PSIOXUS-THERAPEUTICS
15.9.2021 15:02:12 CEST | Business Wire | Press release
PsiOxus Therapeutics, Ltd . (PsiOxus), a tumor re-engineering company, today announced that they will present key safety and translational data from their first-in-human phase 1 FORTITUDE clinical study at the European Society for Medical Oncology (ESMO) Congress 2021 this week. Data from the completed monotherapy dose-escalation part of the FORTITUDE study, initiated in 2019 to assess the safety and tolerability of the NG-350A T-SIGn® vector, will be presented on Friday 16th September 2021, with the poster available in full at www.psioxus.com shortly afterwards.
NG-350A is a T-SIGn® vector designed to re-engineer cancers by selectively expressing a CD40 agonist monoclonal antibody, a potent activator of immuno-inflammatory responses, within the tumour microenvironment. PsiOxus is developing this agent as one of several products within its T-SIGn® portfolio of vectors that combine systemic delivery with localized production of powerful transgene payloads to allow the selective re-engineering of both primary and metastatic tumors.
The data to be presented at the ESMO Congress show that IV delivery of NG-350A results in sustained elevations of inflammatory cytokines in the phase 1 FORTITUDE trial. In particular, marked and persistent dose-dependent increases in both IL-12 and IFNγ were observed after a single 1-week course of NG-350A, indicative of robust activation of antigen presenting cells via CD40 agonism generated within the tumor. Expansion of new T cell clones, a high proportion of which were new clones, was also observed following a single cycle of NG-350A. Safety data from the 25 patients treated with NG-350A as part of the now completed monotherapy dose-escalation part of FORTITUDE demonstrated that NG‑350A was well-tolerated, with few of the adverse events associated with systemic delivery of anti-CD40 agonists observed.
Together, these data suggest NG-350A contributes to the re-programming of the tumour microenvironment while avoiding the toxicity associated with systemic non-localized dosing of anti-CD40 antibodies.
“The headline data shared at the ESMO Congress confirms previous findings that our T-SIGn vector replicates selectively in primary tumor cells and metastases and persists for several months after intravenous delivery. Even more importantly, the biomarker data indicates that ongoing vector replication in tumors effectively translates into sustained production of the transgene payload, in this case a CD40 agonistic antibody. This translational data is a first in class demonstration of a downstream effect of tumor re-engineering, using T-SIGn vectors to turn the patient’s tumor cells into small drug factories,” said Tom Lille, M.D., Ph.D., Chief Medical Officer, PsiOxus.
Based on these highly promising data, NG-350A will be assessed in combination with an anti–PD-1 checkpoint inhibitor in Part B of FORTITUDE.
About PsiOxus
PsiOxus is a clinical stage oncology company pioneering systemic immune oncology products that drive sustained reprogramming of the tumor microenvironment to overcome the central challenge of resistance to therapy. Our flexible and validated T‑SIGn® vector platform can deliver multiple transgene payloads that re-engineer both primary and metastatic tumors. We have a rapidly expanding pipeline of novel monotherapy and combination products to dramatically improve outcomes for patients with cancer. For more information, please visit https://psioxus.com/ .
About T-SIGn®
Tumor-Specific Immuno-Gene Therapy (T-SIGn) is a broad platform for tumor re-engineering by delivering combinations of transgenes encoding immunotherapeutic proteins in a single agent. Transgenes are selected based on their functional abilities to reprogram the tumor microenvironment and thus promote anti-tumor responses. T-SIGn utilizes a systemically deliverable viral vector with clinically demonstrated selectivity for, and activity in, tumor cells. In addition to NG-350A, NG-641 (a bi-specific antibody approach targeting the tumor stroma) is also in ongoing clinical trials and further candidates are in late-stage preclinical development. This portfolio of multi-targeted vector candidates are being developed by PsiOxus alone or in collaboration with partners.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210915005675/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Xsolla Announces Reseller Program to Help Game Developers Unlock New Revenue Streams in Local Markets5.3.2026 18:00:00 CET | Press release
Game Developers And Publishers Can Now Reach More Players By Partnering with Official Distributors And Resellers Globally Without Building Local Infrastructure Xsolla, a leading global video game commerce company, today announced the Xsolla Reseller Program, a new product designed to help game developers scale and capture untapped revenue in local markets with no development needed. The program launches with a curated cohort of resellers and distributors in Southeast Asia and Latin America, with expansion into additional regions throughout 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305047070/en/ Graphic: Xsolla As game developers pursue global growth, they face a fundamental infrastructure challenge: billions of dollars in revenue remain untapped in emerging, cash-dependent economies, such as Southeast Asia, Latin America, the Middle East, and North Africa, where players purchase digital content through local di
Andersen Consulting styrker sine kompetencer inden for cybersikkerhed gennem samarbejde med A3Sec5.3.2026 17:16:00 CET | Pressemeddelelse
Andersen Consulting styrker sine tilbud inden for cybersikkerhed og teknologisk transformation gennem en samarbejdsaftale med A3Sec, et firma, der specialiserer sig i datadrevet trusselsdetektion, hændelsesrespons og exposure management. Med hovedsæde i Spanien og kontorer i Mexico og Colombia har A3Sec mere end 14 års erfaring med at hjælpe offentlige og private organisationer inden for finans, telekommunikation, energi, den offentlige sektor og erhvervslivet med at sikre deres digitale aktiver. Virksomheden driver sit Security and Digital Surveillance Center® (CSVD®) døgnet rundt med et team på over 180 cybersikkerhedseksperter og betjener mere end 280 kunder verden over. Firmaet leverer integrerede cybersikkerhedstjenester, herunder managed detection and response, cybertelemetri, trusselsanalyse og krisestyring, og hjælper kunder med at styrke deres robusthed og omdanne risiko til en strategisk fordel, samtidig med at de effektivt håndterer eksponering og minimerer risiko. "Vores fo
Xsolla Agency Launches to Empower Creators Across Entertainment-Based Intellectual Property5.3.2026 16:23:00 CET | Press release
New Service Simplifies Access to Premium IP Licensing, Driving Discoverability, Player Engagement, and Revenue for Game Developers Xsolla, a global video game commerce company, today launched Xsolla Agency, a comprehensive service connecting game developers with premium entertainment-based intellectual property (IP). The integrated offering addresses critical challenges for game creators: access to world-class IP, global monetization capabilities, and the operational infrastructure needed to build sustainable businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305044119/en/ Graphic: Xsolla Xsolla Agency simplifies access to entertainment-based licenses through expert-led negotiations and industry relationships, offering affordable, monetization-focused deals structured for maximum ROI. Strategic IP partnerships increase discoverability, reduce user acquisition costs, and drive higher player spend through impactful
Vertex to Present New Data on JOURNAVX® That Demonstrates Effective Pain Management Following Aesthetic and Reconstructive Procedures5.3.2026 16:00:00 CET | Press release
-Over 90% of patients in the study were opioid free through the end of multimodal treatment with JOURNAVX--These data have been accepted for oral presentation at the American Academy of Pain Medicine Meeting- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from a Phase 4 study of JOURNAVX® (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These dat
Onego Bio and Sigma Foods Enter Collaboration to Strengthen Egg Protein Innovation and Supply Resilience5.3.2026 16:00:00 CET | Press release
Onego Bio, a food ingredient company producing non-animal egg protein, and Sigma Foods ("SIGMA"), a leading multinational food company, have entered into a collaboration agreement to evaluate the functionality and commercial potential of Bioalbumen®, a non-animal egg protein made with using precision fermentation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305756400/en/ The partnership focuses on advancing ingredient innovation while addressing urgent challenges in today’s egg supply chain—including volatility, rising prices, and avian flu-related disruptions. Bioalbumen® offers a shelf-stable, animal-free alternative that delivers the same functional, nutritional, and sensory performance as traditional eggs, while helping safeguard supply continuity for food manufacturers. Additionally, this collaboration supports Sigma’s commitment to offering safe, nutritious, and high-quality food, while driving science-based inno
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom