Business Wire

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


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 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 ​

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, please give your consent at the top of this page.

Contact information

PsiOxus Therapeutics Ltd.
Priya Mande
+44 1235 42 98 40

Media Requests
Mario Brkulj and Amanda Houlihan
+49 175 5711562 or +1 781-235-3060

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

EngageSmart Announces Pricing of Initial Public Offering23.9.2021 02:48:00 CEST | Press release

EngageSmart, Inc., a leading provider of vertically-tailored customer engagement software and integrated payments solutions, today announced the pricing of its initial public offering of 14,550,000 shares of its common stock at a price of $26.00 per share. Of the offered shares, 13,000,000 shares are being offered by EngageSmart and 1,550,000 shares are being offered by certain of EngageSmart’s existing stockholders. In addition, the underwriters will have a 30-day option to purchase from EngageSmart and the selling stockholders up to an additional 2,182,500 shares of their common stock at the initial public offering price, less underwriting discounts and commissions. EngageSmart will not receive any proceeds from the sale of shares of common stock by the selling stockholders. The shares are expected to begin trading on the New York Stock Exchange on Thursday, September 23, 2021, under the ticker symbol “ESMT.” The offering is expected to close on September 27, 2021, subject to customa

InvestaX Gets Closer to Tokenizing the World with MAS Fintech Sandbox23.9.2021 02:00:00 CEST | Press release

InvestaX (IC SG Pte Ltd) launches exchange in the Monetary Authority of Singapore (MAS) sandbox, providing key infrastructure for bringing liquidity to digital securities. This press release features multimedia. View the full release here: Next Generation Digital Assets (Photo: Business Wire) InvestaX is a Singapore-headquartered, MAS-licensed* online investment and trading platform for Digital Securities (DSO) and Security Tokens (STO) of global private markets deals, focusing on exciting growth industries including crypto, gaming, blockchain, digital assets, venture, private equity and real estate. InvestaX, announces entry in the sandbox for its exchange, and now provides a one-stop shop solution for the issuance and trading of digital securities, for global products and global investors. Targeting the $8T USD tokenization of the private markets, InvestaX is built with open infrastructure for scalability and interoperability,

AWS to Open Data Centers in New Zealand23.9.2021 00:52:00 CEST | Press release

Today, Amazon Web Services (AWS), an, Inc. company (NASDAQ: AMZN), announced plans to open an infrastructure region in Aotearoa New Zealand in 2024. The new AWS Asia Pacific (Auckland) Region will consist of three Availability Zones (AZs) and join the existing 81 Availability Zones across 25 geographic AWS Regions at launch. The Region will be owned and operated by a local AWS entity in New Zealand. Globally, AWS has announced plans for 24 more Availability Zones and eight more AWS Regions in Australia, India, Indonesia, Israel, Spain, Switzerland, the United Arab Emirates, and the new AWS Region in New Zealand. The new AWS Asia Pacific (Auckland) Region will enable even more developers, startups, and enterprises as well as government, education, and nonprofit organizations to run their applications and serve end users from data centers located in New Zealand, ensuring that customers who want to keep their data in New Zealand are able to do so. AWS also released an economic

Procore to Acquire Levelset to Simplify Lien Management Workflows for Construction22.9.2021 22:05:00 CEST | Press release

Procore Technologies, Inc., (NYSE: PCOR), a leading provider of construction management software, has signed a definitive agreement to acquire Levelset. This acquisition will add lien rights management to the Procore platform, enabling Procore to manage complex compliance workflows and improve the payment process in construction. It also presents future growth opportunities for Procore, including capitalizing on the companies’ complementary data assets. This press release features multimedia. View the full release here: Burdensome compliance workflows contribute to the construction industry’s median of 90 days sales outstanding and 74 days payable outstanding, the slowest of all industries surveyed across the globe. (Graphic: Business Wire) Procore Founder and CEO Tooey Courtemanche said, “Construction work is hard enough — getting paid shouldn’t be. Levelset helps the construction industry get paid faster, and their offering wi

Leaders in Cloud Adoption Approach Cloud Differently and Achieve 10x Greater ROI, Says Research by Wipro FullStride Cloud Services22.9.2021 18:24:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today released a report indicating that leaders in cloud adoption approach their cloud journey differently than beginners, enabling them to achieve a 10x greater annualized return on investment. Wipro’s report, “Making Business Thrive: A Cloud Leader Roadmap for Achieving 10x ROI,” outlines these best practices for enterprises beginning their cloud journey or seeking to accelerate their results. The report also identifies dozens of key cloud-adoption metrics for multiple industries and countries. Wipro FullStride Cloud Services developed the report based on a survey of 1,300 global C-level executives and key decision-makers from 11 industries and six countries (see “Methodology” below). Wipro considered leaders to be the top 19% of respondents based on cloud maturity, while beginners represented the lowest 32%; this was not based on revenue. Thi

Nathan's Famous Continues International Expansion with European Push to Offer Hot Dogs in France22.9.2021 17:57:00 CEST | Press release

Nathan's Famous, Inc., the American tradition serving New York favorites for more than 100 years, announces a new collaboration with Tommy's Diner, a 50's throwback American diner based in France, to offer its hot dogs in all locations across the country, making it the first time Nathan's Famous is served in France. This relationship continues Nathan's Famous growth in Europe and beyond. This press release features multimedia. View the full release here: Nathan's Famous Menu. (Photo: Business Wire) "Nathan's Famous is known the world over, which is why we've had such great success in recent years growing in the Middle East, Asia, and Great Britain," states James Walker, Senior Vice President, Restaurants. "This new relationship with Tommy's is a big step for us as we look to see that growth spread throughout Europe, and we're excited that they are our first French outpost and will be one of the first internationally to have our

IHMA Opens Microbiology Reference Laboratory in Shanghai, China to Further Support Global Anti-Infective Product Discovery and Development22.9.2021 16:30:00 CEST | Press release

IHMA has opened a microbiology reference laboratory in Shanghai, China in February of 2021. This facility will join IHMA locations in the USA, Switzerland and India to allow the company to provide more robust global support for anti-infective product discovery and development. The China facility will provide microbiology testing to support profiling of new antimicrobial products, antimicrobial resistance surveillance, molecular characterization of resistant organisms, and serve as a central laboratory for clinical trials conducted in China. “We have been working for almost 30 years to maximize our in vitro support for clients who are developing anti-infective products globally. Our facility in China will greatly enhance that effort and support clients wishing to conduct studies in this important market,” said Jack L. Johnson, President/CEO of IHMA. About IHMA: As the leading global microbiology service provider to the biopharmaceutical industry, IHMA utilizes its extensive laboratory a