Climb Bio to Provide Budoprutug Development Strategy and Corporate Update at Virtual Investor Event
October 15 2024 - 6:00AM
Climb Bio, Inc. (Nasdaq: CLYM), will be hosting a virtual investor
event, today, October 15, 2024, from 12:00 p.m. to 2:00 p.m. ET.
The event will feature members of Climb Bio’s management team who
will provide an update on the Company’s development strategy for
budoprutug, an anti-CD19 monoclonal antibody with potential to
treat a broad range of B-cell mediated diseases. The event will
also feature Dr. Frank Cortazar, Director of the New York
Vasculitis and Glomerular Center and Chief of Clinical Research at
St. Peter's Health Partners, who was the primary investigator in
the Phase 1b trial of budoprutug in pMN. Dr. Cortazar will present
additional data from the completed pMN trial and share clinical
data from a single patient with Minimal Change Disease (MCD)
treated with budoprutug.
“Our mission at Climb Bio is to develop better treatments for
the approximately 50 million patients in the U.S. and many more
globally living with immune-mediated diseases,” said Aoife Brennan,
President and CEO of Climb Bio. “We are off to a great start with
some world class talent and a cornerstone asset, budoprutug. We
believe CD19 is the optimal target for B-cell mediated diseases and
that an antibody is the modality with the broadest potential to
help patients. We are thrilled today to share our development
strategy and promising preclinical and clinical data that
underscore our enthusiasm for budoprutug’s potential.”
Dr. Cortazar added, “I know firsthand the challenges of managing
patients with pMN and the need for new treatment options. The
patients in the pMN trial demonstrated high rates of complete
clinical remission, as well as rapid reductions in B-cells and
anti-PLA2R antibodies, two key biomarkers for pMN. These data
potentially support a significant advancement in our fight against
this challenging condition, and I am hopeful to continue to help
advance this innovative therapy for those in need.”
Event Highlights
Rational and data driven clinical development
strategy
- The Company’s strategic approach to developing budoprutug will
consider indications across three opportunity sets, including;
- IgG4-mediated diseases, such as pMN;
- Diseases caused by IgG1-3 that impact a single organ system,
such as ITP; and
- Complex systemic diseases, such as SLE.
Budoprutug is a differentiated anti-CD19 monoclonal
antibody with potential for potent B-cell depletion
- The Company will share data supporting budoprutug’s potential
for deep and durable depletion of both peripheral and
tissue-resident B-cells in patients with immune-mediated diseases
- In a transgenic mouse model expressing human CD19, budoprutug
achieved dose-dependent B-cell depletion in bone marrow, lymph
nodes, and spleen.
- Doses as low as 100 mg induced B-cell depletion to undetectable
levels in pMN patients treated with budoprutug.
Continued advancement of subcutaneous formulation of
budoprutug
- Budoprutug has been successfully formulated above 175 mg/ml
while maintaining low viscosity, creating an opportunity to pursue
a subcutaneous dosing form that potentially features a low volume
injection.
- The Company plans to continue to advance the subcutaneous
formulation clinical program, with non-clinical data expected in
the first half of 2025.
Additional promising Phase 1b Study Results in
pMN
- Dr. Frank Cortazar, Director of the New York Nephrology
Vasculitis and Glomerular Center, will present additional data from
the Phase 1b study of budoprutug in patients with pMN.
- The study demonstrated the following for the 5 patients who
received all 4 doses of budoprutug:
- Complete remission of proteinuria achieved by 3/5 (60%) of
patients.
- Rapid and significant reductions in anti-PLA2R autoantibodies,
a key driver of pMN, with serological remission occurring in the 3
patients that were PLA2R positive at baseline.
- Complete and sustained B-cell depletion was observed in all
patients, with undetectable levels of B-cells occurring after just
two doses of study drug as low as 100 mg.
- Budoprutug was generally well-tolerated, with no reported
drug-related serious adverse events.
- Full data from this study will be presented in a poster
presentation on October 24th at the American Society of
Nephrology’s Kidney Week 2024 being held in San Diego, CA.
- Dr. Cortazar will also share data from a single patient trial
for MCD showing the MCD patient was able to fully taper steroid and
remains in complete remission 18 months following final
administration of budoprutug, given as 4 doses over 6 months, 600mg
cumulative dose.
Initiation of Phase 1b clinical trial in SLE planned for
the first half of 2025, subject to regulatory
clearance
- SLE is a complex, chronic systemic disease opportunity
affecting multiple organ systems, leading to significant morbidity
and mortality that affects approximately 200,000 to 300,000 people
in the U.S.
- Design of Phase 1b
trial in SLE:
- An open-label trial
in patients with active lupus is planned.
- Endpoints will
include clinical response, decline in pathogenic autoantibodies,
and assessment of B-cell subsets upon recovery.
- The trial will utilize informative serum biomarkers to
accelerate proof-of-concept, optimize dosing, and benchmark against
other B-cell depleting therapies.
Initiation of Phase 2 clinical trial in
ITP planned for the first half of 2025, subject to
regulatory clearance
- ITP is an IgG 1-3 immune-mediated disorder affecting an
estimated 60,000 adults in the U.S. and where there is compelling
proof-of-concept validating the clinical rationale for using B-cell
depletion therapies.
- Design of Phase 2 trial in ITP:
- Single-arm,
open-label study in adult patients with chronic ITP is
planned.
- Primary endpoint
will measure platelet improvement along with other disease
parameters.
- A unique
"treat-to-target" approach is included in the study protocol to
allow for personalized redosing based on individual patient
needs.
Corporate Update and Upcoming Milestones
- As of September 30, 2024, the Company had cash, cash
equivalents and marketable securities of approximately $218
million, which is expected to fund operations through 2027.
- Initiation of clinical trials in SLE and ITP with first
patients dosed targeted for the first half of 2025, subject to
regulatory clearance.
- Advancement of subcutaneous formulation clinical program, with
non-clinical data expected in the first half of 2025.
- Advancement of pMN clinical program to late phase development
expected in 2025.
Event DetailsClimb Bio, Inc. will host its
virtual investor event, today, October 15, 2024, from 12:00 p.m. to
2:00 p.m. ET. To attend the virtual event, please register here.
The live webcast of the event, as well as a replay, will be
available under "Events and Presentations" in the Investors section
of the Company's website: climbbio.com.
About Climb Bio, Inc. Climb Bio, Inc. is a
clinical-stage biotechnology company developing therapeutics for
patients with immune-mediated diseases. The Company’s lead product
candidate, budoprutug, is an anti-CD19 monoclonal antibody that has
demonstrated B-cell depletion and has potential to treat a broad
range of B-cell mediated diseases. For more information, please
visit climbbio.com.
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including without
limitation statements regarding: future expectations, plans and
prospects for Climb Bio; the anticipated benefits of the
acquisition of Tenet Medicines, Inc.; expectations regarding
budoprutug’s therapeutic benefits, clinical potential and clinical
development; the trial design for the planned clinical trials of
budoprutug; plans to optimize the administration of budoprutug; the
anticipated timelines for initiating clinical trials of budoprutug;
the sufficiency of Climb Bio’s cash resources for the period
anticipated and other statements containing the words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “would,” “will,” “working” and similar expressions.
Forward-looking statements are based on management’s current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in, or implied by,
such forward-looking statements. Climb Bio may not actually achieve
the plans, intentions or expectations disclosed in these
forward-looking statements, and you should not place undue reliance
on these forward-looking statements. These risks and uncertainties
include, but are not limited to, important risks and uncertainties
associated with: the ability of Climb Bio to timely and
successfully achieve or recognize the anticipated benefits of its
acquisition of Tenet Medicines, Inc.; changes in applicable laws or
regulation; the possibility that Climb Bio may be adversely
affected by other economic, business and/or competitive factors;
Climb Bio’s ability to advance budoprutug on the timelines expected
or at all and to obtain and maintain necessary approvals from the
U.S. Food and Drug Administration and other regulatory authorities;
obtaining and maintaining the necessary approvals from
investigational review boards at clinical trial sites and
independent data safety monitoring boards; replicating in clinical
trials positive results found in early-stage clinical trials of
budoprutug; competing successfully with other companies that are
seeking to develop treatments for systemic lupus erythematosus,
immune thrombocytopenia and membranous nephropathy and other
immune-mediated diseases; maintaining or protecting intellectual
property rights related to budoprutug and/or its other product
candidates; managing expenses; and raising the substantial
additional capital needed, on the timeline necessary, to continue
development of budoprutug and any other product candidates Climb
Bio may develop. For a discussion of other risks and uncertainties,
and other important factors, any of which could cause Climb Bio’s
actual results to differ materially from those contained in the
forward-looking statements, see the “Risk Factors” section, as well
as discussions of potential risks, uncertainties and other
important factors, in Climb Bio’s most recent filings with the U.S.
Securities and Exchange Commission. In addition, the
forward-looking statements included in this press release represent
Climb Bio’s views as of the date hereof and should not be relied
upon as representing Climb Bio’s views as of any date subsequent to
the date hereof. Climb Bio anticipates that subsequent events and
developments will cause Climb Bio’s views to change. However, while
Climb Bio may elect to update these forward-looking statements at
some point in the future, Climb Bio specifically disclaims any
obligation to do so, except as required by law.
InvestorsChris Brinzey ICR
Westwickechris.brinzey@westwicke.com 339-970-2843
MediaJon YuICR
Westwickejon.yu@westwicke.com475-395-5375
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