On July 31, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its Quarterly Activities Report and Appendix 4C for the period ended 30 June 2023 (Q4 FY23) (Press release, Starpharma, JUL 31, 2023, View Source;mc_eid=bf52dd3418 [SID1234633509]). Starpharma’s closing cash balance as at 30 June 2023 was $35.2 million. Net cash outflows for FY23 totalled $14.7 million, with a net cash outflow of $3.7 million for the June quarter.

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"During the quarter, Starpharma made significant progress across multiple DEP programs and marketed products. We completed recruitment in the monotherapy arm of the Phase 2 clinical trial of DEP irinotecan, and the Starpharma team is currently working closely with our specialist clinical partners to finalise patient data sets and complete quality control processes, ahead of reporting top-line clinical data from our three Phase 2 clinical trials. Top-line data for DEP cabazitaxel and DEP docetaxel as monotherapy are expected in Q3 CY23.

"We look forward to the quarter ahead and a number of important milestones for DEP and VIRALEZE. Starpharma closed the year in a strong financial position, with $35.2 million cash in the bank, providing a solid foundation for the future," said Dr Jackie Fairley.

DEP Programs
Starpharma recently announced1 new data for DEP HER2-zirconium, a HER2-targeted radiodiagnostic product, demonstrating imaging benefits in a HER2+ breast cancer model. These benefits include a favourable biodistribution profile, excellent imaging contrast between tumour and normal tissues, rapid uptake, high levels of tumour accumulation, and rapid clearance. Translated clinically, DEP HER2-zirconium has the potential to detect cancers more accurately with greater sensitivity than traditional imaging methods.

DEP HER2-zirconium is a radiodiagnostic product that belongs to the rapidly growing "radiotheranostic" category – which includes both radiodiagnostic and radiotherapeutic products. DEP HER2-zirconium is designed to specifically diagnose, stage, and monitor HER2+ cancers with greater sensitivity, meaning that patients suffering from these cancers could be diagnosed earlier and monitored more accurately during cancer treatment.

As part of Starpharma’s research and development in the radiotheranostics area, the Company announced a new partnership with The University of Queensland’s Hub for Advanced Manufacture of Targeted Radiopharmaceuticals (AMTAR Hub), which has been awarded $4.8 million from the Australian Government’s Australian Research Council. The partnership will allow Starpharma to leverage these specialist capabilities to expedite the development of Starpharma’s targeted DEP radiotheranostic products.

Starpharma completed patient enrolment in the monotherapy arm of the Phase 2 clinical trial of DEP irinotecan during the quarter. With this development, Starpharma has completed enrolment for the monotherapy arms of all three of its Phase 2 clinical trials and is progressing with the final requisite data verification and review process. Starpharma expects to report top-line results for the Phase 2 trial of DEP cabazitaxel and the Phase 2 monotherapy trial of DEP docetaxel in Q3 CY23.

DEP irinotecan is a highly optimised nanoparticle formulation of SN-38, the active metabolite of irinotecan, which is marketed by Pfizer as Camptosar. Irinotecan is a common treatment regimen either alone or in combination with other agents for a number of cancers including colorectal cancer. The DEP irinotecan Phase 2 trial involves both monotherapy and combination arms.

In the monotherapy arm, 88 patients across multiple sites in the UK and Australia have been enrolled. Encouraging results have been seen in patients with multiple cancer types, including colorectal cancer, platinum-resistant ovarian cancer, gastrointestinal cancer, and breast cancer, including durable responses for up to 72 weeks.

Additionally, DEP irinotecan has demonstrated a significantly better tolerability profile compared to conventional irinotecan. Approximately 20-40% of patients treated with conventional irinotecan experience severe diarrhoea (seven or more bowel movements per day), frequently leading to hospitalisation2. However, during treatment with DEP irinotecan, there have been no reports of severe diarrhoea.

Starpharma has also been progressing well with the combination arms of the DEP docetaxel and DEP irinotecan Phase 2 trials. The DEP docetaxel and gemcitabine combination arm continues to recruit patients, focusing on pancreatic cancer. The DEP irinotecan and 5-FU/leucovorin (equivalent to the commonly used ‘FOLFIRI’ regimen) combination arm, which is focused on colorectal cancer, is also progressing well with recruitment ongoing.

Alongside completing the relevant clinical activities for these trials, Starpharma is engaging with various potential partners for these products.

Starpharma notes a positive development, during the quarter, for Sanofi in the US. A key Jevtana patent was upheld, preventing the sale of generic cabazitaxel formulations in the US until 2030. This is also a positive outcome for Starpharma’s DEP cabazitaxel, which has its own unique suite of patents that extend to at least 2039. This development would likely make DEP cabazitaxel the only alternative to Jevtana in the US market, enhancing the value of DEP cabazitaxel. In contrast to generic products, DEP cabazitaxel is water-soluble and does not require pre-treatment with corticosteroids or antihistamines.

During the period, Starpharma also progressed with its other preclinical programs in DEP antibody-drug conjugates (ADCs) and DEP radiotheranostics. These programs are also the subject of commercial discussions with potential collaboration and licensing partners.

Starpharma continues to make important progress with its DEP programs with industry leaders MSD and Genentech, as well as Chase Sun. This quarter saw an expansion of our existing partnered DEP programs. These programs involve the application of Starpharma’s DEP platform to a number of novel therapeutic modalities including antibody-drug conjugates. Starpharma is also in discussions with a number of potential new DEP partners for programs across several therapeutic areas.

On 27 June 2023, Starpharma announced that a voluntary partial clinical hold had been implemented by AstraZeneca on the trial of AZD0466 in patients with advanced haematological malignancies (NCT04865419). AstraZeneca confirmed that the asymptomatic reported events leading to the voluntary partial hold were assessed as not related to Starpharma’s DEP technology.

Marketed Products
Starpharma received regulatory approval for its VIRALEZE antiviral nasal spray product in Malaysia and is in discussions with potential distribution partners to provide access to the country’s population of over 33 million. VIRALEZE continues to be marketed in various jurisdictions, including Hong Kong, Macau, Vietnam, Italy, the UK, and Europe. The Company has also expanded its e-commerce channels in the UK, making VIRALEZE available to consumers in the UK through a dedicated product website and Amazon UK, in addition to its arrangement with LloydsPharmacy. Starpharma is also actively working on bringing VIRALEZE to new markets, with active commercial discussions with potential partners in several countries. 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.

Starpharma’s post-market clinical study of VIRALEZE in individuals with COVID-19 will support marketing activities. The study is recruiting ahead of schedule, with recruitment now ~90% complete.

Starpharma’s VivaGel BV product continues to be marketed by its partners, with registrations and product launches planned in additional markets, including the Middle East and Southeast Asia. During the quarter, iNova Pharmaceuticals (iNova) announced the acquisition of part of Mundipharma’s consumer health product portfolio. In the United States, a formal dispute resolution process is ongoing with the FDA for VivaGel BV. As previously reported, Starpharma plans to lodge a further submission to the FDA, which will include precedents of other FDA approvals.

Corporate
During the quarter, Starpharma’s CEO, Dr Jackie Fairley, advised the Board of her intention to retire in 2024. An international search process is underway and Dr Fairley, the Board, and the senior executive team are working closely to facilitate a seamless transition.

Cash Flows for the Quarter
Starpharma’s cash balance as at 30 June 2023 was $35.2 million, with net cash outflows of $3.7 million for Q4 FY23. Receipts from customers for FY23 were $3.1 million, with $0.9 million for Q4. Receipts from customers include VIRALEZE and VivaGel BV product sales, royalties, and research revenues. Cash outflows for the quarter comprised research and development costs of $1.9 million related to Starpharma’s internal DEP clinical programs, which are at advanced stages, with monotherapy enrolment now complete for all three trials, as well as preclinical targeted DEP programs. Product manufacturing and operating costs were $0.4 million. Staffing costs were $2.0 million and include non-executive and executive directors’ fees of $263,000. Other related party payments include $6,636 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.