Oncurious NV Reports Encouraging Data from Phase 1 Dose Escalation
Study of TB-403 in Paediatric Subjects with Relapsed or Refractory
Medulloblastoma Presented at the American Association for Cancer
Research 2021 Annual Meeting
Leuven, Belgium, Boston, MA, US, 12
April 2021 – 7.30 AM CET – ONCURIOUS
NV, a Belgium-based biotech company focused on developing
innovative oncology treatments, today announces that encouraging
data from a Phase 1 dose escalation study of TB-403 in pediatric
subjects with relapsed or refractory medulloblastoma (MB), was
presented at the annual meeting of the American Association for
Cancer Research (AACR).
The data was presented by Dr. Giselle Sholler,
Director, Isabella Santos Foundation Solid and Rare Tumor Program,
Chair at Beat Childhood Cancer Research Consortium, and Professor,
Paediatric Oncology at the Levine Children’s Hospital in Charlotte,
NC.
The Phase 1 trial (ONC-403-001) was an
open--label, multi-center, dose escalation study of TB--403 in a
total of 15 pediatric subjects - 11 with relapsed or refractory MB,
2 with Ewing Sarcoma (ES) and 2 with alveolar rhabdomyosarcoma
(ARMS). The study was conducted in conjunction with the Beat
Childhood Cancer Research Consortium, Massachusetts General
Hospital and Atrium Health Levine Children's Hospital.
The study evaluated 4 dose levels of TB-403: 20
mg/kg, 50 mg/kg, 100 mg/kg, and 175 mg/kg. The dose limiting
toxicity (DLT) assessment cycle for the study was 28 days with
subjects receiving 2 doses of TB-403 at Day 1 and Day 15
respectively. After the DLT period, temozolomide or etoposide could
be added to the subject’s treatment regimen.
Evaluations for the response to TB-403 were made
at the end of cycle 1 and every 2 cycles thereafter.
The key safety findings from the study were as
follows:
- TB-403 was safe and well tolerated at all dose levels: no
maximum tolerated dose (MTD) was reached
- TB-403 exposure of children is in accordance with the exposure
of the drug in adults
- TB-403 exposure and concentration increased dose-proportionally
over the dose range of 20-175 mg/kg
The
key response findings were as follows:
- At the 3 highest dose levels of TB-403, 7 out of 8 of
medulloblastoma patients had stable disease
- 4 medulloblastoma patients had prolonged stabilization of
disease > 100 days
Exploratory biomarker analysis showed a decrease
in plasma levels of free placental growth factor (PlGF) to
undetectable levels at all doses of TB-403, with no apparent
changes in other angiogenic or inflammatory factors.
The results of the Phase 1 study warrant further
evaluation of TB-403 in pediatric subjects with relapsed or
refractory medulloblastoma (MB).
Dr. Giselle Sholler,
Chair at Beat Childhood Cancer Research
Consortium, commented: ”I am pleased that
the Beat Childhood Cancer Research Consortium has been able to play
a key role in this important study. The encouraging data that I
presented at AACR show that treatment with TB-403 can produce a
clinically meaningful response in a significant number of children
with relapsed and refractory medulloblastoma. The encouraging
results, in what is a very difficult to treat patient population,
warrant further clinical investigation, and we at the Beat
Childhood Cancer Research Consortium would be happy to play our
role in any such effort.”
TB-403 is a humanized monoclonal antibody
against PlGF which is expressed in several types of cancer,
including medulloblastoma. A paper in Cell (Cell, 152, 1065-76,
2013), highlighted that PlGF plays a role in the growth of
medulloblastoma. The paper was based on preclinical research
conducted by Prof Rakesh Jain from the Massachusetts General
Hospital at Harvard (Boston) and the team of Prof Dr. Peter
Carmeliet from the VIB/ KU Leuven.
Prof Dr. Peter Carmeliet from the VIB/
KU Leuven, added, ”I am pleased that our preclinical
research showing that PlGF plays a key role in the growth of
medulloblastoma has been confirmed in this Phase 1 clinical study
with TB-403. I look forward to following the further clinical
development of this novel PIGF inhibitor and am confident that it
has the potential to benefit children suffering from this
devastating brain cancer.”
Dr. Patrik De Haes, Executive Chairman
of Oncurious said, “I would like to thank everyone who has
taken part in the execution of this successful study with TB-403,
especially the patients and their families. The data that has been
generated show that TB-403 could expand the treatment options for
children with relapsed and refractory medulloblastoma. Meanwhile,
Oncurious’ international patent application, published with a
positive indication on the patentability of the combination of
TB-403 with etoposide or temozolomide, and expiring as late as
2040, puts Oncurious in a good position to evaluate potential
partnering options for future development and manufacturing of
TB-403.”
- END –
For further information please
contact:
Oncurious NVWouter Piepers, Investor Relations& Corporate
CommunicationsTel: +32 478 33 56
32wouter.piepers@oncurious.com |
VIBElisabeth StesExternal Relations Manager+32 9 244 66 11 / +32
486 825 902Elisabeth.stes@vib.be |
Citigate Dewe Rogerson David Dible/ Sylvie Berrebi/Frazer HallTel:
+44 20 7638 9571oncurious@citigatedewerogerson.com |
About Oncurious
ONCURIOUS NV is a Belgium-based biotech company
focused on developing innovative oncology treatments derived from a
series of promising new targets that are designed to enhance T cell
activity and migration and infiltration into resistant tumour
sites, boosting the response to immunotherapy in the large numbers
of patients who respond sub-optimally to existing treatment.
Oncurious is working on a series of novel
immuno-modulatory targets offering the potential to overcome tumor
resistance mechanisms, which current immune checkpoint inhibitors
cannot address, and thereby significantly enhancing the responses
to immunotherapy across multiple tumor types. The team has
discovered a potent and diverse panel of leads targeting human CCR8
and is entering the final stage of preclinical candidate
selection.
Oncurious is majority owned by Oxurion NV
(Euronext Brussels: OXUR), a biopharmaceutical company developing
next generation standard ophthalmic therapies designed to better
preserve vision in patients with retinal vascular disorders,
and VIB. Oncurious notes that BioInvent AB contributed to the
initial stages of the trial, holding some co-rights to the
project.
More information: www.oncurious.com
About VIB
VIB is a strategic research center in life
sciences and biotech. The results of VIB’s top research are
actively translated into added value for society. VIB unites the
expertise of 81 research groups thematically organized into 8
research centers. VIB’s technology transfer team proactively
translates new biological findings into new economic activities,
such as starting up new companies and partnerships with the biotech
and pharmaceutical industry. Since its foundation in 1996, VIB has
created 20 start-up companies. VIB also engages actively in the
public debate on biotechnology by developing and disseminating a
wide range of science-based information about all aspects of
biotechnology. VIB has a close partnership with five Flemish
universities – Ghent University, KU Leuven, University of Antwerp,
Vrije Universiteit Brussel and Hasselt University.
More information: www.vib.be
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