Debiopharm Further Explores the Potential of its Potent, Highly Selective WEE1 Inhibitor Debio 0123 In Phase 1 Cancer Study
PR93742
LAUSANNE, Switzerland, December 16, 2021 /PRNewswire=KYODO JBN/ -
- Dose escalation, monotherapy trial launched to access the safety and
preliminary anti-tumor activity of Debio 0123 in the treatment of advanced
solid tumors
Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company,
announced today the first patient treated in the newly launched open-label,
phase I study evaluating Debio 0123, an oral, potent and highly selective WEE1
inhibitor, as monotherapy in patients with advanced solid tumors (NCT05109975
[https://clinicaltrials.gov/ct2/show/NCT05109975?term=debio+0123&draw=2&rank=2])
. Part of an emerging new class of drugs working within the DNA damage response
(DDR) pathway, the compound's anti-tumor capacity has been evaluated in several
preclinical studies along with the ongoing phase I study in combination with
carboplatin-based chemotherapy. This new trial's primary objective is to
identify the maximum tolerated dose and/or recommended phase II dose in adults
with advanced solid tumors that have recurred or progressed after prior therapy
and/or for whom no standard therapy of proven benefit is available.
The development of the Debio 0123 program is rooted in the growing
understanding of the DNA damage response of cancer cells. Research reveals that
cancer cell survival relies on the tightly regulated cell cycle that pauses at
certain points to allow the repair of damaged DNA so that tumor cells can
continue to divide and grow. WEE1 is a catalyzing enzyme implicated in these
"DNA repair stops" helping cancer to thrive. By inhibiting WEE1, the cell cycle
checkpoints are compromised, driving cancer cells to start their replicating
prematurely, or before the repair of detrimental DNA damage, ultimately leading
to cell death. Furthermore, WEE1 inhibitors are suspected to selectively target
tumor cells, inducing synthetic lethality without impacting survival of normal
cells. The potential best-in class status of Debio 0123 relies on its highly
selective inhibition against WEE1.
"We're intrigued to learn more about the clinical benefits that WEE1
inhibition with Debio 0123 alone could offer cancer patients. We believe that
this new modality can effectively exploit the genomic instability and
malfunctioning of the DNA repair process in cancer cells in hopes that
ultimately tumor progression is halted and patient survival is improved," Dr.
Esteban Rodrigo Imedio, Senior Medical Director, Oncology Research &
Development, Debiopharm. "As Debio 0123 is highly selective against WEE1, in
time, ongoing clinical research could confirm Debio 0123's potential
best-in-class status."
Initially discovered by Almac Discovery before being in-licensed by
Debiopharm in 2017, the evaluation of Debio 0123 as monotherapy could help to
better characterize the safety and efficacy profile of the compound in a
clinical setting and define the parameters for eventual phase II research.
Pre-clinical research suggests potential activity for cancer patients,
particularly in combination with DNA damaging agents such as chemo- and
radiotherapy. WEE1 inhibitors are promising drug candidates as they inhibit
DDR, offering the possibility to enhance the efficacy of these agents,
frequently part of the standard-of-care of various cancer types. Debiopharm
plans to advance the clinical program while simultaneously negotiating
potential partnerships, such as during the upcoming JP Morgan 2022 conference,
with larger pharmaceutical companies for eventual commercialization.
Dr. Stephen Barr, Managing Director & President, Almac Discovery commented,
"Since the discovery of our highly selective WEE1 inhibitor, now known as Debio
0123, we have looked forward with anticipation to understanding its potential
therapeutic benefit for cancer patients across the globe. We are therefore
delighted that, in addition to the ongoing combination clinical study, Debio
0123 is also being evaluated as a monotherapy in the treatment of advanced
solid tumors. We look forward to seeing further progress from this ongoing
clinical research."
About Debio 0123
Debio 0123 [https://www.debiopharm.com/pipeline/debio-0123/] is a WEE1
kinase inhibitor, a key regulator of the G2/M and S phase checkpoints,
activated in response to DNA damage, allowing cells to repair their DNA before
resuming their cell cycle. WEE1 inhibition, particularly in combination with
DNA damaging agents, induces an overload of DNA breaks. In conjunction with
abrogation of other checkpoints such as G1, the compound pushes the cells
through cycle without DNA repair, promoting mitotic catastrophe and inducing
apoptosis of cancer cells.
About Almac Discovery
Almac Discovery is an innovative research driven biotech company dedicated
to the discovery and development of First in Class therapeutics across a range
of therapeutic areas including neuroscience, muscle-wasting, oncology and
inflammation. Almac Discovery focuses on the discovery to preclinical stage,
seeking to licence programmes with a pharmaceutical partner for further
development.
For more information, please visit www.almacgroup.com/discovery or e-mail
alan.lamont@almacgroup.com.
Debiopharm's commitment to patients
Debiopharm develops innovative therapies that target high unmet medical
needs in oncology and infectious diseases. Bridging the gap between disruptive
discovery products and international patient reach, we identify high-potential
compounds and technologies for in-licensing, clinically demonstrate their
safety and efficacy and then select large pharmaceutical commercialization
partners to maximize patient access globally.
Visit us www.debiopharm.com/
Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews
Debiopharm Contact
Dawn Bonine – Head of Communications
dawn.bonine@debiopharm.com
Tel: +41 (0)21 321 01 11
Source: Debiopharm International SA
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