Press release
PEP-Therapy and Institut Curie Announce
First Patients Dosedin Phase Ib Clinical Trial
Evaluating PEP-010in Ovarian and Pancreatic
Cancers
Paris (France), April 25, 2024 –
PEP-Therapy, a clinical-stage biotechnology company developing
first-in-class peptides as targeted therapies in oncology, and
Institut Curie, France’s leading cancer center, today announced the
dosing of the first patients in a Phase Ib clinical trial
evaluating PEP-Therapy’s lead candidate, PEP-010, based on highly
encouraging Phase Ia results. This second part ot the Phase I study
is evaluating PEP-010 in combination with chemotherapy (paclitaxel
or gemcitabine), in advanced or metastatic ovarian cancer (OC) and
in metastatic pancreatic ductal adenocarcinoma (PDAC), two
indications with high unmet medical need.
PEP-010 is a first-in-class bifunctional
therapeutic peptide that penetrates cells and specifically disrupts
the interaction between Caspase-9 and PP2A, leading to the
inhibition of key pathological mechanisms, without altering
physiological mechanisms. PEP-010 is a pro-apoptotic agent which
has demonstrated a good safety and tolerability profile and first
signals of efficacy in the CLEVer-PEPtide Phase Ia dose escalation
clinical trial.
The two-cohort, open-label, non-controlled,
multicenter Phase Ib program will evaluate the safety and
tolerability, complete or assess the pharmacokinetics, and evaluate
the anti-tumor activity of intravenous PEP-010 when administered in
combination with paclitaxel or gemcitabine. The first cohort
(expansion cohort) will evaluate the efficacy of PEP-010 at the
recommended Phase II dose (RP2D) in combination with paclitaxel in
patients with metastatic PDAC. The second cohort (dose escalation)
will determine the maximum tolerated dose (MTD) and the RP2D of
PEP-010 when administered in combination with gemcitabine in
patients with metastatic PDAC or advanced or metastatic OC. Target
enrollment is up to 53 patients. Four sites in France are currently
recruiting: Institut Curie, Gustave Roussy, Centre François
Baclesse and Institut de Cancérologie de l'Ouest.
“We are thrilled to see the first patients dosed
in this Phase Ib trial. PEP-010 represents a potentially safer and
effective new option for patients with few therapeutic
alternatives. I am delighted to work with our clinical team and the
different centers to determine if PEP-010, when combined with
chemotherapies, can provide therapeutic benefits for patients.”
said Pr. Christophe Le Tourneau, Medical
Oncologist at Institut Curie, Head of the Department of Drug
Development and Innovation (D3i), and Principal Investigator of the
CLEVer-PEPtide trial.
Antoine Prestat, CEO and co-founder of
PEP-Therapy added: “We are delighted with the start of our
Phase Ib trial, and we are grateful for the support of the
participating cancer centers which has enabled this important new
milestone for our company. This study reflects our commitment to
provide a new treatment that addresses unmet medical needs and
improve patient outcomes in combination with the standard-of-care.
Reactivating apoptosis of cancer cells using peptide technology
represents a promising and innovative therapeutic modality. We look
forward to confirming the potential of PEP-010 in this Phase Ib
trial."
Encouraging data from the Phase Ia study were
presented at the AACR-NCI-EORTC Conference on Molecular Targets and
Cancer Therapeutics 2023 confirming the safety of PEP-010 with
encouraging preliminary signals of antitumoral activity in 13
patients who experienced partial response or stable disease,
including 2 confirmed partial responses in combination with
paclitaxel in ovarian and pancreatic cancers, along with a good
safety profile in patients with recurrent and/or metastatic solid
cancers.
XXX
About PEP-010PEP-010 is a
first-in-class bifunctional peptide that penetrates cells and
specifically disrupts the interaction between Caspase-9 and PP2A,
two key proteins involved in the apoptotic pathway. PP2A and
Caspase-9, when released, restore normal apoptosis in cancer cells.
PEP-010 is currently evaluated in a Phase Ia/b clinical trial.
About CLEVer-PEPtide
trialCLEVer-PEPtide is a Phase Ia/b, open-label,
non-controlled, multicenter clinical study (NCT 04733027). It is a
first-in-human dose escalation and expansion study that is expected
to enroll up to 87 patients to evaluate the safety,
pharmacokinetics and preliminary antitumor activity of intravenous
PEP-010, administered as single agent and in combination with
paclitaxel or with gemcitabine in patients with recurrent and/or
metastatic solid cancer.In Phase Ia, results obtained on 34
patients showed good safety profile of PEP-010 in monotherapy, the
Recommended Phase 2 Dose (RP2D) being the highest dose level
tested. In combination with paclitaxel, preliminary antitumor
activity (4 confirmed Partial Responses) was observed, including in
OC and PDAC patients. The clinical development continues with a
Phase Ib focusing on two indications, advanced/metastatic OC and
PDAC. A new combination of PEP-010 with a standard-of-care in these
two indications, gemcitabine, will also be evaluated.PEP-010
clinical development is conducted in partnership with two leading
European cancer centers, Institut Curie and Gustave Roussy, and
also recruiting at Centre François Baclesse and Institut de
Cancérologie de l'Ouest. CLEVer-PEPtide is led by Professor
Christophe Le Tourneau, Medical Oncologist at Institut Curie, Head
of the Department of Drug Development and Innovation (D3i), and
Principal Investigator of the trial.
About PEP-TherapyPEP-Therapy is
a Paris-based clinical-stage biotechnology company developing
first-in-class peptides as targeted therapies in oncology. PEP-010,
lead drug candidate, is a pro-apoptotic agent currently evaluated
in a Phase Ia/b clinical trial. The company also develops a
pipeline of peptide-based products in oncology.Founded in 2014,
PEP-Therapy builds on research from Sorbonne University and
Institut Curie, and is backed by international investors: Seventure
Partners (Quadrivium 1 Seed Fund), CapHorn, i&i Prague, Italian
Angels for Growth (IAG), Doorway, Magna Capital Partners (MCP),
Business Angels des Grandes Ecoles (BADGE), and Jérôme Majoie
(former Managing Director of Laboratoires Fournier affiliates (USA,
UK, Sweden, Japan), CEO of La Fondation Fournier-Majoie).For more
information, please visit www.pep-therapy.com.
About Institut CurieInstitut
Curie, France’s leading cancer center, combines an
internationally-renowned research center with a cutting-edge
hospital group, treating all types of cancer, including the rarest.
Founded in 1909 by Marie Curie, Institut Curie has 3 sites (Paris,
Saint-Cloud and Orsay) with over 3,700 researchers, physicians and
health professionals working on its 3 missions: treatment, research
and teaching. A private foundation with public utility status,
Institut Curie is authorized to accept donations and bequests, and
thanks to the support of its donors, is able to accelerate
discoveries and improve patient treatment and quality of
life. To find out more: www.curie.fr
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Institut Curie has been a certified
“Carnot Curie Cancer Institute” since 2011. The Carnot
certification is a recognition of excellence awarded to academic
research organizations whose quality and involvement in
partnership-based research have been demonstrated. Curie Cancer
offers industrial partners the opportunity to implement research
collaborations utilizing the expertise of Institut Curie’s research
teams to develop innovative therapeutic solutions for cancer, from
therapeutic target to clinical approval. Curie Cancer is a member
of the Carnot FINDMED network, a group of thirteen Carnot
institutes, to facilitate access to their technological platforms
and to their innovations for very small and medium-sized companies
in the pharmaceutical industry. Find out more:
http://www.instituts-carnot.eu/fr/institut-carnot/curie-cancer -
https://findmed.fr
Contacts
PEP-Therapy Antoine Prestat, CEO &
co-founderhello.pep@pep-therapy.com |
ATCG PartnersMarie
PuvieuxPEP-Therapy@atcg-partners.com+33 6 10 54 36 72 |
Institut CurieElsa Champion, Press Relations
Officer elsa.champion@curie.fr+ 33 7 64 43 09 28 |