Full Press Release Details
Jasper Therapeutics Announces Development
Prioritization of Briquilimab in Chronic Diseases, including Urticaria and Lower-Risk MDS, and Stem Cell Transplant for Sickle Cell Disease
and Other Rare Diseases
REDWOOD CITY, Calif., January 10, 2023 -
Jasper Therapeutics, Inc. (Nasdaq: JSPR) ("Jasper" or the "Company"), a biotechnology company developing
novel antibody therapies and stem cell transplant conditioning agents targeting c-Kit, today announced, as part of an overall
portfolio prioritization, that the Company will focus on the development of its lead product candidate, briquilimab
(formerly known as JSP191), in chronic diseases and stem cell transplant for rare diseases. This portfolio includes a new program on chronic urticaria, along with the Company's existing programs for lower-risk myelodysplastic syndrome (MDS), sickle
cell disease, Fanconi anemia and severe combined immunodeficiency (SCID).
Based on preclinical and clinical studies showing
inhibition of c-Kit signaling, depletion of mast cells in skin and lung and extended pharmacokinetics of subcutaneous dosing, the Company
has prioritized rapidly starting a clinical study in severe chronic urticaria. In the meantime, while the Company does not have any near-term
plans to initiate a Phase 3 study in AML/MDS, the Company will continue to work with the U.S. Food and Drug Administration, the transplant
community and potential partners to explore development pathways and ensure briquilimab remains ready for a pivotal Phase 3 study in AML/MDS
stem cell transplant.
"We are ecstatic about the growing body
of clinical and scientific evidence that show briquilimab has an attractive tolerability profile in a number of potential
indications and may provide clinically meaningful results for a wide range of patients, and are grateful to our team, clinical
investigators, patients and external partners for helping us advance this drug into later stage trials so quickly in such a
challenging environment over the past two years," said Ronald Martell, President and Chief Executive Officer of Jasper.
"We believe focusing on the most well-characterized opportunities with the clearest and potentially fastest pathway to market
is in the best interest of patients and our shareholders. As such, our near-term development program will consist of moving rapidly
into a clinical trial in chronic severe urticaria and initiating our chronic lower-risk MDS study, while continuing recruitment in
the SCID, Fanconi anemia and sickle cell disease transplant studies."
Briquilimab's potential has been consistently
validated across five indications: SCID, acute myeloid leukemia, MDS, Fanconi anemia and, most recently, sickle cell disease. The Company
expects new supportive data to be presented at the upcoming 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT
and CIBMTR that will further reinforce the broad opportunity for briquilimab.
Clinical studies with briquilimab and investigational
agents from other companies suggest that targeting c-Kit has strong therapeutic potential for chronic mast cell diseases such as urticaria
and allergic asthma. This therapeutic approach has also shown promise in lower-risk MDS.
"We believe prioritizing these opportunities
provides the best path forward to near-term, clinical milestones for patients and value creation for investors," added Mr. Martell.
"We want to show as soon as possible how briquilimab's differentiated mechanism and therapeutic profile has the potential
to overcome challenges encountered by other therapies in development for these indications. We also remain committed to exploring briquilimab's
long-term potential to become a leading antibody targeting c-Kit for use as a standalone therapy and as a conditioning agent to help reduce
the toxicity of existing conditioning approaches for cell and gene therapies."
About Briquilimab (formerly known as JSP191)
Briquilimab is a targeted, monoclonal antibody
that inhibits the cell-surface receptor c-Kit, also known as CD117. It is currently being evaluated as a primary therapeutic for mast
cell diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and allergic asthma, and for lower-risk
MDS patients. It is also being studied as a conditioning agent for cell and gene therapies for rare diseases. To date, briquilimab has
a demonstrated efficacy and safety profile in 130 dosed subjects and healthy volunteers, with clinical outcomes as a conditioning agent
in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle
cell disease (SCD). In addition, briquilimab is being advanced as a transformational non-genotoxic conditioning agent for gene therapy.
Jasper is a clinical-stage biotechnology company
developing novel antibody therapies and stem cell transplant conditioning agents targeting c-Kit (CD117), an important receptor found
on stem cells and mast cells. The Company's lead program is briquilimab, a first-in-class monoclonal antibody being developed as
a therapeutic for chronic diseases and as a conditioning agent for stem cell transplants for rare diseases. For more information, please
visit us at jaspertherapeutics.com.
Forward-Looking Statements
Certain statements included in this press release
that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private
Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe,"
"may," "will," "estimate," "continue," "anticipate," "intend,"
"expect," "should," "would," "plan," "predict," "potential," "seem,"
"seek," "future," "outlook" and similar expressions that predict or indicate future events or trends
or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding
briquilimab's potential, Jasper's expectations regarding a potential pivotal Phase 3 study in AML/MDS stem cell transplant
and Jasper's near-term development focus. These statements are based on various assumptions, whether or not identified in this press
release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are
provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an
assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control
of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political
and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development
or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety,
potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully
market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper's
product candidates may not be beneficial to patients or successfully commercialized; patients' willingness to try new therapies
and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper's business; the risk that third
parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily;
the risk that Jasper's business, operations, clinical development plans and timelines, and supply chain could be adversely affected
by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain
sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of
others; and other risks and uncertainties indicated from time to time in Jasper's filings with the SEC, including its Annual Report
on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper's
assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While
Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation
to do so. These forward-looking statements should not be relied upon as representing Jasper's assessments of any date subsequent
to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
John Mullaly (investors)
Jeet Mahal (investors)
Lauren Barbiero (media)