WT1

SELLAS Provides Corporate Updates and Highlights Key Upcoming Milestones

Retrieved on: 
Wednesday, January 3, 2024

NEW YORK, Jan. 03, 2024 (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 provided a business update and will host a corporate webinar at 8:30 am ET.

Key Points: 
  • “2023 was a very productive year for SELLAS,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • Dr. Stergiou continued: “We hope to build on this excellent progress and look forward to multiple clinical milestones that have the potential to create significant value for our shareholders.
  • Meaningful cell killing activity, defined as ≥50% reduction in blasts in the bone marrow, was observed at several dose levels.
  • This study is fully funded by the Company’s partner for SLS009, GenFleet Therapeutics (Shanghai), Inc. and is being conducted in China.

SELLAS Life Sciences Reports Positive Follow-Up Immune Response and Survival Data in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma

Retrieved on: 
Wednesday, December 27, 2023

NEW YORK, Dec. 27, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, today announced follow-up clinical/immune-response data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo®) in patients with refractory/relapsed malignant pleural mesothelioma (MPM).

Key Points: 
  • Nine out of ten patients (90%) had sufficient samples collected to be analyzed for GPS-specific immune response.
  • All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy.
  • Additional analyses for the correlation of immune response and survival benefit were performed.
  • Among the nine evaluable patients, four patients had a CD4+ immune response (44.4%) and three patients had a CD8+ immune response (33.3%) to GPS.

Biocytogen and CtM Bio Achieve Milestone Progress in Co-Developing a TCR-mimic Antibody-based Multi-Specific T Cell Engager Targeting WT1/HLA-A02

Retrieved on: 
Wednesday, December 27, 2023

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) and CtM Biotech (Shanghai) Co., Ltd ("CtM Bio") today jointly announce that the development of a tri-specific T cell engager for an intracellular target achieved milestone progress.

Key Points: 
  • Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) and CtM Biotech (Shanghai) Co., Ltd ("CtM Bio") today jointly announce that the development of a tri-specific T cell engager for an intracellular target achieved milestone progress.
  • The incorporation of the T co-stimulatory signal for WT1-targeting T cell engager further gives it the best-in-class properties and first-in-class potential.
  • Dr. Yuelei Shen, President and CEO of Biocytogen, said, “Our collaborative efforts with CtM Bio have progressed rapidly, resulting in the identification of novel immunotherapies targeting WT1.
  • This rapid and effective development of multi-specific T cell engagers undoubtedly validates CtM Bio’s advanced T-cell engager technology, along with our expertise in discovering fully human TCR-mimic antibodies against intracellular targets.

SELLAS Life Sciences Receives Favorable FDA Type C Meeting Feedback on Chemistry, Manufacturing, and Controls (CMC) Biologics License Application (BLA) Filing Strategy for Galinpepimut-S (GPS)

Retrieved on: 
Monday, November 13, 2023

NEW YORK, Nov. 13, 2023 (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 that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (“BLA”) for SELLAS’ lead product candidate, galinpepimut-S (GPS). SELLAS submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans. The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance.

Key Points: 
  • SELLAS submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans.
  • The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance.
  • GPS is expected to be stored at 2-8 C (36 – 46 F) making it more accessible for end-users.
  • GPS has the potential to offer clinical benefit to this population of leukemia patients and the positive CMC regulatory feedback is a critical step in its development.”

Cue Biopharma Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, November 9, 2023

BOSTON, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, provided a business and financial update for the third quarter of 2023.

Key Points: 
  • BOSTON, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, provided a business and financial update for the third quarter of 2023.
  • Presented positive data from ongoing Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer’s 38th Anniversary Annual Meeting (SITC 2023) held November 1-5.
  • Completed enrollment of 20 patients for the ongoing Phase 1b study of CUE-101 in combination with pembrolizumab.
  • The Company reported collaboration revenue of approximately $3.7 million and $1.1 million for the nine months ended September 30, 2023 and 2022, respectively.

SELLAS Life Sciences Presents Positive Key Immunobiological and Clinical Data from Phase 1/2 Trial of Galinpepimut-S (GPS) in Combination with Keytruda® in WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 202

Retrieved on: 
Monday, November 6, 2023

GPS is an HLA-unrestricted heteroclitic immunotherapy against WT1, an antigen highly expressed in more than 85% of patients with ovarian cancer.

Key Points: 
  • GPS is an HLA-unrestricted heteroclitic immunotherapy against WT1, an antigen highly expressed in more than 85% of patients with ovarian cancer.
  • This Phase 1/2 trial was an open-label, multicenter, multi-arm basket study examining the effects of the combination of GPS and pembrolizumab in patients with measurable advanced selected cancers.
  • In the ovarian cancer arm of the study, the effect of the combination was investigated in patients with measurable WT1+ platinum-resistant ovarian cancer relapsed after or refractory to 1st/2nd -or later- line of therapy.
  • Today’s presentation reported clinical efficacy and safety results as well as demographic and disease parameter data in a total of 16 evaluable patients.

Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and CUE-102 in Wilms’ Tumor 1 Positive Cancers at SITC 2023

Retrieved on: 
Friday, November 3, 2023

New clinical data will also be reported from the company’s ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) recurrent/metastatic cancers.

Key Points: 
  • New clinical data will also be reported from the company’s ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) recurrent/metastatic cancers.
  • I look forward to evaluating the trial results as they continue to mature and remain highly encouraged by the observations to date.
  • Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reduction in tumor burden.
  • Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study.

Cue Biopharma to Host Business Update Call and Webcast

Retrieved on: 
Thursday, November 2, 2023

BOSTON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, announced today that it will host a conference call and webcast to provide a business and clinical update on Thursday, November 9, 2023 at 4:30 p.m.

Key Points: 
  • BOSTON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of T cell engagers to selectively modulate tumor-specific T cells, announced today that it will host a conference call and webcast to provide a business and clinical update on Thursday, November 9, 2023 at 4:30 p.m.
  • ET.
  • Live and archived versions of the event can be accessed via the Company’s website .
  • Additional clinical, pipeline and business updates will also be addressed.

SELLAS Life Sciences to Present Final Data from Phase 1/2 Study of Galinpepimut-S in Combination with Keytruda® (pembrolizumab) in Patients with WT1+ Platinum-Resistant Advanced Ovarian Cancer at the International Gynecologic Cancer Society 2023 Annual Gl

Retrieved on: 
Tuesday, October 17, 2023

Based on data in this e-Poster presentation, SELLAS is planning the submission of a full-length manuscript to a peer-reviewed journal during the first half of 2024.

Key Points: 
  • Based on data in this e-Poster presentation, SELLAS is planning the submission of a full-length manuscript to a peer-reviewed journal during the first half of 2024.
  • Abstract Publication and Poster presentation details:
    Title: Phase 1/2 study of galinpepimut-S plus pembrolizumab combination in patients with WT1+ platinum-resistant ovarian cancer in 2nd/3rd line of therapy.
  • Galinpepimut-S (GPS) is an HLA-unrestricted heteroclitic peptide vaccine against WT1, an antigen highly expressed in ovarian cancer.
  • GPS has previously shown promising activity as maintenance therapy in combination with checkpoint blockade in patients with advanced ovarian cancer in 2nd/3rd remission.

SELLAS Life Sciences Provides Business Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023

NEW YORK, Aug. 10, 2023 (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 provided a business update and reported its financial results for the quarter ended June 30, 2023.

Key Points: 
  • NEW YORK, Aug. 10, 2023 (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 provided a business update and reported its financial results for the quarter ended June 30, 2023.
  • The next routine IDMC meeting is scheduled for the third quarter of 2023.
  • SELLAS expects to receive milestone payments totaling $13.0 million from 3D Medicines by the end of the third quarter of 2023.
  • Financial Results for the Second Quarter 2023:
    R&D Expenses: Research and development expenses for the second quarter of 2023 were $5.9 million, compared to $5.5 million for the same period in 2022.