Melbourne, Australia; 19 January 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today announces the presentation of the positive results from its Phase 2 clinical trial of DEP^® cabazitaxel at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium[1], which is being held from 18 to 20 January 2024 in San Francisco, US. ASCO is the world's leading professional organisation for physicians and oncology professionals. The ASCO GI Cancers Symposium is the only global meeting of its kind focusing on the latest innovative science and clinical developments in GI cancer treatment, research, and care. It brings together oncology thought leaders, practising clinicians, novel drug developers, and GI specialists from around the world.

Starpharma’s scientific poster presents the key results from the Phase 2 trial of DEP^® cabazitaxel in patients with advanced gastro-oesophageal cancers, announced on 18 October 2023[2], and additional efficacy data for DEP^® cabazitaxel in two subgroups of the gastro-oesophageal cohort with different types of cancers: adenocarcinoma and squamous cell carcinoma (SCC). DEP^® cabazitaxel achieved disease control rates of 100% and 50%, respectively, in these advanced and typically hard-to-treat gastro-oesophageal cancers, which have a one-year survival rate of approximately 20%[3]^,[4].

The ASCO GI Cancers Symposium poster will be presented by Associate Professor David Pinato, a leading Clinician Scientist and Consultant Medical Oncologist at the Imperial College London and an investigator for the DEP^® cabazitaxel study.

Associate Professor David Pinato, MD, MRCP (UK), MRes, PhD, Clinical Reader and Consultant Medical Oncologist, Director of Developmental Cancer Therapeutics Imperial College London, and Investigator for the trial, said:

“I am excited to share the impressive data on Starpharma's novel dendrimer formulation of cabazitaxel with the gastrointestinal cancer community at this specialist ASCO GI cancers conference.  

“DEP^® cabazitaxel showed very encouraging efficacy signals in hard-to-treat gastro-oesophageal cancers, in addition to prostate cancer and advanced platinum-resistant ovarian cancer. The patients in this trial had a poor prognosis with few treatment options remaining.

“In the study, DEP^® cabazitaxel was well tolerated, including in patients with high-risk clinical features. A number of our patients experienced reduced cancer-related pain, leading to reduced opiate usage, and other improvements in quality of life.

“Based on the data and my experience with DEP^® cabazitaxel, it represents a well-tolerated and promising treatment alternative for gastro-oesophageal cancers, with the benefit of less frequent treatment than the standard-of-care taxane option.”

The key results from the Phase 2 trial of DEP^® cabazitaxel demonstrated highly encouraging anti-tumour activity in advanced gastro-oesophageal cancers in multiple anatomic locations (oesophagus, gastro-oesophageal junction and stomach), including a median progression-free survival (PFS) of 4.0 months and a median overall survival (OS) of 8.6 months.

The results for DEP^® cabazitaxel in advanced gastro-oesophageal cancers compare very favourably to standard-of-care paclitaxel treatment in patients with oesophageal or gastro-oesophageal junction cancers. DEP^® cabazitaxel achieved clinically meaningful improvements with a more than 50% longer median progression-free survival and a 29% longer median overall survival than published data on paclitaxel administered weekly as a second-line treatment[5].

Despite the majority of patients with gastro-oesophageal cancer in Starpharma’s study being refractory to first-line therapy, DEP^® cabazitaxel achieved a disease control rate (DCR) of 80% and an objective response rate (ORR) of 30%, including stable disease (SD) for up to 27 weeks and partial responses (PR) for up to 17 weeks in evaluable gastro-oesophageal cancer patients.  

The DEP^® cabazitaxel efficacy results in gastro-oesophageal cancer patients, along with highly encouraging efficacy results in patients with metastatic castrate-resistant prostate cancer and platinum-resistant ovarian cancer, indicate the promising clinical potential of DEP^® cabazitaxel in multiple cancer types, including cancers for which conventional cabazitaxel is not indicated[6].

As reported previously, DEP^® cabazitaxel was also well-tolerated, with most treatment-related adverse events (TRAEs) being mild to moderate (Grade 1/2, 83%).

Starpharma Chief Executive Officer, Cheryl Maley, commented:

“We are pleased to present the data on DEP^® cabazitaxel in gastro-oesophageal cancers at the ASCO GI cancers meeting. Starpharma’s dendrimer platform has shown promise in multiple therapeutic areas, and the recent Phase 2 results have clinically validated the effectiveness and safety of Starpharma’s DEP^® technology, which is designed to improve the therapeutic benefits of drugs while minimising their side effects. We are encouraged by these results and the feedback from patients and clinical trial investigators, which underscore the potential of Starpharma’s DEP^® technology and its ability to improve treatment outcomes for patients.”

View/download the ASX Announcement: DEP® cabazitaxel data presentation at ASCO GI cancer meeting.

View/download the ASCO GI Cancer Symposium poster.

About DEP^® cabazitaxel

Developed by Starpharma, DEP^® cabazitaxel is a patented, dendrimer nanoparticle version of conventional cabazitaxel, which is marketed as Jevtana^® and widely used in the treatment of prostate cancer. Unlike standard cabazitaxel, DEP^® cabazitaxel is highly water soluble, does not contain toxic detergent-like excipients associated with anaphylaxis, and avoids the need for steroid pre-medication. In both preclinical and clinical studies, DEP^® cabazitaxel has shown an improved side effect profile, notably markedly reduced bone marrow toxicity demonstrated by lower rates of severe neutropenia, thrombocytopenia, and severe anaemia, which are all reportedly experienced by a significant proportion of patients treated with Jevtana^®.

About Starpharma’s DEP^® platform

Starpharma has developed a unique and valuable delivery platform known as DEP^® (Dendrimer Enhanced Product), which utilises dendrimers to improve the effectiveness and safety of conventional and new drugs. DEP^® has been widely applied in oncology but also has application to other classes of drugs, such as anti-infectives. DEP^® opens new possibilities for more controlled and precisely targeted drug delivery, enhancing therapeutic and commercial opportunities and creating significant optionality. Additionally, the use of DEP^® can create new intellectual property and extend the patent life for value-added versions of existing drugs.

Starpharma has developed a deep pipeline of novel DEP^® oncology assets. Its clinical-stage assets, DEP^® cabazitaxel, DEP^® docetaxel and DEP^® irinotecan, are improved versions of commonly used chemotherapeutic drugs that have demonstrated improved anti-cancer effects and safety profiles. Additionally, Starpharma has a promising preclinical pipeline, including DEP^® Antibody-Drug Conjugates (ADCs) and DEP^® radiotheranostic products.

In addition to its internal programs, Starpharma has a number of partnered DEP^® programs with global companies, including MSD, Genentech, Chase Sun, and AstraZeneca.

[1] https://conferences.asco.org/gi/attend

[2] ASX Announcement dated 18 October 2023: Positive DEP® Cabazitaxel Phase 2 Results in Multiple Cancers

[3] https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival

[4] https://www.cancerresearchuk.org/about-cancer/oesophageal-cancer/survival

[5] Stockton S, et al., The Oncologist, 2023;28(9):827-e822

[6] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201023s026lbl.pdf