Gynecologic Oncology (journal)

Memorial Sloan Kettering Cancer Center Now Enrolling Patients in Phase 1/2 Clinical Trial of IMUNON’s IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer

Retrieved on: 
Tuesday, February 27, 2024

LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer. IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.

Key Points: 
  • LAWRENCEVILLE, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2 clinical trial evaluating IMUNON’s IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer.
  • IMNN-001 is a DNA-based interleukin-12 (IL-12) immunotherapy currently in the Phase 2 OVATION 2 Study for the localized treatment of advanced ovarian cancer.
  • We believe this combination therapy holds promise based on our preclinical animal studies, which showed strong synergies between IMNN-001 and bevacizumab.
  • Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab vs. chemotherapy plus bevacizumab and IMNN-001.

Zai Lab to Present Final Overall Survival (OS) Data from Phase 3 NORA Study of ZEJULA (niraparib) in Platinum-Sensitive Recurrent Ovarian Cancer (PSROC)

Retrieved on: 
Wednesday, March 6, 2024

“Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.

Key Points: 
  • “Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.
  • “We look forward to sharing the final OS findings from this study at both the 2024 ESGO and SGO conferences.
  • The final OS analysis was conducted after ≥ 50% of OS events occurred in the intent-to-treat population.
  • No new safety signals were identified during the long-term follow up period subsequent to the primary analysis.

FDA Grants Priority Review to Merck's Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Primary Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Tuesday, February 20, 2024

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.
  • The sBLA is based on data from the Phase 3 NRG-GY018 trial.
  • Health authorities in Israel, Canada, Australia, Singapore and Brazil will review this application as part of Project Orbis.
  • In endometrial cancer, Merck is evaluating KEYTRUDA in the first-line setting for advanced or recurrent disease that is dMMR (KEYNOTE-C93/ENGOT-en15/GOG-3064) and in the adjuvant setting (KEYNOTE-B21/ENGOT-en11/GOG-3053).

The Inner Circle acknowledges Nana E. Tchabo, MD, FACOG as a Pinnacle Life Member

Retrieved on: 
Thursday, March 7, 2024

CHESTER, N.J., March 7, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Nana E. Tchabo, MD, FACOG, is acknowledged as a Pinnacle Life Member for her contributions to the field of Gynecologic Oncology.

Key Points: 
  • CHESTER, N.J., March 7, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Nana E. Tchabo, MD, FACOG, is acknowledged as a Pinnacle Life Member for her contributions to the field of Gynecologic Oncology.
  • Dr. Tchabo pursued higher education at Brown University where she received a Bachelor of Science in Neuroscience and a minor in Women's Studies.
  • She then attended the Warren Alpert Brown University School of Medicine, where she was cited for academic excellence.
  • Dr. Tchabo currently works at Atlantic Women's Cancer Associates, a part of Atlantic Health System Morristown and Overlook Medical Centers.

Theratechnologies Completes Enrollment of First Six Patients in Updated Phase 1 Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer

Retrieved on: 
Thursday, February 15, 2024

Theratechnologies announced dosing of the first patient in Part 3 of the Phase 1 trial in October 2023. In June 2023, the U.S. Food and Drug Administration (FDA) accepted the Company’s amended protocol for the Phase 1 trial, which is designed to optimize the dosing, improve the therapeutic window and extend the duration of therapy of sudocetaxel zendusortide. The amendment, which the Company submitted in May 2023, also narrows the patient population to focus on individuals with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer -- a population in which sudocetaxel zendusortide has demonstrated preliminary efficacy. After establishing the safety of the initial dose in the first six patients for a period of three months, the enrollment of the next cohort of six patients at a higher dose will be initiated.

Key Points: 
  • MONTREAL, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced completion of enrollment of the first six participants in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer.
  • Sudocetaxel zendusortide, also known as TH1902, is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin receptor (SORT1) and aims to expedite the internalization and delivery of the cytotoxic payload (docetaxel) directly into cancer cells.
  • “Reaching this important milestone gives fresh momentum to the Phase 1 trial of sudocetaxel zendusortide, and to our overall oncology clinical development program,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies.
  • Details about the study design, participation criteria and contact information for the sites can be found at: https://clinicaltrials.gov/study/NCT04706962 .

NRMP® Specialties Matching Service® Matched Nearly 12,000 Applicants into Fellowship Programs for the 2024 Appointment Year

Retrieved on: 
Tuesday, February 13, 2024

WASHINGTON, Feb. 13, 2024 /PRNewswire/ -- The National Resident Matching Program® (NRMP®) has released a new data report, the Results and Data Specialties Matching Service®, 2024 Appointment Year, for Fellowship Matches in the Specialties Matching Service® (SMS®). The report shows that 14,034 active applicants submitted a rank order list of programs, competing for 14,169 fellowship positions in 6,116 programs. Of those applicants, 11,853 were matched to a fellowship position, an increase of 305 active applicants from the 2023 appointment year.  

Key Points: 
  • The report shows that 14,034 active applicants submitted a rank order list of programs, competing for 14,169 fellowship positions in 6,116 programs.
  • Of those applicants, 11,853 were matched to a fellowship position, an increase of 305 active applicants from the 2023 appointment year.
  • The number of applicants matched for the 2024 appointment year increased for all applicant types compared to 2023.
  • The number of U.S. MD graduates matched was 6,667, an increase of 110 applicants from the 2023 appointment year.

New Study Validates Signatera™ in Endometrial Cancer

Retrieved on: 
Monday, February 5, 2024

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Gynecologic Oncology validating its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in endometrial cancer.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in Gynecologic Oncology validating its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in endometrial cancer.
  • The full study can be found here .
  • Endometrial cancer (EC) is the most common gynecologic malignancy in the United States.
  • “This study provides clinical validation of Signatera as a powerful post-surgical biomarker of recurrence risk for patients with endometrial cancer,” said Minetta Liu, MD, chief medical officer of oncology at Natera.

First Patient Dosed with LIXTE’s LB-100 and GSK’s Immunotherapy Dostarlimab-gxly in Ovarian Clear Cell Carcinoma Trial

Retrieved on: 
Monday, January 29, 2024

The clinical trial was initiated by and is being conducted at The University of Texas MD Anderson Cancer Center.

Key Points: 
  • The clinical trial was initiated by and is being conducted at The University of Texas MD Anderson Cancer Center.
  • LIXTE is providing LB-100; GSK is providing dostarlimab-gxly and financial support for the clinical trial.
  • The clinical trial (NCT06065462) is based on the observation by the lead clinical investigator of the trial, Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, that a genetically acquired reduction in PP2A may enhance sensitivity to immunotherapyi.
  • This raises the possibility that reducing PP2A pharmacologically with LB-100 may enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody, dostarlimab-gxly, in patients with OCCC lacking the genetic reduction in PP2A.

Sutro Biopharma Highlights Potential Multi-Cancer Opportunity for Luvelta, a FolRα-targeting ADC

Retrieved on: 
Thursday, January 4, 2024

SOUTH SAN FRANCISCO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), is hosting an investor webcast today highlighting the significant potential of luveltamab tazevibulin (luvelta), a novel folate receptor-α (FolRα) targeting ADC. The presentation will include an overview of the clinical data supporting luvelta’s broad opportunity to address the unmet need in several FolRα-expressing cancers, including platinum-resistant ovarian cancer (PROC), endometrial cancer, CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), and non-small cell lung cancer (NSCLC).

Key Points: 
  • “Luvelta has been studied in over 180 patients to-date, and has demonstrated both promising clinical activity and a tolerable safety profile.
  • We are optimistic about its potential to change the cancer treatment landscape,” said Bill Newell, Sutro’s Chief Executive Officer.
  • “This includes the potential to be the first ADC to treat ovarian cancer patients with low to medium FolRα expression, which could double the current eligible patient population relative to the FolRα-targeting ADC on the market.
  • Sutro management and Dr. Monk will participate in a Q&A session at the end of the presentation.

HCW Biologics Reports Third Quarter 2023 Financial Results And Recent Business Highlights

Retrieved on: 
Tuesday, November 14, 2023

MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.

Key Points: 
  • MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.
  • We are pleased to see the consistency of results in humans with those that we saw in our preclinical animal studies.
  • Third Quarter 2023 Financial Results:
    Revenues: Revenues for the quarter ended September 30, 2022 and 2023 were $1.8 million and $853,102, respectively.
  • Revenues for the nine months ended September 30, 2022 and 2023 were $5.4 million and $1.5 million, respectively.