OPSCC

HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab

Retrieved on: 
Thursday, April 25, 2024
FDA, Patient, Cancer, Food, Pembrolizumab, Infection, ASCO, Arenavirus, PRIME, Society, Head, Annual general meeting, European Medicines Agency, OPSCC, Pharmaceutical industry

The Phase 2/3 trial design and protocol are based on alignment with the U.S. Food and Drug Administration (FDA) following the Company’s Type C meeting with the FDA.

Key Points: 
  • The Phase 2/3 trial design and protocol are based on alignment with the U.S. Food and Drug Administration (FDA) following the Company’s Type C meeting with the FDA.
  • The presentation will include data for approximately 40 head and neck cancer patients treated with HB-200 in combination with pembrolizumab.
  • We believe our trial design and alignment with our primary regulators can help us reach a potential registration more quickly.
  • The trial is expected to enroll approximately 250 patients across the seamless Phase 2/3 design.

HOOKIPA Pharma to Host Investor Call on HB-200 and Planned Path to Registration

Retrieved on: 
Wednesday, April 10, 2024
FDA, Pembrolizumab, Arenavirus, PRIME, Patient, EMA, European Medicines Agency, OPSCC, Pharmaceutical industry

HOOKIPA and the FDA have aligned on the design and protocol of the Company’s upcoming pivotal Phase 2/3 clinical trial of HB-200 in combination with pembrolizumab.

Key Points: 
  • HOOKIPA and the FDA have aligned on the design and protocol of the Company’s upcoming pivotal Phase 2/3 clinical trial of HB-200 in combination with pembrolizumab.
  • The investor call will be held on April 25, 2024, at 8:00 a.m.
  • PRIME designation is intended to expedite development and review of drug candidates, alone or in combination with other drugs.
  • “We have had positive conversations with our regulators as we have outlined our clinical trial plans for HB-200.

Coherus BioSciences Reports Fourth Quarter, Full Year 2023 Financial Results and Provides Current Business Update

Retrieved on: 
Wednesday, March 13, 2024
HCC, Research, PIN, Conference call, Congress, Relative value unit, Conference, Head, Exercise, NSCLC, Risk, Patient, CHRS, Otorhinolaryngology, Biomarker, Sale, Acquisition, NCCN, NPC, Ophthalmology, IL-27, IND, Bevacizumab, OPSCC, Investigational New Drug, Investment, ESMO, GAAP, Workforce, Medicare, FDA, COGS, Total, Development, Pharmaceutical industry

UDENYCA net product sales increased 10% in the fourth quarter 2023 to $36.2 million compared to $33.0 million in the third quarter.

Key Points: 
  • UDENYCA net product sales increased 10% in the fourth quarter 2023 to $36.2 million compared to $33.0 million in the third quarter.
  • Since commercial launch in May 2023, more than 727 accounts have ordered the Autoinjector presentation.
  • “Throughout 2023, Coherus demonstrated significant progress in transforming the Company’s business model and product portfolio for long-term sustainable growth,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer.
  • Coherus is introducing a guidance range of combined 2024 R&D and SG&A expenses from $250 to $265 million.

Naveris Announces Two Peer-Review Publications Validating NavDx® Performance in Daily Clinical Practice

Retrieved on: 
Thursday, October 12, 2023
Radiology, Health, Surgery, Oncology, Diagnosis, Neoplasm, TTMV, Physician, Ferrandino, Doctor of Philosophy, Research, Dana–Farber Cancer Institute, MD, DNA, CCR, Recurrence, Disease, Human, JAMA, HPV, Literature, Clinical Cancer Research, MRD, Liquid biopsy, OPSCC, Patient, Vaccine

Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance (Hanna, G.J.

Key Points: 
  • Negative Predictive Value of Circulating Tumor Tissue Modified Viral (TTMV)-HPV DNA for HPV-driven Oropharyngeal Cancer Surveillance (Hanna, G.J.
  • ), published in CCR, is a retrospective observational cohort study involving 543 patients who completed therapy for HPV-driven oropharyngeal squamous cell carcinoma (OPSCC).
  • “NavDx has consistently exhibited stellar performance in well over a dozen peer-reviewed studies following thousands of HPV-driven OPSCC patients.
  • “We congratulate these investigators on their outstanding research, and look forward to our ongoing partnerships with the clinical research community to support bringing NavDx testing to more patients.”

Naveris Announces New Data Featuring NavDx® in Oral Highlight and Poster Presentations at Upcoming ASTRO and AAO-HNSF 2023 Meetings

Retrieved on: 
Thursday, September 28, 2023
Biotechnology, Other Health, Health, General Health, Oncology, Other Science, Medical Devices, Research, Hospitals, Science, Clinical Trials, TTMV, Abstract, DNA, Session, San Diego Convention Center, Head, ASTRO, OPSCC, Booth, Cancer, American Academy of Otolaryngology–Head and Neck Surgery, American Academy, Radiation therapy, American Society for Radiation Oncology, MRD, MD, Annual general meeting, HPV, AM, Neoplasm, Recurrence, Society, Neck, Vaccine, Raoul de Navery

Naveris will be exhibiting at both meetings, providing the latest information on NavDx®, Naveris’ proprietary flagship blood test for tumor tissue modified viral (TTMV®)-HPV DNA.

Key Points: 
  • Naveris will be exhibiting at both meetings, providing the latest information on NavDx®, Naveris’ proprietary flagship blood test for tumor tissue modified viral (TTMV®)-HPV DNA.
  • The company will also highlight its TTMV-DNA platform in abstracts selected for oral presentation at both meetings.
  • “There is growing enthusiasm for the use of NavDx in daily practice across the continuum of HPV-driven OPSCC care, especially in the surveillance setting,” said Barry M. Berger, MD, Chief Medical Officer of Naveris.
  • Naveris and NavDx will be on exhibit at AAO-HNSF 2023 at Booth #608 and at ASTRO 2023 at Booth #3325.

Precigen Announces Positive Phase 1 Data for Off-the-Shelf PRGN-2009 AdenoVerse™ Immunotherapy Alone and in Combination with an Investigational Checkpoint Inhibitor in Patients with Recurrent/Metastatic HPV-associated Cancers

Retrieved on: 
Saturday, June 3, 2023
US Foods, Precigen, RRP, Medicine, Risk, OPSCC, COVID-19, Infection, Immunotherapy, Investigational New Drug, TTY, Patient, Annual report, Immune system, Security (finance), Trial of the century, FDA, Pembrolizumab, NCI, IND, Food, Safety, Pharmaceutical industry, Vaccine

GERMANTOWN, Md., June 3, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today presented positive clinical data from the Phase 1 study of the off-the-shelf (OTS) PRGN-2009 AdenoVerse™ immunotherapy alone and in combination with an investigational anti-PDL1/TGF-Beta Trap checkpoint inhibitor (bintrafusp alfa) in patients with recurrent/metastatic (R/M) HPV-associated cancers (clinical trial identifier: NCT04432597) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# 2628).

Key Points: 
  • An interim clinical data presentation from the Phase 2 monotherapy arm is expected in the second half of 2023.
  • Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization.
  • For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen , LinkedIn or YouTube .
  • Superior performance characteristics and high yield manufacturing of AdenoVerse vectors leveraging UltraVector® technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases.

Repertoire® Immune Medicines Presents New Data From Its DECODE™ Platform Identifying Highly Prevalent Immunotherapeutic Targets in HPV-Positive Cancers, Unlocking Pathways for Potential Therapeutics

Retrieved on: 
Thursday, November 10, 2022
Oncology, Health, Other Health, Research, Science, Pharmaceutical, Biotechnology, Repertoire, Flagship Pioneering, Head, Epitope, Prevalence, Human papillomavirus infection, Annual general meeting, EST, Immunotherapy, Interleukin, Research, Cancer, Center, Technology, Development, Population, HPV, CD8, Dana–Farber Cancer Institute, Society for Immunotherapy of Cancer, Haplotype, B cell, Infection, SITC, E7, HLA, Neoplasm, Research and development, E5, OPSCC, Patient, Autoimmune disease, TCR, Society, Degenerative disease, Antigen, Vaccine, E6, Poster

Importantly, we now have data that point to antigens active in driving these malignancies, which we can use to develop novel targeted medicines.

Key Points: 
  • Importantly, we now have data that point to antigens active in driving these malignancies, which we can use to develop novel targeted medicines.
  • DECODE is being used to assess the immunogenicity profile of HPV 16 and HPV 33-positive tumors in oropharyngeal squamous cell carcinoma (OPSCC).
  • Using the DECODE platform, we have a window into the mechanisms involved in the immune surveillance of cancer, which offers us the ability to develop highly selective immune-based medicines, said Anthony Coyle, Ph.D., President, Research and Development, Repertoire Immune Medicines.
  • Repertoire intends to utilize these insights into key drivers that govern immune function to design and develop novel immune product candidates.

Naveris Collaborators Present Award-winning Abstract at ASTRO 2022 on Potential of NavDx to Inform Treatment Strategies in HPV-driven Cancers

Retrieved on: 
Monday, October 24, 2022
Biotechnology, Health, Oncology, LinkedIn, Papilloma, CLIA, College of American Pathologists, Risk, Mayo Clinic, Disease, American Society for Radiation Oncology, Head, Radiation, DART, TTMV, List of pathologists, Society, Patient, Biotechnology, Twitter, Annual general meeting, Cancer, III, DRS, MRD, Radiation therapy, ASTRO, Progression-free survival, Toxicity, CEO, College, Recurrence, HPV, OPSCC, DNA, Medical imaging, Pharmaceutical industry, Vaccine, Raoul de Navery

radiation oncologist, Mayo Clinic, and first author of the study, was honored with the ASTRO Basic/Translational Science Award for this work.

Key Points: 
  • radiation oncologist, Mayo Clinic, and first author of the study, was honored with the ASTRO Basic/Translational Science Award for this work.
  • The presence of MRD, both in the post-operative setting and at 3 months post-treatment, was significantly associated with shorter progression-free survival.
  • Results from the MC1675 trial were initially presented at the ASTRO 2021 annual meeting and follow-up is ongoing.
  • More information on Naveris and NavDx can be found at booth #2348, or look for highlights from #ASTRO22 Twitter and LinkedIn .

Bio-Techne Announces Launch of the CE-IVD RNAscope™ ISH Probe High Risk HPV Assay for Head and Neck Cancer

Retrieved on: 
Wednesday, July 6, 2022
Diagnosis, IHC, Molecular diagnostics, Patient, ISH, HPV, Research, Leica Biosystems, Bio-Techne, Genomics, Marie Cassidy, In situ hybridization, Publication, Technology, Signal-to-noise ratio, NASDAQ, Approximation error, BOND, Vaccine, Medical imaging, OPSCC

MINNEAPOLIS, July 6, 2022 /PRNewswire/ -- Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities today announced the European launch of the CE-IVD marked RNAscope ISH Probe High Risk HPV, intended for use in patients diagnosed with oropharyngeal squamous cell carcinoma (OPSCC) to aid in the identification of high-risk human papillomavirus (HPV).

Key Points: 
  • "We are excited to launch the new CE-IVD RNAscope ISH Probe High Risk HPV, which provides pathologists a highly accurate tool for the direct detection of HPV mRNA to inform treatment selection in oropharyngeal squamous cell carcinoma patients."
  • RNAscope ISH Probe High Risk HPV is used in an RNAscope ISH assay for the qualitative detection of HPV E6/E7 mRNA in FFPE tissue specimens.
  • RNAscope ISH Probe High Risk HPV is for use in clinical laboratories with the CE-IVD marked BOND RNAscope Brown Detection kit on the automated Leica Biosystems BOND-III stainer.
  • To learn more about RNAscope ISH Probe High Risk HPV, please visit www.bio-techne.com/rnascope-hpv

PDS Biotech Announces Clinical Trial with Mayo Clinic to Study PDS0101 in Early Stage Pre-Metastatic- HPV-Associated Head and Neck Cancer

Retrieved on: 
Tuesday, February 15, 2022
PDSB, Tissue, TORS, Vaccine, Death, Lung, HPV, HPV-associated oropharyngeal cancer awareness and prevention, Goal, Oropharyngeal cancer, Cancer, Population, Colon, ITT, DNA, COVID-19, Neoplasm, Biotechnology, Mayo Clinic, American Cancer Society, Smoking, Company, Recurrence, SEC, Risk, Mayo, Twitter, Infection, Research, Nature, Human, OPSCC, National Cancer Institute, Incidence, Review, Immune system, Nasdaq, Breast, DRS, HPV16, Communication, Disease, Circulating tumor DNA, GLOBE, Patient, Food, National, Neck, Forward-looking statement, Immunotherapy, Tongue, Prostate, Food and Drug Administration, Head, Pharmaceutical industry

FLORHAM PARK, N.J., Feb. 15, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced the initiation of an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the checkpoint inhibitor, KEYTRUDA®, in patients with HPV-associated oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

Key Points: 
  • David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar of Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.
  • HPV(+)OPSCC is now the most common type of head and neck cancer and has been increasing significantly in recent years.
  • Oropharyngeal cancer is a disease in which cancer cells form in the tonsil tissues of the back (base of tongue) and side (palatine tonsils) of the throat.
  • According to the National Cancer Institute, smoking or being infected with the human papillomavirus (HPV), especially HPV16, can increase the risk of oropharyngeal cancer.