DEP irinotecan (DEP SN38) / Starpharma - LARVOL DELTA

Starpharma receives positive feedback from FDA on DEP SN38 clinical pathway for platinum-resistant ovarian cancer (Starpharma Press Release) - "Starpharma...announces a positive development regarding its DEP SN38 (DEP irinotecan) program following a meeting with the US Food and Drug Administration (FDA)....The FDA agreed with Starpharma’s proposal that DEP SN38 could be considered for FDA Fast Track designation, acknowledging that platinum-resistant ovarian cancer is a serious condition with significant unmet medical need. The FDA also agreed that a '505(b)(2)' regulatory approval pathway is appropriate for DEP SN38, as the product delivers the active moiety of the FDA-approved drug, irinotecan (Camptosar)....The FDA indicated that DEP SN38 may qualify for accelerated approval based on an interim analysis of early surrogate endpoints from the proposed Phase 2/3 clinical trial program....The FDA’s feedback provides confidence for an Investigational New Drug (IND) application for DEP SN38, which could be advanced by a commercial partner."

FDA event • Ovarian Cancer

Starpharma Receives $5.5M R&D Tax Incentive Refund (Starpharma Press Release) - "'Starpharma is pleased to announce the receipt of $5.5 million under the Australian Government’s R&D Tax Incentive program. This program is important in driving innovation and product development within our sector, enabling local companies to invest in addressing significant health challenges.'....'We are continuing to focus on translating this progress into tangible results that align with our three strategic priorities: maximising DEP asset value, accelerating early asset development, and building long-term sustainability.'"

Financing • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Infectious Disease • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Solid Tumor

Dendrimer-enhanced (DEP) SN38 (DEP irinotecan) in patients (pts) with advanced solid tumors: A phase 1/2 trial. (ASCO 2024) - P1/2 | " Pts who had exhausted standard therapy were enrolled in dose assessment (P1)/dose expansion (P2) cohorts of DEP SN38 given IV 3-weekly (Q3W) or Q2W alone or in combination with 5-fluorouracil & leucovorin (5FU/LV combo). DEP SN38 shows promising clinical utility with encouraging antitumor activity including prolonged disease control & durable PRs in heavily pre-treated CRC, HGSOC & BC pts. DEP SN38 is well-tolerated with significantly fewer severe gastrointestinal TRAEs compared to c-IRI, & warrants further clinical assessment."

Clinical • Metastases • P1/2 data • Alopecia • Anemia • Constipation • Fatigue • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Neutropenia • Oncology • Ovarian Serous Adenocarcinoma • Solid Tumor • Thrombocytopenia

Starpharma announces positive final DEP irinotecan Phase 2 clinical trial results (ASX Announcement) (Starpharma Press Release) - P1/2 | N=149 | 2019-001318-40 | Sponsor: Starpharma Pty Ltd | "DEP irinotecan clinical efficacy results (Phase 1/2 combined data)...Median progression-free survival (mPFS) was 4.2 months when DEP irinotecan was administered once every 2 weeks (Q2W) in combination with 5‑FU/LV in patients who had received a median of 3 prior anticancer regimens (N=17)...Key efficacy results in heavily pre-treated patients with advanced platinum-resistant/refractory ovarian cancer include: Median progression-free survival (mPFS) was 9.3 months when DEP irinotecan was administered as a monotherapy Q2W in patients who had received a median of 6 prior anticancer regimens and 30 prior treatment cycles (N=8)....These final clinical data from the DEP irinotecan Phase 1/2 trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held from 31 May to 4 June 2024 in Chicago."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Quarterly Activities Report & Appendix 4C (ASX Announcement) (Starpharma Press Release) - "Starpharma’s Phase 1/2 clinical data for DEP cabazitaxel and DEP irinotecan have both been accepted for oral presentations at the ASCO Annual Meeting, which will take place in Chicago, US, from 31 May to 4 June 2024...Starpharma’s Phase 2 clinical trial of DEP irinotecan as monotherapy and in combination with 5-fluorouracil (5FU) and leucovorin (LV) is nearing database lock. Preparations for analysis of the full data are well underway, with the data to be released ahead of and presented at the ASCO meeting in early June...Starpharma will present data from its internally developed DEP HER2 radiotheranostic program at the upcoming SNMMI Annual Meeting, which will be held from 8 to 11 June in Toronto, Canada....This quarter’s R&D costs included clinical trial close-out costs of $1.6 million related to the completion of the DEP cabazitaxel, DEP docetaxel..."

Clinical data • Commercial • Oncology • Solid Tumor

Half Yearly Report and Accounts (ASX Announcement) (Starpharma Press Release) - "Starpharma...releases its Interim Report and Half-Year Financial Results for the period ended 31 December 2023 (H1 FY24)....The half-year loss after tax was $1.0M (H1 FY23: $8.3M) and includes research and product development expenses of $5.3M (H1 FY23: $5.6M) net of the Australian Government’s R&D tax incentive. Research expenditures were primarily associated with Starpharma’s internal DEP drug delivery programs, including DEP docetaxel, DEP cabazitaxel, DEP irinotecan, DEP ADCs and DEP radiotheranostics, and the Viraleze post-market study."

Commercial • Breast Cancer • Gastrointestinal Cancer • Infectious Disease • Oncology • Pancreatic Cancer • Solid Tumor

DEP irinotecan IO/PARP combination data presented at AACR (ASX Announcement) (Starpharma Press Release) - "Starpharma...today provides a copy of the DEP^® irinotecan combination data poster, showcasing the recently announced data for DEP^® irinotecan in combination with leading anticancer therapies, including immuno-oncology (IO) agents, in human colorectal cancer (CRC) models. The data show that DEP^® irinotecan in combination with an IO agent or a PARP inhibitor demonstrated superior anti-tumour activity and significant survival benefit when compared to these agents delivered alone in multiple CRC models....The poster was presented over the weekend in Boston, US, at the international oncology conference, International Conference on Molecular Targets and Cancer Therapeutics, co-hosted by the American Association of Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) from 11 to 15 October 2023."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

DEP irinotecan combination data to be presented at international oncology conference (ASX Announcement) (Starpharma Press Release) - "Starpharma...announces the presentation of data that demonstrate the benefits of combining DEP® irinotecan with other important classes of anti-cancer therapies, including immuno-oncology (IO) agents, in models of human colorectal cancer. The data will be presented in Boston, US, at the International Conference on Molecular Targets and Cancer Therapeutics, co-hosted by the American Association For Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) from 11 to 15 October 2023. This poster presentation is one of three by Starpharma at the AACR-NTI-EORTC conference showcasing multiple DEP® programs, including DEP® irinotecan and Starpharma’s radiotheranostic, DEP® HER2-zirconium."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor