DELTA-FLY-PHARMA
2.2.2024 07:16:29 CET | Business Wire | Press release
We are excited to share our latest development status.
As presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months).
Subsequently, based on these results, we have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in our decision to conduct a Phase III clinical trial (superiority study) of DFP-14323 in combination with afatinib (20 mg/day) versus afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive based on the PMDA's recommendation.
And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.
This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, we believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical.
Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.
We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.
Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.
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/20240201128942/en/
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
Airship Announces Results Guarantee; Releases Commissioned Study Finding 476% ROI for Composite Organization22.7.2026 17:00:00 CEST | Press release
Airship stands behind results with new guarantee offer*; also launches a commissioned study quantifying how a composite organization moved past vanity metrics to drive $7.3M in value Airship, the mobile-first customer experience platform leader, today announced its Airship Results Guarantee, a corporate commitment to achieve predetermined business outcomes for new customers. Concurrently, the company released the results of a separate, commissioned Total Economic Impact™ (TEI) study conducted by Forrester Consulting on behalf of Airship, July 2026. The study found that a composite organization based on interviewed customers achieved a 476% Return on Investment (ROI) with a payback period of less than six months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722832535/en/ Airship has launched a new results guarantee offer to stand behind its value. Alongside this offer, the team shared the results of a new Total Economic
Arrakis Comes out of Stealth With $38M to Help Industrial Enterprises Compete in the AI Era22.7.2026 15:56:00 CEST | Press release
Funding led by Blossom Capital with participation from Accel, GFC, MainObject, and Rerail, bringing total raised to around $38 million in just six months. Arrakis helps industrial companies deploy AI agents into mission-critical operations, tackling the "last mile" challenge that prevents most AI projects reaching production. The funding will enable office openings in New York and the Middle East, platform development and AI deployment in the world's most operationally complex industries. Arrakis, the AI deployment company helping industrial companies install AI agents for mission-critical operations, today announced a $30 million Series A led by Blossom Capital, with participation from existing investor Accel, which also led the company's $7.5 million seed round. The round brings total funding to around $38 million and includes backing from prominent technology leaders, including Olivier Pomel, founder and chief executive of Datadog, Olivier Godement, OpenAI’s Head of business product
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 15:00:00 CEST | Press release
Cambridge University's Energy & Environment Group Deploys Planetary-Scale Foundation Model on Vultr Cloud GPU Infrastructure Powered by AMD Instinct™ MI325X GPUs Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Se
StructureCraft Scales Data-Driven Design on NetApp22.7.2026 14:00:00 CEST | Press release
Structural engineering firm modernizes data infrastructure to support global collaboration NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that StructureCraft, an award-winning global structural engineering and construction firm known for complex timber and hybrid builds, is now using NetApp to modernize and create an AI-ready data infrastructure. The new infrastructure enables the company’s employees to collaborate globally, store and manage large-scale design workloads, and take advantage of AI-driven tools on a scalable, centralized platform. StructureCraft specializes in innovative timber engineering, structural design, and sustainable building solutions for large-scale architectural projects worldwide. Its globally distributed team delivers complex projects across North America, Europe, and Asia, guided by a core purpose to engineer and build beautiful, efficient structures. The StructureCraft team regularly takes on complex projects such as de
OneSpan Introduces DigipassONE, Bringing a Unified Platform Approach to Authentication Modernization22.7.2026 14:00:00 CEST | Press release
A new authentication platform helps financial institutions support diverse customer authentication preferences while modernizing at their own pace Organizations are under increasing pressure to modernize authentication while supporting existing infrastructure, meeting evolving regulatory requirements, deploying emerging technologies, and reducing operational complexity. For financial institutions in particular, authentication modernization must balance security, compliance, and operational efficiency while meeting the evolving expectations and preferences of their customers. Yet the journey to modern authentication is rarely a single technology transition. Organizations must continue supporting multiple authentication methods while gradually adopting new technologies, making it essential to modernize without disrupting existing environments, user experiences, or business operations. To help organizations navigate this transition, OneSpan Inc. (NASDAQ: OSPN) today announced DigipassONE™
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