Hillstream BioPharma Announces Strategic Reprioritization of Pipeline to Targeting HER2/HER3 Solid Tumors via Bispecific and ADC Antibodies and Biologics
10 Julio 2023 - 7:47AM
Hillstream BioPharma (Nasdaq: HILS) a biotechnology company
developing innovative therapeutic candidates targeting drug
resistant and devastating cancers that can make a difference in
patients’ lives, today announced a strategic reprioritization of
its pipeline and provided a corporate update. The strategic
assessment took into account, the pipeline’s near-term value
creation opportunity and other factors. Hillstream will focus its
pipeline on advancing novel oncology assets with the greatest
potential and strong competitive profiles to address unmet needs
across multiple solid tumors, such as bispecific antibodies and
ADCs targeting novel conformational epitopes on high value
validated targets, HER2 and HER3, with a more potent Bystander
Effect.
Bispecific antibodies (BsAbs) refer to a diverse
group of molecules that recognize distinct epitopes on two
different antigens, such as HER2 and HER3. These validated targets
have been extensively studied and belong to the ERBB receptor
tyrosine kinase family and are exploited by cancer cells to promote
tumorigenesis and metastasis. HER2, an extensively studied and
validated target, has multiple approved therapeutics for solid
tumors. Meanwhile, emerging evidence suggests that HER3 plays a
central role through interacting with neighboring receptors. While
HER3 has little to no tyrosine kinase activity on its own, its
activation to promote tumors depends on heterodimerization or
locking into place with HER2 and EGFR, which is believed to unlock
its cancer-causing potential.
Hillstream’s lead asset, HSB-3215 is designed as
a bispecific humanized immunoglobulin containing two arms targeting
the extracellular domains of HER2 and HER3. HSB-3215 binds to both
overlapping and different epitopes on HER2 when compared to
trastuzumab, the first approved antibody against HER2, while
adhering to novel epitopes on HER3, thus creating novel
conformational epitopes. The Company intends to develop this novel
BsAb and file an IND application with the US FDA late next
year.
By exploiting the “Bystander Effect”, a key
aspect of ADCs which has been recently highlighted by the improved
clinical efficacy of Daiichi Sankyo/AstraZeneca’s ENHERTU®
(trastuzumab deruxtecan), the Company plans to optimize its BsAb
pipeline with BiSpecific ADCs, i.e. BiSpecific antibodies
conjugated with novel toxin payloads which are optimized to
generate a more powerful Bystander Effect. ADCs are comprised of a
targeting antibody chemically conjugated via a proprietary linker
to a powerful, cancer-killing compound/toxin (payload). With a BsAb
backbone utilizing HSB-3215, the Company intends to develop novel
ADCs, targeting HER2/HER3 and better direct a payload to cancer
cells overexpressing these receptors, while healthy cells don’t
take up the unwanted compound.
Hillstream also intends to further enhance its
previously announced collaborations with Applied Biomedical Science
Institute (ABSI) and Minotaur to develop novel bovine-derived
biologics in multiple formats against highly validated targets,
including PD-1, HER2 and TROP-2, referred to as PicoKnobsTM. An
update regarding these collaborations will be announced during an
R&D Day in the third quarter.
“Our recently announced collaborations with ABSI
are transforming Hillstream into a focused and targeted cancer
biologics company,” said Randy Milby, Chairman and CEO of
Hillstream. “With the HER2 and HER3 platform, we are building a
diverse foundation of targeted biologics which can be utilized for
our current portfolio as well for future in-licensed assets. We are
confident that our focused approach and experienced management team
best positions us for success.”
The Company also announced the appointment of
Sireesh Appajosyula, Pharm.D.as as Chief Operating Officer (COO).
Sireesh brings over 20 years of experience in creating and advising
biotechnology companies such as 9 Meters Biopharma Inc. through
targeted transactions thus creating a pipeline as well as accessing
the public capital markets. He was responsible for corporate
development including portfolio strategy, in-licensing transactions
and alliances for 9 Meters’s core assets as well as monetization of
non-core assets. Previously, he spent eight years at Salix
Pharmaceuticals, Inc. in various roles including medical &
clinical affairs, product commercialization and business
development culminating in Salix’s acquisition for $16 billion by
Bausch Health. Prior to Salix, Sireesh held increasing roles and
responsibilities at Amgen, Chiesi (Critical Therapeutics) and
Sanofi S.A. (Aventis). Sireesh holds a Doctor of Pharmacy degree
from the Ernest Mario College of Pharmacy at Rutgers University in
New Jersey.
“I am thrilled to join Hillstream and look
forward to working alongside the team as we further our development
programs. I believe the Company’s precision oncology strategy with
the current HER2/HER3 antibody programs and pipeline have the
potential to bring much needed treatments to cancer patients,” said
Dr. Appajosyula.
About Hillstream BioPharma,
Inc.Hillstream BioPharma, Inc. is a biotechnology company
developing a focused portfolio of therapeutic candidates targeting
drug resistant and devastating cancers. The Company’s emerging
immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2
monoclonal antibody targeting unique epitopes with a novel
mechanism of action. The erbB/HER family of cell surface proteins
include well-known and validated drug targets including HER2 and
HER3 found in multiple solid tumors, including breast, lung, GYN,
endocrinological and CNS. For more information, please
visit: www.hillstreambio.com.
Forward Looking StatementsCertain statements in
this press release are forward-looking within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
may be identified using words such as “anticipate,” “believe,”
“forecast,” “estimated” and “intend” or other similar terms or
expressions that concern Hillstream’s expectations, strategy, plans
or intentions. These forward-looking statements are based on
Hillstream’s current expectations and actual results could differ
materially. There are several factors that could cause actual
events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, clinical trials involve a lengthy and expensive process
with an uncertain outcome, and results of earlier studies and
trials may not be predictive of future trial results; our clinical
trials may be suspended or discontinued due to unexpected side
effects or other safety risks that could preclude approval of our
product candidates; risks related to business interruptions which
could seriously harm our financial condition and increase our costs
and expenses; dependence on key personnel; substantial competition;
uncertainties of patent protection and litigation; dependence upon
third parties; and risks related to failure to obtain Food and Drug
Administration (“FDA”) clearances or approvals and noncompliance
with FDA regulations. Investors should read the risk factors set
forth in our Form 10-K for the year ended December 31, 2022, and
our periodic reports filed with the Securities and Exchange
Commission. However, these risks are not exhaustive and new
risks and uncertainties emerge from time to time and it is not
possible for us to predict all risks and uncertainties that could
have an impact on the forward-looking statements contained in this
press release. Forward-looking statements included herein are made
as of the date hereof, and Hillstream does not undertake any
obligation to update publicly such statements to reflect subsequent
events or circumstances, except as may be required by law.
Investor Relations
ContactEmail: investorrelations@hillstreambio.comwww.hillstreambio.com
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