TriSalus Life Sciences Acquires Dynavax’s SD-101 Oncology Program in Purchase Agreement for up to $250 million in Milestone...
August 03 2020 - 8:00AM
Dynavax Technologies Corporation (Nasdaq: DVAX), a
biopharmaceutical company focused on developing and commercializing
novel vaccines, and TriSalus Life Sciences (TriSalus), an emerging
immuno-oncology company committed to transforming outcomes for
liver and pancreatic tumors, today announced that they have entered
into an asset purchase agreement under which TriSalus has purchased
SD-101, a proprietary investigational, second-generation, Toll-like
receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide, which
has been studied in advanced cutaneous melanoma, and is
currently in clinical trials for high risk Stage II/III breast
cancer. Purchased assets include SD-101-related Intellectual
Property, clinical data, regulatory filings, and inventory.
“We are excited to take on development of
SD-101, which expands our integrated therapeutic and drug delivery
portfolio,” said Mary Szela, President and CEO of TriSalus.
“Promising clinical study data with this investigational agent has
been shown as an important component of combination immuno-therapy
for the treatment of advanced cutaneous melanoma. We believe by
integrating our novel delivery technology with SD-101, our company
will have the potential to improve outcomes in liver and pancreas
tumor patients that presently have few viable options.”
“We are pleased TriSalus will be driving the
future development of SD-101 to ensure it reaches its full
potential and ultimately benefit patients,” said Ryan Spencer,
Chief Executive Officer of Dynavax. “We will continue to focus our
resources and efforts to drive value through the advancement of our
vaccine business.”
Under the terms of the agreement, TriSalus will
pay Dynavax $5 million upfront, an additional cash payment of $4
million on December 30, 2020, for reimbursement of research and
development expenses, up to an additional $250 million upon the
achievement of certain development, regulatory, and commercial
milestones, and low double-digit royalties based on potential
future net sales.
About DynavaxDynavax is a
commercial stage biopharmaceutical company developing and
commercializing novel vaccines. The Company launched its first
commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant),
Adjuvanted], in February 2018, following U.S. FDA approval for
prevention of infection caused by all known subtypes of hepatitis B
virus in adults age 18 years and older. Dynavax is also
advancing CpG 1018 as a premier vaccine adjuvant through research
collaborations and partnerships. Current collaborations
are focused on adjuvanted vaccines for COVID-19, pertussis and
universal influenza. For more information, visit www.dynavax.com
and follow the company on LinkedIn.
About TriSalus Life
SciencesTriSalusTM Life Sciences is an emerging
immuno-oncology company dedicated to developing immunotherapy
treatments for liver and pancreatic tumors using our novel delivery
technology to improve patient outcomes. TriSalus intends to pursue
multiple solid tumor indications with investigational agent, SD-101
and acquire other immuno-oncology agents to combine with our
proprietary Pressure-Enabled Drug Delivery™ technology to
administer therapeutics intrasvascularly into visceral organ solid
tumors. Our focus is to reprogram the dominant immunosuppressive
cell population in the liver and pancreatic tumors in combination
with checkpoint inhibitors. This innovative approach in development
has the potential to leverage multiple mechanisms that can work
together with the goal to overcome inherent immune suppression
within the solid tumor microenvironment. For more information,
please visit www.trisaluslifesci.com.
Dynavax Forward-Looking StatementsThis press
release contains "forward-looking" statements, including statements
regarding the potential for SD-101 to be successfully developed as
a treatment for cancer and regarding potential future payments by
TriSalus to Dynavax, including research and development
reimbursement payments and development and commercial milestone and
royalty payments. Actual results may differ materially due to
the risk and uncertainties in the development and commercialization
of oncology treatments, including the timing and results of
pre-clinical and clinical trials, whether the results will support
continued development and regulatory approval and if so whether and
when approval would be received and in what countries, the ability
to successfully commercialize and sell a product after approved and
the amount of sales, and whether commercial sales milestones will
be achieved, as well as other risks detailed in the "Risk Factors"
section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2019, as well as discussions of potential risks,
uncertainties and other important factors in our other filings with
the U.S. Securities and Exchange Commission. We undertake no
obligation to revise or update information herein to reflect events
or circumstances in the future, even if new information becomes
available. Information on Dynavax's website at www.dynavax.com is
not incorporated by reference in our current periodic reports with
the SEC.
TriSalus Life Sciences
Contact:Emmie TwomblyMedia
SpecialistLaVoieHealthScience(857)
389-6042etwombly@lavoiehealthscience.com
Dynavax Contacts:Nicole Arndt, Senior Manager,
Investor Relationsnarndt@dynavax.com510-665-7264
Derek Cole, President Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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