Pembrolizumab

Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024

Retrieved on: 
Tuesday, April 9, 2024

Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.

Key Points: 
  • Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.
  • SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) -- Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce poster presentations featuring its CF33 oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx at the American Association for Cancer Research (AACR) Annual Meeting 5-10 April 2024, in San Diego, CA.
  • HER-Vaxx induced HER2-specific antibodies able to mediate antibody-dependent cell cytotoxicity (ADCC) and inhibit intracellular HER2 phosphorylation and correlated with tumour reduction.
  • The HER-Vaxx induced HER2-specific antibodies demonstrate a similar mechanism of action to HERCEPTINâ validating B cell immunotherapy as an alternative anti-cancer agent to monoclonal antibodies.

RAPT Therapeutics Announces Promising Results from Phase 2 Trial of Tivumecirnon in Combination with Anti-PD-1 Immunotherapy in CPI-Experienced Head and Neck Cancer Patients

Retrieved on: 
Tuesday, April 9, 2024

SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) --  RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced safety and efficacy data from its ongoing Phase 2 trial of tivumecirnon in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab in the cohort of patients with advanced head and neck squamous cell carcinoma (HNSCC) whose disease progressed despite previous treatment with CPI therapy (CPI-experienced). The results were presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.

Key Points: 
  • The results were presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA.
  • The AACR poster highlighted data from the 32-patient CPI-experienced HNSCC cohort in the trial evaluating tivumecirnon, an oral small molecule CCR4 antagonist designed to block the migration of regulatory T cells, in combination with pembrolizumab.
  • Patients in this cohort had heavily pretreated disease, with 69% of patients having received three or more (up to six) prior lines of treatment.
  • In the entire cohort, confirmed responses were observed in 5/32 patients (15.6%) regardless of PD-L1 or HPV status.

NuCana Presents Data at the AACR 2024 Annual Meeting Highlighting the Ability of NUC-7738 to Profoundly Alter Tumor Biology in a Paired Biopsy Clinical Study

Retrieved on: 
Tuesday, April 9, 2024

SAN DIEGO, April 09, 2024 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced two posters being presented today at the American Association of Cancer Research (AACR) Annual Meeting.

Key Points: 
  • The tumor microenvironment (TME) is a complex interplay of various cell types, extracellular matrix, signalling molecules and physical factors that collectively influence tumor growth.
  • Lipids play an important role in the TME, contributing to various aspects of cancer progression and therapy resistance.
  • They also further explain the compelling clinical data we have generated with NUC-7738 as a monotherapy and in combination with pembrolizumab.
  • Our translational data help us to understand these clinical observations and guide the optimal development pathway for NUC-7738.

Kineta Reports Initial Clinical Response Data at AACR 2024 of its Ongoing Phase 1/2 VISTA-101 Clinical Trial

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Monday, April 8, 2024

SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today at the American Association for Cancer Research (AACR) in San Diego, CA an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123, an anti-VISTA monoclonal antibody, as monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors.

Key Points: 
  • KVA12123 cleared the fifth of six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab.
  • KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level.
  • Patients currently enrolled in the trial will be permitted to continue to participate.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights

Retrieved on: 
Monday, April 8, 2024

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.

Key Points: 
  • BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.
  • The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.
  • As of December 31, 2023, the Company had approximately $48.5 million in cash, cash equivalents and marketable securities compared with $76.3 million as of December 31, 2022.
  • We expect our current cash, cash equivalents, and marketable securities to fund operations into the first quarter of 2025.

Lipella Pharmaceuticals to Publish Abstract Detailing Compelling Preclinical Support for New Product Candidate at ASCO 2024

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Friday, April 5, 2024

Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .

Key Points: 
  • Lipella’s abstract, “Intravesical local administration of pembrolizumab for treatment of bladder cancer: A novel strategy to minimize toxicity” will be published at www.asco.org/abstracts .
  • Dr. Jonathan Kaufman, Chief Executive Officer of Lipella, said, “ASCO’s 2024 meeting is the ideal venue for dissemination of our recent progress in the treatment of bladder cancer.
  • Lipella’s new product candidate, LP-50 (intravesical pembrolizumab), is intended to be indicated for non-muscle invasive bladder cancer (NMIBC).
  • Dr. Michael Chancellor, Lipella’s Chief Medical Officer, emphasized the significance of this milestone for advancing the company’s LP-50 program.

eFFECTOR Therapeutics Announces Topline Results of Phase 2 KICKSTART Trial of Tomivosertib Combined with Pembrolizumab in Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, April 4, 2024

The two-sided p value for PFS, based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.

Key Points: 
  • The two-sided p value for PFS, based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.
  • The median PFS was 13.0 weeks in the tomivosertib plus pembrolizumab arm and 11.7 weeks in the placebo plus pembrolizumab arm, respectively.
  • There were 67% Grade 3 or higher treatment emergent adverse events in the tomivosertib plus pembrolizumab arm versus 37% in the placebo plus pembrolizumab arm.
  • “We sincerely appreciate the contributions of all the patients, their families, and trial site professionals who contributed to the execution of the trial.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 29, 2024

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Mural Oncology Announces Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024

WALTHAM, Mass. and DUBLIN, Ireland, March 26, 2024 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update.

Key Points: 
  • “We have made significant progress since becoming an independent company during the fourth quarter of 2023.
  • Financial Results for the Quarter Ended December 31, 2023
    Cash Position: As of December 31, 2023, cash and cash equivalents were $270.9 million.
  • G&A Expenses: General and administrative expenses were $16.3 million for the fourth quarter of 2023, including $9.7 million in non-cash, share-based compensation expenses.
  • Furthermore, the company’s 2023 financial results reflect carve-out financials until the date of the spin out.