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The FDA has granted fast track designation to the oncolytic immunotherapy NG-350A for use as a potential therapeutic option in patients with mismatch repair–proficient (pMMR) locally advanced rectal cancer (LARC), according to an announcement from Akamis Bio.¹

NG-350A is a clinical-stage T-SIGn® therapy that is delivered intravenously and engineered to encourage intratumoral expression of a CD40 agonist monoclonal antibody; this stimulates activation of antigen-presenting cells (APCs) within solid tumors and their draining lymph nodes. Activated APCs then draw T cells to the tumor site, introducing a strong antitumor immune response. The agent is being explored in combination with chemoradiotherapy in adult patients with LARC with at least 1 risk factor for local or distant recurrence or with oligometastatic disease as part of the phase 1b FORTRESS trial (NCT06459869).² In April 2025, it was announced that the first patient was enrolled in the study,³ which is still actively recruiting.¹

“The NG-350A fast track designation from the FDA is a recognition of the significant unmet need for new therapies to treat LARC,” Oliver Rosen, MD, chief medical officer at Akamis Bio, stated in a news release. “The global incidence of LARC continues to rise, with a particularly alarming increase of this cancer among younger populations. Patients with pMMR tumors account for approximately 90% of LARC cases, and this population has the greatest need for evolution in the standard of care to include treatments that may enable patients to avoid surgical interventions.”

NG-350A in Locally Advanced Rectal Cancer and Beyond: Top Takeaways

• The FDA granted fast track designation to NG-350A for mismatch repair–proficient locally advanced rectal cancer, highlighting the urgent need for new therapies in this population.

• NG-350A, an intravenous T-SIGn® therapy, activates antigen-presenting cells and recruits T cells to tumors; it has shown persistence in blood, dose-dependent tumor activity, and cytokine boosts in early clinical studies.

• The phase 1b FORTRESS study is testing NG-350A with capecitabine and radiotherapy in approximately 30 patients, with clinical complete response at 12 weeks as the primary end point and safety and tumor regression as secondary outcome measures of interest.

What First-in-Human Clinical Outcomes Have Been Reported With NG-350A?

Data from a phase 1a/1b study (NCT03852511) showed that in heavily pretreated patients with metastatic or advanced epithelial tumors (n = 25), the drug was well tolerated irrespective of administration approach: intravenous, which comprised 4 dose levels each with infusions on days 1, 3, and 5 of 57-day periods, and IT, which comprised solitary injection on day 1 only or injections on days 1, 8, 15, and 22.⁴ There was no evidence of transgene-related or off-target viral toxicity.

Additional findings revealed:

• Continued persistence of the drug in blood samples up to 7 weeks following the last dose, especially with higher IV dose levels
• Dose-dependent pattern was observed with IV infusion, with 4 patients positive for vector DNA in biopsies at day 57
• Transgene messenger RNA from replicating NG-350A was identified in 5 of 12 patients who received the agent IV and in 1 of 9 patients who had IT administration
• Sustained boosts in inflammatory cytokines were noted after dosing, particularly at higher IV dose levels

What Are the Design and Key Objectives of the FORTRESS Study?

The open-label, single-arm, multicenter phase 1b trial plans to enroll approximately 30 patients aged 18 years or older with histologically confirmed adenocarcinoma of the rectum with locally advanced disease and microsatellite stable or pMMR status.^2,3 Patients are required to have an ECOG performance status of 0 or 1 and acceptable lung, renal, hepatic, and bone marrow function at least 10 days before their first dose of treatment. If they had recurrent rectal cancer, distant metastatic disease not amenable to radical treatment or chemoradiation, another active prior malignancy within the past 3 years, or underwent splenectomy, they were excluded.

Patients will receive NG-350A plus oral capecitabine and long-course intensity-modulated radiotherapy during a 12-week active study treatment period. The primary outcome measure is the proportion of patients achieving a clinical complete response at week 12, and secondary outcome measures include incidence and severity of adverse effects (AEs), clinical response outcomes, and MRI-based tumor regression grade.

“We have previously demonstrated that intravenously administered T-SIGn® therapeutics can reach both primary and metastatic tumor sites to drive local expression of immunotherapeutic payloads,” Rosen said in a previous news release.³ “The results from prior clinical studies have provided what we believe is a clear roadmap for the design of the FORTRESS trial, where our aim is to demonstrate the safety and efficacy of NG-350A in LARC in order to advance a new therapeutic approach that can improve the current standard of care for patients living with this disease.”

Is NG-350A Under Investigation in Any Additional Studies?

The open-label, nonrandomized, multicenter, phase 1a/1b FORTIFY study (NCT05165433) will explore the combination of NG-350A and pembrolizumab (Keytruda) in patients with metastatic or advanced epithelial tumors.⁵

The phase 1a portion of the research will enroll patients with histologically or cytologically documented metastatic or advanced epithelial cancer that has relapsed from or is refractory to standard treatment or for which no standard option is available. Patients will be required to have at least 1 measurable disease site by RECIST 1.1 criteria and an ECOG performance status up to 1. Here, NG-350A will be given intravenously in combination with fixed-dose pembrolizumab.

All patients, irrespective of the portion of the trial, need to be at least 18 years of age, have a life expectancy of at least 6 months, and have acceptable lung, renal, hepatic, and bone marrow function. The primary outcome measure is the incidence of AEs.

References

1. Akamis Bio receives FDA fast track designation for NG-350A for the treatment of mismatch repair-proficient locally advanced rectal cancer. News release. Akamis Bio. October 14, 2025. Accessed October 14, 2025. https://www.akamisbio.com/items/akamis-bio-receives-fda-fast-track-designation-for-ng-350a
2. NG-350A plus chemoradiotherapy for locally advanced rectal cancer (FORTRESS). ClinicalTrials.gov. Updated August 11, 2025. Accessed October 14, 2025. https://clinicaltrials.gov/study/NCT06459869
3. Akamis Bio announces enrollment of first patient in phase 1b FORTRESS trial of NG-350A in patients with locally advanced rectal cancer. News release. Akamis Bio. April 3, 2025. Accessed October 14, 2025. https://www.akamisbio.com/items/akamis-bio-announces-enrollment-of-first-patient-in-phase-1b-fortress-trial-of-ng-350a-in-patients-with-locally-advanced-rectal-cancer
4. Naing A, Khalil D, Rosen O, et al. First-in-human clinical outcomes with NG-350A, an anti-CD40 expressing tumor-selective vector designed to remodel immunosuppressive tumor microenvironments. J Immunother Cancer. 2024;12(10):e010016. doi:10.1136/jitc-2024-010016
5. Study of NG-350A plus pembrolizumab in metastatic or advanced epithelial tumors (FORTIFY) (FORTIFY). ClinicalTrials.gov. Updated August 11, 2025. Accessed October 14, 2025. https://clinicaltrials.gov/study/NCT05165433

NEW DELHI and MUMBAI and ARMONK, N.Y., Oct. 15, 2025 /PRNewswire/ — Bharti Airtel, one of India’s leading telecommunications service providers has entered into a strategic partnership with IBM (NYSE: IBM) to augment its recently launched Airtel Cloud. The partnership is expected to bring together the telco-grade reliability, high security, and data residency of Airtel Cloud with IBM’s leadership in cloud solutions, and advanced infrastructure and software technologies designed for AI inferencing. 

Together, Airtel and IBM will aim to enable enterprises in regulated industries to scale AI workloads more efficiently, delivering interoperability across infrastructure including on-premise, in the cloud, across multiple clouds and at the edge. 

In the photo standing Left to Right: Hans Dekkers, GM, APAC, IBM; Jagat Killawala, Member Managing Committee & Executive Committee and Chairman IT, NMIMS; Jayanta Banerjee, CIO, Tata Steel; Jayen Mehta, MD, Amul; Dinesh Nirmal, SVP, Software Products, IBM; Sandip Patel, MD, IBM India & South Asia

Through this partnership, Airtel Cloud customers will be able to deploy the IBM Power systems portfolio as-a-Service, including the latest-generation IBM Power11 autonomous, AI-ready servers for mission-critical applications in regulated industries like banking, healthcare, government and others. The Power11 hybrid platform will also support critical enterprise workloads including IBM Power AIX, IBM i, Linux and SAP Cloud ERP.  Additionally, this partnership will help enable SAP customers on IBM Power with their enterprise resource planning transformation to SAP Cloud ERP on IBM Power Virtual Server.

Gopal Vittal, Vice Chairman & Managing Director, Bharti Airtel, said, “Airtel Cloud is designed to be highly secure and compliant, setting new industry benchmarks as an agile and resilient cloud platform. Today, with the IBM partnership, we are adding substantial capabilities to our Cloud platform to address the unique needs of several industries that require migration from IBM Power systems and allow for AI readiness. With this partnership, we are also extending the footprint of our availability zones in India from four to ten, hosting these on our own next-gen sustainable data centers. We will, together, also establish two new Multizone Regions (MZRs) in Mumbai and Chennai soon.”

Rob Thomas, SVP and Chief Commercial Officer, IBM, said, “Enterprises today need to balance modernization with the growing regulated technology and AI requirements. Through our partnership with Bharti Airtel, clients across India can leverage IBM’s innovative cloud offerings designed for workloads that address their strategic business priorities. Together, we will help clients drive true transformation in the era of AI.”

With IBM’s software stack for AI inferencing, built on IBM watsonx and Red Hat OpenShift AI, clients in India will have the ability to run AI inference across hybrid cloud environments. These capabilities are coupled with IBM’s enterprise-grade cloud platform with innovative IaaS and PaaS offerings, as well as IBM’s automation portfolio designed for accelerating the impact of generative AI in core enterprise workflows to drive productivity. Customers will be able to access Red Hat’s hybrid cloud solutions including Red Hat OpenShift Virtualization, Red Hat OpenShift and Red Hat AI. Beyond these capabilities, IBM’s hybrid cloud architecture is designed to help clients enable future innovation in AI and quantum computing. 

Airtel Multizone Regions will help Indian enterprises strengthen their resilience, address data residency requirements and keep mission-critical workloads and applications up and running at all times. Together, the Airtel and IBM partnership will enable Indian enterprises to accelerate digital innovation at scale.

Statements regarding IBM’s future direction and intent are subject to change or withdrawal without notice and represent goals and objectives only.

About Bharti Airtel

Headquartered in India, Airtel is a global communications solutions provider with over 600 million customers in 15 countries across India and Africa. The company also has its presence in Bangladesh and Sri Lanka through its associate entities. The company ranks amongst the top three mobile operators globally and its networks cover over two billion people. Airtel is India’s largest integrated communications solutions provider and the second largest mobile operator in Africa. Airtel’s retail portfolio includes high-speed 4G/5G mobile, Wi-Fi (FTTH+ FWA) that promises speeds up to 1 Gbps with convergence across linear and on-demand entertainment, video streaming services, digital payments and financial services. For enterprise customers, Airtel offers a gamut of solutions that includes secure connectivity, cloud and data centre services, cyber security, IoT, and cloud-based communication. Airtel’s digital arm – Xtelify, empowers telcos globally to leverage the power of AI, data and technology to accelerate their digital transformation and drive growth. Xtelify also offers Airtel Cloud in India enabling enterprises with a sovereign, telco-grade cloud platform that guarantees secure migration, effortless scaling, lower costs and no vendor lock-ins. Within its diversified portfolio, Airtel also offers passive infrastructure services through its subsidiary Indus Tower Ltd. For more details visit www.airtel.com.

About IBM

IBM is a leading provider of global hybrid cloud and AI, and consulting expertise. We help clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. Thousands of government and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in AI, quantum computing, industry-specific cloud solutions and consulting deliver open and flexible options to our clients. All of this is backed by IBM’s long-standing commitment to trust, transparency, responsibility, inclusivity and service. Visit www.ibm.com and www.ibm.com/cloud for more information.

Media Contact:

Kate Gazzillo

Kate.gazzillo@ibm.com 

Prasanna Ramanathan

Prasanna.s.r@ibm.com 

SOURCE IBM

Shein has reported a 20% rise in global revenues to $37bn (£27.7bn) but profits have fallen as the fast-fashion retailer faced increased costs, even before it felt the impact of recent changes to US tax laws.

The Singaporean parent company of the rapidly growing retailer said pre-tax profits had fallen by 13% to $1.5bn last year from $1.3bn in 2023 after an increase in selling and marketing costs, according to new accounts.

Shein is thought to be trying to list on the Hong Kong stock exchange after efforts to list in the US and UK for an estimated £50bn valuation went awry.

The China-founded online seller warned that changes to US tariff policies since April this year and their “frequent evolution” had “increased the level of uncertainties in the global economy”.

“The ongoing evolution of trade policies continues to introduce complexities for businesses that may affect the group’s and the company’s future financial condition and operations,” it warned.

Shein, which makes its revenues from selling goods and from fees on marketplace sellers, is thought to have taken a big hit to trade in the US this year after Donald Trump’s administration closed a loophole which allowed goods worth less than $800 being imported and sent directly to shoppers without certain checks and duty.

The de minimis exemption, which had been in place since 1938, was intended to foster growth for importers of small goods, latterly including e-commerce marketplaces. However, the exemption had been criticised for enabling the rapid growth of cheap imports from China via Shein and Temu.

Income tax paid by the group remained steady at about $188m although that included $6.1m deferred and adjusted tax relating to prior years.

Shein’s UK arm has been accused of transferring the “vast bulk of income” to its Singaporean parentto cut its British tax bill.

The company paid £9.6m in corporation tax in the UK despite making £2bn in sales last year.

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Paul Monaghan at the Fair Tax Foundation said: “It’s still the case that Shein aggressively avoids tax, facilitated by a chain of companies in Singapore, the British Virgin Islands and the Cayman Islands.

“The move of its headquarters to Singapore has seen profits taxed at 5%-8% over the past four years, with tax relief relocation perks benefiting them by US$74.4m in Singapore in 2024 alone.”

The company paid no dividend in 2024 after a $484.5m payout in 2023.

Shein said in a statement: “The claim that Shein is avoiding tax is wholly false. Like any other international company, Shein pays all applicable taxes, including, but not limited to, VAT, corporate tax, and labour taxes, as required, and operates in compliance with the relevant laws and regulations of every market where we operate.”