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
Europe’s Tech Services Market Hits New High in Q4, on Strong AI, Cloud, Managed Services Demand: ISG Index™19.1.2026 10:00:00 CET | Press release
Combined market ACV up 27%, to record US $10.9 billionManaged services ACV up 19%, while XaaS soars 34% Demand for technology services in Europe reached a new high in the fourth quarter as the region turned in its best quarterly performance of the year to close out 2025, according to the latest state-of-the-industry report from Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm. The EMEA ISG Index™, which measures commercial outsourcing contracts with annual contract value (ACV) of US $5 million or more, shows fourth-quarter ACV for the combined market (both managed services and cloud-based as-a-service) advanced 27 percent, to a record US $10.9 billion. It was the region’s eighth consecutive quarter of combined market growth, averaging 16 percent in that span. “Europe saved its best for last, with accelerating, AI-fueled demand for cloud services, coupled with renewed momentum in managed services, leading the region to its strong
Celonis Champions “Free the Process” Movement at WEF Davos 202619.1.2026 10:00:00 CET | Press release
Process Intelligence leader to demonstrate why open ecosystems and open data access are critical to bridge the gap between AI hype and economic impact Celonis, a global leader in Process Intelligence - a key enabler of enterprise AI, today announced its participation in the World Economic Forum (WEF) Annual Meeting 2026. Under the event’s theme “A Spirit of Dialogue,” Celonis leaders — including Co-founder and Co-CEO Bastian Nominacher and President Carsten Thoma — will outline what’s needed to make the critical shift from AI experimentation to responsible AI implementation and meaningful RoAI (Return on AI Investment). In an AI-driven world, processes are the engine of enterprise value, and process intelligence is the essential foundation for AI, giving it the cross-system context needed to drive real growth. At WEF 2026, Celonis will outline how an open ecosystem enables organizations to "Free the Process" from rigid systems and vendor-locked silos, so that teams can collaborate, com
Posiflex to Showcase AI-Powered Retail Innovation at EuroShop 202619.1.2026 09:57:00 CET | Press release
From AI-powered self-checkout to next-generation Tap-to-Pay transactions, Posiflex presents end-to-end solutions that redefine the modern retail journey Posiflex Technology, Inc., a global leader in Point of Sale (POS) systems and Online-to-Offline (O2O) solutions, will present its latest portfolio of AI-powered retail innovations at EuroShop 2026, taking place from February 22 to 26, 2026 at Messe Düsseldorf, Germany. Celebrating the 60th edition of the world’s leading retail trade fair, Posiflex will demonstrate how AI-enabled technologies and scenario-driven system design can address the evolving demands of modern retail environments, spanning self-checkout, AI recognition, contactless transactions, kitchen operations, and next-generation self-service. Visitors are invited to explore these solutions at Hall 6, Booth C42, and discover how Posiflex supports retailers in building agile, future-ready business models. This press release features multimedia. View the full release here: ht
Alta Semper Signs Definitive Agreements to Acquire a Majority Stake in Nature’s Rule, a MENA-Focused Leader in Dietary Supplements and Sports Nutrition19.1.2026 09:13:00 CET | Press release
Alta Semper, a London-based private equity firm focused on healthcare and consumer investments across growth markets, today announced that it has signed definitive agreements to acquire a majority stake in Nature’s Rule, a leading sports nutrition and dietary supplements company headquartered in the UAE, with an established manufacturing presence in Egypt. The acquisition is a majority investment in Prowell Holding, the parent company of Nature’s Rule, the operator of the largest fully dedicated sports nutrition and dietary supplements manufacturing facility in MENA. The company’s infrastructure and in-house R&D capabilities support a portfolio of private-label clients and proprietary brands, including Redrex, its flagship, market-leading sports nutrition brand developed in collaboration with global bodybuilding icon Mamdouh Elssbiay (“Big Ramy”). The founders will retain a significant stake and continue to lead the business. The partnership will execute a focused value-creation plan t
The UK Chooses Bridge Over Troubled Water as the Nation’s Favourite Song of Hope in Solidarity With Refugees19.1.2026 09:00:00 CET | Press release
Simon and Garfunkel classic named the UK’s top #HopeHitOver 1000 people from across the country nominated songs to show their solidarity with refugees around the world this winterThe most popular Hope Hits available on the Hope On Repeat playlist to get you through Blue Monday Simon and Garfunkel’s Bridge Over Troubled Water has been votedas the UK’s number one #HopeHit ― as part of UK for UNHCR’s ‘Hope on Repeat’ campaign, raising awareness of the hardships facing refugees across the globe this winter. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260119165712/en/ Simon & Garfunkel's Bridge Over Troubled Water voted the UK's number one #HopeHit With 10% of the public vote, Bridge Over Troubled Water emerged as the UK’s most popular #HopeHit. Since November, the UN Refugee Agency’s national charity partner has invited people to nominate their #HopeHits - the tunes that connect us and warm our hearts as the weather gets cold
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