BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring”
or the “Company”), a clinical-stage global biopharmaceutical
company focused on developing innovative cancer therapies, today
announced that it hosted a virtual Research and Development
(R&D) Day to discuss its lead asset Plinabulin, a dendritic
cell (DC) maturation agent, in drug combinations to potentially
address the current unmet medical needs in cancer indications where
patients failed prior PD-1/PD-L1 inhibitors, as well as updates for
SEED Therapeutics which focuses on target protein degradation (TPD)
platform for innovative molecular glue drug discovery on May 15,
2024.
The R&D Day was led by Key Opinion Leaders (KOLs) Trevor M.
Feinstein, M.D. (Piedmont Cancer Institute), Alberto Chiappori,
M.D. (Moffitt Cancer Center), and Steven Lin, M.D., Ph.D. (MD
Anderson Cancer Center), as well as BeyondSpring and SEED
Therapeutics management.
Invited KOLs shared their latest insights on plinabulin’s
durable anti-cancer benefit, mechanism-of-action (MOA), and its
unique potential as an I/O combination agent with chemotherapy or
radiation, in patients that have progressed on PD-1/PD-L1 therapy.
Over time, plinabulin may have the potential to move into earlier
lines of treatment in combination with I/O:
- As a unique tubulin binder, plinabulin drives dendritic cell
(DC) maturation/T-cell activation by effectively liberating the
immune defense protein GEF-H1 from microtubules.
- Plinabulin alone or in combination has been well-tolerated in
>700 cancer patients in two positive phase 3 studies.
- In a phase 3 study with EGFR wild-type 2L/3L NSCLC, the
combination of plinabulin and docetaxel significantly extended OS
in all subgroup analyses and doubled 2-year and 3-year OS rates
compared to docetaxel alone.
- In an MD Anderson phase 1 study, in combination with
radiotherapy and a PD-1 inhibitor, plinabulin demonstrated its DC
maturation MOA in responding patients (PR+SD) in multiple cancers
that had progressed during PD-1/PD-L1 inhibitor therapy with
>50% disease control rate (PR+SD). The most responding cancers
include NSCLC, HNSCC and Hodgkin’s lymphoma.
- PD-1/PD-L1 inhibitors have been approved in approximately 20
cancer indications with >$40 billion annual sales, and yet
around 60% of patients eventually fail, leaving them with limited
treatment options.
- Plinabulin’s potent DC maturation effect, in combination with
PD-1/PD-L1 and radiation or chemotherapy, may address unmet medical
needs across numerous patient settings following progression from
PD-1/PD-L1 inhibitor therapy.
- Plinabulin has the potential to fill a substantial gap in
cancer treatment for precisely the same patient settings that have
been found elusive to other mechanisms or combinations.
“Additionally, significant headway is being made through various
Investigator-Initiated Trial (IIT) studies of plinabulin at leading
institutions in the U.S. and China. Preliminary results are
expected to be reported in 2H 2024, that are expected to reinforce
our unique MOA and lead to a transformative year for BeyondSpring.
If interim clinical data from our ongoing studies further validates
our unique MOA, then we will look for opportunities to extend and
accelerate plinabulin’s outreach through third-party partnerships,”
said Dr. Lan Huang, Co-Founder, Chairman and CEO of
BeyondSpring.
Following the plinabulin presentations, Dr. Lan Huang discussed
how BeyondSpring’s majority-owned subsidiary, SEED Therapeutics,
uses its proprietary TPD platforms to develop “molecular glues” for
undruggable targets. Different from PROTAC platforms, molecular
glues have the potential advantage of targeting un-ligandable
proteins, including proteins without ligandable pocket, and
unfolded protein, such as Tau. The SEED TPD platform referred to as
RITE3, has translated the scientific breakthroughs and insights of
its co-founders, including a Nobel Laureate and two Howard Hughes
Medical Institute investigators, into a diversified and
fast-evolving drug development pipeline:
- Differentiated from other molecular glue companies, which are
mainly “E3 centric”, SEED’s RITE3 platform is “target centric” and
uses novel E3 ligases for protein targets. With detectable weak
basal interaction between selected E3 and protein target, the
binder hit rates from its high throughput screening is higher.
- 6 internal pipeline assets and 2 partnered assets, in oncology,
neurodegeneration, immunology, and virology used 5 novel E3
ligases.
- SEED expects to file an IND in early 2025 for its IND Candidate
oral RBM39 degrader, for the treatment of rationally selected
cancer indications.
- SEED R&D has a focus on the development of orally delivered
molecular glues for CNS indications, with a lead internal program
against Tau.
Eli Lilly is a current investor and R&D collaborator with
upfront and milestone payments up to $780 million, plus tiered
royalties. SEED has achieved 3 milestones with Lilly R&D
collaboration.
“I'm delighted to announce SEED's substantial progress in
advancing internal initiatives, including an oncology asset
advancing towards first human dose in the first half of 2025, Tau
degraders for neurodegeneration advancing towards lead molecule
status towards the end of 2024. In addition, we have a synergistic
collaboration with Eli Lilly, which achieved multiple milestone
payments. In the recent “Nature Biotechnology” review article on
molecular glues, it was truly a privilege for SEED Therapeutics to
be recognized alongside other prominent companies employing
groundbreaking TPD molecular glue strategies. Leveraging our unique
and proprietary RITE3 platform that focuses on predicting,
detecting, and utilizing a pre-existing weak interaction between an
E3 ligase and the target disease-causing protein, SEED consistently
garners growing interest for additional partnerships and
investment,” said Dr. James Tonra, President and CSO of SEED
Therapeutics.
An archived replay of the webinar will be available on
BeyondSpring’s website www.beyondspringpharma.com under “Events and
Presentations” in the Investors section.
Trevor M. Feinstein, M.D.Dr. Feinstein is board
certified in medical oncology and hematology. He joined Piedmont
Cancer Institute in 2011 and is the Director of Research at
Piedmont Fayette Hospital. Dr. Feinstein is actively involved in
clinical trials focused on improved therapies for various cancers.
He is a member of Georgia CORE’s research committee along with
Georgia Society for Clinical Oncology Clinical Practice Committee.
He also chairs the Lung Disease Group for the entire OneOncology
network. He is a co-investigator on several peer-reviewed research
projects and has authored numerous publications and abstracts in
Hematology and Oncology. Dr. Feinstein graduated from the
University of Illinois medical school and completed his residence
and fellowships at the University of Pittsburgh.
Alberto Chiappori, M.D.Dr. Chiappori is board
certified in medical oncology. He serves as senior member of
oncology and medicine for the Thoracic Oncology Program at the H.
Lee Moffitt Cancer Center and Research Institute in Tampa and
Florida. Dr. Chiappori is an active member of the American Society
of Clinical Oncology, the European Society of Medical Oncology, the
American Association for Cancer Research, and the International
Association for the Study of Lung Cancer (IASLC). Dr. Chiappori
received his M.D. from the Universidad Peruana Cayetano Heredia in
Lima, Peru, completed his residency at Southern Illinois University
School of Medicine in Springfield, Illinois, and finished his
fellowship and senior fellowship in medical oncology-hematology at
Vanderbilt University School of Medicine in Nashville,
Tennessee.
Steven Lin, M.D., Ph.D.Dr. Lin is a Professor
and Physician-Scientist at MD Anderson Cancer Center, with joint
appointments in the Departments of Radiation Oncology and
Experimental Radiation Oncology. Dr. Lin’s practice focuses on
thoracic malignancies, and he oversees several clinical trials
including the use of proton beam therapy for esophageal cancer and
in the combination of immunotherapy with radiotherapy in lung and
esophageal cancers. Dr. Lin runs a translational research team that
evaluates biomarkers for treatment response and disease outcomes
after cancer therapy. Dr. Lin acquired his M.D. and Ph.D. in the
Medical Scientist Training Program at the University of California
Irvine Medical School. He went on for residency training in
Radiation Oncology at The Johns Hopkins Hospital.
About BeyondSpringBeyondSpring
is a global clinical-stage biopharmaceutical company focused on
developing innovative therapies to improve clinical outcomes for
patients with high unmet medical needs. The Company is advancing
its first-in-class lead asset, Plinabulin, as a direct anti-cancer
agent in various cancer indications and to prevent
chemotherapy-induced neutropenia. BeyondSpring’s pipeline also
includes three preclinical immuno-oncology assets. Additionally,
BeyondSpring’s subsidiary, SEED Therapeutics, leverages a
proprietary TPD drug discovery platform and has an initial R&D
collaboration with Eli Lilly. Learn more by visiting
https://beyondspringpharma.com.
About SEED TherapeuticsSEED
Therapeutics is an innovative biotech company focusing on
harnessing and engineering “molecular glues” and targeted protein
degradation (TPD) to attack previously undruggable targets. Backed
by a comprehensive intellectual property portfolio, SEED
Therapeutics' mission is to positively impact human health by
creating novel protein degradation therapeutics to treat various
severe diseases that currently have limited treatment options for
patients and their families. Through ongoing collaborations with
world-leading academic experts in the field, SEED Therapeutics is
developing a growing pipeline of novel drug candidates on a path to
potential clinical and commercial success. SEED has an initial
R&D collaboration and investment from Eli Lilly and Company.
Learn more by visiting https://seedtherapeutics.com/.
Cautionary Note Regarding Forward-Looking
StatementsThis press release includes forward-looking
statements that are not historical facts. Words such as “will,”
“expect,” “anticipate,” “plan,” “believe,” “design,” “may,”
“future,” “estimate,” “predict,” “objective,” “goal,” or variations
thereof and variations of such words and similar expressions are
intended to identify such forward-looking statements.
Forward-looking statements are based on BeyondSpring’s current
knowledge and its present beliefs and expectations regarding
possible future events and are subject to risks, uncertainties, and
assumptions. Actual results and the timing of events could differ
materially from those anticipated in these forward-looking
statements as a result of several factors including, but not
limited to, our ability to continue as a going concern,
difficulties raising the anticipated amount needed to finance the
Company’s future operations on terms acceptable to the Company, if
at all, unexpected results of clinical trials, delays or denial in
regulatory approval process, results that do not meet the Company’s
expectations regarding the potential safety, the ultimate efficacy
or clinical utility of the Company’s product candidates, increased
competition in the market, the Company’s ability to meet Nasdaq's
continued listing requirements, and other risks described in
BeyondSpring’s most recent Form 20-F on file with the U.S.
Securities and Exchange Commission. All forward-looking statements
made herein speak only as of the date of this release and
BeyondSpring undertakes no obligation to update publicly such
forward-looking statements to reflect subsequent events or
circumstances, except as otherwise required by law.
Investor
Contact:IR@beyondspringpharma.com
Media
Contact:PR@beyondspringpharma.com
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