TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage
biopharmaceutical company focused on the development of T cell
receptor (TCR)-engineered T cell (TCR-T) therapies for the
treatment of patients with cancer, today announced that the first
patient has been dosed in the Company’s Phase 1 trial evaluating
TCR-T therapy for the treatment of solid tumors. The patient,
diagnosed with metastatic melanoma, was dosed with TSC-203-A0201
targeting the cancer-associated antigen PReferentially expressed
Antigen in MElanoma (PRAME).
“Dosing the first patient in our solid tumor
program is a significant milestone for us, as we are now well
underway with both of our core clinical programs,” said Gavin
MacBeath, Ph.D., Chief Executive Officer. “There is a lot of
enthusiasm for this trial, and we are already manufacturing TCR-T
products for three more patients. We have six TCR-Ts cleared under
existing IND applications for patient dosing in this program, and
we plan to file additional IND applications to further expand the
ImmunoBank across diverse targets and HLA types to broaden the
reach of multiplex TCR-T therapy for solid tumors.”
“Solid tumors are notoriously heterogeneous, and
we believe that an effective way to treat solid tumors is through a
multi-pronged approach,” added Chrystal U. Louis, M.D., Chief
Medical Officer. “Customized multiplex TCR-T therapy is designed to
achieve durable responses by overcoming tumor heterogeneity and
resistance that develops from either target or HLA loss. We look
forward to sharing initial data from our solid tumor trial later
this year.”
About TScan’s Solid Tumor
Program
TScan’s Phase 1 clinical trial is designed to
assess the safety and feasibility of T-Plex, autologous customized
TCR-T therapy targeting multiple peptide/human leukocyte antigens
(HLA) targets in participants with antigen-positive, locally
advanced, unresectable or metastatic solid tumors. Multiplex TCR-T
therapy has the potential to overcome tumor heterogeneity and HLA
loss of heterozygosity, commonly observed resistance mechanisms in
solid tumors. First generation TCR-T therapies, targeting single
antigens, have shown encouraging response rates in patients, but
have often shown limited duration of response.
TScan believes that its approach of dosing
patients with more than one TCR-T targeting different
cancer-associated antigens will result in increased response rates
and increased duration of response. To make this possible, TScan is
screening patients (screening protocol: NCT05812027) with melanoma,
non-small cell lung cancer (NSCLC), head and neck cancer, cervical
cancer, ovarian cancer, anogenital cancers, and other solid tumors
for target expression and the presence of intact HLA genes in their
tumor cells. Eligible patients are then enrolled in the study
treatment protocol (NCT05973487) and administered one or more
investigational TCR-T products that are matched to
cancer-associated antigens expressed in their tumors. This is made
possible by the Company’s ImmunoBank, its repository of therapeutic
TCRs that recognize diverse targets and are associated with
multiple HLA types. Currently, the ImmunoBank includes six TCR-T
clinical candidates in Phase 1 development: TSC-203-A0201 (PRAME,
HLA-A*02:01); TSC-200-A0201 (HPV16, HLA-A*02:01); TSC-201-B0702
(MAGE-C2, HLA-B*07:02); TSC-204-A0201 (MAGE-A1, HLA-A*02:01);
TSC-204-C0702 (MAGE-A1, HLA-C*07:02); and TSC-204-A0101 (MAGE-A1,
HLA-A*01:01). TScan intends to continue to expand the
ImmunoBank with TCR-Ts for additional targets and HLA types,
thereby increasing the number of patients that are eligible to
receive multiplex therapy.
About TScan Therapeutics,
Inc.
TScan is a clinical-stage biopharmaceutical
company focused on the development of T cell receptor
(TCR)-engineered T cell therapies (TCR-T) for the treatment of
patients with cancer. The Company’s lead TCR-T candidates, TSC-100
and TSC-101, are in development for the treatment of patients with
hematologic malignancies to prevent relapse following allogeneic
hematopoietic cell transplantation. The Company is also developing
multiplexed TCR-T candidates for the treatment of various solid
tumors. The Company has developed and continues to expand its
ImmunoBank, the Company’s repository of therapeutic TCRs that
recognize diverse targets and are associated with multiple HLA
types, to provide customized multiplex therapeutic TCR-Ts for
patients with a variety of cancers.
Forward-Looking Statements
This release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including, but not limited to, express or implied
statements regarding the Company’s plans, progress, and timing
relating to the Company’s solid tumor program, including dosing of
patients, reporting of data, and filing of INDs; the Company’s
current and future research and development plans or expectations;
the structure, timing and success of the Company’s planned
preclinical development, submission of INDs, and clinical trials;
the potential benefits of any of the Company’s proprietary
platforms, multiplexing, or current or future product candidates in
treating patients; and the Company’s goals and strategy. TScan
intends such forward-looking statements to be covered by the safe
harbor provisions for forward-looking statements contained in
Section 21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995. In some cases, you can
identify forward-looking statements by terms such as, but not
limited to, “may,” “might,” “will,” “objective,” “intend,”
“should,” “could,” “can,” “would,” “expect,” “believe,”
“anticipate,” “project,” “target,” “design,” “estimate,” “predict,”
“potential,” “plan,” “on track,” or similar expressions or the
negative of those terms. Such forward-looking statements are based
upon current expectations that involve risks, changes in
circumstances, assumptions, and uncertainties. The express or
implied forward-looking statements included in this release are
only predictions and are subject to a number of risks,
uncertainties and assumptions, including, without limitation: the
beneficial characteristics, safety, efficacy, therapeutic effects
and potential advantages of TScan’s TCR-T therapy
candidates; the progress of the solid tumor Phase 1 clinical
program being indicative or predictive of the success of such
program; TScan’s expectations regarding its preclinical studies
being predictive of clinical trial results; the timing of the
initiation, progress and expected results of TScan’s preclinical
studies, clinical trials and its research and development programs;
TScan’s plans relating to developing and commercializing its TCR-T
therapy candidates, if approved, including sales strategy;
estimates of the size of the addressable market for TScan’s TCR-T
therapy candidates; TScan’s manufacturing capabilities and the
scalable nature of its manufacturing process; TScan’s estimates
regarding expenses, future milestone payments and revenue, capital
requirements and needs for additional financing; TScan’s
expectations regarding competition; TScan’s anticipated growth
strategies; TScan’s ability to attract or retain key personnel;
TScan’s ability to establish and maintain development partnerships
and collaborations; TScan’s expectations regarding federal, state
and foreign regulatory requirements; TScan’s ability to obtain and
maintain intellectual property protection for its proprietary
platform technology and our product candidates; the sufficiency of
TScan’s existing capital resources to fund its future operating
expenses and capital expenditure requirements; and other factors
that are described in the “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” sections of TScan’s most recent Annual Report on Form
10-K and any other filings that TScan has made or may make
with the SEC in the future. Any forward-looking
statements contained in this release represent TScan’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date. Except as required by law,
TScan explicitly disclaims any obligation to update any
forward-looking statements.
Contacts
Heather SavelleTScan Therapeutics, Inc.VP, Investor
Relations857-399-9840hsavelle@tscan.com
Maghan MeyersArgot
Partners212-600-1902TScan@argotpartners.com
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