Clinical Trials

Diakonos Oncology’s Unique Dendritic Cell Vaccine (DOC1021) Improves Survival Compared to Standard of Care in Phase 1 Trial for Glioblastoma

Retrieved on: 
Tuesday, April 9, 2024

Twelve of 16 patients with newly diagnosed GBM remain alive with no serious adverse events attributable to DOC1021.

Key Points: 
  • Twelve of 16 patients with newly diagnosed GBM remain alive with no serious adverse events attributable to DOC1021.
  • “These very encouraging results support our confidence in the potential for our dendritic cell vaccines to significantly improve the lives of patients with the most deadly cancers,” said Mike Wicks, Diakonos CEO.
  • Despite their challenging prognosis, these patients saw a statistically significant improvement in expected overall survival of 7.7 months for similar patients.
  • Diakonos’ dendritic cell vaccines are made with a patient’s own immune cells combined with RNA and proteins prepared from a sample of their tumor.

Former QuidelOrtho CEO Douglas Bryant Joins Board of Directors of Vital Biosciences

Retrieved on: 
Tuesday, April 9, 2024

Vital Biosciences today announced that Mr. Douglas Bryant has joined the company’s Board of Directors.

Key Points: 
  • Vital Biosciences today announced that Mr. Douglas Bryant has joined the company’s Board of Directors.
  • Vital Biosciences announced its work on a revolutionary new product, the VitalOne.
  • “Doug grew QuidelOrtho into a global leader in diagnostics, and a category defining company in point-of-care,” according to Vasu Nadella, CEO of Vital Biosciences.
  • He led the company during the acquisition of Ortho Clinical Diagnostics and subsequent renaming to QuidelOrtho in May 2022.

AffyImmune Presents Preclinical Data on AIC100 Affinity-Tuned CAR T Targeting ICAM-1 in Additional Solid Tumor Types at AACR 2024

Retrieved on: 
Tuesday, April 9, 2024

The data showcases the efficacy of AIC100 in non-small cell lung cancer (NSCLC) and cervical cancer in preclinical models expressing cell surface ICAM-1.

Key Points: 
  • The data showcases the efficacy of AIC100 in non-small cell lung cancer (NSCLC) and cervical cancer in preclinical models expressing cell surface ICAM-1.
  • Affinity tuned AIC100 is expected to selectively bind and kill tumor cells expressing cell surface ICAM-1 while sparing healthy cells.
  • “We are excited to share preclinical proof-of-concept data for our affinity-tuned CAR T program AIC100 in new solid tumor types.
  • “This promising preclinical data presented at AACR 2024 suggest that AIC100 could be a potential new option for patients with these ICAM-1-positive tumors.”

City of Hope Scientists Present Leading-Edge Research at American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Monday, April 8, 2024

“City of Hope’s research presented at AACR’s conference this year reinforces our focus on early detection, smarter and more precise treatments, and achieving health equity.

Key Points: 
  • “City of Hope’s research presented at AACR’s conference this year reinforces our focus on early detection, smarter and more precise treatments, and achieving health equity.
  • “Cancer is complex and the breadth and diversity of research this year further underscores the talent, scientific rigor and curiosity at City of Hope,” Van den Brink added.
  • But those diagnosed when the cancer is contained to the pancreas have a 44.3% relative survival rate after five years.
  • Scientists with Translational Genomics Research Institute, part of City of Hope, also contributed to the study.

Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints

Retrieved on: 
Monday, April 8, 2024

Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.

Key Points: 
  • Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints.
  • In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX14.
  • The agreement covers markets such as the United States, the European Union, and Canada.
  • The primary endpoints of this study were met.

Launch of two first-in-class medicines in 2023 marks start of exciting phase of growth for Ferring

Retrieved on: 
Tuesday, April 9, 2024

EBITDA increased by +€43 million (+12% at AER) to reach €406 million and operating profit for the year reached €139 million.

Key Points: 
  • EBITDA increased by +€43 million (+12% at AER) to reach €406 million and operating profit for the year reached €139 million.
  • The year marked a major turning-point for Ferring with the launch of two innovative first-in-class medicines in the United States.
  • Ferring is evolving to make the most of these opportunities, and there were a number of significant changes to the senior leadership.
  • Jean-Frédéric Paulsen, Chairman of the Board of Directors, said: “The launch of two groundbreaking medicines in the US, along with the other important changes in 2023, mark the start of an exciting new phase of growth for Ferring.

Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax

Retrieved on: 
Monday, April 8, 2024

Accordingly, we can start the Phase I/II combo-study very soon.

Key Points: 
  • Accordingly, we can start the Phase I/II combo-study very soon.
  • The aim for conducting this study is to judge if DFP-10917 combined with VTX is to show superiority to the standard chemotherapy (azacitidine combined with VTX) for AML.
  • This combo-study shall be done by major clinical sites in US like Wake Forest University, expertise with clinical study of novel chemotherapy for AML.
  • Please take notice of our own innovative approach for miserable cancer patients and contact with us.

Blue Earth Therapeutics Announces Promising Results from Preclinical Evaluation of Synergistic Drug Combinations with Radiopharmaceutical 177Lu-rhPSMA-10.1 for Treatment of Prostate Cancer

Retrieved on: 
Monday, April 8, 2024

Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced results from a series of preclinical analyses designed to identify synergistic combinations of known anticancer drugs with 177Lu-rhPSMA-10.1 radioligand therapy, and from a preclinical efficacy analysis of the lead novel drug combination for the treatment of prostate cancer.

Key Points: 
  • Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced results from a series of preclinical analyses designed to identify synergistic combinations of known anticancer drugs with 177Lu-rhPSMA-10.1 radioligand therapy, and from a preclinical efficacy analysis of the lead novel drug combination for the treatment of prostate cancer.
  • “Combination approaches are of increasing interest among the medical community, as we know tumors are heterogeneous and some prostate cancer cells do not express PSMA.
  • Results from this preclinical study presented at AACR demonstrated a synergistic therapeutic effect between 177Lu-rhPSMA-10.1 and an MEK inhibitor.
  • This may be due to inhibition of the MEK-MAPK pathway during DNA damage response, resulting in radiosensitization of cancer cells to 177Lu-rhPSMA-10.1.

PureTech Launches Seaport Therapeutics with $100 Million Oversubscribed Series A and Announces Management Transitions

Retrieved on: 
Tuesday, April 9, 2024

Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.

Key Points: 
  • Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.
  • Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.
  • Eric Elenko, Ph.D., a PureTech co-founder and current Chief Innovation Officer, has been promoted to the role of President of PureTech.
  • Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics.

Domain Therapeutics to Participate at Premier Investor and Healthcare Conferences

Retrieved on: 
Monday, April 8, 2024

Domain Therapeutics (“Domain” or “the Company”), a global clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announced its President and Chief Executive Officer, Anthony Johnson, M.D., and its Chief Business Officer, Sean A. MacDonald, will participate in the following investor, partnering and healthcare industry conferences in April-May, 2024:

Key Points: 
  • Domain Therapeutics (“Domain” or “the Company”), a global clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announced its President and Chief Executive Officer, Anthony Johnson, M.D., and its Chief Business Officer, Sean A. MacDonald, will participate in the following investor, partnering and healthcare industry conferences in April-May, 2024:
    This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240408769768/en/
    Anthony Johnson & Sean A. MacDonald (Photo: Domain Therapeutics)
    Location: Metro Toronto Convention Centre (North Building), Toronto, Canada