TIDMHCM
Hutchison China Meditech Limited
26 May 2020
Press Release
Chi-Med and BeiGene Enter into Clinical Collaboration to
Evaluate Combinations of Surufatinib and Fruquintinib with
Tislelizumab
- Collaboration to explore multiple solid tumor cancer
indications -
- Initial development focused on multi-cohort trials in the
U.S., Europe, China and Australia -
LONDON, UK; CAMBRIDGE, Mass. and BEIJING, China: May 26, 2020:
Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) and
BeiGene, Ltd. ("BeiGene") (Nasdaq: BGNE; HKEX: 06160) today
announced that they have entered into a clinical collaboration
agreement to evaluate the safety, tolerability and efficacy of
combining two of Chi-Med's drug candidates, surufatinib and
fruquintinib, with BeiGene's anti-PD-1 antibody tislelizumab, for
the treatment of various solid tumor cancers, in the U.S., Europe,
China and Australia.
Under the terms of the agreement, Chi-Med and BeiGene each plan
to explore development of the combination of surufatinib with
tislelizumab or fruquintinib with tislelizumab in different
indications and regions. The companies have agreed to provide
mutual drug supply and other support.
"We are very pleased to enter into this clinical collaboration
with BeiGene, a company with which we share a vision to discover,
develop and commercialize innovative targeted therapies and
immunotherapies worldwide," said Dr. Marek Kania, Senior Vice
President and Chief Medical Officer, Hutchison MediPharma
International.(1)
"By working together with a partner like Chi-Med, we hope to
understand and develop innovative combination therapies that may
bring meaningful treatments to cancer patients around the world.
Through this collaboration we plan to further evaluate tislelizumab
in combination with oral VEGFR inhibitors to target a variety of
solid tumor cancers," said Lai Wang, Ph.D., Senior Vice President,
Head of Global Research, Clinical Operations & Biometrics and
APAC Clinical Development, at BeiGene.
Each of these three compounds are currently in late-stage global
clinical development across many countries outside of China.
Tislelizumab is a humanized IgG4 anti-programmed death-1 ("PD-1")
monoclonal antibody specifically designed to minimize binding to Fc
receptor gamma ("Fc<GAMMA>R"), which is believed to play an
essential role in activating phagocytosis in macrophages, to
minimize its negative impact on T effector cells. Fruquintinib is
designed to improve kinase selectivity against vascular endothelial
growth factor receptors ("VEGFR") in order to minimize off-target
toxicities, and thereby provide consistent coverage and better
tolerability, which is very important in combinations. Surufatinib,
a VEGFR inhibitor, inhibits colony stimulating factor-1 receptor
("CSF-1R") additionally, thereby blocking the accumulation of tumor
associated macrophages and promoting infiltration of T effector
cells into tumors, leading to possible synergistic anti-tumor
activity with PD-1 inhibitors.
Tislelizumab and fruquintinib have both been approved by the
China National Medical Products Administration ("NMPA"), which is
also currently reviewing the New Drug Application ("NDA") for
surufatinib that was submitted late last year.
[1] Hutchison MediPharma International - the international arm
of Chi-Med's innovative drug R&D operations.
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal
antibody specifically designed to minimize binding to
Fc<GAMMA>R on macrophages. In pre-clinical studies, binding
to Fc<GAMMA>R on macrophages has been shown to compromise the
anti-tumor activity of PD-1 antibodies through activation of
antibody-dependent macrophage-mediated killing of T effector cells.
Tislelizumab is the first drug from BeiGene's immuno-oncology
biologics program and is being developed internationally as a
monotherapy and in combination with other therapies for the
treatment of a broad array of both solid tumor and hematologic
cancers.
Tislelizumab is approved by the China NMPA as a treatment for
patients with classical Hodgkin's lymphoma ("cHL") who received at
least two prior therapies and for patients with locally advanced or
metastatic urothelial carcinoma (UC) with PD-L1 high expression
whose disease progressed during or following platinum-containing
chemotherapy or within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy.
Currently, 15 potentially registration-enabling clinical trials
are being conducted in China and globally, including 11 Phase 3
trials and four pivotal Phase 2 trials.
Tislelizumab is not approved for use outside of China.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor
angiogenesis. Fruquintinib was designed to improve kinase
selectivity to minimize off-target toxicities, improve tolerability
and provide more consistent target coverage. The generally good
tolerability in patients to date, along with fruquintinib's low
potential for drug-drug interaction based on preclinical
assessment, suggests that it may be highly suitable for
combinations with other anti-cancer therapies.
Fruquintinib was approved for marketing in China by the NMPA in
September 2018 and commercially launched by Eli Lilly and Company
("Lilly") in late November 2018 under the brand name Elunate(R) .
Elunate(R) is for the treatment of patients with metastatic
colorectal cancer that have been previously treated with
fluoropyrimidine, oxaliplatin and irinotecan, including those who
have previously received anti-VEGF therapy and/or anti-EGFR therapy
(RAS wild type). Results of the FRESCO study, a Phase III pivotal
registration trial of fruquintinib in 416 patients with colorectal
cancer ("CRC") in China, were published in The Journal of the
American Medical Association, JAMA, in June 2018
(clinicaltrials.gov identifier: NCT02314819).
Chi-Med retains all rights to fruquintinib outside of China and
is partnered with Lilly in China.
Global development of fruquintinib in CRC : We intend to
initiate a Phase III registration study, known as the FRESCO-2
study, in the U.S., Europe and Japan in CRC. FRESCO-2 is expected
to start enrolling patients in mid-2020. Based on our agreement
with the U.S. Food and Drug Administration (FDA), the FRESCO and
FRESCO-2 studies, if positive, could support our NDA
application.
Gastric Cancer in China : In October 2017, we initiated the
FRUTIGA study, a randomized, double-blind, Phase III study in China
to evaluate the efficacy and safety of fruquintinib combined with
paclitaxel (Taxol(R) ) compared with paclitaxel monotherapy in the
treatment of patients with advanced gastric adenocarcinoma or
gastroesophageal junction (GEJ) adenocarcinoma who have progressed
after first-line standard chemotherapy (clinicaltrials.gov
identifier: NCT03223376). Over 540 patients are expected to be
enrolled into the FRUTIGA study at a 1:1 ratio with the primary
endpoint of this study being overall survival (OS). In April 2019,
we conducted the first interim analysis of the FRUTIGA study for
futility. Following the analysis of safety and efficacy of the
first 100 patients, the Independent Data Monitoring Committee
("IDMC") recommended to continue the study without changes. We
expect to conduct a second interim analysis in mid-2020 and
complete enrollment of the study in 2020.
Immunotherapy combinations: In November 2018, we entered into
two collaboration agreements to evaluate the safety, tolerability
and efficacy of fruquintinib in combination with PD-1 monoclonal
antibodies, including with Tyvyt(R) (sintilimab) and geptanolimab
(GB226, genolimzumab).
Fruquintinib is not approved for use outside of China.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
VEGFR and fibroblast growth factor receptor (FGFR), which both
inhibit angiogenesis, and CSF-1R, which regulates tumor-associated
macrophages, promoting the body's immune response against tumor
cells. Its unique dual mechanism of action may be very suitable for
possible combinations with other immunotherapies, where there may
be synergistic anti-tumor effects.
Chi-Med currently retains all rights to surufatinib
worldwide.
Neuroendocrine tumors ("NET") in the U.S., Europe and Japan: We
are preparing for regulatory interactions in the U.S., Europe and
Japan to confirm clinical development and path to registration,
based on the robust data from the two positive Phase III studies of
surufatinib in NET in China, and the ongoing multi-cohort Phase Ib
study in the U.S. (clinicaltrials.gov identifier: NCT02549937). In
the U.S., surufatinib was granted Fast Track Designations for
development in pancreatic and non-pancreatic (extra-pancreatic) NET
in April 2020, and Orphan Drug Designation for pancreatic NET in
November 2019.
Non-pancreatic neuroendocrine tumors in China: In November 2019,
a New Drug Application ("NDA") for surufatinib for the treatment of
patients with advanced non-pancreatic NET was accepted for review
by the China NMPA and granted Priority Review status in December
2019. The NDA is supported by data from the successful SANET-ep
study, a Phase III study of surufatinib in advanced neuroendocrine
tumors - extra-pancreatic patients in China for whom there is no
effective therapy. A 198-patient interim analysis was conducted in
June 2019, leading the IDMC to determine that the study met the
pre-defined primary endpoint of progression-free survival ("PFS")
and should be stopped early. The positive results of this trial
were highlighted in an oral presentation at the 2019 European
Society for Medical Oncology Congress (clinicaltrials.gov
identifier: NCT02588170).
Pancreatic neuroendocrine tumors in China: In 2016, we initiated
the SANET-p study, which is a pivotal Phase III study in patients
with low- or intermediate-grade, advanced pancreatic NET in China.
A second NDA for surufatinib for the treatment of patients with
advanced pancreatic NET is being prepared for submission, following
an interim analysis review conducted in January 2020 by the IDMC
that recommended the registrational study be terminated early as
the pre-defined primary endpoint of PFS had already been met
(clinicaltrials.gov identifier: NCT02589821). Study results will be
submitted for presentation at an upcoming scientific
conference.
Biliary tract cancer in China: In March 2019, we initiated a
Phase IIb/III study comparing surufatinib with capecitabine in
patients with advanced biliary tract cancer whose disease
progressed on first-line chemotherapy. The primary endpoint is
overall survival ("OS") (clinicaltrials.gov identifier
NCT03873532).
Immunotherapy combinations: In November 2018 and September 2019,
we entered into collaboration agreements to evaluate the safety,
tolerability and efficacy of surufatinib in combination with
anti-PD-1 monoclonal antibodies, including with Tuoyi (R)
(toripalimab) and Tyvyt (R) , which are approved in China.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical
company committed, over the past twenty years, to the discovery and
global development of targeted therapies and immunotherapies for
the treatment of cancer and immunological diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world and extensive commercial infrastructure in
its home market of China. For more information, please visit:
www.chi-med.com.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company
focused on discovering, developing, manufacturing, and
commercializing innovative medicines to improve treatment outcomes
and access for patients worldwide. Our 3,800+ employees in China,
the United States, Australia, and Europe are committed to
expediting the development of a diverse pipeline of novel
therapeutics for cancer. We currently market two
internally-discovered oncology products: BTK inhibitor BRUKINSA(TM)
(zanubrutinib) in the United States, and anti-PD-1 antibody
tislelizumab in China. We also market or plan to market in China
additional oncology products licensed from Amgen Inc., Celgene
Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA
Pharma. To learn more about BeiGene, please visit www.beigene.com
and follow us on Twitter at @BeiGeneUSA.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and other federal securities laws, including statements
regarding the clinical development of surufatinib and fruquintinib
in combination with tislelizumab , Chi-Med's and BeiGene's roles
and responsibilities in the collaboration, the opportunity and
potential benefits of their product candidates both as
monotherapies and in combination, and other information that is not
historical information. Actual results may differ materially from
those indicated in the forward-looking statements as a result of
various important factors, including the ability of Chi-Med and
BeiGene to develop and receive regulatory approvals for the
combination therapies in the collaboration; the risk that the
potential benefits of the collaboration do not materialize or do
not outweigh the costs; the ability of Chi-Med and BeiGene to
demonstrate the efficacy and safety of their respective drug
candidates as monotherapies or in combination ; the clinical
results for such drug candidates, which may not support further
development or marketing approval; actions of regulatory agencies,
which may affect the initiation, timing and progress of clinical
trials and marketing approval; Chi-Med's and BeiGene's ability to
achieve commercial success for their marketed products and drug
candidates, if approved; Chi-Med's and BeiGene's ability to obtain
and maintain protection of intellectual property for their
respective technology and drugs; BeiGene's and Chi-Med's reliance
on third parties to conduct drug development, manufacturing and
other services; BeiGene's limited operating history and BeiGene's
and Chi-Med's ability to obtain additional funding for operations
and to complete the development and commercialization of their drug
candidates; and the impact of the COVID-19 pandemic on BeiGene's
and Chi-Med's clinical development, commercial and other operations
. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. For further discussion of these and
other risks, see Chi-Med's or BeiGene's filings with the U.S.
Securities and Exchange Commission and, in the case of Chi-Med, on
AIM. All information in this press release is as of the date of
this press release, and neither
Chi-Med nor BeiGene undertakes a duty to update such information unless required by law.
Chi-Med Contacts
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
BeiGene Investor Contact BeiGene Media Contact
Craig West Liza Heapes
+1 857-302-5189 +1 857-302-5663
ir@beigene.com media@beigene.com
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END
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