CS1001 is the first anti-PD-L1 mAb to
demonstrate overwhelming efficacy as First Line treatment of Stage
IV squamous and non-squamous NSCLC in a randomized, double-blind
Phase 3 trial
CS1001 combined with chemotherapy had a
statistically significant prolongation of progression-free survival
(PFS), the primary endpoint of the trial, compared with placebo
combined with chemotherapy, reducing the risk of disease
progression or death by 50%
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announces CStone Pharmaceuticals (“CStone”, HKEX: 2616) recently
reported that its OmniAb-derived anti-PD-L1 mAb CS1001 combined
with platinum-based chemotherapy met its pre-specified primary
endpoint, as assessed by the independent Data Monitoring Committee
at the planned interim analysis of CS1001-302, a randomized,
double-blind Phase 3 clinical trial for the first-line treatment of
stage IV squamous and non-squamous NSCLC patients.
Key data highlights include:
- In the overall population containing both squamous and
non-squamous NSCLC patients, investigator-assessed progression free
survival (PFS) HR (95% CI) was 0.50 (0.39, 0.64), p<0.0001. The
median PFS was 7.8 months vs. 4.9 months in CS1001 combined with
chemotherapy and placebo combined with chemotherapy,
respectively.
- Subgroup analyses showed clinical benefit across histology
subtypes and PD-L1 expression levels.
- Blinded independent central review (BICR)-assessed PFS as a
secondary endpoint was consistent with the investigator-assessed
PFS. Other secondary endpoints also supported the primary endpoint
result.
- CS1001 in combination with chemotherapy was well tolerated,
with no new safety signal detected.
“This is an outstanding clinical report by CStone and also the
most substantial, pivotal-stage data to be reported to date for an
OmniAb-derived antibody,” said John Higgins, Chief Executive
Officer of Ligand. “These results, coupled with data recently
announced by Genentech relating to their OmniAb-derived anti-TIGIT
program, are ushering in what we believe will be a period of major
data, breakthroughs and late-stage developments for new potential
OmniAb-derived human therapeutics. Our OmniAb platform continues to
be a valuable tool to efficiently discover high-quality fully human
antibody therapeutics. We congratulate CStone on this remarkable
achievement and contribution to improving potential treatment
options for lung cancer.”
Dr. Frank Jiang, Chairman and CEO of CStone, said, “Currently,
there is no anti-PD-L1 monoclonal antibody approved for NSCLC in
China. CS1001 is the first anti-PD-L1 monoclonal antibody combined
with chemotherapy to demonstrate significant improvement in PFS in
Chinese NSCLC patients. It has the potential of becoming the
world’s first anti-PD-L1 monoclonal antibody that can be combined
with chemotherapy as the first-line treatment of both squamous and
non-squamous NSCLC patients. This further strengthens our
confidence in the development of CS1001 and greatly expediate
CStone’s commercialization progress.”
Dr. Jason Yang, Chief Medical Officer of CStone, said, “Compared
with published results of other anti-PD-1/PD-L1 monoclonal
antibodies in combination with chemotherapy in first-line NSCLC
trials, the CS1001-302 study, with an innovative design, is the
first phase 3 clinical study in China for the first-line treatment
of both squamous and non-squamous NSCLC subtypes. We will continue
to make every effort to promote and more extensively evaluate the
potential clinical benefit of this product in patients with
hematological malignancies, stage III NSCLC, advanced gastric
cancer, liver cancer and esophageal cancer.”
About OmniAb®
OmniAb is a three-species transgenic-animal platform consisting
of five different technologies used for producing mono- and
bispecific human therapeutic antibodies. OmniRat® animals comprise
the industry’s first human monoclonal antibody technology based on
rats. Because they have a complete immune system with a diverse
antibody repertoire, OmniRat animals generate antibodies with human
idiotypes as effectively as wild-type animals make rat antibodies.
OmniMouse® is a transgenic mouse that complements OmniRat and
expands epitope coverage. OmniFlic® is an engineered rat with a
fixed light chain for development of bispecific, fully human
antibodies. OmniChicken animals comprise the industry’s first human
monoclonal antibody technology based on chickens. The OmniClic
chicken is specifically developed to facilitate the generation of
bispecific antibodies and retains the ability to generate diverse,
high quality affinity matured antibodies. All five types of OmniAb
therapeutic human antibody platform, OmniRat, OmniFlic, OmniMouse,
OmniChicken® and OmniClic®, use patented technology, have broad
freedom to operate, produce highly diversified, fully human
antibody repertoires optimized in vivo for immunogenicity,
manufacturability, and therapeutic efficacy, and deliver fully
human antibodies with high affinity, specificity, expression,
solubility and stability - Naturally Optimized Human
Antibodies®.
About Non-Small Cell Lung Cancer and China
In contrast to most Western countries, where lung cancer death
rates are decreasing, lung cancer incidence rates are still
increasing in China. There were approximately 770,000 new cases of
lung cancer in China in 2018, and it is the leading cause of
cancer-related death in both men and women, with approximately
690,500 deaths in China in 2018. Non-small cell lung cancer
comprises the most common form of lung cancer in China.
CS1001-302 Study
CS1001-302 is a multicenter, randomized, double-blind Phase 3
clinical trial (CS1001-302; clinicaltrials.gov registration number:
NCT03789604; drug clinical trial registration number: CTR20181452),
designed to evaluate the efficacy and safety of CS1001 in
combination with platinum-containing chemotherapy versus placebo in
combination with platinum-containing chemotherapy in first-line
naïve patients with stage IV NSCLC. The primary endpoint of the
trial was PFS as assessed by the investigators; the secondary
endpoints include overall survival, PFS and the safety profile as
assessed by BICR committee.
About CS1001
CS1001 is an investigational anti-PD-L1 monoclonal antibody
discovered by CStone using Ligand Pharmaceuticals’ OmniRat®
transgenic animal platform, which can generate fully human
antibodies. As a fully human, full-length anti-PD-L1 monoclonal
antibody, CS1001 mirrors the natural G-type immunoglobulin 4 (IgG4)
human antibody, which can reduce the risk of immunogenicity and
potential toxicities in patients, representing a unique advantage
over similar drugs. CS1001 has completed a Phase 1 dose-escalation
study in China. During Phase 1a and Phase 1b of the study, CS1001
showed good antitumor activity and tolerability in multiple tumor
types. Currently, CS1001 is being investigated in a number of
ongoing clinical trials. In addition to a Phase 1 bridging study in
the U.S., the clinical program in China includes one multi-arm
Phase 1b study for several tumor types, two Phase 2 registrational
studies for lymphoma, and four Phase 3 registrational studies,
respectively, for stage III/IV NSCLC, gastric cancer, and
esophageal cancer.
About CStone
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical
company focused on developing and commercializing innovative
immuno-oncology and precision medicines to address the unmet
medical needs of cancer patients in China and worldwide.
Established in 2015, CStone has assembled a world-class management
team with extensive experience in innovative drug development,
clinical research, and commercialization. The company has built an
oncology-focused pipeline of 15 drug candidates with a strategic
emphasis on immuno-oncology combination therapies. Currently, five
late-stage candidates are at pivotal trials. With an experienced
team, a rich pipeline, a robust clinical development-driven
business model and substantial funding, CStone’s vision is to
become globally recognized as a leading Chinese biopharmaceutical
company by bringing innovative oncology therapies to cancer
patients worldwide.
About Ligand Pharmaceuticals
Ligand is a revenue-generating biopharmaceutical company focused
on developing or acquiring technologies that help pharmaceutical
companies discover and develop medicines. Our business model
creates value for stockholders by providing a diversified portfolio
of biotech and pharmaceutical product revenue streams that are
supported by an efficient and low corporate cost structure. Our
goal is to offer investors an opportunity to participate in the
promise of the biotech industry in a profitable, diversified and
lower-risk business than a typical biotech company. Our business
model is based on doing what we do best: drug discovery,
early-stage drug development, product reformulation and partnering.
We partner with other pharmaceutical companies to leverage what
they do best (late-stage development, regulatory management and
commercialization) to ultimately generate our revenue. Ligand’s
OmniAb® technology platform is a patent-protected transgenic animal
platform used in the discovery of fully human mono- and bispecific
therapeutic antibodies. The Captisol platform technology is a
patent-protected, chemically modified cyclodextrin with a structure
designed to optimize the solubility and stability of drugs. The
Vernalis Design Platform (VDP) integrates protein structure
determination and engineering, fragment screening and molecular
modeling, with medicinal chemistry, to help enable success in novel
drug discovery programs against highly-challenging targets. Ab
Initio™ technology and services for the design and preparation of
customized antigens enable the successful discovery of therapeutic
antibodies against difficult-to-access cellular targets. Ligand has
established multiple alliances, licenses and other business
relationships with the world’s leading pharmaceutical companies
including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier,
Gilead Sciences and Baxter International. For more information,
please visit www.ligand.com.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand
that involve risks and uncertainties and reflect Ligand's judgment
as of the date of this release. These forward-looking statements
include, without limitation, statements regarding: the potential
for major data, breakthroughs and developments for new potential
OmniAb-derived therapeutics; Ligand’s belief that the OmniAb
platform can efficiently discover high-quality antibody therapeutic
candidates; and the potential that CS1001 could be a treatment
option for lung cancer patients. Actual events or results may
differ from Ligand’s expectations due to risks and uncertainties
inherent in Ligand’s business, including, without limitation:
regulatory authorities such as FDA may not agree with CStone’s
interpretation of the results from the Phase 3 clinical trial;
CS1001 may not be approved for lung cancer or any other indication
and Ligand may not receive any milestone payments or royalties from
the development of CS1001; the OmniAb platform faces specific
risks, including the fact that no product using antibodies from the
platform has been approved by the FDA or similar regulatory agency;
unexpected adverse side effects or inadequate therapeutic efficacy
of Ligand’s or Ligand’s partners’ product(s) could delay or prevent
regulatory approval or commercialization; and other risks described
in Ligand’s prior press releases and filings with the SEC. The
failure to meet expectations with respect to any of the foregoing
matters may reduce Ligand's stock price. Ligand disclaims any
intent or obligation to update these forward-looking statements
after the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
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version on businesswire.com: https://www.businesswire.com/news/home/20200807005223/en/
Ligand Pharmaceuticals Incorporated Patrick O'Brien Email:
investors@ligand.com Phone: (858) 550-7893 Twitter:
@Ligand_LGND
LHA Investor Relations Bruce Voss Email: bvoss@lhai.com Phone:
(310) 691-7100
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