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
New Clinical Study Publication Validates Respiratory Outcomes for the Onera Home-polysomnography System12.1.2026 14:30:00 CET | Press release
The results of this study provide further clinical evidence that patient-applied, patch-based PSG is a viable alternative to in-lab PSG, enabling broader access to gold-standard sleep testing. Onera Health, a leader in transforming sleep medicine, announces the recent publication of a multicenter validation study of its Onera Sleep Test System (STS) in the ERJ Open Research, a leading, fully open-access scientific journal published by the European Respiratory Society (ERS). This is the second publication from this study, and it demonstrates that the patch-based Onera STS home-polysomnography (hPSG) device accurately identifies respiratory events and distinguishes AHI severity when validated against simultaneous in-lab polysomnography and is a viable option for unattended home use. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112821647/en/ Patient sleeps with the patient-applied Onera home Polysomnography (Onera hPSG) so
Riskified Analysis Reveals 1 in 4 Refund Dollars Is Abusive; Introduces "Dynamic Returns," a New Policy Protect Feature, to Safeguard Revenue While Increasing Customer Satisfaction12.1.2026 14:00:00 CET | Press release
Riskified (NYSE: RSKD) a leader in ecommerce fraud and risk intelligence, today released a research analysis highlighting a growing customer experience dilemma: As merchants tighten controls to fight a surge in return and refund abuse, they are inadvertently creating a more restrictive and frustrating experience for their best customers. To help retailers mitigate this challenge, Riskified has introduced a new feature in its Policy Protect solution, Dynamic Returns, AI-powered return decisions that adapt in real-time based on customer eligibility. Riskified's 2024 analysis of over a million refund claims found that 1-2% of total order value measured in sales dollars was requested back as refunds, with nearly 1 in 4 dollars claimed being abusive. In response to rising abuse, many retailers are implementing restrictive tactics like flat return fees, shorter return windows, and delaying refunds, often taking 10+ days for warehouse inspection. These measures frustrate good customers, as 68
Esri’s Custom Chart Builder Adopted by the Shom (French Hydrographic and Oceanographic Office) for Nautical Chart Production12.1.2026 14:00:00 CET | Press release
Geospatial Solution for Safety-Critical Maritime Use Sets Global Benchmark for Chart Automation Esri, the global leader in location intelligence, announced today that the Shom (French Hydrographic and Oceanographic Office) has officially adopted Custom Chart Builder (CCB) for automated production of all paper nautical charts. Following extensive testing and configuration, Shom confirmed that CCB-generated charts meet the stringent safety standards required by the French Navy, marking a pivotal advancement in automating maritime cartography and reinforcing its role as a pioneer in maritime digital transformation. “This adoption demonstrates that high-quality, regulation-compliant paper charts can now be produced without manual intervention, dramatically reducing production time and cost,” said Rafael Ponce, Esri principal maritime consultant. “Shom’s endorsement validates Esri’s CCB as a trusted solution for hydrographic offices worldwide, supporting the transition to digital-first work
Cellares Expands Global Smart Factory Network With European Headquarters in the Netherlands12.1.2026 13:30:00 CET | Press release
Cellares’ new IDMO Smart Factory in Leiden, Netherlands, expands commercial-scale manufacturing capacity for European cell therapy patient populations through a standardized, automated, and highly scalable facility model Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced it has secured a site and signed a long-term lease for a new IDMO Smart Factory at Leiden Bio Science Park (LBSP) with Dura Vermeer Commercieel Vastgoed. The facility will serve as Cellares’ European headquarters and expand the company’s global manufacturing network with dedicated regional capacity. Cell therapy manufacturing is patient-specific and time-sensitive, making regional production capacity increasingly important as programs advance from clinical development toward commercial supply. The new Netherlands hub is designed to provide European drug developers with access to automated manufacturing infrastructure, while maintaining alignment to a common production stan
France Expands National AAC Access for Agenus' Botensilimab + Balstilimab for Ovarian Cancer and Soft-Tissue Sarcomas12.1.2026 13:30:00 CET | Press release
Updated national AAC protocol supports hospital-based, fully-reimbursed compassionate access across three solid tumor settings Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that France’s National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for botensilimab (BOT) plus balstilimab (BAL) under France’s Autorisation d’Accès Compassionnel (AAC) framework. The updated protocol expands France’s previously granted AAC authorization for BOT+BAL in patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases to eligible patients with certain ovarian cancers and soft-tissue sarcomas—diseases with substantial unmet medical need after standard options have been exhausted. The revised protocol is designed to broaden the eligibility criteria, allowing more patients with advanced solid tumors to have early access to BOT+BAL under reimbursed compassionate
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