HNSCC

Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

HOOKIPA Pharma Provides Update on Business Priorities and Oncology Partnership Programs

Retrieved on: 
Monday, January 29, 2024

The totality of the HB-200 data presents a clear opportunity for HOOKIPA to advance this program in a randomized trial starting in mid-2024.

Key Points: 
  • The totality of the HB-200 data presents a clear opportunity for HOOKIPA to advance this program in a randomized trial starting in mid-2024.
  • “HOOKIPA has a tremendous opportunity to transform treatment of multiple disease areas using an entirely new class of medicines,” said Joern Aldag, Chief Executive Officer at HOOKIPA.
  • HOOKIPA will reduce its workforce by approximately 30 percent and rebalance its cost structure in alignment with the new prioritization of the Company’s programs.
  • The strategic priorities for HOOKIPA are to advance its clinical programs including HB-200 and its two Gilead-partnered infectious disease programs.

AVEO Oncology Enrolls First Patient in Pivotal FIERCE-HN Clinical Trial to Evaluate Ficlatuzumab in Combination with ERBITUX® (cetuximab) in Patients with HPV-negative Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Retrieved on: 
Tuesday, January 16, 2024

BOSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) -- AVEO Oncology (“AVEO”), an LG Chem company, today announced enrollment of the first patient in the FIERCE-HN trial, a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Key Points: 
  • BOSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) -- AVEO Oncology (“AVEO”), an LG Chem company, today announced enrollment of the first patient in the FIERCE-HN trial, a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
  • Ficlatuzumab is AVEO’s investigational antibody that targets hepatocyte growth factor (HGF).
  • That designation followed AVEO’s June 2021 announcement of positive results from a randomized phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory, metastatic HNSCC.
  • “We therefore approach the FIERCE-HN trial with a mix of urgency and optimism, as the combination of ficlatuzumab and cetuximab has the potential to expand the range of viable therapeutic options for this underserved population.”

iTeos Announces 2024 Strategic Priorities and Anticipated Milestones

Retrieved on: 
Monday, January 8, 2024

WATERTOWN, Mass. and GOSSELIES, Belgium, Jan. 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today outlined business updates and strategic priorities for 2024.

Key Points: 
  • and GOSSELIES, Belgium, Jan. 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today outlined business updates and strategic priorities for 2024.
  • “Over the past twelve months, the TIGIT competitive landscape has substantially evolved, further positioning iTeos and GSK as a potential leader with our high-quality TIGIT:PD-1 doublet, belrestotug + dostarlimab.
  • The Company plans to integrate IO-001 biomarker knowledge into the development strategy of future inupadenant clinical trials.
  • The Company continues to expect its cash balance to provide runway through 2026, which includes the initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.

Ascendis Pharma Introduces Vision 2030

Retrieved on: 
Sunday, January 7, 2024

COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030.
  • Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.
  • Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
  • The Company’s slides from the J.P. Morgan presentation will be available on the same Investor Relations website at https://investors.ascendispharma.com .

Merus Presents Interim Data on MCLA-129 at ESMO Asia Congress 2023

Retrieved on: 
Sunday, December 3, 2023

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 02, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced updated interim clinical data on MCLA-129 from ongoing expansion cohorts in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) were presented at the European Society for Medical Oncology (ESMO) Asia Congress 2023.

Key Points: 
  • UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 02, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced updated interim clinical data on MCLA-129 from ongoing expansion cohorts in non-small cell lung cancer (NSCLC) and in previously treated head and neck squamous cell carcinoma (HNSCC) were presented at the European Society for Medical Oncology (ESMO) Asia Congress 2023.
  • “MCLA-129 is a very active drug in EGFRm NSCLC and we’re planning a focused investment to evaluate MCLA-129 in combination with chemotherapy, which we expect to start early in 2024,” said Bill Lundberg M.D., President, Chief Executive Officer of Merus.
  • “We are in a fortunate position to have a strong balance sheet.
  • per investigator assessment
    The full presentations are available on the Publications page of our website.

KSQ Therapeutics Announces FDA Clearance of IND Application for KSQ-001EX, a CRISPR/Cas9 Engineered Tumor Infiltrating Lymphocyte (eTIL®) Therapy

Retrieved on: 
Wednesday, November 29, 2023

KSQ-001EX consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing.

Key Points: 
  • KSQ-001EX consists of TILs in which the SOCS1 gene is inactivated by CRISPR/Cas9 gene editing.
  • Through our platform insights, we've identified how to enhance the effectiveness of T cells in the treatment of solid tumors.
  • We believe our eTIL® cell therapies have tremendous potential to benefit patients with cancer who have limited treatment options.
  • “Our partnership with CTMC has yielded a robust manufacturing process for our eTIL® cell therapy that is derived from patient tumor samples, including core biopsies.

Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib (AN2025) in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

Retrieved on: 
Friday, November 17, 2023

This clinical study evaluates buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Key Points: 
  • This clinical study evaluates buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
  • This represents the first global multicenter phase III trial for HNSCC in the class of PI3K inhibitors.
  • "There is a high unmet medical need for patients with recurrent or metastatic HNSCC after anti-PD-1/anti-PD-L1 therapy.
  • As the trial is now fully enrolled, we eagerly look forward to the results which may change the paradigm of second-line treatment for HNSCC and provide a new treatment option for patients worldwide," said Lars Birgerson, President and Chief Medical Officer of Adlai Nortye Ltd.

Vaccinex Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023

ROCHESTER, N.Y., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs.

Key Points: 
  • ROCHESTER, N.Y., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs.
  • The potential impact of the AD program on Vaccinex valuation and financial resources make this Vaccinex’s most important near-term catalyst.
  • On August 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.20 million shares1 of common stock for aggregate proceeds of $0.7 million.
  • Similarly, on September 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.25 million shares of common stock for aggregate proceeds of $0.6 million.