Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference
25 11월 2024 - 9:30PM
Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the
“Company”), a clinical-stage pharmaceutical company developing
targeted radiotherapeutics with advanced platform technologies for
central nervous system cancers, presented data updating the
progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium
(186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal
disease (LM). The data were presented at the 2024 Society for
Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston,
Texas.
“The combination of a high absorbed radiation
dose, favorable safety profile, and consistent response data is
very encouraging, particularly in a Phase 1 trial,” said Dr. Andrew
Brenner, M.D., Ph.D. “Furthermore, the observed median overall
survival rate and long tail survivors receiving multiple doses via
compassionate use are uncommon in LM patients, driving our
commitment to move rapidly into dose expansion and multiple-dose
trials.”
The data were presented in a session titled,
“Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the
treatment of leptomeningeal metastases (LM): Summary of the Phase 1
dose escalation study and Phase 2 administered dose selection,” by
Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed
Chair Neuro-Oncology Research; Co-Leader, Experimental and
Developmental Therapeutics Program, University of Texas Health, San
Antonio.
KEY HIGHLIGHTS
ReSPECT-LM Single Administration Dose
Escalation Trial
Overview:
- Twenty patients
with LM were treated and evaluable through Cohort 5, receiving a
single intrathecal dose of Rhenium (186Re) Obisbemeda of up to
66.14 mCi of radiation
- Primary cancer
diagnosis for the 20 patients with LM included breast cancer (n =
9), non-small cell lung cancer (n = 5), and other primary cancers
(n = 6)
Safety:
- The safety
profile through Cohort 5 was favorable, with 1 dose-limiting
toxicity (thrombocytopenia) observed in Cohort 5
- Pharmacodynamic
and pharmacokinetic analyses indicated that after a single
administration, Rhenium (186Re) Obisbemeda remained in the
cerebrospinal fluid space for at least 7 days and achieved average
absorbed doses of up to 253 Gy to the cranial subarachnoid space in
Cohort 5
Response:
- The best
clinical benefit rate from a single dose of Rhenium (186Re)
Obisbemeda, assessed from baseline to day 112, was measured through
complete response, partial response, and stable disease across
three key metrics:
- Circulating
tumor cells: 93% (14/15 patients) responded, including 1 complete
response and 1 stable case
- MRI imaging: 75%
(12/16 patients), with 5 responses and 7 stable cases
- Clinical
Response: 86% (12/14 patients), with 2 responses and 10 stable
cases
- Median overall
survival for Cohorts 1-4 was 9 months, with 6 out of the 16
patients alive at the time of analysis
- Three of the 20
patients received up to 3 doses of Rhenium (186Re) Obisbemeda under
compassionate use IND, all surviving over 400 days, with one
exceeding 30 months
Next steps:
- The first
patient in Cohort 6 has been treated using a modified dose of 75
mCi
- Cohort 6 is
anticipated to conclude in Q1 2025
- Planning is
underway for a Phase 1b single dose expansion cohort trial using
the Cohort 4 dose of 44 mCi, which is expected to fully enroll in
2025
ReSPECT-LM Multiple Administration Dose
Interval Compression Trial
- Obtained agreement from FDA to
begin the ReSPECT-LM multi-administration trial for patients with
LM (IND 153715); enrollment is expected to begin in early 2025 at
seven U.S. trial sites
- The trial will be a two-part study
aimed at evaluating the safety, dosing intervals, and efficacy of
administering multiple doses of Rhenium (186Re) Obisbemeda to
patients with LM
About Leptomeningeal Metastases
(LM)LM is a rare complication of cancer in which the
primary cancer spreads to the cerebrospinal fluid (CSF) and
leptomeninges surrounding the brain and spinal cord. All
malignancies originating from solid tumors, primary brain tumors,
or hematological malignancies have this LM complication potential
with breast cancer as the most common cancer linked to LM, with
3-5% of breast cancer patients developing LM. Additionally, lung
cancer, GI cancers and melanoma can also spread to the CSF and
result in LM. LM occurs in approximately 5% of people with cancer
and is usually terminal with 1-year and 2-year survival of just 7%
and 3%, respectively. The incidence of LM is on the rise, partly
because cancer patients are living longer and partly because many
standard chemotherapies cannot reach sufficient concentrations in
the spinal fluid to kill the tumor cells; yet, there are no
FDA-approved therapies specifically for LM patients, who often
succumb to this complication within weeks to several months, if
untreated.
About Rhenium (186Re)
obisbemedaRhenium (186Re) obisbemeda is a novel injectable
radiotherapy specifically formulated to deliver direct targeted
high dose radiation in CNS tumors in a safe, effective, and
convenient manner to optimize patient outcomes. Rhenium (186Re)
obisbemeda has the potential to reduce off target risks and improve
outcomes for CNS cancer patients, versus currently approved
therapies, with a more targeted and potent radiation dose.
Rhenium-186 is an ideal radioisotope for CNS therapeutic
applications due to its short half-life, beta energy for destroying
cancerous tissue, and gamma energy for real-time imaging. Rhenium
(186Re) obisbemeda is being evaluated for the treatment of
recurrent glioblastoma and leptomeningeal metastases in the
ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is
supported by an award from the National Cancer Institute (NCI),
part of the U.S. National Institutes of Health (NIH), and
ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer
Prevention & Research Institute of Texas (CPRIT).
About Plus TherapeuticsPlus
Therapeutics, Inc. is a clinical-stage pharmaceutical company
developing targeted radiotherapeutics for difficult-to-treat
cancers of the central nervous system with the potential to enhance
clinical outcomes for patients. Combining image-guided local beta
radiation and targeted drug delivery approaches, the Company is
advancing a pipeline of product candidates with lead programs in
recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
The Company has built a supply chain through strategic partnerships
that enable the development, manufacturing, and future potential
commercialization of its products. Plus Therapeutics is led by an
experienced and dedicated leadership team and has operations in key
cancer clinical development hubs including Austin and San Antonio,
Texas. For more information, visit
https://plustherapeutics.com/.
Cautionary Statement Regarding
Forward-Looking StatementsThis presentation contains
statements that may be deemed “forward-looking statements” within
the meaning of U.S. securities laws, including statements regarding
clinical trials, expected operations and upcoming developments. All
statements in this press release other than statements of
historical fact are forward-looking statements. These
forward-looking statements may be identified by future verbs, as
well as terms such as “potential,” “anticipating,” “planning” and
similar expressions or the negatives thereof. Such statements are
based upon certain assumptions and assessments made by management
in light of their experience and their perception of historical
trends, current conditions, expected future developments and other
factors they believe to be appropriate. These statements include,
without limitation, statements regarding the following: the planned
dose expansion and multiple-dose trials of patients with
leptomeningeal metastases; the timeline for completing the
Company’s leptomeningeal metastases patient Cohort 6; the timeline
for commencing the Company’s expansion trial of patients with
leptomeningeal metastases; and timeline for the Company’s
ReSPECT-LM multi-administration trial of patients with
leptomeningeal metastases.
The forward-looking statements included in this
press release could differ materially from those expressed or
implied by these forward-looking statements because of risks,
uncertainties, and other factors that include, but are not limited
to, the following: the early stage of the Company’s product
candidates and therapies; the results of the Company’s research and
development activities, including uncertainties relating to the
clinical trials of its product candidates and therapies; the
Company’s liquidity and capital resources and its ability to raise
additional cash to fund its operations in the near term and long
term, on terms acceptable to us or at all; the outcome of the
Company’s partnering/licensing efforts; risks associated with laws
or regulatory requirements applicable to the Company, including the
ability to come into compliance with The Nasdaq Capital Market
listing requirements; market conditions; product performance;
litigation or potential litigation; competition within the cancer
diagnostics and therapeutics field; ability to develop and protect
proprietary intellectual property or obtain licenses to
intellectual property developed by others on commercially
reasonable and competitive terms; manufacturing and supply chain
risks; and material security breach or cybersecurity attack
affecting the Company’s operations or property. This list of risks,
uncertainties, and other factors is not complete. Plus Therapeutics
discusses some of these matters more fully, as well as certain risk
factors that could affect Plus Therapeutics’ business, financial
condition, results of operations, and prospects, in its reports
filed with the SEC, including Plus Therapeutics’ annual report on
Form 10-K for the fiscal year ended December 31, 2023, quarterly
reports on Form 10-Q, and current reports on Form 8-K. These
filings are available for review through the SEC’s website at
www.sec.gov. Any or all forward-looking statements Plus
Therapeutics makes may turn out to be wrong and can be affected by
inaccurate assumptions Plus Therapeutics might make or by known or
unknown risks, uncertainties, and other factors, including those
identified in this press release. Accordingly, you should not place
undue reliance on the forward-looking statements made in this press
release, which speak only as of its date. The Company assumes no
responsibility to update or revise any forward-looking statements
to reflect events, trends or circumstances after the date they are
made unless the Company has an obligation under U.S. federal
securities laws to do so.
Investor ContactCharles Y.
Huang, MBADirector of Capital Markets and Investor RelationsOffice:
(202)-209-5751 | Direct
(301)-728-7222chuang@plustherapeutics.com
Plus Therapeutics (NASDAQ:PSTV)
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Plus Therapeutics (NASDAQ:PSTV)
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