Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
2024年5月24日 - 6:00AM
ビジネスワイヤ(英語)
Oral presentation at ASCO on June 3 to include
Phase 1 OBX-115 data incremental to the abstract released today
Obsidian Therapeutics, Inc., a clinical-stage biotechnology
company pioneering engineered cell and gene therapies, today
announced positive updated safety and efficacy data from its
first-in-human study of OBX-115, a novel engineered tumor-derived
autologous T cell immunotherapy (tumor-infiltrating lymphocyte
[TIL] cell therapy) armored with pharmacologically regulatable
membrane-bound IL15 (mbIL15), in patients with immune checkpoint
inhibitor (ICI)-resistant advanced or metastatic melanoma
(NCT05470283). The data will be presented at an oral poster
presentation at the 2024 American Society of Clinical Oncology
Annual Meeting, taking place in Chicago on June 3. The oral poster
titled, “OBX-115, an interleukin 2 (IL2)-sparing engineered
tumor-infiltrating lymphocyte (TIL) cell therapy, in patients (pts)
with immune checkpoint inhibitor (ICI)-resistant unresectable or
metastatic melanoma,” will be presented by Rodabe Amaria, M.D.,
professor of Melanoma Medical Oncology at The University of Texas
MD Anderson Cancer Center, and principal investigator of the
study.
The single-center study is evaluating the safety, tolerability,
dosing, and efficacy of OBX-115 in patients with ICI-resistant
metastatic melanoma. As of January 2, 2024, all 9 patients had
disease that was primary-resistant to anti–PD-1 therapy, with a
median of 3 (range, 1–6) lines of prior therapy. Post-infusion
safety results included no dose limiting toxicities and no Grade 4
or higher non-hematologic treatment emergent adverse events (TAEs),
and 2 patients with Grade 3 nonhematologic TEAEs. Updated efficacy
data on 9 patients with a minimum of a 12-week post-infusion
follow-up will be presented by Dr. Amaria at the oral presentation
on June 3 at 9:45 a.m. CT/10:45 a.m. ET.
In addition to the first-in-human study, Obsidian is actively
enrolling patients with metastatic melanoma and non-small cell lung
cancer (NSCLC) at multiple sites in the company’s ongoing Phase 1/2
multicenter study. Additional details may be found at
clinicaltrials.gov, using identifier: NCT06060613. Obsidian is
presenting a trials in progress poster at ASCO 2024:
Title: A phase 1/2 study to investigate the safety and
efficacy of OBX-115 engineered tumor-infiltrating lymphocyte (TIL)
cell therapy in patients (pts) with advanced solid tumors.
Presenting Author: Adam J Schoenfeld, M.D., Memorial Sloan
Kettering Cancer Center Date and Time: June 1, 1:0 p.m. CT /
2:30 p.m. ET Abstract #: TPS9599 Poster Bd: 383a
About OBX-115 Obsidian’s lead investigational cytoTIL15™
program, OBX-115, is a novel engineered tumor-derived autologous T
cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell
therapy) armored with pharmacologically regulatable membrane-bound
IL15 (mbIL15). OBX-115 has the potential to become a meaningful
therapeutic option for patients with advanced or metastatic
melanoma and other solid tumors by leveraging the expected benefits
of mbIL15 and Obsidian’s proprietary, differentiated manufacturing
process to enhance persistence, antitumor activity, and clinical
safety of TIL cell therapy. OBX-115 is being investigated in two
ongoing clinical trials in advanced or metastatic melanoma and
non-small cell lung cancer (NSCLC) (NCT05470283 and
NCT06060613).
About Obsidian Therapeutics
Obsidian Therapeutics, Inc. is a clinical-stage biotechnology
company pioneering engineered cell and gene therapies to deliver
transformative outcomes for patients with intractable diseases.
Obsidian’s proprietary cytoDRiVE® technology is designed to
precisely regulate the timing and level of protein function by
using FDA-approved small-molecule drugs. Obsidian is headquartered
in Cambridge, MA. The Company has collaborations with Bristol Myers
Squibb and Vertex Pharmaceuticals. For more information, please
visit www.obsidiantx.com and follow us on LinkedIn.
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