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
MTU Maintenance Lease Services Invests in TRecs to Digitalise Engine Transition Management13.5.2026 10:05:00 CEST | Press release
MTU’s engine leasing arm becomes a shareholder in TRecs, reinforcing its commitment to digitalising engine lifecycle management MTU Maintenance Lease Services B.V. (“MLS”), the engine leasing and asset management arm of MTU Maintenance, today announced a strategic minority investment in TRecs (trecs.aero). TRecs is a platform digitalising Open Item List (OIL) management across the engine lifecycle, from initial technical review through transitions, shop visits, and beyond. Terms of the transaction are kept confidential. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513682497/en/ Through its deployment of TRecs, MLS moves further into its leading role in moving the engine leasing industry toward a cloud-based, collaborative standard designed specifically for leasing and asset management customers. MLS will use the platform across the engine lifecycle, from the initial technical review of acquired or leased-in engines thro
NIPPON KINZOKU Strengthens Promotion of "L-Core" as an Eco-Product: Functional Stainless Steel Achieving High Conductivity via Surface Modification13.5.2026 10:01:00 CEST | Press release
- Eliminates Plating, Lowers Costs, and Resists Corrosion even in high-temperature, high-humidity environments - NIPPON KINZOKU CO., LTD. (TOKYO: 5491) (Headquarters: Minato-ku, Tokyo) is proud to announce the strengthened promotion of "L-Core," a functional stainless steel that utilizes proprietary surface modification technology to achieve extremely low contact resistance while maintaining the inherent corrosion resistance of stainless steel. We have repositioned L-Core as a strategic "Eco-Product" to support sustainable manufacturing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513728897/en/ While conventional stainless steel excels in corrosion resistance due to its "passive film," this same film typically acts as an electrical insulator. Consequently, components requiring conductivity have traditionally relied on high-cost nickel (Ni) plating or conductive tapes. L-Core solves this challenge by making the passive
Hermes Reply Presents Brick Cognitive, the Agentic Operating System for Manufacturing13.5.2026 10:00:00 CEST | Press release
Hermes Reply, the Reply Group company specialized in digital transformation for manufacturing, presents Brick Cognitive, the new agentic operating system designed to bring AI to the centre of industrial operations. A natural extension of Brick Reply, Reply’s next-generation MES/MOM platform, Brick Cognitive introduces a model in which factory systems no longer simply execute and monitor operations, but isable to interpret what is happening, correlate events and guide action across production, quality, maintenance and planning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513981153/en/ Brick Reply, Reply’s next-generation MES/MOM platform, Brick Cognitive introduces a model in which factory systems no longer simply execute and monitor operations, but is able to interpret what is happening, correlate events and guide action across production, quality, maintenance and planning. In production environments, data and processe
MC Advances Supply Chain Transformation with Blue Yonder Cognitive Solutions13.5.2026 10:00:00 CEST | Press release
Leadingretailer strengthens agility with AI and machine learning to improve allocation and replenishment decisions across its network and brands MC, the retail division of Sonae and a leading player in Portugal’s grocery market and health, wellness, and beauty retail across the Iberian Peninsula, has selected Blue Yonder Cognitive Solutions for Allocation and Replenishment to advance its supply chain transformation. With more than 400 stores across multiple formats, MC operates major supermarkets and hypermarkets such as Continente, along with convenience stores, health and wellness shops, and online grocery services. Blue Yonder’s advanced artificial intelligence (AI) and machine learning (ML) enabled solutions will help the company improve visibility into demand forecasting. The new solutions will be implemented by Blue Yonder Services. “The grocery retail sector is adapting to a period of significant change, underlining the need for more agile operations across the supply chain. We
Oral‑B Announces The Big Rethink 2026, Launching One of Europe’s Largest Disability‑Focused Oral Health Studies13.5.2026 09:06:00 CEST | Press release
Oral‑B and iADH build on four years of action to advance inclusive oral care and whole‑body health41% of Europeans identify as living with a disability, representing a four‑point increase wave‑on‑wave Oral‑B today announces The Big Rethink 2026, the next evolution of its flagship oral health inclusion programme, developed in partnership with the International Association for Disability and Oral Health (iADH). The new phase introduces Project Steady, one of Europe’s largest real‑world studies exploring oral care experiences among people with disabilities, their carers and dental professionals. The programme aims to reduce everyday barriers to oral care through inclusive design, evidence-based research and professional education. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511175864/en/ Oral B Announces The Big Rethink 2026, Launching One of Europe’s Largest Disability Focused Oral Health Studies Oral health for Whole-Bo
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