CRADA

ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer

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Monday, April 8, 2024
JHU, NCI, Development, Carcinoma, CRADA, National Cancer Institute, MSKCC, IND, Investigational New Drug, Genomics, Immune system, Bangladesh Technical Education Board, FDA, SCLC, Food, Pharmaceutical industry

This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.

Key Points: 
  • This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.
  • The trial ( NCT06287775 ) is entitled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”.
  • “We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-in-human Phase I/II combination trial with iadademstat plus immune check point inhibitors” stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon.
  • “The molecular mechanisms underlying the ability of iadademstat to render small cell lung cancer cells visible to the immune system while simultaneously enhancing immune activity to aggressively target these malignant cells have been clearly elucidated.

Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update

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Thursday, March 28, 2024
Cream, Dysmenorrhea, Patient, History, Bacteria, G&A, Vaginal discharge, IND, Bayer, Human development, Investment, Diclofenac, NSAID, Menstruation, Research, Hormone, Bacterial vaginosis, P-value, Webcast, SAN, NIH, Trial of the century, Pleasure, Woman, Breast cancer, Safety, Pharmacokinetics, Food, Development, Menopause, Nonsteroidal anti-inflammatory drug, HR, ARPA, VVA, Tamoxifen, FDA, Attention, CRADA, Female, Dyspareunia, Ecosystem, NICHD, Bangladesh Technical Education Board

SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.

Key Points: 
  • In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
  • Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
    Cash and cash equivalents: $10.5 million at December 31, 2023.
  • Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.

MAX Power Mining Receives BLM Permits For Phase 2 Drilling at Willcox

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Friday, March 22, 2024
Max Power, National Instrument 43-101, ITG, Five-hole, BLM, Bureau, CRADA, Research, News, University, MAXX, Willcox Playa, IIROC, National instrument, Anomaly, DLE, Lawrence Berkeley National Laboratory, Lithium, Interstate 10, MAX, Qualified person (European Union), APA, CDN, Interstate Highway System

Mr. Peter Lauder, Senior Geologist and Exploration Manager for MAX Power, commented: “The first five diamond drill holes at Willcox have supported initial theories regarding prospectivity of intense resistivity and gravimetric low anomalies at the Playa.

Key Points: 
  • Mr. Peter Lauder, Senior Geologist and Exploration Manager for MAX Power, commented: “The first five diamond drill holes at Willcox have supported initial theories regarding prospectivity of intense resistivity and gravimetric low anomalies at the Playa.
  • The southern block on BLM ground features the largest and most extreme anomalies on MAX Power’s property.
  • This bodes very well for extending the discovery of clay-rich sediments with high lithium values.
  • MAX Power reports that it has appointed Independent Trading Group, Inc. ("ITG") as a market maker for its shares traded on the Canadian Securities Exchange ("CSE").

NOAA Selects Parsons as System Integrator for Traffic Coordination System for Space

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Monday, March 18, 2024
Development, Authority, OSC, Environment, SSA, CRADA, STC, Acquisition, Software, PSN, AWS, Commerce, Cloud computing, Parsons Corporation, Safety, Pathfinder, SpaceX, RFI, Government, NOAA, Management

NOAA’s Office of Space Commerce (OSC) is developing TraCSS as a modern, cloud-based IT system that will provide space situational awareness (SSA) and space traffic coordination (STC) services to private and civil space operators.

Key Points: 
  • NOAA’s Office of Space Commerce (OSC) is developing TraCSS as a modern, cloud-based IT system that will provide space situational awareness (SSA) and space traffic coordination (STC) services to private and civil space operators.
  • As the system integrator, Parsons will develop the software backbone for the operational TraCSS platform, including the SSA data repository (TraCSS-OASIS) and the application layer (TraCSS-SKYLINE).
  • The award to Parsons represents OSC’s second major acquisition for the infrastructure components of the operational TraCSS system.
  • Its mission is to foster the conditions for the economic growth and technological advancement of the U.S. commercial space industry.

Virpax Pharmaceuticals Reports 2023 Year-End Results

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Tuesday, March 26, 2024
Other Health, Pharmaceutical, Medical Devices, Infectious Diseases, Hospitals, Science, Surgery, Veterinary, Biotechnology, Practice Management, Other Science, Health, Research, NCATS, Development, Plaintiff, Post-traumatic stress disorder, Central nervous system, CNS, CRADA, Trauma, Bupivacaine, Chronic pain, NIH, IND, United States bankruptcy court, Bankruptcy, Therapy, FINANCIAL, Pain management, Bangladesh Technical Education Board, Pentagon, Government, Pharmaceutical industry

Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced its financial results for the twelve months ended December 31, 2023, and other recent developments.

Key Points: 
  • Virpax® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced its financial results for the twelve months ended December 31, 2023, and other recent developments.
  • “Recently we reported the initial results from the pilot study of Probudur™ performed by the U.S. Army Institute of Surgical Research (USAISR).
  • On November 17, 2023, Virpax announced the resignation of Anthony P. Mack as CEO and Chairman effective immediately.
  • As of December 31, 2023, Virpax had cash of approximately $9.1 million, compared to $19.0 million as of December 31, 2022.

US Critical Materials Corp. Announces Major Discovery of Gallium on their Sheep Creek, Montana Properties

Retrieved on: 
Thursday, March 21, 2024
Gallium, USGS, Republic, Development, PPM, Risk, INL, Bureau, CRADA, Semiconductor, National security, Mining, Rare-earth element

SALT LAKE CITY, March 21, 2024 /PRNewswire/ -- US Critical Materials confirmed a strategically significant deposit of high-grade gallium on its 6700 acres of claims in Sheep Creek, Montana.

Key Points: 
  • SALT LAKE CITY, March 21, 2024 /PRNewswire/ -- US Critical Materials confirmed a strategically significant deposit of high-grade gallium on its 6700 acres of claims in Sheep Creek, Montana.
  • The Chinese government has recently embargoed the export of gallium, which is critical for national defense and many other vital applications.
  • US Critical Materials prime gallium claims average over 300 PPM and go as high as 1370 PPM.
  • US Critical Materials looks forward to being the primary gallium producer in the United States."

Actinium Pharmaceuticals Launches Actinium-225 Focused Strategic Initiative to Leverage Proprietary Cyclotron Based Manufacturing Technology to Address Growing Market Demand

Retrieved on: 
Monday, March 11, 2024
Actinium, Synthase, NCI, Recycling, Actinium-225, International, CRADA, DNA, Research, Thorium, Linear energy transfer, Investment, Cyclotron, DOE, Medicine

Actinium's intellectual property portfolio relating to its cyclotron-based production method includes 5 issued U.S. patents and 49 issued international patents as well as significant technical know-how.

Key Points: 
  • Actinium's intellectual property portfolio relating to its cyclotron-based production method includes 5 issued U.S. patents and 49 issued international patents as well as significant technical know-how.
  • The DOE has stated that it is exploring the generation of new thorium cows and production via a cyclotron.
  • Based on our experience to date, we expect to be able to produce material with high radiochemical purity and at yields not possible with thorium-cow based methods.
  • This has the potential to further establish Actinium as a leader in alpha-particle therapies and remain at the forefront of innovation while addressing a significant and rapidly growing addressable patient population."

Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights

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Wednesday, February 28, 2024
Active, VSIG4, MSS, National Cancer Institute, Society, Sensei, Lung cancer, Patient, Immunotherapy, Trial of the century, Head, Neoplasm, VISTA, SITC, MBA, Annual general meeting, Therapy, Histology, Biology, NSCLC, ESMO, Kinetics, CRC, PD-1, Conference, Safety, Cemiplimab, Pharmacokinetics, CRADA, CD39, IND, Colorectal cancer, Translation, NCI, Aes, Part-time, FDA, Research and development, Administration, KOL, Cancer, Pharmaceutical industry

BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2023, and provided corporate updates.

Key Points: 
  • “2023 saw the entry of our differentiated anti-VISTA antibody, SNS-101, into clinical development,” said John Celebi, President and Chief Executive Officer.
  • Recent updates include:
    A total of 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase of this study.
  • On October 23, 2023 , Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) 2023.
  • On November 1, 2023, Sensei announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer.

Smith+Nephew and U.S. Army Institute of Surgical Research to engage in Master Cooperative Research and Development Agreement

Retrieved on: 
Wednesday, February 28, 2024
Commander, DOD, Life, Master, History, Patient, SNN, CRADA, COL, Development, Sports medicine, Research, Management

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announced they have entered into a Master Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR).

Key Points: 
  • Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announced they have entered into a Master Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR).
  • This marks the first time that the USAISR has entered into a master agreement of this nature with an industry-leading medical technology company.
  • The Master CRADA represents an enterprise-wide opportunity for Smith+Nephew across all business units - Advanced Wound Management, Orthopaedics and Sports Medicine - to enter into multiple collaborative research efforts.
  • “The pre-negotiated key terms and conditions of the Master CRADA provide the broad legal framework under which for multiple, future collaborative research efforts will be assigned.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023

Retrieved on: 
Monday, February 26, 2024
Borderline personality disorder, HOPE, HDAC6, National Cancer Institute, EVOLUTION, CMT, Agitation, Data analysis, Convertible bond, ICIS, ALS, SCLC, Azacitidine, Duration, ICI, IIS, Sciatic nerve, Deficit spending, Paclitaxel, DSM-IV codes, Development, Genomics, ALS Association, FMS, LSD1, AML, Clinical Global Impression, MSKCC, Conference, Aggression, Safety, Biomarker, CNS, Venetoclax, CRADA, OHSU, MRD, Clinical trial, BPD, Measure (mathematics), IND, FCCC, Dor, Human, Innovation, EMA, Kabuki syndrome, NET, NCI, Aes, Glomus tumor, FDA, GST, Food, Platinum, Schizophrenia, Phase II, Charcot–Marie–Tooth disease, Medicine, Patient, BEST, Disease, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.
  • Research and development (R&D) expenses were $3.9 and $16.6 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $5.0 and $18.1 million for the quarter and twelve months ended December 31, 2022.
  • General and administrative expenses were $1.2 and $4.2 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.2 and $4.8 million for the quarter and twelve months ended December 31, 2022.
  • Net losses were $1.4 and $5.0 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.6 and $5.9 million for the quarter and twelve months ended December 31, 2022.