Clinical Ovarian Cancer & Other Gynecologic Malignancies

SELLAS Announces Confirmatory Top-Line Data Showing Survival and Clinical Benefits Based on the Final Analysis of the Phase 1/2 Clinical Trial of Galinpepimut-S in Combination with Keytruda® (pembrolizumab) in Patients with WT1+ Platinum-Resistant Advanc

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Thursday, November 10, 2022
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NEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced confirmatory top-line clinical data from the final analysis of results from its Phase 1/2 clinical trial of galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with Merck’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients diagnosed with WT1(+) relapsed or refractory platinum-resistant advanced metastatic ovarian cancer.

Key Points: 
  • Of the 17 patients, 16 received at least three doses of GPS and had follow-up cross-sectional imaging (CT/MRI) to determine tumor status.
  • Importantly, survival and disease control benefits were observed in patients harboring tumors with any level of detectable PD-L1 expression, i.e., those with Combined Positive Score (CPS) of one or higher.
  • The DCR is 63.6 percent in patients with a CPS of one or higher in this study.
  • These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties.

Nurix Therapeutics Reports Third Quarter Fiscal 2022 Financial Results and Provides a Corporate Update

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Thursday, October 6, 2022
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SAN FRANCISCO, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today reported financial results for the third quarter ended August 31, 2022 and provided a corporate update.

Key Points: 
  • In September, Nurix announced the appointment of leading industry strategist Edward C. Saltzman to its board of directors.
  • Nurix anticipates presenting additional clinical results from the Phase 1a portion of the trial by the end of 2022.
  • Nurix anticipates providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study by the end of 2022.
  • In the three months ended August 31, 2022, Nurix achieved a research milestone under its collaboration with Gilead and anticipates a payment of $2.5 million in the fourth fiscal quarter of 2022.

Xencor to Present Seven Posters on Multiple Clinical Trials and Research-stage Programs at the SITC Annual Meeting

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Wednesday, October 5, 2022
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In the poster hall, odd numbered posters will be displayed on Thursday, November 10, and even numbered posters will be displayed on Friday, November 11.

Key Points: 
  • In the poster hall, odd numbered posters will be displayed on Thursday, November 10, and even numbered posters will be displayed on Friday, November 11.
  • Posters will be archived under "Events & Presentations" in the Investors section of the Company's website located at www.xencor.com .
  • Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases.
  • More than 20 candidates engineered with Xencor's XmAb technology are in clinical development, and three XmAb medicines are marketed by partners.

Mersana Therapeutics Announces Launch of Oncology FACETS, a Resource for Healthcare Providers to Advance Knowledge in Gynecologic Malignancies

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Friday, September 30, 2022
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CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company, today announced the launch of Oncology FACETS: an educational platform for healthcare providers that will address clinically impactful topics in gynecologic oncology.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company, today announced the launch of Oncology FACETS: an educational platform for healthcare providers that will address clinically impactful topics in gynecologic oncology.
  • Oncology FACETS is driven by a Steering Committee of experts in gynecologic oncology and offers content developed in collaboration with Mersana.
  • We believe Oncology FACETS will provide a valuable resource for physicians seeking to keep pace with this fields rapidly evolving science and data.
  • Biomarkers are central to this movement, and their use in gynecologic malignancies promises to shape the treatment paradigm in the near future.

Gradalis to Host Key Opinion Leader Webinar on Unmet Medical Needs in Ovarian Cancer and the Company’s Immuno-Oncology Treatment, Vigil®

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Wednesday, September 28, 2022
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DALLAS, Sept. 28, 2022 (GLOBE NEWSWIRE) -- Gradalis, a privately-held, late-stage biotechnology company developing immunotherapies for ovarian and other cancers, today announced that it will host a key opinion leader (KOL) webinar on the current treatment landscape for ovarian cancer and Vigil®, the company’s fully personalized, patient-specific cancer immunotherapy, on Monday, October 3, 2022 at 1:00 p.m. ET.

Key Points: 
  • Gradalis Chief Scientific Officer John Nemunaitis, M.D., will review results from VITAL, a Phase 2b clinical trial evaluating Vigil as maintenance therapy for ovarian cancer patients and the clinical development path forward.
  • Gradalis is preparing to initiate a Phase 3 trial designed for product registration of Vigil in patients with ovarian cancer.
  • His research interests include genetic/molecular determinants of racial healthcare disparities in gynecologic malignancies as well as understanding the molecular mechanisms of chemoresistance in ovarian cancer.
  • The company is preparing to initiate a clinical trial intended for product registration in patients with the HRP subtype ovarian cancer.

Genelux Corporation Initiates a Pivotal Phase 3 Trial, Evaluating Olvi-Vec for the treatment of Platinum-Resistant/Refractory Ovarian Cancer

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Wednesday, September 21, 2022
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Initiating the OnPrime trial represents a major milestone for Genelux, saidThomas D. Zindrick, President and CEO, Genelux.

Key Points: 
  • Initiating the OnPrime trial represents a major milestone for Genelux, saidThomas D. Zindrick, President and CEO, Genelux.
  • Our goal in Phase 3 is to replicate these positive results and transform the treatment paradigm for this particularly difficult-to-treat cancer.
  • We look forward to progressing our study and sharing updates on the Olvi-Vec clinical development program.
  • Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer.

VBL Therapeutics Announces Top-Line Data from Phase 3 OVAL Trial of Ofra-Vec in Patients with Platinum-Resistant Ovarian Cancer

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Tuesday, July 19, 2022
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The trial did not meet the primary endpoints of achieving a statistically significant improvement in progression-free survival (PFS) or overall survival (OS).

Key Points: 
  • The trial did not meet the primary endpoints of achieving a statistically significant improvement in progression-free survival (PFS) or overall survival (OS).
  • Based on this outcome, we plan to discontinue the OVAL trial and will review the data from our ongoing Phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme to determine next steps with the ofra-vec program.
  • We extend our deepest gratitude to all the patients, families and healthcare professionals who participated in this trial.
  • OVAL (VB-111-701/GOG-3018) was an international, Phase 3, randomized, double-blind, placebo-controlled, clinical trial comparing a combination of ofra-vec (ofranergene obadenovec; VB-111) plus paclitaxel to placebo plus paclitaxel in 409 adult patients with recurrent platinum-resistant ovarian cancer.

Nurix Therapeutics Reports Fiscal Second Quarter 2022 Financial Results and Provides a Corporate Update

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Thursday, July 7, 2022
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An archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website.

Key Points: 
  • An archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website.
  • Nurix anticipates presenting additional clinical results from the Phase 1a portion of the trial in the second half of 2022.
  • Nurix anticipates providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study in the second half of 2022.
  • In the three months ended May 31, 2022, Nurix achieved a research milestone under its collaboration with Gilead and anticipates a payment of $1.5million in the third fiscal quarter of 2022.

SELLAS Reports Preliminary Data Showing Clinical Benefit from Phase 1/2 Clinical Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in Patients with WT1+ Advanced Ovarian Cancer

Retrieved on: 
Thursday, May 26, 2022
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NEW YORK, May 26, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced top-line clinical data from its Phase 1/2 trial of galinpepimut-S (GPS), the Company’s Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients diagnosed with WT1(+) relapsed or refractory platinum resistant advanced metastatic ovarian cancer.

Key Points: 
  • Of the 15 patients, 13 received at least three doses of GPS, the last of which was in combination with pembrolizumab, and were evaluable for response outcomes.
  • The overall response rate (ORR) of the trial is (7.7 percent), similar to the response to checkpoint inhibitors.
  • Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States.
  • These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties.

VBL Therapeutics Receives FDA Fast Track Designation for Ofra-Vec for the Treatment of Platinum-Resistant Ovarian Cancer

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Tuesday, April 26, 2022
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We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer.

Key Points: 
  • We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer.
  • The lead clinical program for ofra-vec is the OVAL Phase 3 registration-enabling trial in recurrent platinum-resistant ovarian cancer patients.
  • Ofra-vec has received orphan designations for the treatment of ovarian cancer and for the treatment of glioma by the European Commission.
  • The FDA granted ofra-vec orphan designation for the treatment of malignant glioma and fast track designation for the treatment of rGBM and the treatment of platinum-resistant ovarian cancer.