carrick Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Samuraciclib in Combination with Elacestrant in Patients with Advanced Breast Cancer

Retrieved on: 
Wednesday, October 18, 2023

"Dosing the first patient in our Phase 2 clinical trial evaluating the combination of samuraciclib and elacestrant is an important milestone in our goal of improving outcomes for women fighting metastatic breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.

Key Points: 
  • "Dosing the first patient in our Phase 2 clinical trial evaluating the combination of samuraciclib and elacestrant is an important milestone in our goal of improving outcomes for women fighting metastatic breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.
  • The Phase 2 clinical trial evaluating the novel combination of samuraciclib and elacestrant is being conducted in collaboration with Menarini, pursuant to a clinical trial collaboration and supply agreement for elacestrant.
  • Clinical trial details can also be found on www.clinicaltrials.gov under study ID: NCT05963997 .
  • For additional information on the clinical trial, please contact [email protected] .

Luoxin Pharmaceutical's LX-039 (Innovative Anti-Tumor Drug): Phase I Clinical Study Data Presented at ESMO 2023

Retrieved on: 
Monday, October 23, 2023

LX-039, an innovative anti-tumor drug developed by Luoxin Pharmaceuticals Group Stock Co., Ltd. (Luoxin Pharmaceutical), was selected for poster presentation at the 2023 ESMO Annual Congress.

Key Points: 
  • LX-039, an innovative anti-tumor drug developed by Luoxin Pharmaceuticals Group Stock Co., Ltd. (Luoxin Pharmaceutical), was selected for poster presentation at the 2023 ESMO Annual Congress.
  • ESMO is one of the most influential oncology conferences globally, attracting over 30,000 professionals every year from more than 150 countries and regions.
  • The Congress covers basic research, translational research, and the latest advancements in clinical studies, providing an exchange platform in clinical diagnosis, treatment, and academic discussions.
  • The study was led by Professor Hu Xichun from Fudan University Shanghai Cancer Center.

Research Conducted by Florida Cancer Specialists & Research Institute Featured at European Society of Medical Oncology 2023 Congress

Retrieved on: 
Friday, October 20, 2023

FORT MYERS, Fla., Oct. 20, 2023 /PRNewswire/ -- Research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is featured this week among the latest advancements and findings in cancer care at the European Society of Medical Oncology (ESMO) Congress in Madrid, Spain. Five FCS physicians are the first authors and/or co-authors of 12 cancer research studies that will be shared at the global gathering of oncologists, researchers, patient advocates, pharmaceutical representatives and journalists. With more than 30,000 members from 168 countries worldwide, ESMO is the leading professional organization for medical oncology.

Key Points: 
  • FORT MYERS, Fla., Oct. 20, 2023 /PRNewswire/ -- Research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is featured this week among the latest advancements and findings in cancer care at the European Society of Medical Oncology (ESMO) Congress in Madrid, Spain.
  • With more than 30,000 members from 168 countries worldwide, ESMO is the leading professional organization for medical oncology.
  • The ESMO Congress 2023 is a global stage for the exchange of potentially practice-changing data and multidisciplinary conversations that will spur transformative therapies against cancer.
  • All of the study abstracts will be published online in the ESMO Congress 2023 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

European Organisation for Research and Treatment of Cancer & the Menarini Group Launch New Clinical Trial in Early-Stage Breast Cancer

Retrieved on: 
Thursday, October 19, 2023

A molecular residual disease (MRD) test for the detection of circulating tumour DNA (ctDNA) will also be used.

Key Points: 
  • A molecular residual disease (MRD) test for the detection of circulating tumour DNA (ctDNA) will also be used.
  • The study was submitted under the new Clinical Trial Regulation, and it is expected to start the activation process in the fourth quarter of 2023.
  • "We are excited to offer to our high-risk, ctDNA positive, ER+/HER2- early-stage breast cancer patients the possibility to participate in the Treat ctDNA trial.
  • This intergroup trial, managed by the EORTC Breast Cancer Group, will be jointly conducted with several national and international cancer clinical research groups, including the German SUCCESS group under the umbrella of BIG (Breast International Group).

Olema Oncology Announces Phase 2 Monotherapy Clinical Results to be Presented at the 2023 ESMO Congress

Retrieved on: 
Monday, October 16, 2023

SAN FRANCISCO, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced an oral presentation on the Phase 2 monotherapy study results of palazestrant (OP-1250), the Company’s complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) for the treatment of metastatic breast cancer, at the upcoming European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023.

Key Points: 
  • Oral presentation by Dr. Nancy U. Lin from Dana-Farber Cancer Institute at 8:55 a.m. CEST/2:55 a.m.
  • ET on October 22, 2023
    Olema will host an investor conference call at 8:00 a.m.
  • ET on October 23, 2023
    SAN FRANCISCO, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced an oral presentation on the Phase 2 monotherapy study results of palazestrant (OP-1250), the Company’s complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) for the treatment of metastatic breast cancer, at the upcoming European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 22, 2023.
  • Details of the ESMO Congress 2023 mini oral session presentation are:
    Updated results from the phase 1/2 study of OP-1250, an oral complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD) in patients with advanced or metastatic ER-positive, HER2-negative breast cancer.

TellBio Announces Consecutive Manuscripts Showcasing Promising Translational and Clinical Applications of the TellDx Platform in Prostate Cancer and Tailoring Therapy in Advanced Breast Cancer

Retrieved on: 
Thursday, July 6, 2023

BEVERLY, Mass., July 06, 2023 (GLOBE NEWSWIRE) -- TellBio, Inc., a development stage biotechnology company focused on revolutionizing detection of cancer through its unique and proprietary circulating tumor cell (CTC) technology, the TellDx System, announces two publications that demonstrate the utility of CTC molecular analyses in patients with prostate cancer or advanced breast cancer. The papers entitled, “DNA hypomethylation silences anti-tumor immune genes in early prostate cancer and circulating tumor cells,” and “Modeling the novel SERD elacestrant in cultured fulvestrant-refractory HR-positive breast circulating tumor cells” were published in Cell (DOI: 10.1016/j.cell.2023.05.028) and Breast Cancer Research and Treatment (DOI: 10.1007/s10549-023-06998-w), respectively. 

Key Points: 
  • “These publications continue to highlight the potential utility of the TellDx technology in a spectrum of clinical settings ranging from early localized disease to advanced metastatic disease.
  • Prostate cancer generally evolves slowly from an indolent low-grade localized condition to poorly differentiated tumor with high likelihood of aggressive metastatic CTCs associated with poor prognosis.
  • Among patients with localized prostate cancer, less than 15% of the cancers are detectable with short circulating tumor DNA hypermethylation assays.
  • Age-matched healthy donors showed minimal signal whereas patients with localized prostate cancer or metastatic prostate cancer revealed a significant DNA hypomethylation signal.

Olema Oncology Announces OP-1250 Continues to Demonstrate Attractive Combinability with CDK4/6 Inhibitor Palbociclib in Phase 1b/2 Study

Retrieved on: 
Thursday, May 11, 2023

No dose-related increases in the incidence, severity, or timing of adverse events were observed, and neutropenia events observed were consistent with the expected profile of palbociclib plus endocrine therapy.

Key Points: 
  • No dose-related increases in the incidence, severity, or timing of adverse events were observed, and neutropenia events observed were consistent with the expected profile of palbociclib plus endocrine therapy.
  • Tumor responses and prolonged disease stabilization were observed in this group of patients, including in those previously exposed to palbociclib and other CDK4/6 inhibitors.
  • “We are very pleased with our emerging combination clinical results of OP-1250 with palbociclib,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology.
  • In a maturing dataset, anti-tumor activity and prolonged disease stabilization was demonstrated in patients previously treated with CDK4/6 inhibitors, including palbociclib.