On October 31, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its Quarterly Activities Report and Appendix 4C for the period ended 30 September 2023 (Q1 FY24) (Press release, Starpharma, OCT 31, 2023, View Source;mc_eid=bf52dd3418 [SID1234636458]). Starpharma’s closing cash balance as at 30 September 2023 was $35.6 million. Starpharma reports positive net cash inflows for the quarter of $0.4 million.

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Starpharma also recently received a $7.2 million Research and Development (R&D) Tax Incentive refund from the Australian Taxation Office after the quarter end.

"Starpharma is delighted with the recent advancements across its DEP portfolio, including completing patient recruitment for all cohorts in all three Phase 2 DEP clinical trials. The final clinical results from the Phase 2 trial of DEP cabazitaxel and interim results from the Phase 2 trial of DEP irinotecan were both highly positive and demonstrated the clinical utility, therapeutic value, and market potential of these DEP products.

"We were also pleased to showcase both DEP irinotecan and our DEP radiotheranostics pipeline at the AACR (Free AACR Whitepaper) international oncology conference this month, where the data generated a lot of interest.

"Starpharma closed Q1 FY24 in a strong cash position, with $35.6 million and a positive cash inflow this quarter. This cash balance excludes the $7.2 million R&D Tax Incentive refund we received in October 2023. With completion of our clinical programs, we also expect to see reductions in operating cash outflows in H2 FY24," said Dr Jackie Fairley, CEO, Starpharma.

Positive clinical results reported for DEP cabazitaxel and DEP irinotecan

Starpharma recently announced1 positive Phase 2 DEP cabazitaxel clinical trial results in multiple cancers, including advanced metastatic castrate-resistant prostate cancer (mCRPC), as well as other difficult-to-treat cancers, including platinum-resistant ovarian cancer and gastro-oesophageal cancers. The trial met its objectives, with endpoints demonstrating positive anti-tumour efficacy and confirming the safety and tolerability of DEP cabazitaxel.

Summary of key efficacy results for DEP cabazitaxel

Heavily pre-treated, advanced prostate cancer patients (mCRPC) treated with DEP cabazitaxel achieved a median progression-free survival (PFS) of 4.4 months, which is more than 50% longer than published data for Jevtana at the same dose2. The median overall survival (OS) of 14.7 months was also 10% longer2. The final progression-free survival result improves upon the interim data on DEP cabazitaxel reported by Starpharma at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 20223.
In advanced, platinum-resistant ovarian cancer patients who were heavily pre-treated with an average of 4 prior lines of chemotherapy, DEP cabazitaxel achieved a disease control rate (DCR) of 66.7% and an objective response rate (ORR) of 17.6%, which also compares favourably to standard-of-care therapies that report ORRs ranging from ~9 to 16%4,5,6.
In advanced gastro-oesophageal cancer patients, DEP cabazitaxel achieved a median progression-free survival (PFS) of 4.0 months and median overall survival (OS) of 8.6 months, which were 53.1% and 28.5% longer, respectively, than similar patient cohorts treated with the standard-of-care product paclitaxel7.
The positive efficacy results reported for DEP cabazitaxel in multiple cancers demonstrate the significant market potential and enhanced utility of DEP cabazitaxel, not only in the approved prostate cancer indication of Jevtana but also in other cancers that have a high unmet medical need.

During the quarter, Starpharma also announced8 positive interim clinical data for DEP irinotecan, its novel, patented nanoparticle formulation of SN38, the active metabolite of the widely used anti-cancer drug irinotecan, which is marketed by Pfizer as Camptosar. DEP irinotecan demonstrated durable anti-tumour responses in advanced colorectal cancer and platinum-resistant/refractory ovarian cancer and was very well-tolerated. Patients and clinicians have also reported significantly better tolerability than conventional irinotecan.

Summary of interim efficacy results for DEP irinotecan

DEP irinotecan monotherapy achieved durable responses for up to 72 weeks in colorectal cancer patients, with a disease control rate (DCR) of 48%; these responses are particularly positive for these patients who were heavily pre-treated, with 97% having progressed after receiving conventional irinotecan, and had exhausted their treatment options.
DEP irinotecan achieved a disease control rate (DCR) of 100% in colorectal cancer patients receiving it in combination with 5-fluorouracil (5-FU) and leucovorin (‘FOLFIRI’), with durable responses of up to 35 weeks to date. Several patients are continuing to receive DEP irinotecan treatment.
DEP irinotecan achieved a disease control rate (DCR) of 100% in ovarian cancer patients receiving DEP irinotecan monotherapy fortnightly (Q2W) and durable responses of up to 45 weeks; this cohort of heavily pre-treated patients achieved an objective response rate (ORR) of 43%, which compares favourably to the reported ORR for other treatments (~9-16%4,5,6) in patients with this stage and category of cancer.
Importantly, DEP irinotecan therapy resulted in no reports of the severe or life-threatening diarrhoea (≥ grade 3) commonly observed with conventional irinotecan. This result for DEP irinotecan across ~100 patients in the study demonstrates a significant improvement in the side effect profile compared to conventional irinotecan (Camptosar), which is associated with severe or life-threatening diarrhoea in more than 20% of patients9. This common side effect with conventional irinotecan is frequently associated with discontinuation of treatment, hospitalisation, and can be fatal. In addition, patients treated with DEP irinotecan did not experience cholinergic syndrome, an unpleasant group of adverse events reported in ~47% of patients treated with conventional irinotecan9.

Patients treated with DEP irinotecan and their oncologists have reported significantly improved tolerability and quality of life with DEP irinotecan compared to their experience with conventional irinotecan, including Camptosar.

Overall, these interim results for DEP irinotecan support the highly promising clinical utility of DEP irinotecan and its potential for application in both colorectal and platinum-resistant/refractory ovarian cancers. Starpharma completed enrolment across the trial during the quarter, with several patients continuing to receive treatment. The final Phase 2 results will be announced following completion of patient treatment and subsequent data analyses.

DEP irinotecan and DEP radiotheranostics presentations at international oncology conferences

Starpharma presented three scientific posters at the AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, US, co-hosted by the American Association of Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) in October 2023. These posters are available on Starpharma’s website.

The posters on DEP irinotecan showcased the recent clinical results10 in advanced colorectal cancer and platinum-resistant/refractory ovarian cancer described above, and DEP irinotecan preclinical combination data11 showing the ability of Starpharma’s DEP irinotecan product to enhance the anti-tumour activity of an immuno-oncology agent, and a PARP inhibitor – both important classes of cancer treatments.

A third poster highlighted the results from a study of DEP HER2-zirconium12, Starpharma’s radiodiagnostic candidate, demonstrating promise in a HER2+ breast cancer model.

Starpharma has been invited to present at the Targeted Radiopharmaceuticals Summit Europe13, a specialist radiotheranostics conference being held in Berlin in December 2023. At the conference, Dr Jeremy Paull, Starpharma’s VP of Development and Regulatory Affairs, will present Starpharma’s DEP radiotheranostics pipeline and the benefits of the DEP platform in radiotheranostics.

Other progress across Starpharma’s DEP pipeline and partnered programs

During the quarter, Starpharma completed recruitment in the DEP docetaxel and gemcitabine combination arm. of its Phase 2 DEP docetaxel trial. As recruitment across all trial cohorts has now completed, Starpharma expects to report the final combined Phase 2 results in Q2 FY24.

Starpharma continues discussions with a number of potential commercial partners for its clinical-stage DEP assets and other partnered and preclinical DEP programs. The recently announced clinical results from these trials will support these ongoing commercial discussions.

During Q1 FY24, Starpharma also progressed its other preclinical programs in DEP antibody-drug conjugates (ADCs) and DEP radiotheranostics.

In parallel with its in-house DEP programs, Starpharma continues to make important progress across its multiple DEP partnerships with top 10 pharmaceutical companies, including MSD and Genentech, as well as Chase Sun. As previously reported, this includes an extension to Starpharma’s partnered ADC programs with MSD.

Marketed product portfolio

In August 2023, Starpharma successfully negotiated a commercial settlement agreement with Mundipharma in relation to VivaGel BV and received a $6.6 million cash payment14. Starpharma is now engaged in discussions with new potential commercial partners to expand VivaGel BV sales in these territories. VivaGel BV is a novel, non-antibiotic therapy for bacterial vaginosis, the most common vaginal infection among women of reproductive age15. VivaGel BV is registered in more than 50 countries and continues to be marketed by Starpharma’s commercial partner, Aspen, in Australia and New Zealand.

Starpharma also completed recruitment16 for its post-market clinical study of VIRALEZE in the UK, with ~200 participants with COVID-19 enrolled. The results from this study will support ongoing commercial and marketing activities for VIRALEZE, building on Starpharma’s extensive dataset and in-market experience with the product. These study results are expected to be reported in Q2 FY24, following completion of data and statistical analyses.

Starpharma and its commercial partners continue to market its broad-spectrum antiviral barrier nasal spray, VIRALEZE, through a number of e-commerce channels, including Amazon and a dedicated product website, as well as through other commercial partner arrangements. VIRALEZE is registered in over 35 countries, and the Company continues to pursue additional registration and marketing opportunities for the product. VIRALEZE is not approved for use or supply in Australia, where the review by the Therapeutic Goods Administration (TGA) for the SPL7013 nasal spray as a medical device is ongoing.

In the United States, a formal dispute resolution process is ongoing with the FDA for VivaGel BV. Starpharma is preparing to lodge a further submission to the FDA in CY23, which will include precedents of other recent FDA approvals.

Corporate

In October 2023, Starpharma’s CEO, Dr Jackie Fairley, presented at the Wilsons Drug and Device Conference17. As part of this presentation, Dr Fairley also participated in a radiotherapy panel discussion, ‘Expanding the scope for theranostics and radioligand therapies,’ alongside Clarity Pharmaceuticals and Telix Pharmaceuticals. Starpharma will also participate in the upcoming Bell Potter Healthcare Conference in November 2023.

Starpharma’s Annual General Meeting (AGM) 2023 will take place on Wednesday, 29 November 2023. Details of the AGM are available on Starpharma’s website18.

As previously advised, following Dr. Fairley’s retirement announcement, the Board commenced a search process to appoint a new CEO. The search, led by recruitment firm Heidrick & Struggles, is progressing well, with a number of impressive candidates being considered. The Board is confident of appointing a high-calibre CEO to lead Starpharma into the future.

Cash Flows for Q1 FY24

Starpharma’s cash balance as at 30 September 2023 was $35.6 million, with positive net cash inflows of $0.4 million for the quarter. Receipts from customers for the quarter were $6.8 million, which included the VivaGel BV settlement payment from Mundipharma. A $7.2 million Research and Development (R&D) Tax Incentive refund was recently received from the Australian Taxation Office after the quarter end.

Cash outflows for the quarter include research and development costs of $3.4 million related to the completion of multiple DEP clinical programs and final stages of the post-market clinical study of VIRALEZE nasal spray. R&D expenditure also included development costs for Starpharma’s targeted DEP radiotheranostics and DEP antibody-drug conjugates programs. As projected in Starpharma’s Annual Report 2023, Starpharma’s low-interest R&D Loan facility of $4.0 million with Invest Victoria was repaid in October 2023. Administration and corporate costs of $0.6 million include insurance costs, annual ASX listing fees and audit fees. Product manufacturing and operating costs for the quarter were $0.5 million. Staffing costs were $2.0 million and included non-executive and executive directors’ fees of $265,000. Other related party payments include $9,028 for consulting services to Centre for Biopharmaceutical Excellence Pty Ltd, of which Starpharma non-executive director Dr Jeff Davies is also a director and shareholder.