PsiOxus to Present Positive Biomarker Data at ESMO 2021 Demonstrating the Potential of Their Novel Tumor-Selective T‑SIGn® vector, NG-350A, to Re-Engineer Advanced Cancers
15.9.2021 16:00:00 EEST | 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210915005675/en/
Contact information
PsiOxus Therapeutics Ltd.
Priya Mande
+44 1235 42 98 40
PublicRelations@psioxus.com
www.psioxus.com
Media Requests
Mario Brkulj and Amanda Houlihan
MacDougall
+49 175 5711562 or +1 781-235-3060
PsiOxus@macbiocom.com
www.macbiocom.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 02:56:00 EEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 19:19:00 EEST | Press release
Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,” she added. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the co
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 18:00:00 EEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 17:13:00 EEST | Press release
For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and more practical: what it takes to make a specific, high-stakes determination reliable, fast and affordable at scale. A vertical, domain-focused process, gro
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 17:08:00 EEST | Press release
Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d
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