HPV16

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025

Retrieved on: 
Wednesday, March 27, 2024

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.

Key Points: 
  • Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.
  • “During 2023 Transgene continued to make significant progress, delivering compelling data that confirm the value of our approach to treating cancer using our novel immunotherapies” commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.
  • As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.
  • In 2024, Transgene expects to communicate progress and significant results and readout on all of its clinical stage assets.

LifeLabs Unveils At Home Kit Program, Empowering Ontarians to Prioritize Health with Ease

Retrieved on: 
Tuesday, March 26, 2024

LifeLabs’ At Home Kit Program provides a diverse range of self-collection kits for various health tests, including cervical to colorectal health, hormonal health, and blood sugar monitoring.

Key Points: 
  • LifeLabs’ At Home Kit Program provides a diverse range of self-collection kits for various health tests, including cervical to colorectal health, hormonal health, and blood sugar monitoring.
  • This proactive and private solution caters to individuals with busy schedules, those facing accessibility challenges, and anyone prioritizing their wellness journey.
  • “Our mission at LifeLabs is to empower individuals to achieve optimal health by facilitating access to essential medical testing and supporting healthy lifestyle habits,” said Charles Brown, President and CEO of LifeLabs.
  • “The Cervical Health (HPV) Kit provides remarkable convenience for those who prioritize regular testing.

Breakthrough in Treatment of Cervical High-Grade Squamous Intraepithelial Lesion: Release of Positive Results from Multicenter Phase III Global Clinical Study

Retrieved on: 
Tuesday, March 19, 2024

This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL.

Key Points: 
  • This study is a prospective, randomized, double-blinded, placebo-controlled multicenter Phase III global clinical study designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL.
  • Primary endpoint of the study is the proportion of responders at 6 months after the initial treatment.
  • The study is led by Dr. Jinghe Lang, an academician at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences.
  • Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "We are extremely proud of the results from the international multicenter Phase III clinical study of APL-1702.

TScan Therapeutics Announces 2024 Clinical Plans and Highlights Recent Progress

Retrieved on: 
Thursday, January 4, 2024

WALTHAM, Mass., Jan. 04, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced its 2024 clinical pipeline plans and highlighted recent corporate achievements.

Key Points: 
  • Additionally, we submitted INDs for two additional TCRs in December and the 30-day review period with the FDA is ongoing.
  • Plans to complete Phase 1 dosing and report clinical and translational data in 2024, and two-year relapse data in 2025.
  • Initiated Phase 1 solid tumor clinical study and expects to dose the first patient in the first quarter of 2024.
  • Plans to continue to build ImmunoBank with additional IND filings throughout 2024.

Replay and its engineered NK cell therapy company Syena announce exclusive licensing agreement with National Institutes of Health for TCRs targeting cancer neoantigens

Retrieved on: 
Monday, December 18, 2023

These will be developed by Replay’s oncology-focused product company, Syena, to expand its pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies.

Key Points: 
  • These will be developed by Replay’s oncology-focused product company, Syena, to expand its pipeline of engineered T-Cell Receptor-Natural Killer (TCR-NK) cell therapies.
  • The TCRs, targeting validated cancer neoantigens KRAS, p53, HPV16 and MAGE, were discovered by Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NIH National Cancer Institute’s (NCI) Center for Cancer Research and a pioneer of immunotherapies and gene therapies for advanced cancers.
  • Preclinical development of the new TCR-NK programs will advance alongside the clinical development of Syena’s lead engineered TCR-NK cell therapy candidate targeting NY-ESO-1, and the PRAME program announced today.
  • Adrian Woolfson, Executive Chairman, President, and Co-Founder of Replay, said: “The TCRs licensed from NIH address several cancer neoantigens of medical importance and will significantly expand our first-in-class, engineered TCR-NK therapy operations.

Nutcracker Therapeutics Demonstrates Anti-tumor Responses of Two Preclinical mRNA Drug Candidates at 2023 SITC Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023

These data were presented at the Society for Immunotherapy of Cancer’s (SITC’s) 38th Annual Meeting.

Key Points: 
  • These data were presented at the Society for Immunotherapy of Cancer’s (SITC’s) 38th Annual Meeting.
  • Anemia is the most common adverse effect of CD47-targeting molecules, since red blood cells also express CD47.
  • Moreover, modifying the RNA sequence of the prospective anti-CD47 molecule is far more efficient than engineering the final protein product.
  • Our platform has made it possible for Nutcracker to lay a strong and early foundation for our future therapeutic work.”

HOOKIPA Pharma Presents Additional Preliminary Phase 2 Data on HB-200 in Combination with Pembrolizumab as First-Line Treatment in Patients with HPV16+ Head and Neck Cancers at European Society for Medical Oncology Congress 2023

Retrieved on: 
Sunday, October 22, 2023

All evaluable patients were alive at the data cutoff (DCO), and the median follow-up time at DCO was 8.3 months.

Key Points: 
  • All evaluable patients were alive at the data cutoff (DCO), and the median follow-up time at DCO was 8.3 months.
  • Importantly, results showed significant activation of antigen-specific CD8+ T cells, the body’s primary driver of tumor killing activity.
  • Out of 17 patients with available peripheral blood mononuclear cells (PMBC) samples, all patients showed an increase of tumor antigen-specific circulating HPV16+ CD8+ T cells.
  • These data represent a doubling of the 19 percent ORR reported for pembrolizumab alone1 and are consistent with previously reported HB-200 data.

PDS Biotech Announces PDS0101 Combined with Chemoradiotherapy Associated with Rapid Decline in Circulating Tumor DNA (ctDNA/cfDNA)

Retrieved on: 
Monday, October 2, 2023

HPV is the primary cause of cervical cancer with over 99% caused by HPV infection, and cfHPV-DNA can be detected in the blood of patients with cervical cancer.

Key Points: 
  • HPV is the primary cause of cervical cancer with over 99% caused by HPV infection, and cfHPV-DNA can be detected in the blood of patients with cervical cancer.
  • HPV type 16 (HPV16) is the most prominent subtype associated with cervical cancer.
  • Longitudinal plasma samples were collected from each patient at baseline, during weeks 1, 3, and 5, and at 3-4 months after CRT.
  • “I look forward to the continued evaluation of PDS0101 in combination with standard-of-care chemoradiotherapy.”

TScan Therapeutics Announces Upcoming Presentations at the 38th Society for Immunotherapy of Cancer Annual Meeting

Retrieved on: 
Wednesday, September 27, 2023

WALTHAM, Mass., Sept. 27, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the acceptance of six abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held from November 1-5, 2023, both in San Diego, CA and virtually.

Key Points: 
  • WALTHAM, Mass., Sept. 27, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced the acceptance of six abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held from November 1-5, 2023, both in San Diego, CA and virtually.
  • Title: Product Characteristics and Clinical Trial Design for T-Plex, a Multiplexed, Enhanced T cell Receptor-Engineered T cell Therapy for Solid Tumors
    Title: Non-clinical development of T-Plex component TSC-200-A0201: A natural HPV16 E7-specific TCR-T cell therapy for the treatment of HPV16-positive solid tumors
    Title: Phase 1 trial of TSC-100 and TSC-101, Engineered T-Cell Therapies Targeting Minor Histocompatibility Antigens to Eliminate Residual Disease after Hematopoietic Cell Transplantation
    A copy of the presentation materials will be added to the “ Events and Presentations ” section of the Company’s Investor Relations website at ir.tscan.com once presentations have concluded.

Nykode Therapeutics Announces Advances in Clinical Pipeline and Research

Retrieved on: 
Wednesday, September 20, 2023

OSLO, Norway, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, announces significant advances in its clinical pipeline and research at the Capital Markets Day in New York.

Key Points: 
  • OSLO, Norway, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, announces significant advances in its clinical pipeline and research at the Capital Markets Day in New York.
  • We today present additional data from both our VB10.16 and VB10.NEO programs supporting a differentiated durable immune response,” said Michael Engsig, CEO of Nykode Therapeutics.
  • Nykode is presenting additional data from the VB-C-02 trial which strongly supports the generation of durable clinically relevant T cell responses.
  • Nykode has top-tier collaborations within oncology and infectious diseases, valued at potentially more than USD 1.6 billion plus royalties.