Ligand Announces Clinical and Regulatory Progress by Multiple Partners with OmniAb® Antibodies
November 23 2020 - 8:30AM
Business Wire
Two large pharma partners reach
clinical-development milestones with OmniAb-derived antibody
programs and Ligand earns $4.5 million in milestone payments
CStone Pharmaceuticals announces China NDA
submission and data for its OmniAb-derived antibody to treat
non-small cell lung cancer in a first-line setting
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announces clinical and regulatory progress by multiple partners
utilizing antibodies from its OmniAb® discovery platform. Two large
multinational pharmaceutical companies with a license to OmniAb
have reached clinical-development milestones with their programs.
The progress by these companies resulted in a total of $4.5 million
in milestone payments being earned by Ligand.
In addition, CStone Pharmaceuticals recently announced that
China’s National Medical Products Administration has accepted for
review CStone’s New Drug Application (NDA) for sugemalimab
(CS1001), an OmniAb-derived anti-PD-L1 monoclonal antibody used in
combination with chemotherapy for the first-line treatment of
advanced squamous and non-squamous non-small cell lung cancer
(NSCLC). This marks the first regulatory submission by CStone for
sugemalimab. Last month, CStone announced a major financial and
commercial partnership with Pfizer to commercialize sugemalimab in
greater China. Ligand is entitled to a 3% royalty on worldwide
commercial sales of sugemalimab.
CStone also announced that positive clinical data based on a
pre-planned interim analysis of the GEMSTONE-302 clinical study
were disclosed in an oral presentation at European Society for
Medical Oncology (ESMO) Asia Virtual Congress 2020 on November 21,
2020 (link to full release here). The GEMSTONE-302 trial is the
first randomized, double-blind, Phase 3 study of an anti-PD-L1
monoclonal antibody plus platinum-based chemotherapy as first-line
treatment for stage IV squamous or non-squamous NSCLC. The results
showed sugemalimab plus chemotherapy as first-line treatment for
advanced NSCLC demonstrated statistically significant and
clinically meaningful benefit in progression free survival (PFS)
compared to chemotherapy across PD-L1 expression levels and
histologies. Specifically, sugemalimab in combination with
chemotherapy reduced the risk of disease progression or death by
50% and produced an objective response rate (ORR) of 61.4%. The
combination therapy was well-tolerated with no new safety signals
detected. CStone reported that these Phase 3 data are amongst the
best of those reported by other anti-PD-L1 monoclonal
antibodies.
"We are very pleased with the progress and impressive data our
partners are reporting with their Ligand OmniAb-derived
antibodies," said John Higgins, Chief Executive Officer of Ligand.
"There are currently more OmniAb programs than ever under
development, and as programs advance Ligand is now collecting more
and larger milestone payments that are contributing to our strong
financial performance. Next year we anticipate the first two
OmniAb-derived antibodies could receive regulatory approvals, and
these events could start the first OmniAb royalty revenue to
Ligand. With partnership and royalty rights on programs that extend
to 2040 and beyond, we believe we are in the early days of a
substantial growth trajectory from our OmniAb business.”
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 Ligand Pharmaceuticals
Ligand is a revenue-generating biopharmaceutical company focused
on developing or acquiring technologies that help pharmaceutical
companies discover and develop medicines. Ligand’s 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.
Ligand’s 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. Ligand’s
business model is based on doing what Ligand does best: drug
discovery, early-stage drug development, product reformulation and
partnering. Ligand partners 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. Ligand’s Protein Expression Technology® is a robust,
validated, cost-effective and scalable approach to recombinant
protein production, and is especially well-suited for complex,
large-scale protein production that cannot be made by more
traditional systems. 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, 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
that Ligand will collect more and larger milestone payments from
its OmniAb programs; Ligand’s expectations regarding its future
financial performance including the potential growth from its
OmniAb business; the potential that any OmniAb-derived antibodies
will receive regulatory approval or whether Ligand will receive any
OmniAb royalty revenue thereafter; the amount of time that Ligand
will benefit from its partnership and royalty rights; and the
potential that CS1001 could be approved to treat 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 China’s National Medical Products Administration or the 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 additional
payments or royalties from the development of CS1001; Ligand may
not generate expected revenues under its existing OmniAb license
agreements; Ligand's partners may terminate any of its agreements
or development or commercialization of any of its products; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201123005686/en/
Ligand Pharmaceuticals Incorporated Patrick O’Brien
investors@ligand.com (858) 550-7893 Twitter: @Ligand_LGND
LHA Investor Relations Bruce Voss bvoss@lhai.com (310)
691-7100
Ligand Pharmaceuticals (NASDAQ:LGND)
Historical Stock Chart
From Apr 2024 to May 2024
Ligand Pharmaceuticals (NASDAQ:LGND)
Historical Stock Chart
From May 2023 to May 2024