DELTA-FLY-PHARMA
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
Perma-Pipe International Holdings, Inc. Announces Third Quarter 2025 Financial Results12.12.2025 15:00:00 CET | Press release
Net sales of $61.1 million for the quarter and $155.8 million year-to-date.Income before income taxes of $10.9 million for the quarter and $21.1 million year-to-date.Diluted earnings per share of $0.77 for the quarter and $1.49 year-to-date.Backlog of $148.9 million at October 31, 2025, up from $138.1 million at January 31, 2025. Perma-Pipe International Holdings, Inc. (NASDAQ: PPIH) announced today financial results for the third quarter ended October 31, 2025. “For the three months ended October 31, 2025, net sales were $61.1 million, an increase of $19.5 million, or 46.9%, compared to $41.6 million in the same quarter of the prior year. Growth was driven by higher sales volumes in both the Middle East and North America. Gross profit was $21.0 million, up $6.9 million from $14.1 million last year, reflecting higher activity levels. Selling, general and administrative expenses increased to $8.3 million from $7.3 million, primarily due to higher payroll and professional fees, including
Capcom’s All-new IP PRAGMATA to Launch on April 24, 2026!12.12.2025 15:00:00 CET | Press release
– The title is now also coming to Nintendo Switch 2; a PC demo releases today – Capcom Co., Ltd. (TOKYO:9697) today announced that sci-fi action-adventure game PRAGMATA, a completely new IP, is scheduled for release on April 24, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212791950/en/ PRAGMATA Key Art PRAGMATA is a new type of sci-fi action-adventure game mixing puzzle and action elements. In the game, which takes place on the moon in a near-future world, the spacesuit-clad Hugh and android girl Diana cooperate while fighting their way back to Earth. By bringing the title to Nintendo Switch™ 2 in addition to PlayStation®5 system, Xbox Series X|S and PC, Capcom looks to further advance its multi-platform strategy and expand its user base. Moreover, a playable demo of the game will be released first on PC starting today, December 12, to further convey the appeal of the title. The company hopes that players look fo
Andersen Consulting udvider sit udbud med LBC12.12.2025 11:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med LBC, en Portugal-baseret international virksomhed kendt for sin integrerede tilgang til forretningsoptimering, digital transformation og udvikling af menneskelig kapital, der kombinerer kreativitet og menneskelig etik med ai med henblik på at accelerere værdiskabelse. LBC blev stiftet i 2001 og bistår internationale organisationer, offentlige instanser og virksomheder inden for adskillige brancher, herunder finans, energi, TMT, transport og den offentlige sektor. LBC betjener kunder i Afrika, Nord- og Sydamerika samt Europa og leverer ydelser inden for management consulting, digital transformation, kapacitetsopbygning og ai-implementering. Virksomheden er kendt for en kultur præget af innovativ transformation med fokus på vedvarende resultater og hjælper kunder med at navigere i komplekse forandringer med målbar effekt. Nylige investeringer i enterprise AI styrker virksomhedens kompetencer inden for UX/UI, auto
INNIO to Supply Technology for a Landmark Project in Texas, Reinforcing Grid Stability12.12.2025 09:59:00 CET | Press release
INNIO Group, a leading energy solution and service provider, is collaborating with the U.S. power utility Greenville Electric Utility System (GEUS) on a landmark 104-megawatt (MW) power plant. The new plant is designed to help reinforce grid stability, cover peak loads, and enable greater integration of renewable energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211712708/en/ Jenbacher J920 FleXtra “This project is a milestone for Texas and for INNIO. With fast-start capability, flexibility, and sustainability, we are creating the energy infrastructure that modern grids need: reliable, growth-promoting, and supporting the expansion of renewables,” said Dr. Olaf Berlien, President and CEO of INNIO Group. Groundbreaking for the plant’s construction took place in early December, with commissioning scheduled for summer 2027. The groundbreaking marks the beginning of the largest installation to date of Jenbacher J920 FleX
Kioxia Develops Core Technology that Will Allow the Practical Implementation of High-density, Low-power 3D DRAM12.12.2025 06:24:00 CET | Press release
Showcase the technology of highly stackable oxide-semiconductor channel transistors Kioxia Corporation, a world leader in memory solutions, today announced the development of highly stackable oxide-semiconductor channel transistors that will enable the practical implementation of high-density, low-power 3D DRAM. This technology was presented at the IEEE International Electron Devices Meeting (IEDM) held in San Francisco, USA, on December 10, and has the potential to reduce power consumption across a wide range of applications, including AI servers and IoT components. In the era of AI, there is growing demand for DRAM with larger capacity and lower power consumption that can process large amounts of data. Traditional DRAM technology is reaching the physical limits of memory cell size scaling, prompting research into the 3D stacking of memory cells to provide additional capacity. The use of single-crystal silicon as the channel material for transistors in stacked memory cells, as is the
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