FDA clears INDs for cell therapies to treat multiple cancer types
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The FDA cleared investigational new drug applications for three cell therapies in development for oncology indications.
They include the following novel agents:
LYL132 for solid tumors
LYL132 (Lyell Immunopharma) — an autologous, T-cell receptor (TCR)-engineered T-cell therapy — is cleared for investigational use by patients with solid tumors that express the New York esophageal squamous cell carcinoma 1 (NY-ESO-1) antigen.
The agent is derived from T cells that are genetically altered to express a TCR that recognizes NY-ESO-1 bound to HLA-A*02 on the surface of cancer cells.
The therapy — which incorporates Lyell’s proprietary Epi-R gene-editing technology to enhance treatment durability — is being developed as part of a research collaboration agreement with GlaxoSmithKline.
LYL132 is being considered as a next-generation enhancement to GlaxoSmithKline’s letetresgene autoleucel undergoing evaluation as part of a phase 2 study of patients with synovial sarcoma or myxoid/round cell liposarcoma.
“Clinically assessing, in a validated target, the potential benefit of reprogrammed T cells designed to have properties of durable stemness is a profoundly important and exciting milestone for Lyell and cancer drug development,” Rick Klausner, MD, chair of Lyell's board of directors, said in a company-issued press release. “We believe lack of durable stemness is a major barrier to successful [adoptive cell transfer] in solid tumors and expect our Epi-R technology platform will offer a path forward to better outcomes for patients.”
The IND clearance will allow GlaxoSmithKline to start enrollment of a planned phase 1 trial that will evaluate the safety and efficacy of LYL132 for patients with NY-ESO-1-positive advanced synovial sarcoma or myxoid/round cell liposarcoma.
TSC-100 for hematologic malignancies
TSC-100 (TScan Therapeutics), an autologous TCR-engineered T-cell therapy, is cleared for investigational use by patients with hematologic malignancies who are undergoing allogeneic hematopoietic stem cell transplantation.
The novel cell therapy targets the minor histocompatibility antigen HA-1, known to be expressed on normal and malignant hematopoietic cells.
The IND clearance will allow TScan to enroll patients in a planned multi-arm, phase 1 umbrella trial to compare TSC-100 with standard-of-care therapy for patients with acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome who are undergoing allogeneic HSCT.
The trial’s primary endpoints will include safety and determination of a recommended phase 2 dose. Exploratory endpoints will include relapse rate and minimal residual disease measurements.
“FDA clearance of our IND application for TSC-100 is an important milestone for our lead liquid tumor program as it marks the first clinical-stage product candidate to advance from our pipeline of therapies geared to treat unmet needs in major cancer indications,” David Southwell, president and CEO of TScan, said in a company-issued press release. “We are looking forward to initiating our phase 1 multi-arm clinical trial in the first half of this year, with preliminary data expected in the second half of 2022.”
SQZ-eAPC-HPV for solid tumors
SQZ-eAPC-HPV (SQZ Biotechnologies) — an autologous, mRNA-based cell therapy — is cleared for investigational use by patients with HPV16-positive cancers.
The novel agent — manufactured in less than 24 hours — uses SQZ’s proprietary Cell Squeeze technology to produce enhanced antigen-presenting cells derived from a patient’s peripheral blood mononuclear cells. The cells are genetically engineered with mRNA encoding for multiple target antigens (E6 and E7 oncoproteins) and to produce immune-stimulatory signals.
The IND clearance will allow SQZ to begin enrollment of its planned phase 1/phase 2 COMMANDER-001 trial of SQZ-eAPC-HPV. The trial will include patients with advanced or metastatic HPV16-positive tumors — including head and neck, cervical and anal cancers — that have progressed after receiving standard therapies.
The study will evaluate the safety and tolerability of SQZ-eAPC-HPV as monotherapy or in combination with pembrolizumab (Keytruda, Merck), a PD-1 inhibitor.
“We believe SQZ eAPCs represent a major advance in cell therapy, with the largest number of multiplexed components ever advanced into clinical testing,” Armon Sharei, PhD, CEO and founder of SQZ Biotechnologies, said in a company-issued press release. “Through multiplexed engineering of a patient’s monocytes, B cells, T cells and [natural killer] cells, we are able to integrate antigen presentation and enhanced immunological functions into a single clinical candidate that could become a powerful weapon against solid tumors.”
References:
Lyell Immunopharma. Lyell Immunopharma announces FDA clearance of IND for LYL132, a T-cell receptor therapy for solid tumors being developed in collaboration with GSK. https://ir.lyell.com/news-releases/news-release-details/lyell-immunopharma-announces-fda-clearance-ind-lyl132-t-cell. Published Jan. 24, 2022. Accessed Feb. 9, 2022.
TScan Therapeutics. TScan Therapeutics announces FDA clearance of investigational new drug application for TSC-100 for the treatment of hematologic malignancies. https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-announces-fda-clearance-investigational-new. Published Jan. 24, 2022. Accessed Feb. 9, 2022.
SQZ Biotechnologies. SQZ Biotechnologies announces FDA clearance of investigational new drug (IND) application for SQZ-eAPC-HPV, a novel mRNA-based cell therapy for the treatment of HPV16 positive solid tumors. https://investors.sqzbiotech.com/news/news-details/2022/SQZ-Biotechnologies-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-SQZ-eAPC-HPV-a-Novel-mRNA-based-Cell-Therapy-for-the-Treatment-of-HPV16-Positive-Solid-Tumors/default.aspx. Published Jan. 24, 2022. Accessed Feb. 9, 2022.
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