OS Therapies Announces Positive Clinical Update from Ongoing Phase 2b Clinical Trial in Resected, Recurrent Osteosarcoma
03 Junho 2024 - 1:44PM
Business Wire
- 1-year Event Free Survival (EFS) of 32.5% vs. 20% 1-year EFS
for comparator
- Interim 1-year and 18-month Overall Survival (OS) of 90.4%
- 0 Grade 3, 4 or 5 Treatment-related Adverse Events (AEs)
- 41 patient trial fully enrolled
- Primary endpoint 12-month EFS data and interim co-primary
endpoint 12-month OS data to be released in the fourth quarter of
2024
- No novel therapeutic interventions for resected, recurrent
osteosarcoma in 40+years
OS Therapies, Inc. (NYSE-A: OSTX), a
clinical-stage oncology-focused immunotherapy company developing
cancer vaccines and antibody drug conjugate (ADC) therapeutic
candidates, today announced a positive clinical update for
AOST-2121 (NCT04974008), its ongoing Phase 2b clinical trial of its
immunotherapy OST-HER2 (OST31-154) in patients with resected,
recurrent osteosarcoma.
OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria
monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine
designed to prevent metastasis, delay recurrence, and increase
overall survival in patients with Osteosarcoma. The AOST-2121 study
is designed to demonstrate efficacy in patients who have already
had recurrent disease and are highly likely to recur again. A total
of 18 OST-HER2 doses are administered once every three weeks, for a
total 51 weeks. Radiographic evaluation of recurrence is evaluated
throughout treatment.
The proposed OST-HER2 mechanism of action is based on innate and
adaptive immune stimulating responses activated by the Lm vector.
This treatment generates T cells that can eliminate or slow
potential micrometastases that can grow into recurrent
osteosarcoma. T cell responses home-in on HER2 expressed by the
tumor and then kill the cell, releasing additional tumor targets.
There are currently no approved adjuvant treatments for recurrent
osteosarcoma in the United States.
AOST-2121 has achieved full enrollment of 41 patients treated
with OST-HER2 at 21 clinical trial sites across the United States.
A few patients remain in the active treatment stage with the
remainder in follow-up for overall survival. The primary endpoints
for the AOST-2121 study are Event Free Survival (‘EFS’, defined as
absence of recurrence of primary tumor or metastasis) at 12 months
and Overall Survival at 36 months, with interim Overall Survival
endpoints at 12 months and 24 months. Topline EFS data, interim
1-year OS data, as well as additional secondary data analyses are
expected to be reported in the fourth quarter of 2024. No novel
therapeutic interventions have improved the clinical outcomes for
patients with resected, recurrent osteosarcoma in over 40
years.
The clinical updates reported today include:
- 1-year EFS rate of 32.5% vs. 20% EFS rate for unsuccessful
investigational therapeutic comparator1
- 1-year overall survival rate of 90.4%
- 18-month overall survival rate of 90.4%
- Treatment has been well tolerated and there have been no grade
3, 4 or 5 treatment-related adverse events reported for the 41
patients.
“OST-HER2’s strong safety profile supports its potential to
become a practical adjuvant therapy to delay or prevent subsequent
recurrences and improve overall survival in the very difficult
challenge of recurrent osteosarcoma. Promoting innate and adaptive
immune surveillance against lurking micrometastases could become a
potentially powerful tool for oncologists as they seek to improve
the quality of life and prolong survival of patients who have
suffered from Osteosarcoma,” said Dr. Robert Petit, Chief Medical
& Scientific Officer of OS Therapies. “OST-HER2 has the
potential to significantly improve the standard of care in this
difficult to treat patient population. In light of today’s
encouraging clinical trial update, we are hopeful that final data
coming in the fourth quarter of this year, combined with
supplemental data that will follow in 2025, positions OST-HER2 to
become available to help clinicians better protect people with
difficult cancers like osteosarcoma.”
“With historical 1-year EFS estimated in the low-to-mid teens
with the current standard of care, and the most recent
investigational therapeutic comparator yielding 1-year EFS of 20%,
we believe that the 32.5% EFS data observed to date in this trial
compares favorably and positions OS Therapies to deliver final
Phase 2b co-primary endpoint data by the end of 2024,” said Paul
Romness, President & CEO of OS Therapies. “With OST-HER2’s
strong safety profile and consistent overall survival at the 1-year
and 18 month timepoints, and given the dearth of therapeutic
options for the resected, recurrent osteosarcoma patient
population, we are hopeful that OS Therapies will be gain approval
for the first new osteosarcoma treatment, a novel immunotherapy, in
over 40 years.”
The FDA has granted Rare Pediatric Disease Designation (RPDD),
Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for
OST-HER2 in Osteosarcoma.
References
- Lagmay JP, Krailo MD, Dang H, et al: Outcome of patients with
recurrent osteosarcoma enrolled in seven Phase II trials through
Children's Cancer Group, Pediatric Oncology Group, and Children's
Oncology Group: learning from the past to move forward. J Clin
Oncol. 2016;34:3031-8.
About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly
occurs in adolescents and young adults (AYA). Standard treatment
includes surgery and chemotherapy. For patients with metastatic
osteosarcoma or have recurrence after chemotherapy, the prognosis
is poor.
About OS Therapies
OS Therapies, Inc. (NYSE-A: OSTX) is a clinical stage oncology
company focused on the identification, development and
commercialization of treatments for Osteosarcoma (OS) and other
solid tumors. OST-HER2 is an immunotherapy leveraging the immune
stimulatory effects of Listeria bacteria to initiate a strong
immune response targeting the HER2 protein. The Company has
fully-enrolled a 41-patient Phase 2b clinical trial of OST-HER2 in
resected, recurrent osteosarcoma, with results expected in the
fourth quarter of 2024. OS Therapies is also developing the next
generations Antibody Drug Conjugate (ADC) platform tunable ADC
(tADC) centered around tunable, tailored antibody-linker-payload
candidates built around the Company’s unique silicone linker
technology that allows for multiple payloads to be delivered per
linker.
About OST-HER2
The OST-HER2 Lm vector platform technology has been administered
to over 450 cancer patients in ongoing and completed clinical
trials. AOST-2121 is a Phase IIB clinical trial intended to prevent
or delay metastasis and improve Overall Survival (OS) in
Osteosarcoma. OST-HER2 has already received Fast-Track, Orphan, and
Rare Disease Designation (RDD). OST hopes to seek a Break-Through
Designation (BTD) based on data from this Phase IIb clinical trial.
OST31-164 has previously received USDA provisional approval for
treatment of Osteosarcoma in canines. In a completed Phase III
study in canines (n=180), early data demonstrated a clear
separation of treated and untreated canine patients (p=.0007) in
Overall Survival (OS) and Disease Progression.
For more information, please see the Company's website at
www.ostherapies.com
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