App 4E/Annual Report to shareholders
Released
Released
Announcement PDF
Appendix 4E: Preliminary Financial Report
under ASX Listing Rule 4.3A
Current reporting period: Year ended 30 June 2023
Prior corresponding period: Year ended 30 June 2022
Results for announcement to the market
$’000
Revenue from continuing operations
(Appendix 4E item 2.1)
Down
14%
to
$4,208
Loss from continuing operations after tax
attributable to members
(Appendix 4E item 2.2)
Down
(decrease)
3%
to
$15,638
Loss for the period attributable to members
(Appendix 4E item 2.3)
Down
(decrease)
3%
to
$15,638
Dividends (Appendix 4E items 2.4 and 2.5)
No dividends have been paid or declared by the entity since the beginning of the current reporting period. No
dividends were paid for the previous corresponding period. No record date for determining entitlements to
dividends has been declared.
Explanation of Revenue (Appendix 4E item 2.6)
Revenue of $4,208,000 (2022: $4,899,000) for the year includes $2,938,000 for VIRALEZE™ and VivaGel®
product sales, royalty, licensing revenue, and research revenue from commercial partners. Interest income on
cash invested of $1,269,000 (2022: $217,000) is also included.
For further details, refer to the Annual Report which follows this announcement.
Explanation of Loss (Appendix 4E item 2.6)
The loss after tax was $15,638,000 (2022: $16,154,000) and includes research and product development
expenses of $11,239,000 (2022: $11,680,000) net of the Australian Government’s R&D tax incentive. Research
expenditures are primarily associated with the internal DEP® drug delivery programs including DEP® docetaxel,
DEP® cabazitaxel, DEP® irinotecan, DEP® ADCs and DEP® radiotheranostics, and the VIRALEZE™ post-market
clinical study.
For further details, refer to the Annual Report which follows this announcement.
Financial Statements (Appendix 4E items 3, 4 and 5)
Refer to the Annual Report which follows this announcement.
Retained Earnings / Accumulated Losses (Appendix 4E item 6)
Refer to note 18 in the Annual Report, which follows this announcement.
Net Tangible Asset Backing (Appendix 4E item 9)
Net tangible asset (NTA) backing per ordinary share at 30 June 2023 is $0.08 (2022: $0.12).
Other Significant Information (Appendix 4E item 12)
Refer to the Annual Report which follows this announcement.
Commentary on Results (Appendix 4E item 14)
Refer to the Annual Report, which follows this announcement, including the Operating and Financial Review in
the Directors’ Report.
Audit (Appendix 4E items 15 to 17)
The audit of the financial statements and notes has been completed and the Auditors’ Report to members is
contained in the Annual Report, which follows this announcement. The above NTA backing calculation is
considered a non-IFRS value and has not been audited or reviewed in accordance with Australian Accounting
Standards.
Appendix 4E items 7, 8, 10, 11, and 13 are not applicable.
Starpharma annual report and full-year financial results
Melbourne, Australia; 24 August 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) today releases its
annual report and full-year financial results for the year ended 30 June 2023.
Financial Results
•
Strong balance sheet with cash of $35.2 million at 30 June 2023. This excludes A$6.6M received
from Mundipharma in August 2023, following the recent commercial settlement for VivaGel® BV.
•
Reported loss down 3% to $15.6M (FY22: $16.2M).
•
Revenue down 14% to $4.2M (FY22: $4.9M).
•
Starpharma received a $7.1 million R&D tax incentive refund in December 2022, with an
anticipated R&D tax incentive refund of $7.6 million expected in FY24.
Operational Highlights
•
Expanded partnerships with multinational pharmaceutical companies MSD and Genentech,
exploring the application of DEP® across several novel therapeutic modalities, including AntibodyDrug Conjugates (ADCs).
•
Generated additional clinical data across our three clinical DEP® programs, including promising
data for DEP® cabazitaxel in patients with advanced prostate cancer, which were presented at the
European Society of Medical Oncology (ESMO) Congress in Paris.
•
Completed recruitment of patients for all three in-house Phase 2 monotherapy clinical programs:
DEP® cabazitaxel, DEP® docetaxel, and DEP® irinotecan.
•
Launched VIRALEZE™ Antiviral Nasal Spray in Hong Kong and Macau through our partner
Hengan Group, shortly after signing a new distribution agreement for these markets.
•
Commenced a post-market clinical study of VIRALEZE™ in patients with COVID-19 in the UK. The
study has recruited ahead of target with more than 90% of the target participants now enrolled.
•
Advanced two new DEP® pipeline products which demonstrated the unique benefits of the DEP®
platform in radiotheranostics and ADCs:
o DEP® HER2-zirconium, a radiodiagnostic for HER2-positive cancers, such as breast
cancer and gastric cancer; and
o HER2-targeted DEP® SN38 ADC, a targeted ADC therapeutic, which outperformed leading
ADC therapy Enhertu® in a HER2+ human ovarian cancer model.
Dr Jackie Fairley, Starpharma CEO, commented, “Starpharma made significant progress across its
portfolio during the 2023 financial year. Across our three Phase 2 DEP® clinical programs, which have
now completed recruitment in the monotherapy arms, we have seen encouraging efficacy signals and
reductions in multiple clinically important side effects, compared to adverse events for conventional
formulations of these drugs. Our trial clinicians continue to report improved patient experiences with
DEP® therapies. We were pleased to present data from the prostate cancer cohort of the DEP®
cabazitaxel trial at ESMO and look forward to releasing and presenting more data from our Phase 2
trials in Q3 CY23.
“We were delighted to expand our DEP® partnerships with leading, global companies, MSD and
Genentech, adding new programs of work, which are progressing well. Our antiviral nasal spray,
VIRALEZE™, was launched in Hong Kong and Macau, and new product registrations were achieved
in Indonesia and Malaysia with further applications underway. Our post-market clinical study of
VIRALEZE™ in people with COVID-19 is recruiting ahead of schedule, with more than 90% of
participants enrolled and data expected soon after completion.
“Starpharma remains in a very strong financial position, with cash reserves of $35.2 million at 30 June
2023, and the subsequent receipt of A$6.6M in August 2023, from Mundipharma, following the signing
of a settlement agreement related to VivaGel® BV.
“Looking ahead, we have a number of exciting milestones, including results from our DEP® oncology
trials, multiple upcoming presentations at international oncology and radiotheranostics meetings, as
well as results from our post-market VIRALEZE™ study. We also expect advances in our partner and
preclinical DEP® programs, as well as for VIRALEZE™ and VivaGel® BV.”
Key Activities
DEP® Drug Delivery Programs
Starpharma’s Phase 2 clinical trial of DEP® cabazitaxel completed the enrolment and treatment of
patients, with 76 participants enrolled. Encouraging efficacy signals following treatment with DEP®
cabazitaxel have been observed, including significant tumour shrinkage and tumour biomarker
reductions, in heavily pre-treated patients with advanced cancers, including prostate, ovarian, gastrooesophageal, cholangiocarcinoma and head and neck cancer. In September 2022, Starpharma
presented promising results from the prostate cancer cohort at the European Society of Medical
Oncology (ESMO) Congress. Starpharma expects to report the Phase 2 results from this trial in Q3
CY23, with partnering discussions ongoing.
The Phase 2 monotherapy arm of the DEP® docetaxel trial also completed enrolment and treatment of
patients. 50 patients were recruited and treated with DEP® docetaxel in the monotherapy arm, and
encouraging efficacy signals, including prolonged stable disease and significant tumour shrinkage, have
been observed in heavily pre-treated patients with multiple cancer types, including pancreatic cancer,
gastro-oesophageal cancer, and cholangiocarcinoma. Starpharma expects to report the Phase 2 results
from this trial in Q3 CY23, with partnering discussions ongoing.
Starpharma also completed patient enrolment in the monotherapy arm of the Phase 2 clinical trial of
DEP® irinotecan, with 88 patients having been enrolled in the monotherapy arm. Encouraging results
have been seen in patients with multiple cancer types, including colorectal, platinum-resistant ovarian,
gastrointestinal, and breast cancer, with durable responses for up to 72 weeks. Starpharma also
progressed the combination arms of the DEP® irinotecan (5-FU/leucovorin) and DEP® docetaxel
(gemcitabine) Phase 2 trials, with final patient recruitment underway. The irinotecan plus 5FU/leucovorin combination is a standard-of-care treatment regimen for colorectal cancer.
In parallel with completing these Phase 2 programs, Starpharma continued to build its pipeline of DEP®
assets, advancing the development of two promising products in DEP® radiotheranostics and DEP®
ADCs. In June 2023, Starpharma announced that DEP® HER2-zirconium, a HER2-targeted
radiodiagnostic, demonstrated imaging benefits in a HER2+ breast cancer model. The demonstrated
benefits included a favourable biodistribution profile, excellent imaging contrast between tumour and
normal tissues, rapid uptake, and high levels of tumour accumulation.
In addition, Starpharma announced the development of a HER2-targeted DEP® SN38 ADC, which
demonstrated significant anti-tumour activity and improved survival in a HER2-positive (HER2+) human
ovarian cancer xenograft model, outperforming a leading HER2-ADC, Enhertu®.
Starpharma’s partners include some of the world's largest pharmaceutical companies, such as MSD,
Genentech, Chase Sun and AstraZeneca. During the financial year, Starpharma expanded its DEP®
programs with MSD and Genentech to include new programs of work. Starpharma’s partnered
programs apply the Company’s DEP® platform technology to several novel therapeutic modalities,
including Antibody-Drug Conjugates. In late July 2023, AstraZeneca announced it had made the
decision to discontinue the development of AZD0466, following an internal review of its haematology
portfolio. AstraZeneca confirmed that the asymptomatic adverse events leading to this decision were
not related to the dendrimer component of AZD0466. Starpharma’s DEP® License Agreement with
AstraZeneca remains in effect.
Starpharma maintains an active business development program for the DEP® platform, with commercial
discussions underway in a number of areas, including DEP® radiotheranostics and DEP® ADCs. The
recently released positive data in both these areas feed into these discussions and will be showcased
at upcoming international conferences.
2
VIRALEZE™ Antiviral Nasal Spray
During the financial year, Starpharma’s antiviral nasal spray, VIRALEZE™, was launched in new
markets, including Hong Kong and Macau, through an extensive network of retail stores, online, and
other channels. The launch followed the signing of a sales and distribution agreement with Hengan
Group and was supported by marketing activities. Hengan is based in China, listed on the Hong Kong
Stock Exchange, has an annual turnover of ~A$4.5 billion and employs ~23,000 staff.
Marketing of VIRALEZE™ continued in multiple jurisdictions, including Hong Kong, Macau, Vietnam,
the UK, and Europe. During the year, Starpharma expanded its e-commerce channels in the UK,
making VIRALEZE™ available through a dedicated product website and Amazon UK.
This year, Starpharma achieved registration for VIRALEZE™ in Malaysia and Indonesia, bringing the
number of countries where VIRALEZE™ is registered to more than 35, and submitted regulatory
applications in other jurisdictions. VIRALEZE™ is not approved for use or supply in Australia. The
review by the Therapeutic Goods Agency (TGA) for the SPL7013 nasal spray as a medical device is
ongoing.
Starpharma commenced a post-market clinical study of VIRALEZE™ in the UK in December 2022. The
study will provide valuable clinical data on the antiviral performance of VIRALEZE™ in COVID-19positive individuals. The study has recruited ahead of schedule, with more than 90% of participants
enrolled to date.
Starpharma presented new data on the efficacy of VIRALEZE™ against SARS-CoV-2 omicron infection
in an animal challenge model at the international virology conference Respi DART in December 2022.
These data, which were generated at Scripps Research in the US, showed that VIRALEZE™ was able
to eliminate the SARS-CoV-2 omicron virus by more than 99.99% in the lung and trachea of animals
that were exposed to the virus, even when VIRALEZE™ was administered after exposure.
VivaGel® Portfolio
Starpharma’s VivaGel® BV product continued to be marketed in multiple jurisdictions, including by
Starpharma’s partner Aspen in Australia and New Zealand. Marketing campaigns by partners to build
brand awareness and sales are ongoing, including for consumer and professional healthcare
audiences.
In August 2023, Starpharma announced it had negotiated a commercial settlement agreement with
Mundipharma for VivaGel® BV, which included a A$6.6M cash payment to Starpharma. Under the
agreement, Starpharma also regained all commercial rights to VivaGel® BV, enabling Starpharma to
appoint new marketing partners, with commercial interest already expressed in the product. In the US,
a formal dispute resolution process is ongoing with the Food and Drug Administration (FDA) for
VivaGel® BV. As part of this process, Starpharma has received extensive external advice, met the FDA
on multiple occasions, and made a number of submissions of data and analyses to the regulator. The
Company is preparing to lodge a further submission to the FDA, including precedents of other FDA
approvals, with the timing of lodgement governed by the publication and incorporation of relevant
precedent information.
Starpharma’s VivaGel® Condom continues to be marketed by Okamoto in Japan, with Okamoto also
pursuing approvals in other Asian countries.
Corporate
Ms Zita Peach retired from the Board in November 2022 after 11 years. In February 2023, Starpharma
welcomed medical oncologist and former senior executive Dr Russell Basser to the Board. Dr Basser
has substantial expertise in international drug and vaccine development, having held multiple senior
executive roles at CSL.
In April 2023, Mr Justin Cahill joined Starpharma as Chief Financial Officer (CFO) and Company
Secretary. Mr Cahill has extensive corporate finance and leadership experience in the
biopharmaceutical, food, and agricultural sectors with several private and ASX-listed companies,
including CSL. In February 2023, Starpharma appointed Ms Tracy Weimar as interim Company
Secretary.
3
In June 2023, Dr Jackie Fairley advised the Board of her intention to retire as CEO in 2024 after 17
years. A search process is underway and Dr Fairley, the Board, and the senior executive team are
working closely to ensure a seamless transition.
Financials
Starpharma concluded FY23 in a strong financial position with a cash balance of $35.2 million. Net
operating cash outflows for the year were $13.5 million (FY22: $13.2 million). This excludes A$6.6M
received from Mundipharma in August 2023 following the recent commercial settlement for VivaGel®
BV.
Revenue for FY23 was $4.2 million (FY22: $4.9 million), which included $2.9 million from VIRALEZE™
and VivaGel® product sales, royalties, licensing revenue, and research revenue from commercial
partners, as well as interest income of $1.3 million.
The FY23 loss after tax continued to trend downwards to $15.6 million (FY22: $16.2 million).
Expenditure included investment in research and product development associated with the internal
DEP® drug delivery programs, including Starpharma’s clinical-stage products, DEP® cabazitaxel, DEP®
docetaxel, DEP® irinotecan, which have now largely completed recruitment, as well as DEP® ADCs,
and DEP® radiotheranostics, and the post-market clinical study of VIRALEZE™.
Starpharma received a $7.1 million R&D tax incentive refund in December 2022, with an anticipated
R&D tax incentive refund of $7.6 million expected in FY24.
About Starpharma
Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a world leader in dendrimer technology for medical applications.
As an innovative Australian biopharmaceutical company, Starpharma is focussed on developing and commercialising novel
therapeutic products that address significant global healthcare needs. Starpharma boasts a strong portfolio of products,
partnerships, and intellectual property.
Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically
manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of
branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications.
Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing
pharmaceuticals. Starpharma’s portfolio includes multiple clinical-stage oncology products, which utilise its Dendrimer Enhanced
Product (‘DEP®’) drug delivery technology, and marketed products, including VIRALEZE™ and VivaGel® BV, which utilise
SPL7013, a proprietary dendrimer with antimicrobial properties.
Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to
reduce drug-related toxicities through controlled and specified drug delivery.
In addition to Starpharma’s internal DEP® programs, Starpharma has multiple DEP® partnerships with international
biopharmaceutical companies, including AstraZeneca (oncology); MSD (Antibody-Drug Conjugates); Chase Sun (anti-infectives);
and other world-leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform,
partnered DEP® programs have the potential to generate significant future milestones and royalties.
Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including Europe, the UK,
and Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention
of recurrent BV, is registered in more than 50 countries, including in the UK, Europe, Southeast Asia, South Africa, Australia and
New Zealand.
For more information about Starpharma, visit www.starpharma.com or connect with Starpharma on LinkedIn.
Media: Sumit Media
Grant Titmus
Mob: +61 419 388 161
grant@sumitmedia.com.au
Starpharma Holdings Limited
Dr Jackie Fairley, Chief Executive Officer
Justin Cahill, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement was
authorised for release by the
Board of Directors.
4
Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of
forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”,
“targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”,
“outlook”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future
sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from any future results, performance or achievements expressed or implied by such
statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’
requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved
by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations
regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results,
including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally;
our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry,
and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product
candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or
expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any
forward-looking statements contained in this document as a result of new information, future events or developments or otherwise. Clinical
case studies and other clinical information given in this document are given for illustrative purposes only and are not necessarily a guide
to product performance and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness
of future results. Nothing contained in this document nor any information made available to you is, or shall be relied upon as, a promise,
representation, warranty or guarantee as to the past, present or the future performance of any Starpharma product.
5
Annual Report
2023
Contents
Highlights
01
Chairman’s Report
02
Chief Executive Officer’s Report
04
Enhancing Global Healthcare
with Improved Medicines
06
Rethinking the Science Behind
Oncology Treatments
07
Driving Innovation Through Strategic
Partnerships with Leading Global
Companies
13
Creating Medical Innovations That
Make a Difference Worldwide
14
Environment, Social and Governance
16
3-Year Financial Summary
18
Directors’ Report
20
Remuneration Report
33
Auditor’s Independence Declaration
62
Annual Financial Report
63
Independent Auditor’s Report
96
Shareholder Information
101
Intellectual Property Report
103
Corporate Directory
105
Starpharma Holdings Limited
ABN 20 078 532 180
Starpharma is a world leader in
dendrimer technology for medical
applications. As an innovative
Australian biopharmaceutical
company, Starpharma is focussed
on developing and commercialising
novel therapeutic products that
address significant global healthcare
needs. Starpharma boasts a strong
portfolio of products, partnerships,
and intellectual property.
Highlights
Expanded partnership with
leading biotech, Genentech,
applying Starpharma’s DEP®
platform to a number of novel
therapeutic modalities.
Presented promising
new clinical data on
DEP® cabazitaxel in
patients with advanced
prostate cancer at the
2022 European Society
of Medical Oncology
(ESMO) Congress.
Commenced recruitment
in the UK for a post-market
clinical study of VIRALEZE™
nasal spray in patients with
recently diagnosed COVID-19.
The study has since recruited
more than 90% of the target
participants.
New registrations were achieved
for VIRALEZE™ nasal spray in
Indonesia and Malaysia, bringing
the number of countries where
VIRALEZE™ is registered to more
than 35 globally.
Completed recruitment of
patients for all three in-house
Phase 2 monotherapy clinical
trials: DEP® cabazitaxel, DEP®
docetaxel, and DEP® irinotecan.
DEP® HER2-zirconium, a
HER2-targeted radiodiagnostic
developed by Starpharma,
demonstrated imaging benefits
in a HER2+ breast cancer model.
Newly developed internal DEP®
Antibody-Drug Conjugate,
HER2-targeted DEP® SN38,
demonstrated significant antitumour activity in a HER2+ human
ovarian cancer model.
Data on DEP® based AZD0466
presented by AstraZeneca
at three international cancer
research conferences, including
impressive preclinical data in small
cell lung cancer at the American
Association for Cancer Research
(AACR) Annual Meeting.
Experienced executive and
oncologist Dr Russell Basser
appointed to Starpharma’s
Board, and Justin Cahill
appointed Chief Financial Officer
and Company Secretary.
In recognition of
Starpharma’s positive
workplace and
company culture,
we were awarded
Great Place to Work®
certification.
Expanded partnership with
multinational pharmaceutical
company, MSD, to explore the
anti-cancer properties of DEP®
Antibody-Drug Conjugates.
Launched VIRALEZE™
antiviral nasal spray
in Hong Kong and
Macau through our
new commercial
partner, Hengan,
shortly after entering
a distribution
agreement.
Received a $7.1 million
research and development
(R&D) tax incentive refund
in December 2022.
Starpharma Holdings Limited
Annual Report 2023
01
Chairman’s Report
Starpharma’s dendrimer platform continues
to demonstrate outstanding versatility
and optionality across its internal and
partnered programs.
Rob Thomas AO
Starpharma Chairman
On behalf of the Board of Directors, I am
pleased to present Starpharma’s 2023
Annual Report to fellow shareholders.
First, let me acknowledge the
disappointing share price performance
that has significantly impacted our
shareholders. The biotechnology
industry has been extraordinarily
difficult globally and we have not
been immune to these sector-wide
pressures. Our share price suffered
disproportionately following
AstraZeneca’s recent decision
regarding the AZD0466 development.
While such setbacks are not unexpected
in our industry, AstraZeneca’s decision
did not relate to Starpharma’s dendrimer
platform and it has no impact on our
other partnerships or internal DEP®
programs. Notwithstanding this,
the Board and management are very
focused on improving shareholder
returns. Assisting us in this endeavour
is a strong cash position, further
strengthened with the receipt of
A$6.6 million from Mundipharma in
August 2023. Starpharma’s strong
balance sheet position excludes any
licensing transactions from either our
own internal drug candidates or existing
multiple global partnerships.
Underpinning Starpharma is our
steadfast pursuit to improve patient
health worldwide, with innovation
driving our people and products.
We remain committed to bringing highquality healthcare products to patients
and global markets, with a focus on
cancer treatments.
Our Company prides itself on having
a strong portfolio of high-calibre
partnerships with multinational
pharmaceutical companies, multiple
oncology drugs under development,
02
Annual Report 2023
and several anti-infective products
in the market. The importance of this
portfolio approach is even more
apparent with the recent developments.
During the 2022-23 financial year,
we were delighted to expand our
international presence, achieving
new registrations and launches for
our marketed products, VIRALEZE™
Antiviral Nasal Spray and VivaGel® BV.
Starpharma’s dendrimer platform
technology continues to demonstrate
outstanding versatility and optionality,
reflected in the diversity of our clinical
programs and global partnerships.
Our dendrimer enhanced product
(‘DEP®’) portfolio is strongly validated
through our internal clinical programs
and collaborative research with
partners. Rethinking the science behind
conventional chemotherapeutics and
novel approaches to oncology, such
as Antibody-Drug Conjugates and
radiotheranostics, is central to what
Starpharma’s scientists aim for
every day.
A key milestone achieved this year was
the completion of the recruitment and
treatment of patients for all three of our
internal monotherapy clinical trials –
DEP® cabazitaxel, DEP® docetaxel,
and DEP® irinotecan.
We have already seen promising
responses in patients across these
trials, including longer progressionfree survival, significant tumour
shrinkage, and an improved safety
profile compared to published data
on the original formulations of these
oncology drugs.
We were pleased to present additional
interim results from the prostate cancer
cohort of the Phase 2 DEP® cabazitaxel
Starpharma Holdings Limited
clinical trial at the European Society of
Medical Oncology (ESMO) Congress
in September 2022, and we expect
to report top-line results for both
the Phase 2 DEP® cabazitaxel and
DEP® docetaxel (monotherapy)
trials in Q3 CY23. We will also present
our clinical results at upcoming
international conferences.
Our Phase 2 clinical trials of DEP®
docetaxel in combination with
gemcitabine, and DEP® irinotecan
in combination with 5-FU/leucovorin
continue enrolling patients and are
nearing completion.
Alongside these clinical advancements,
we also reported exciting results
for a DEP® radiodiagnostic imaging
candidate and a new DEP® ADC
candidate – both of which target the
HER2 receptor that is prevalent in
many cancers, particularly breast
and gastric cancers.
Our DEP® partnerships with MSD,
Genentech, Chase Sun, and
AstraZeneca are also key drivers
of Starpharma’s DEP® portfolio.
AstraZeneca presented exciting
clinical and nonclinical data on
AZD0466 throughout the year at
several international cancer research
conferences, including in small cell
lung cancer. Although AstraZeneca
decided to discontinue the
development of AZD0466, prompted
by a small number of asymptomatic
adverse events in haematological
cancer trials, Starpharma’s multiproduct DEP® Licence Agreement
with AstraZeneca remains on foot.
We note that these events were unrelated
to Starpharma’s dendrimer drug delivery
technology. Interest in our dendrimer
platform continues unabated.
Starpharma’s DEP®-related
collaborations with MSD and
Genentech involve researching
and developing dendrimer-drug
candidates, including oncology
therapeutics and ADCs. Our current
programs with these
Share your feedback
Discover