JITC

Checkpoint Therapeutics Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Friday, March 22, 2024

WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights.

Key Points: 
  • WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights.
  • We look forward to providing additional updates in the second quarter.”
    2023 and Recent Corporate Highlights:
    Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023 and the FDA accepted the BLA for filing in March 2023.
  • In December 2023, Checkpoint announced that the U.S. Patent and Trademark Office (“USPTO”) issued a new patent (U.S. Patent No.
  • In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC.

Medicenna Announces First Patient Dosed in ABILITY-1 Study of MDNA11 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors

Retrieved on: 
Tuesday, February 13, 2024

The combination portion of the study is designed to evaluate the potential for a synergistic effect of MDNA11 with KEYTRUDA® in patients with advanced solid tumors.

Key Points: 
  • The combination portion of the study is designed to evaluate the potential for a synergistic effect of MDNA11 with KEYTRUDA® in patients with advanced solid tumors.
  • “Dosing the first patient in the combination arm with MDNA11 and KEYTRUDA® is a significant milestone for Medicenna and are excited with the progress of our novel IL-2 superkine," said Fahar Merchant, PhD, President and CEO of Medicenna.
  • “By combining MDNA11 with KEYTRUDA®, we are building upon the promising data generated to date by MDNA11 as a single agent.
  • MDNA11, with its uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Forum Communications International's Flagship Consortium III System Attains Significant Certification from the US Department of Defense

Retrieved on: 
Friday, February 2, 2024

RICHARDSON, Texas, Feb. 2, 2024 /PRNewswire-PRWeb/ -- The Joint Interoperability Test Command (JITC) issued the following certification:

Key Points: 
  • Being on the DoD Information Network Approved Products list for many years is a testament to our commitment to excellence."
  • Following a meticulous review of the cybersecurity testing results for Forum's Consortium III UCCS Software Release 13.0.0, the RE5 has confirmed that it meets the rigorous requirements for Certification Approval.
  • The approved products list can be viewed at: https://aplits.disa.mil/apl
    Consortium III System and Platform Products Overview:
    The Consortium III UCCS system delivers real-time audio-conferencing capabilities tailored for the Department of Defense.
  • Memorandum for Approved Products Certification Office: Department of Defense Information Network Approved Products List Recommendations for Forum Communications Consortium III Unified Capabilities Conference (UCCS) Software Release 13.0.0 (TN# 2308901/R2-16269-U)

Actelis Announces U.S. Department of Defense JITC Labs Approval for Cybersecurity and Interoperability and Approved Products List Status

Retrieved on: 
Tuesday, January 16, 2024

The DoDIN APL, maintained by the Defense Information Systems Agency (DISA) , is the single consolidated list of products that have completed Cybersecurity and Interoperability certification.

Key Points: 
  • The DoDIN APL, maintained by the Defense Information Systems Agency (DISA) , is the single consolidated list of products that have completed Cybersecurity and Interoperability certification.
  • Now, with Actelis products on the APL, the procurement process for JITC certified, cost-effective, and immediately deployable connectivity is now much faster and simpler.
  • “The JITC cybersecurity certification by the Department of Defense demonstrates Actelis’ strength in the area of network security and data protection,” said Barlev.
  • “Security is a core pillar of the Actelis solution, and we are very proud to be certified by the United States military.”

Medicenna Commences Enrollment in the ABILITY-1 Study Combining MDNA11 with Pembrolizumab

Retrieved on: 
Tuesday, January 9, 2024

“We are very pleased to announce initiation of the combination study of MDNA11 and the PD-1 inhibitor, pembrolizumab, the leading checkpoint inhibitor therapy,” said Fahar Merchant, Ph.D., President and CEO of Medicenna.

Key Points: 
  • “We are very pleased to announce initiation of the combination study of MDNA11 and the PD-1 inhibitor, pembrolizumab, the leading checkpoint inhibitor therapy,” said Fahar Merchant, Ph.D., President and CEO of Medicenna.
  • “Having established an appropriate dose for monotherapy as well as demonstrating its early clinical validation we believe MDNA11 may further enhance anti-tumor activity when combined with pembrolizumab in patients that do not respond or develop resistance to checkpoint therapy.
  • We look forward to reporting preliminary results from both the monotherapy expansion and combination escalation arms of the Phase 2 study in the first half of 2024.”
    In the Phase 1 monotherapy dose escalation and dose evaluation portions of the study, MDNA11 was well tolerated with promising single-agent activity.
  • MDNA11, with its uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors.

Checkpoint Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, November 13, 2023

WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2023, and recent corporate highlights.

Key Points: 
  • Biologics License Application for cosibelimab under review by U.S. FDA; PDUFA goal date of January 3, 2024
    WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2023, and recent corporate highlights.
  • In July 2023, Checkpoint announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC.
  • Also in July 2023, Checkpoint completed a registered direct offering priced at-the-market under Nasdaq rules for total gross proceeds of $10 million.
  • Net loss for the third quarter of 2023 included $0.9 million of non-cash stock expenses, compared to $0.8 million for the third quarter of 2022.

Cyberlux Corporation (OTC: CYBL) Releases Third Quarter 2023 Financial and Operational Results; Announces Transformative Actions to Refocus the Company on the Defense Technology Sector

Retrieved on: 
Tuesday, November 21, 2023

Our operating period ended September 30, 2023, has set the stage for the Company to capitalize on remarkable opportunities across the global Defense Technology markets.

Key Points: 
  • Our operating period ended September 30, 2023, has set the stage for the Company to capitalize on remarkable opportunities across the global Defense Technology markets.
  • Our work to remove the CE designation continues, but the Company is driving breakthrough results regardless of these temporary obstacles.
  • As the Company develops advanced technology products, we will identify core technology and product companies, and these companies will become the Cyberlux growth catalysts.
  • As the results show, Cyberlux is building a global enterprise and developing into a leading technology growth company.

Agile Defense Wins TEC II Single Award IDIQ Contract Supporting DISA

Retrieved on: 
Tuesday, November 21, 2023

"Agile Defense's unwavering commitment to the defense mission is driving how we impact the market with our client-focused solutions," Agile Defense CEO Rick Wagner explained.

Key Points: 
  • "Agile Defense's unwavering commitment to the defense mission is driving how we impact the market with our client-focused solutions," Agile Defense CEO Rick Wagner explained.
  • "Being able to compete and win a full-and-open IDIQ contract confirms our strategic investments align with our customer needs."
  • News of the award arrived during an energetic period of rapid growth for Agile Defense, just weeks after welcoming Rick Wagner as the new CEO.
  • Agile Defense's joint venture, Agile-Bot II, was also recently selected to deliver credentialing services to DISA Joint Service Provider (JSP).

Eventide Communications' NexLog DX-FIPS Recorders Achieve JITC Certification

Retrieved on: 
Tuesday, November 14, 2023

"The JITC certification is a testament to our unwavering commitment to delivering secure, reliable, and cutting-edge solutions that meet the highest industry standards," said Brad Basile, COO of Eventide Communications.

Key Points: 
  • "The JITC certification is a testament to our unwavering commitment to delivering secure, reliable, and cutting-edge solutions that meet the highest industry standards," said Brad Basile, COO of Eventide Communications.
  • "Our NexLog DX-FIPS recorders not only meet, but exceed the stringent guidelines set by NIST and the various applicable Security Technical Implementation Guides (STIGs) within."
  • Our JITC-approved recorders are designed with military-grade security and reliability to provide clear, reliable audio capture and advanced data management capabilities.
  • If you are interested in learning more about the advantages of implementing JITC-certified recorders, please visit our JITC landing page or contact our Eventide sales team to request a demo today.

Enterome Presents Immune-Monitoring Data on EO2401 at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)

Retrieved on: 
Wednesday, November 1, 2023

PARIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced the presentation of immune-monitoring data from the ongoing trials of EO2401 in adrenal tumors and recurrent glioblastoma at the 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting taking place from November 1-5, 2023, in San Diego, California, and virtually.

Key Points: 
  • PARIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, today announced the presentation of immune-monitoring data from the ongoing trials of EO2401 in adrenal tumors and recurrent glioblastoma at the 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting taking place from November 1-5, 2023, in San Diego, California, and virtually.
  • EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics™ peptide-based immunotherapy.
  • The poster details are as follows:
    Title: “EO2401, a new peptide immunotherapy against cancer, in combination with nivolumab, induces a strong and durable immune response in patients from the EOADR1-19/SPENCER Study”
    In addition, research collaborator from Tübingen University, Germany, presents immune response data from the ongoing Phase 1/2 ROSALIE study of EO2401 in combination with nivolumab in recurrent glioblastoma.
  • Title: “Characterisation of the immune response to EO2401, a new immunotherapy approach against cancer, plus nivolumab in recurrent glioblastoma: The EOGBM1-18/ROSALIE study”
    All abstracts will subsequently be published as a supplement in the Journal for ImmunoTherapy of Cancer (JITC), Dec. 2023.