Highlights:

• Preliminary clinical trial data showed AZD0466 to be well tolerated at multiple escalating doses in patients with advanced relapsed/refractory leukemia, as presented by AstraZeneca at the American Society of Hematology (ASH) 2022 Annual Meeting
• Internal Phase 2 DEP^® trials are expected to complete recruitment soon, with the final patient in screening for DEP^® docetaxel and a small number of patients to be recruited into the final monotherapy cohorts in the DEP^® cabazitaxel and DEP^® irinotecan trials
• Continued commercialisation and registrations of VIRALEZE™ across Asia, including the launch of VIRALEZE™ in Hong Kong and Macau by Hengan, and the registration of VIRALEZE™ in Indonesia
• Commencement of recruitment in the UK for the post-market clinical study of VIRALEZE™ nasal spray in patients with COVID-19
• Strong cash position with a closing cash balance of $44.0 million as at 31 December 2022, including receipt of a $7.1 million R&D tax incentive refund

Melbourne, Australia; 30 January 2023: Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) today releases its Quarterly Activities Report and Appendix 4C for the period ended 31 December 2022 (Q2 FY23).

Starpharma’s cash balance as at 31 December 2022 was $44.0 million, with a positive net operating cash flow of $2.2 million for the quarter. Total receipts of $8.1 million in the quarter include $7.1 million received from the Australian Government under its R&D tax incentive scheme[1] and receipts from customers of $1.0 million. Customer receipts, including from sales of VIRALEZE™ and VivaGel^® BV, were up 59% from the previous quarter (Q1 FY23: $0.6 million).

Partnered DEP^® Programs

During Q2 FY23, Starpharma announced preliminary AZD0466[2] safety and tolerability results from AstraZeneca’s ongoing Phase 1/2 clinical trial in patients with advanced relapsed/refractory leukemia (NCT04865419). The preliminary safety and tolerability results from 18 patients showed that AZD0466 was very well tolerated at multiple escalating dose levels (between 75 mg and 2400 mg), with no dose-limiting toxicities (DLTs) reported and no discontinuations due to treatment-related adverse events. The data showing increased patient numbers and significantly higher doses, with no DLTs, are significant in the context of the clinical trial. These preliminary results were presented by AstraZeneca at the American Society of Hematology (ASH) Annual Meeting in December 2022. This Phase 1/2 clinical trial continues with further dose escalations planned. AstraZeneca is currently enrolling patients at 17 sites across the United States, Europe, Asia and Australia, with more than 30 sites expected to participate in the study.

AZD0466 is also the subject of a second Phase 1/2 clinical trial in patients with advanced non-Hodgkin lymphoma (NCT05205161). AstraZeneca is enrolling patients into this trial at six sites across the United States, Korea and Italy, with 18 additional sites planned.

Starpharma’s other partnered DEP^® programs with MSD, Genentech, and Chase Sun continued to progress well during the quarter. These partnered programs include DEP^® antibody drug conjugates (ADCs) and other DEP^® products across both oncology and anti-infectives. These and other DEP^® programs continue to be the subject of active discussions with Starpharma’s partners, including at the J.P. Morgan Healthcare Conference in January 2023. Meetings held at the JPM Conference included both new and existing partners.

Internal DEP^® Programs

Starpharma’s internal clinical DEP^® programs continue to advance, and are approaching completion of recruitment.

The DEP^® docetaxel clinical program continued to progress during the quarter, with 76 patients enrolled across the monotherapy and combination arms. The monotherapy arm is expected to complete recruitment within the next month, with the final patient now in screening. The DEP^® docetaxel and gemcitabine combination arm continues to recruit. Encouraging efficacy signals have been observed, including in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.

The DEP^® cabazitaxel Phase 2 trial has enrolled 76 patients to date, with the final patients with specific tumour types currently being screened and scheduled for treatment. Recruitment is expected to complete within the next 1-2 months. Data analyses and biostatistics activities are already underway. Starpharma has previously reported promising interim results from the prostate cancer cohort[3] of this trial. Other encouraging observations include significant tumour shrinkage and substantial tumour biomarker reductions in heavily pre-treated patients with advanced ovarian, gastro-oesophageal, cholangiocarcinoma, and head and neck cancers.  

The DEP^® irinotecan Phase 2 trial continued to progress during the quarter, with 89 patients now recruited across both the monotherapy and combination arms. Final recruitment for the monotherapy arm is focused on platinum resistant ovarian cancer, where particularly encouraging responses have been observed, and is expected to complete within 2 months. Encouraging efficacy signals with DEP^® irinotecan have also been observed in heavily pre-treated patients with multiple other tumour types, including colorectal, breast, pancreatic, lung, and oesophageal cancers.

Starpharma continue commercial discussions with potential licensing partners for these internal DEP^® assets, as well as other commercial and collaborative discussions for other DEP^® programs and opportunities. Starpharma’s internal preclinical DEP^® programs, including DEP^® radiotheranostics and DEP^® ADCs, continue to progress in parallel.

Marketed Products

Soon after signing a sales and distribution agreement with Hengan[4]VIRALEZE™ nasal spray was launched in Hong Kong and Macau both online and in major pharmacy and retail outlets, Mannings; and PARKnSHOP, which is part of the A.S. Watson Group. The VIRALEZE™ rollout continues to be supported with marketing activities by Hengan, including advertising on television, newspapers and online platforms; billboards; and in-store promotion.

VIRALEZE™ sales and marketing activities also continue elsewhere, including in the UK, Italy, and Vietnam where Starpharma has distribution arrangements in place. In December 2022, Starpharma achieved VIRALEZE™ registration in Indonesia[5], a country with a population of more than 280 million. Starpharma continues to pursue registration and commercialisation activities for VIRALEZE™ in multiple other countries, with a focus on commercially attractive markets with rapid regulatory pathways. In Australia, the review by the Therapeutic Goods Administration (TGA) for the SPL7013 nasal spray as a medical device is ongoing.

New data generated by Scripps Research in the US on the efficacy of VIRALEZE™ against SARS-CoV-2 Omicron infection in an animal challenge model were presented at international virology conference, Respi DART[6], held in Mexico in December 2022[7]. In the study presented, VIRALEZE™ essentially eliminated SARS-CoV-2 Omicron virus (≥99.99% reduction in viral load compared with saline-treated animals) in the lung and trachea of virus-challenged animals, even when VIRALEZE™ was administered only after animals were exposed to virus. VIRALEZE™-treated animals also exhibited significantly reduced proinflammatory cytokines compared with saline-treated animals; and achieved normal body weight gain compared to significant weight loss observed in saline-treated animals. Collectively, the results from this experiment indicate that VIRALEZE™ provides protection against SARS-CoV-2 infection and disease in animals challenged with the virus[8].

In December 2022, Starpharma commenced recruitment in the UK for a post-market clinical study of VIRALEZE™. The study is enrolling patients with COVID-19 at Ashford and St Peter’s Hospitals NHS Foundation Trust (ASPH) in the UK. The post-market study will support ongoing marketing and commercial activities and will build on the positive in-market experience with the product.

Starpharma continues to work with its VivaGel^® BV partners, Mundipharma and Aspen. Further VivaGel^® BV registrations and product launches are planned in the Middle East and Philippines. Marketing campaigns by partners to build brand awareness and sales are ongoing, including for consumer and healthcare professional audiences.

Commenting on the Quarter’s highlights, Starpharma CEO, Dr Jackie Fairley, said:

“Starpharma continues to progress and drive value through its multiple internal and external DEP^® programs, including AZD0466, and its marketed product pipeline. We continue to maintain a strong cash position and were pleased to receive $7.1 million from the Federal Government’s R&D tax incentive scheme this quarter. Starpharma has continued to progress its multiple DEP^® partnerships with AstraZeneca, MSD, Genentech and Chase Sun. In parallel, Starpharma’s internal Phase 2 DEP^® trials are expected to complete recruitment soon, with only a handful of patients to be recruited into the monotherapy arms.

“It was exciting to attend the ASH Meeting in December to hear firsthand the presentation of updated preliminary clinical data in relation to AZD0466, and to engage with AstraZeneca. AZD0466 is a novel dendrimer nanoparticle, which was developed under Starpharma’s multiproduct license with AstraZeneca. The preliminary results presented showed AZD0466 to be very well tolerated in patients with advanced relapsed/refractory leukemia, with no dose-limiting toxicities reported.

“Starpharma also continues to expand the sales and distribution of its antiviral nasal spray, VIRALEZE™, with the product launched in Hong Kong and Macau and the registration of VIRALEZE™ in Indonesia during the quarter. Our post-market clinical study of VIRALEZE™  also commenced in the UK. This will support ongoing marketing and commercialisation of VIRALEZE™.”

“The Company looks forward to continuing this momentum and activity in calendar year 2023.”

Cash Flows

Starpharma’s closing cash balance as at 31 December 2022 was $44.0 million, with net operating cash inflows of $2.2 million for the quarter. Total receipts of $8.1 million in the quarter includes $7.1 million received under the Australian Government’s R&D Tax Incentive scheme and receipts from customers of $1.0 million. Customer receipts include sales from VIRALEZE™ and VivaGel^® BV. R&D cash outflows of $2.6 million include clinical trial costs for Starpharma’s ongoing internal DEP^® clinical programs. Product manufacturing and operating costs were $0.9 million and include inventory and manufacturing costs related to the ongoing supply of VIRALEZE™ and VivaGel^® BV. Staffing costs were $2.6 million and include non-executive and executive directors’ fees of $442,000. Other related party transactions include $7,000 for consulting services to Centre for Biopharmaceutical Excellence Pty Ltd, which Starpharma non-executive director Dr Jeff Davies is also a director and shareholder. Cash outflows from investing activities of $0.4 million reflects investment in new scientific equipment for Starpharma’s laboratories.

View/Download ASX Announcement: Quarterly Activities Report & Appendix 4C

[1] See company announcement dated 23 December 2022.

[2] AZD0466 is a highly optimised dendrimer nanoparticle formulation of AstraZeneca’s dual Bcl-2/xL inhibitor, which utilises Starpharma’s DEP^® technology and is being developed by AstraZeneca under their multi-product DEP^® license with Starpharma.

[3] See company announcement dated 12 September 2022.

[4] See company announcement dated 21 October 2022.

[5] See company announcement dated 14 December 2022.

[6] Respi DART brings together key opinion leaders and experts from around the world to discuss innovative strategies to tackle respiratory virus disease, including the SARS-CoV-2 pandemic.

[7] See AGM Presentation dated 29 November 2022 (pp. 35 – 36)

[8] Gallay PA, et al. Utility of 1% astodrimer sodium nasal spray for pandemic preparedness demonstrated by broad-spectrum antiviral effects and protection against SARS-CoV-2 Omicron, and Influenza A and B virus infection. Global Antiviral Journal (Online) 2022; Abstract RP4, HIV & Respi DART 2022 Abstract Booklet.