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
Horizon3 and Pax8 Expand Partnership to Bring Autonomous Security Testing to MSPs Across Europe16.10.2026 08:03:00 CEST | Press release
NodeZero® gives partners a repeatable way to identify exploitable attack paths, guide remediation, and prove fixes worked Horizon3, the AI-Native Proactive Security Company, today announced the expansion of its Pax8 partnership across Europe, bringing the NodeZero® Proactive Security Platform to the region’s managed service providers (MSPs) through the Pax8 Marketplace. The expansion enables partners to build recurring security services that help small and midsized businesses understand how attackers could compromise their environments, prioritize corrective actions, and verify remediation. Building on the companies’ North American marketplace launch, the European expansion makes autonomous offensive security testing accessible to more MSPs and the businesses they protect. Partners can use NodeZero to deliver initial assessments, support remediation engagements, and establish ongoing testing programs without conducting every penetration test manually. “MSPs are accountable for protecti
MSCI Launches a Consultation on a Proposal to Reclassify Indonesia from Emerging Market to Standalone Market Status15.10.2026 23:47:00 CEST | Press release
MSCI to consult on proposal to reclassify the MSCI Indonesia Indexes to Standalone Market status Existing freeze on Indonesian securities in MSCI Indexes to remain in place until further notice MSCI announced the launch of a consultation on a proposal to reclassify the MSCI Indonesia Indexes from Emerging Market to Standalone Market status. MSCI will announce its final decision by the end of June 2027 and may provide an interim update on market participant feedback during the consultation period. As part of the June 2026 Market Classification Review, MSCI reported that market participants had raised significant concerns regarding the investability of the Indonesian equity market, including persistent opacity in shareholding structures and suspected coordinated trading behavior. While the Indonesian authorities have announced reforms, including enhanced disclosure of shareholders with ownership above 1%, more granular investor classification disclosure, High Shareholding Concentration (
Nekome: Nazi Hunter Unmasks Hitler’s Hyenas in New Trailer Ahead of Steam Next Fest Demo15.10.2026 21:38:00 CEST | Press release
Free demo offers players the first chance to pick up the knife in ProbablyMonsters’ narrative-driven action game beginning on October 19 ProbablyMonsters, an independent video game company creating original AA games with AAA sensibilities, today unveiled a new trailer for Nekome: Nazi Hunterat the Galaxies Autumn Showcase, pulling back the curtain on the game’s villains, Hitler’s Hyenas. Alongside the new trailer, ProbablyMonsters announced that Nekome: Nazi Hunter will participate in October’s Steam Next Fest, giving players their first opportunity to experience this violent odyssey of revenge with a free PC demo available on Steam from October 19 through 26. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014661905/en/ “Nekome is Vano’s story: an exploration of a young Romani man who has had everything taken away from him, and who decides to pick up a knife and exact revenge on his family’s murderers,” said Jeronimo Barr
The Estée Lauder Companies Announces BEAUTY&YOU India 2026 Winners and Marks Five Years of Advancing Indian Beauty Entrepreneurship15.10.2026 17:58:00 CEST | Press release
In partnership with Startup India and Nykaa, the program recognizes five winners across in-market beauty brands, early-stage concepts, fragrance innovation, creative design, and women’s entrepreneurship. The Estée Lauder Companies, in partnership with Nykaa and Startup India, an initiative of the Department for Promotion of Industry and Internal Trade (DPIIT) within India’s Ministry of Commerce and Industry, announced the winners of BEAUTY&YOU India 2026, the country’s leading beauty entrepreneurship program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015612324/en/ (L to R) BEAUTY&YOU India 2026 Winners Ajaykumar Mehta, Shriya Rambhia, and Dheer Rambhia, Directors, Goyam Green Tech (BREAKTHROUGH), Nirja Bhatt, Founder & CEO, Laani (GROW), Khatija Shabana, CEO, and Syed Mohammad Fouzan, Director, Boldpurity (IMAGINE), Rinzing Choden Bhutia, Founder, Agapi Sikkim (Visionary Women’s Award), and Pankti Sheth, Founder & Cr
Body of Waves, a New Artwork Only at teamLab Planets TOKYO, Unveiled15.10.2026 17:00:00 CEST | Press release
The visitor experiences offered by “Existence in the Flow Creates Vortices” and “Waterfall of Ephemeral Crystals” have also been further expanded. teamLab Planets TOKYO (hereinafter referred to as “teamLab Planets”) has unveiled Body of Waves, a new artwork in which visitors enter a soft sculpture with their entire bodies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014474897/en/ teamLab, Body of Waves, 2026, from the series Soft Black Hole - Your Body Becomes a Space that Influences Another Body, 2016-© teamLab *Shot in real space. No AI or CGI. In addition, Existence in the Flow Creates Vortices—where vortices are created behind people as they climb against the flow—and Waterfall of Ephemeral Crystals—where shining particles cascade down to create a waterfall of light particles—have also evolved, further expanding the experience at teamLab Planets. New Artwork Body of Waves As you walk, your feet sink. This force is
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