Clinical Trials

OrganaBio Launches New Website

Retrieved on: 
Monday, January 9, 2023

OrganaBio, LLC launches a brand-new website at www.organabio.com .

Key Points: 
  • OrganaBio, LLC launches a brand-new website at www.organabio.com .
  • The new website expounds on OrganaBio’s mission to empower and strengthen customers’ people, processes, and products on their journey to commercialization and embraces the colorful culture of OrganaBio’s headquarters in Miami.
  • View the full release here: https://www.businesswire.com/news/home/20230109005793/en/
    Attending Phacilitate at Advanced Therapies Week in Miami between January 17-20?
  • Products are offered “off-the-shelf”, ready to ship for preclinical research and in custom and cGMP-compliant formats for clinical development and manufacturing.

LinKinVax Just Completed a New Round of Financing, Initiated in 2022, for a Total of €7,3 M 

Retrieved on: 
Monday, January 9, 2023

LinKinVax’s innovative technology directly targets dendritic cells (“DC”), which play a crucial role in the immune system, stimulating and regulating immune responses.

Key Points: 
  • LinKinVax’s innovative technology directly targets dendritic cells (“DC”), which play a crucial role in the immune system, stimulating and regulating immune responses.
  • It is predicated on work by the Vaccine Research Institute/Inserm (VRI) in which Inserm, University of Paris Est Créteil (UPEC), and the Mondor Institute of Biomedical Research (IMRB) participate.
  • Englehart, Director, IQT International Ltd UK: “We are impressed by LinKinVax’s team and its vision for developing world-class vaccine technology.
  • This new financing, completed in December 2022, includes a seed funding from private shareholders, beginning of 2022.

Rocket Pharmaceuticals Expands Cardiac Gene Therapy Portfolio with Addition of RP-A601 for PKP2-ACM and Announces Positive Updated Phase 1 Data for RP-A501 in Danon Disease

Retrieved on: 
Monday, January 9, 2023

We have shared these updates with the FDA as part of our pivotal Phase 2 study design discussions.

Key Points: 
  • We have shared these updates with the FDA as part of our pivotal Phase 2 study design discussions.
  • “Lastly, I am pleased to note an extension of our cash runway, which we expect to fund operations through 2024.
  • Available treatments fail to address the underlying genetics and disease biology and do not alter disease progression.
  • A live audio webcast of the presentation is available under “Events” in the Investors section of the Company’s website at https://ir.rocketpharma.com .

Valbiotis Announces Its Roadmap for 2023: a Pivotal Year in the Execution of Its Clinical, Industrial and Commercial Strategy

Retrieved on: 
Tuesday, January 10, 2023

In parallel, clinical results on the mode of action of TOTUM•63 will be obtained and communicated this year.

Key Points: 
  • In parallel, clinical results on the mode of action of TOTUM•63 will be obtained and communicated this year.
  • The results of the clinical bioavailability and mode of action study will be known early in the year.
  • Market research with healthcare professionals and consumers has helped establish the commercial strategy, combining medical recommendation and open access for consumers.
  • Valbiotis considers that these projections are based on rational hypotheses and the information available to Valbiotis at the present time.

Therapeutic Solutions International Identifies Novel Cellular Marker Associated with Therapeutic Response to JadiCell Stem Cell Treatment

Retrieved on: 
Monday, January 9, 2023

Therapeutic Solutions International (TSOI) announced today identification and patent filing of a previously unexpected discovery that responsiveness to JadiCell stem cell therapy appears to correlate with alternations of a specific type of B cell producing the cytokine interleukin-10 and possessing unique surface markers.

Key Points: 
  • Therapeutic Solutions International (TSOI) announced today identification and patent filing of a previously unexpected discovery that responsiveness to JadiCell stem cell therapy appears to correlate with alternations of a specific type of B cell producing the cytokine interleukin-10 and possessing unique surface markers.
  • Therapeutic Solutions International has a Phase III clinical trial ongoing for COVID-19 acute respiratory distress syndrome (ARDS) and has been granted IND numbers for use of JadiCells in Chronic Obstructive Pulmonary Disease (COPD) and Chronic Traumatic Encephalopathy.
  • Additionally, the Company has active, ongoing, collaborations with physicians to provide the cells under Emergency IND and Right to Try.
  • It is reasonable to believe that if today’s results are reproducible on a larger scale, we will possess a new tool to advance the field of stem cell sciences.”

Boehringer Ingelheim and 3T Biosciences Join Forces to Develop Next-Generation Cancer Immunotherapies

Retrieved on: 
Monday, January 9, 2023

Boehringer Ingelheim and 3T Biosciences, today announced they have entered into a strategic collaboration and licensing agreement to discover and develop next-generation cancer therapies to address high unmet patient needs.

Key Points: 
  • Boehringer Ingelheim and 3T Biosciences, today announced they have entered into a strategic collaboration and licensing agreement to discover and develop next-generation cancer therapies to address high unmet patient needs.
  • Cancer immunotherapies have brought dramatic breakthroughs, but only for a minority of cancer patients.
  • “On behalf of the entire team at 3T Biosciences, we are extremely pleased to partner with Boehringer Ingelheim, a company advancing transformative cancer treatments,” said Stefan J. Scherer, M.D., Ph.D., president and CEO of 3T Biosciences.
  • Boehringer Ingelheim is eligible to receive royalties on future product sales by 3T Biosciences arising from the agreement.

Azafaros Strengthens Medical and Scientific Management Team Reflecting Clinical Progress

Retrieved on: 
Monday, January 9, 2023

Dr. Christian Freitag joins the company as Chief Medical Officer and Dr. Kyle Landskroner has been promoted to Chief Scientific Officer.

Key Points: 
  • Dr. Christian Freitag joins the company as Chief Medical Officer and Dr. Kyle Landskroner has been promoted to Chief Scientific Officer.
  • With their comprehensive expertise in clinical and early-stage drug development, they will support the transition of Azafaros’ lead program, AZ-3102, into late-stage clinical evaluation and the expansion of Azafaros’ pipeline.
  • Prior to joining Azafaros, Dr. Freitag was Chief Medical Officer at Dynacure, where he was responsible for medical and regulatory strategy, including clinical development of the lead compound in Myotubular and Centronuclear Myopathies (CNM).
  • Christian Freitag, Chief Medical Officer of Azafaros, commented: “Joining Azafaros at this time is very exciting.

Servier and Aqemia Extend Collaboration on Undruggable Target in Immuno-Oncology

Retrieved on: 
Monday, January 9, 2023

Servier and Aqemia announce the extension of their new-molecule discovery collaboration on an undruggable therapeutic target in immuno-oncology.

Key Points: 
  • Servier and Aqemia announce the extension of their new-molecule discovery collaboration on an undruggable therapeutic target in immuno-oncology.
  • This extension follows Servier and Aqemia’s successful partnership program, initiated in December 2021 , to accelerate drug candidate discovery in immuno-oncology using artificial intelligence.
  • This extension shows the common willingness to join our forces and expertise to drug this highly difficult target."
  • Aqemia has successfully employed its unique quantum-physics-inspired artificial intelligence technology to identify innovative, patentable molecules that are experimentally active on an undruggable target in immuno-oncology.

Anebulo Pharmaceuticals Announces Completion of Dosing and Preliminary Data from Part B of its Phase 2 Study of ANEB-001 for Acute Cannabinoid Intoxication

Retrieved on: 
Monday, January 9, 2023

In total, Parts A and B of the Phase 2 study enrolled 134 healthy subjects.

Key Points: 
  • In total, Parts A and B of the Phase 2 study enrolled 134 healthy subjects.
  • Delayed dosing of ANEB-001 was also examined by introducing a one-hour pause between the THC challenge and treatment with the ANEB-001 or placebo.
  • The final cohort of the study included administration of a high fat meal prior to the THC challenge.
  • Administration of a high fat meal delayed the THC effects and the reversal of feeling high by ANEB-001.

Cellworks Expands Into Precision Pharma to Accelerate the Development of Cancer Drugs and Revive Shelved Pharmaceutical Assets

Retrieved on: 
Monday, January 9, 2023

“But in many instances, the Cellworks Platform has the ability to predict the human clinical response to drug candidates years earlier than traditional development pipelines.

Key Points: 
  • “But in many instances, the Cellworks Platform has the ability to predict the human clinical response to drug candidates years earlier than traditional development pipelines.
  • Cellworks biosimulation results may provide guidance for additional indications to target for clinical development.
  • “We are well-positioned to enhance clinical markets by addressing the significant unmet needs in both precision pharma and personalized oncology.
  • I am looking forward to advancing Cellworks mission to improve patient outcomes through precision drug development and personalized therapy selection.”