SYDNEY, April 19, 2021 /PRNewswire/ -- Kazia Therapeutics
Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug
development company, is pleased to announce that it has entered
into a worldwide exclusive licensing agreement and a master
services agreement with Evotec SE (FRA: EVT), a leading European
drug discovery and development company, for EVT801, a
small-molecule, first-in-class oncology drug candidate. Kazia
expects to launch a phase I clinical trial of EVT801 in CY2021.
Key Points
- Evotec has granted Kazia an exclusive global worldwide license
to develop, manufacture, and commercialise EVT801 in all
territories and indications.
- Under the terms of the agreement, Kazia will pay an immediate
upfront of €1 million (AU$ 1.6 million), contingent milestones of
up to €308 million (AU$ 480 million) related to achievement of
clinical, regulatory, and commercial outcomes over the lifetime of
the drug, and a tiered single-digit royalty on net sales.
- Evotec is a leading drug discovery and development company,
headquartered in Hamburg, Germany,
and listed on the Frankfurt Stock Exchange.
- EVT801 is a small-molecule inhibitor of VEGFR3. Its primary
activity is to inhibit lymphangiogenesis, the formation of new
lymphatic vessels around a growing tumour. By doing so, EVT801 is
expected to starve the tumour of vital nutrients and to reduce
metastasis. EVT801 also has marked activity on the immune system
within the tumour and may therefore enhance the activity of
immuno-oncology therapies.
- Kazia and Evotec have also entered into a master services
agreement, under which the two companies will collaborate closely
on the further development of EVT801.
- EVT801 was originally discovered by Sanofi (NASDAQ: SNY), the
largest pharmaceutical company in France and among the five largest in the world
and was developed through a partnership between Sanofi and
Evotec.
- Kazia expects to launch a phase I clinical trial in CY2021. The
initial exploratory indications for EVT801 include renal cell
carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer),
and soft tissue sarcoma.
Kazia CEO, Dr James Garner,
commented, "We are delighted to add this tremendously exciting new
compound to the Kazia pipeline. Evotec have done first-class work
in the early development of EVT801, and the preclinical data
package is exceptionally strong. We intend to fast track a phase I
clinical trial of the drug, which we expect to commence in
CY2021."
He added, "As we have built Kazia over the past five years, our
strategy has been to assemble a portfolio of world-class
development candidates through in-licensing. The EVT801 transaction
is wholly consistent with that strategy. We have demonstrated,
through the paxalisib program, our ability to add value to a
development candidate, and we intend to similarly accelerate EVT801
via a rich and innovative development program."
Evotec CEO, Dr Werner Lanthaler,
commented, "we are very pleased to partner with Kazia for this
promising asset, for which we have high hopes. Our corporate
strategy does not provide for Evotec to take EVT801 through
clinical trials itself, so we have sought to identify a partner who
can do justice to the drug's potential. We recognise Kazia's track
record and look forward to working together to make EVT801
available to patients and clinicians."
EVT801
EVT801 is a small molecule inhibitor of vascular endothelial
growth factor receptor 3 (VEGFR3). It is orally available, and so
can be administered to patients by mouth.
For more than two decades, one of the most successful approaches
in the treatment of cancer has been to target angiogenesis, the
formation of new blood vessels. Drugs which inhibit angiogenesis,
such as Avastin® (bevacizumab), starve the growing tumour of
nutrients. However, inhibiting angiogenesis also results in hypoxia
(low levels of oxygen) around the tumour, and this is thought to
generate resistance to treatment. Almost all cancers treated with
current anti-angiogenic drugs will eventually develop
resistance.
An alternative approach, which may avoid this problem, is to
target lymphangiogenesis, which is the formation of new lymphatic
vessels. Doing so achieves many of the same objectives as targeting
angiogenesis but may avoid the problem of resistance induced by
hypoxia. Moreover, the lymphatic system is a common route by which
tumours spread (metastasise) throughout the body, and so inhibiting
lymphangiogenesis may help to limit the ability of the tumour to
spread.
In recent years, several new drug candidates have attempted to
inhibit lymphangiogenesis. For example, Nexavar® (sorafenib)
inhibits several forms of VEGFR, as well as other targets, and is
approved for the treatment of renal cell carcinoma and
hepatocellular carcinoma. Several drugs described as angiokinase
inhibitors are in development, and some of these inhibit VEGFR3.
However, each of these drugs has multiple targets, leading in many
cases to significant side effects. The distinguishing feature of
EVT801 is a high degree of specificity for VEGFR3, which should
allow it to minimise toxicity.
In addition, EVT801 has shown powerful evidence in the
laboratory of an ability to change the balance of immune cells
within the tumour. Many tumours are resistant to the newest
generation of immuno-oncology therapies because they do not contain
the right immune cells for the drugs to act upon. It is hoped that
administration of EVT801 may help to sensitise these tumours to
immuno-oncology therapies such as Keytruda® (pembrolizumab) and
Opdivo® (nivolumab) and thereby extend their use.
Kazia expects to explore all these potential uses of EVT801
during the clinical program. The initial focus will be on a phase I
study, which is expected to be conducted at one or more leading
hospitals in France and to
commence in CY2021.
Master Services Agreement
In parallel with the license agreement, Kazia and Evotec have
entered into a Master Services Agreement (MSA), under which they
will collaborate on the further development of EVT801. Kazia
intends to utilise Evotec's substantial capabilities and expertise
in research, clinical trial management, biomarker development, and
manufacturing, to expedite the development of EVT801.
Investor Conference Call
Kazia is pleased to invite investors to attend a conference call
to further discuss the EVT801 in-licensing.
The call will be held on Tuesday 20 April
2021 at 8:00am, Sydney time (AET), which is 6pm on Monday 19 April in New York (ET) and 3pm
on Monday 19 April in San
Francisco (PT).
Participants will need to pre-register for the call via
the following link:
Registration Link:
https://s1.c-conf.com/diamondpass/10013602-bric5f.html
Click the 'Register Now' button and follow the prompts to
complete pre-registration. You will then receive a calendar invite
with dial in numbers, a passcode and a PIN to dial into the
conference call.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an
oncology-focused drug development company, based in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of
the PI3K / Akt / mTOR pathway, which is being developed to treat
glioblastoma, the most common and most aggressive form of primary
brain cancer in adults. Licensed from Genentech in late 2016,
paxalisib commenced recruitment to GBM AGILE, a pivotal study in
glioblastoma, in January 2021. Seven
additional studies are active in other forms of brain cancer.
Paxalisib was granted Orphan Drug Designation for glioblastoma by
the US FDA in February 2018, and Fast
Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted
Rare Pediatric Disease Designation and Orphan Designation by the US
FDA for DIPG in August 2020.
Kazia is also developing EVT801, a small-molecule inhibitor of
VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to
be active against a broad range of tumour types and has provided
compelling evidence of synergy with immuno-onocology agents. A
phase I study is expected to begin in CY2021.
For more information, please visit www.kaziatherapeutics.com or
follow us on Twitter @KaziaTx.
About Evotec SE
Evotec is a drug discovery alliance and development partnership
company focused on rapidly progressing innovative product
approaches with leading pharmaceutical and biotechnology companies,
academics, patient advocacy groups and venture capitalists.
We operate worldwide and our more than 3,500 employees provide
the highest quality stand-alone and integrated drug discovery and
development solutions. We cover all activities from
target-to-clinic to meet the industry's need for innovation and
efficiency in drug discovery and development (EVT Execute). The
Company has established a unique position by assembling top-class
scientific experts and integrating state-of-the-art technologies as
well as substantial experience and expertise in key therapeutic
areas including neuronal diseases, diabetes and complications of
diabetes, pain and inflammation, oncology, infectious diseases,
respiratory diseases, fibrosis, rare diseases and women's
health.
On this basis, Evotec has built a broad and deep pipeline of
more than 100 co-owned product opportunities at clinical,
pre-clinical and discovery stages (EVT Innovate). Evotec has
established multiple long-term alliances with partners including
Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis,
Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For
additional information please go to www.evotec.com and follow us on
Twitter @Evotec.
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SOURCE Kazia Therapeutics Limited