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
Vertex to Present New Data on ALYFTREK® at the North American Cystic Fibrosis Conference9.10.2026 19:15:00 CEST | Press release
- Data on ALYFTREK in children ages 2 to 5 years demonstrate recovery of pancreatic function in some children –- Additional abstracts on clinical and real-world evidence on CFTR modulators also presented - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new interim data from the ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor) 2 to 5 years old open-label extension study, highlighting recovery of exocrine pancreatic function in some children in that age group, allowing those children to discontinue pancreatic enzyme replacement therapy (PERT). Pancreatic exocrine insufficiency in children with cystic fibrosis (CF) was previously believed to be irreversible. These data were presented at the North American Cystic Fibrosis Conference (NACFC). “The data presented at NACFC underscore the safety and efficacy of our CF medicines in the real world and in clinical trials in younger age groups. The data from the Phase 3 open-label study in 2 to 5 year olds evaluating exocrine p
Andersen Consulting udvider med TalentSmartEQ for at fremme lederskab og virksomhedstransformation9.10.2026 18:48:00 CEST | Pressemeddelelse
Andersen Consulting styrker sine kompetencer inden for humankapital gennem en samarbejdsaftale med TalentSmartEQ, en San Diego-baseret virksomhed, der har fokus på at skabe praktiske, engagerende og handlingsorienterede læringsoplevelser med udgangspunkt i emotionel intelligens (EQ) og lederudvikling. I mere end to årtier har TalentSmartEQ arbejdet sammen med organisationer verden over med henblik på at udvikle ledelseskompetencer ved hjælp af emotionel intelligens og dermed styrke medarbejderengagement, teamwork og de samlede resultater. Virksomheden kombinerer forskningsbaserede metoder med praktiske læringsforløb, vurderinger, coaching og skræddersyede programmer, der skal omsætte opbygningen af emotionel intelligens til vedvarende ændringer i adfærden på arbejdspladsen. Som førende aktør i branchen samarbejder TalentSmartEQ med organisationer lige fra Fortune 500-virksomheder til offentlige myndigheder og privatejede virksomheder. "Organisationer stiller stadig større krav til dere
Verdant Rock Receives A (low) Financial Strength Rating from Morningstar DBRS, Adding a Second International Investment-Grade Assessment9.10.2026 16:00:00 CEST | Press release
Verdant Rock now holds Financial Strength Ratings from both Fitch Ratings and Morningstar DBRS, providing counterparties with dual-agency confirmation and reinforcing the security architecture behind each financial guarantee Verdant Rock Limited, a Bermuda Monetary Authority-regulated Class 3B insurance company, has received an A (low) Financial Strength Rating from Morningstar DBRS. The rating reflects Verdant Rock’s financial strength and its capacity to meet policyholder obligations as an investment-grade financial guarantor for Emerging Markets credit. Morningstar DBRS is a global credit rating agency with coverage across North America, Europe, Asia, and Latin America. Its assessment of Verdant Rock reflects the company’s strong projected earnings ability, robust risk profile, sound liquidity, and good capitalization. Morningstar DBRS also assigned an A (low) Issuer Rating to Verdant Rock. The rating follows Verdant Rock’s BBB+ Long-Term Insurer Financial Strength Rating with a Sta
Tecnotree Named a Visionary in the Inaugural 2026 Gartner® Magic Quadrant™ for CSP AI-Enabled Marketing and Sales Solutions9.10.2026 15:17:00 CEST | Press release
We think Gartner recognizes Tecnotree's open, governed approach to agentic AI as operators make AI the engine of their revenue operations Tecnotree, a global digital platform and services leader for AI, 5G, and cloud-native technologies, today announced that Gartner has positioned it as a Visionary in the first-ever Magic Quadrant for AI-Enabled CSP Marketing and Sales Solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261009905430/en/ Tecnotree Named a Visionary in the Inaugural 2026 Gartner® Magic Quadrant™ for CSP AI-Enabled Marketing and Sales Solutions A new category for a new operating model. CSPs are fighting saturated markets, rising acquisition costs, and accelerating churn. They are responding with AI-driven automation across the full revenue cycle, from segmentation and campaigns to lead management, CPQ, and renewals, increasingly executed by autonomous agents. According to us, Gartner creation of this Magi
Positive New Data on Corcym’s Perceval Plus Sutureless Aortic Heart Valve Encompasses up to 7-Year Follow-up9.10.2026 15:15:00 CEST | Press release
Data Presented at Annual Meeting of European Association for Cardio-Thoracic Surgery (EACTS), Along with 6 Perceval Plus E-PostersEACTS Also Marks Commercial Launch of TriMemo and Memo 4D Curve, Innovative Repair Devices for Tricuspid and Mitral Valves Corcym, a global medical device company dedicated to cardiac surgery, today announced that positive mid-term data from a sub-analysis of its Perceval Plus sutureless aortic heart valve as part of its MANTRA clinical trial was featured in an oral presentation today at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS). The study is the longest follow-up available for Perceval Plus and the FREE tissue treatment from an international multicenter study, and demonstrated excellent durability, safety and quality of life improvements. Perceval Plus is the only sutureless and collapsible aortic surgical heart valve. Its unique design performs in any surgical scenario and is optimal for endoscopy and robotics. 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