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
Thales at Eurosatory 2026: Ready today. Ready tomorrow15.6.2026 14:01:00 CEST | Press release
Thales pavilion (stand C247),Parc des Expositions, Paris Nord Villepinte, FranceMonday 15 to Friday 19 June, 2026. As Eurosatory 2026 opens its doors, Thales is pleased to share with you a complete overview of the announcements that will be made during the first day of this international defense and security show. This document centralises all our news, innovations and partnerships, released on June, 15th, 2026 with direct links to the associated press releases: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615204020/en/ Thales at Eurosatory 2026: Ready today. Ready tomorrow.Thales unveils new AI-powered training data analytics platform to enhance military training.Thales launches next-generation 70mm laser-guided rocket dedicated for counter-drone operations.Thales unveils next-generation Bushmaster Mulga Utility Variant.Thales launches RapidStriker, a complete system for protection against drones.Renault Group and Thal
Biocytogen Earns Full AAALAC Accreditation, Reinforcing Excellence in Translational Research and Drug Discovery15.6.2026 14:00:00 CEST | Press release
Biocytogen today announced that its Boston research facility has been awarded Full Accreditation by AAALAC International, a globally recognized organization dedicated to promoting excellence in laboratory animal care and use. The accreditation reflects Biocytogen’s continued commitment to maintaining the highest standards of animal welfare, scientific integrity, and operational excellence across its preclinical research and drug discovery activities. Biocytogen’s Boston facility serves as a key hub supporting the company’s expanding portfolio of drug discovery and translational research capabilities. The facility enables a broad range of in vivo studies supporting antibody therapeutics, multispecific antibodies, ADCs, cell therapies, and other innovative biologics programs for pharmaceutical and biotechnology partners worldwide. Through its proprietary BioMice™ platform, Biocytogen has established one of the industry’s most comprehensive collections of genetically engineered disease mo
SINOVAC Regained Compliance With the Nasdaq Global Market’s Listing Requirements15.6.2026 12:00:00 CEST | Press release
Sinovac Biotech Ltd. (Nasdaq: SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that it received a notification letter dated June 10, 2026 (the "Notification Letter"), from Hearing Advisor of The Nasdaq Stock Market LLC., indicating that the Company has regained compliance with Listing Rule 5250(c)(1) and that the Company is therefore in compliance with the Nasdaq Global Market's listing requirements. As noted in the Hearing Panel's May 20, 2026 compliance determination, the Company remains under a Mandatory Panel Monitor pursuant to Listing Rule 5815(d)(4)(B) until May 20, 2027. The Company filed its annual report on Form 20-F for the year ended December 31, 2025 on June 5, 2026. The Notification Letter also stated that the hearing before the Hearings Panel, applied for by the Company, had accordingly been canceled. About SINOVAC Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission
KRM22 partners with Sigma AI to enhance market surveillance and risk intelligence capabilities15.6.2026 12:00:00 CEST | Press release
KRM22, the technology and software investment company focused on risk management solutions for capital markets, today announced a strategic partnership with Sigma AI, a leading provider of AI-driven financial insights, to integrate advanced news sentiment analytics into its risk management application suite. The integration marks a significant enhancement to KRM22’s capabilities, enabling clients to incorporate real-time market sentiment insights derived from global news sources directly into their risk frameworks. By leveraging Sigma AI’s proprietary natural language processing and machine learning models, KRM22 will help firms better identify emerging risks, anticipate market-moving events, and make more informed trading and compliance decisions. Advancing risk management through AI-driven sentiment analysis As part of the first phase of the collaboration, KRM22 will embed Sigma AI’s news sentiment engine within its application suite. This will provide users with actionable intellige
HUI (HUI:VSE) Merges Traditional and Crypto Finance: Commences Continuous Trading in Vienna With Leading Market Maker and Announces Impending Token Listing on Major Global Exchange15.6.2026 11:15:00 CEST | Press release
The first SaaS SuperApp for startups and VCs capitalizes on a $25M round a from Nimbus Capital and a +15% stock surge, unveiling a v3/v4 roadmap that bridges public equity with digital asset liquidity. HUI S.p.A., the pioneering vertical SuperApp and SaaS company dedicated to the global Venture Capital and startup ecosystem listed on the Vienna Stock Exchange, today released its global product strategy, marking an unprecedented convergence between traditional regulated markets and decentralized finance. Driven by a +15% stock surge and the consolidation of its $25 million round a equity commitment fully subscribed by global institutional fund Nimbus Capital, the company announced its upcoming transition to continuous trading on the Vienna market in partnership with a leading European market maker, alongside the activation of the initial PUT options tied to the round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/2026061293689
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