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
BTG Pactual Timberland Investment Group Raises US$1.24 Billion for Largest Reforestation Fund to Date[1]28.4.2026 17:00:00 CEST | Press release
Milestone positions Latin American reforestation strategy as a leading model for scalable, high-integrity conservation and restoration—combining sustainable commercial reforestation with large-scale ecosystem conservation and restoration to target economic returns, climate and biodiversity gains, and rural community benefits. Conservation International serves as Impact Adviser for social and environmental outcomes. BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland managers, today announced the close of fundraising for its Latin American Reforestation Strategy, reaching US$1.24 billion in commitments. This represents the largest reforestation fund closed to date,1 providing a model for large-scale reforestation and restoration that seeks to deliver durable climate impact, tangible benefits for rural communities, biodiversity outcomes, and sustainable commercial production. Global environmental organization Conservation International serves
Qatar Implements Relief Measures to Support Business Community28.4.2026 16:56:00 CEST | Press release
Qatar has activated a comprehensive package of support measures designed to maintain market stability and reinforce investor confidence amid evolving regional conditions. These measures, delivered through the nation’s foreign direct investment ecosystem, provide immediate financial, regulatory and operational relief to Qatar’s international business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428904909/en/ Infographic highlights key relief measures implemented in Qatar to support the business community (Infographic: AETOSWire) H.E. Sheikh Faisal bin Thani Al Thani, Minister of Commerce and Industry and Chairman of Invest Qatar, stated: “Qatar’s commitment to its business community is unwavering. As regional conditions continue to evolve, we remain fully focused on acting decisively to support companies operating in our market, safeguard business continuity and reinforce confidence. Our approach is grounded i
Dubai’s Medcare Hospital Becomes the World’s First to Treat an Adult Spinal Muscular Atrophy (SMA) Patient Outside the US28.4.2026 15:57:00 CEST | Press release
Medcare Royal Speciality Hospital (MRSH) in Dubai has become the world’s first hospital outside the USA, to offer a newly licensed intrathecal gene therapy - Itvisma, to adult patients with Spinal Muscular Atrophy (SMA). This one-time treatment was recently administered to a 22-year-old Egyptian patient, who was diagnosed at 18 months and confined to a wheelchair for most of his life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428038416/en/ Dr. Vivek Mundada with Medcare multidisciplinary medical team (Photo: AETOSWire) Last year, Medcare also became the first healthcare provider globally to administer the newly licensed Itvisma to a four-year-old international SMA patient. SMA is a rare neuromuscular disease that leads to progressive muscle weakness and loss of mobility, impacting movement, breathing, and swallowing. Until now, advancements in gene therapy for SMA were primarily restricted to children under the age o
Perpetual Atomics and QSA Global Fuel the World’s First Americium-Powered Radioisotope Heater Unit Core28.4.2026 15:48:00 CEST | Press release
In a landmark achievement for international space exploration, Perpetual Atomics, QSA Global, Inc. and the University of Leicester have completed the first historical production of an Americium-fuelled Radioisotope Heater Unit (RHU) full scale core containing ceramic form americium-241 pellets in a metal containment structure. This breakthrough builds on the successful americium pelleting work in late 2025 and on two decades of experience in leading the development of americium space nuclear power systems by the Leicester team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428027123/en/ QSA Global and Perpetual Atomics Team Born out of ENDURE, a European Space Agency (ESA) project, and part of a transatlantic collaboration, this achievement provides the steppingstones for an industrial pathway to deliver radioisotope power systems for spacecraft enabling these to survive and thrive in the most extreme environments in the
Alipay Launches AI Payment Processing Product to Help Businesses and OPCs Thrive in the Agentic Economy28.4.2026 15:47:00 CEST | Press release
New solution enables businesses to monetize services through AI agents Alipay today launched a new AI payment processing product that enables businesses, large and small, including One Person Companies (OPCs) in the Chinese mainland, to receive payments seamlessly when autonomous AI agents, including OpenClaw-type agents, purchase their services. This new product is being launched as AI agents are increasingly executing tasks on behalf of users, from booking travel and comparing prices, to allocating computing power and buying tokens. The product is available on Alipay’s website (https://aipay.alipay.com/). With Alipay’s AI payment processing product, small and medium-sized businesses do not need to build complex payment or settlement systems. By simply onboarding their monetizable services, businesses can reach more customers and receive payment each time an AI agent purchases their service. Bocha, an AI-powered search tool offering web search support for AI applications including Dee
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