On March 8, 2023 TScan Therapeutics, Inc. (Nasdaq: TCRX), 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, reported financial results for the three months and full year ended December 31, 2022, and highlighted upcoming anticipated milestones (Press release, TScan Therapeutics, MAR 8, 2023, View Source [SID1234628321]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This will be a pivotal year for TScan. We expect to have patients enrolled in all three arms of our hematologic malignancies program and plan to provide a clinical update by mid-year," said David P. Southwell, President and Chief Executive Officer. "Our solid tumor program is also advancing to the clinic this year. TScan is the first company to launch a trial that will treat cancer patients with multiplexed TCR-T cell therapies matched to the HLA and target profile of their tumors. This approach should help overcome target and HLA loss, which are known mechanisms of resistance. Following the clearance of the first three INDs for our solid tumor program in January, including our T-Plex IND enabling the combination of different TCRs, we are rapidly populating our ImmunoBank to enable a broad range of multiplexed T cell therapies for patients. We plan to file INDs for four additional solid tumor TCRs throughout the year. With $120 million of cash on hand, we are well capitalized to execute on these upcoming milestones."

"We are now actively recruiting patients into our hematologic malignancies program," commented Debora Barton, M.D., Chief Medical Officer. "Several sites are currently recruiting patients, with additional sites to be activated throughout this year. We expect that we will reach the recommended Phase 2 dose for TSC-100 and TSC-101 and report further clinical safety and biomarker data for the program by the end of 2023. Many of the clinical sites enrolling patients in our hematologic malignancies program are planning to join our solid tumor study. That study is planned to begin enrolling patients into the screening protocol by the middle of this year, with patient dosing expected to commence in the third quarter. We plan to share initial safety and biomarker data for single agent TCRs by the end of 2023, with initial multiplexing data expected in the first half of 2024."

"TScan’s TCR-T cell products have been designed to improve upon first-generation TCR-T in two important ways: by increasing depth of response and by extending duration of response," said Gavin MacBeath, Ph.D., Chief Scientific and Operations Officer. "Our non-viral, in-house manufacturing platform allows us to add enhancements to our TCRs, including CD8α/β to

increase depth of response by enlisting helper T cells, and a dominant negative form of TGFβRII to overcome inhibition of T cells by TGFβ in the hostile tumor microenvironment. To address antigen heterogeneity and HLA loss, our recently approved T-Plex IND allows us to multiplex our enhanced TCR-Ts across targets and HLA types at the same time, bringing us closer to our goal of providing customized TCR-T therapy to treat patients with a wide variety of solid tumor malignancies."

Recent Corporate Highlights

·
TScan filed three investigational new drug (IND) applications with the U.S. Food and Drug Administration (FDA) for its solid tumor program in December 2022. The IND applications for T-Plex, TSC-204-A0201, and TSC-204-C0702 have now been cleared by the FDA. T-Plex will serve as the primary IND for TScan’s solid tumor program, enabling customized mixtures of TCR-Ts to be administered to patients based on tumor antigen positivity and HLA expression. Along with T-Plex, the FDA has approved secondary INDs for two TCR-T products, TSC-204-A0201 and TSC-204-C0702, that target melanoma-associated antigen 1 (MAGE-A1) presented on HLA A*02:01 and C*07:02, respectively. MAGE-A1 is a validated cancer-associated antigen overexpressed in 45% of head and neck cancers and 50% of melanoma, cervical, and non-small cell lung cancers. TScan believes that TSC-204-C0702 is the first TCR to enter clinical trials for an epitope of MAGE-A1 presented on an HLA type other than A*02:01.

·
In December 2022, the Company presented a poster on the clinical trial design and trial in progress for the Phase 1 umbrella trial of TSC-100 and TSC-101 to treat residual leukemia and prevent relapse after hematopoietic cell transplant (HCT) at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2022.

·
In November 2022, the Company presented two posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting:

o
Discovery of PRAME-specific TCR-T cell therapy candidates for the treatment of solid tumors, presented by Mollie Jurewicz, Ph.D.
o
Multiplexed TCR-T cell therapy targeting MAGE-A1 and PRAME enhances the activity of adoptive T cell therapy in pre-clinical models, presented by Antoine Boudot, Ph.D.

·
During the fourth quarter of 2022, TScan was named the best mid-sized biotechnology company in the Top Places to Work for 2022 by The Boston Globe. Top Places to Work recognizes the most admired workplaces in the state voted on by the people who know them best – their employees. The survey measures employee opinions about their Company’s direction, execution, connection, management, work, pay and benefits, and engagement.

Upcoming Anticipated Milestones

Hematologic Malignancies Program:

·
Expects to enroll patients in all three arms in the Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 and start reporting preliminary safety and biomarker data mid-year 2023.
·
Expects to reach the recommended Phase 2 dose for TSC-100 and TSC-101 and report interim clinical data for the program by the end of 2023.

·
The Company expects to report prevention of relapse data in 2024.

Solid Tumor Program:

·
Anticipate further expansion of the ImmunoBank by filing INDs for four TCRs throughout 2023.
·
Anticipate sharing preliminary safety and biomarker data for the most advanced TCRs by the end of 2023.
·
The Company expects to report initial multiplex therapy data for its first combination of TCRs under T-Plex in the first half of 2024.

Fourth Quarter 2022 Financial Results

Revenue for the three months ended December 31, 2022, was $3.1 million, compared to $2.9 million for the three months ended December 31, 2021 (2021 Quarter). This increase is due to the timing of research activities related to our target discovery collaboration with Novartis (the "Novartis Agreement").

Research and development expenses for the three months ended December 31, 2022, were $15.6 million, compared to $12.6 million for the 2021 Quarter. The increase of $3.0 million was primarily driven by an increase in personnel expense, expansion of leased facilities, and preclinical activities to support solid tumors, and Phase 1 study start-up activities for TSC-100 and TSC-101.

General and administrative expenses for the three months ended December 31, 2022, were $6.1 million, compared to $4.4 million for the 2021 Quarter. The increase of $1.7 million in general and administrative expenses was primarily driven by increased personnel and facilities related costs to support the progress of the Company into the clinic.

For the three months ended December 31, 2022, TScan Therapeutics reported a net loss of $18.7 million, compared to a net loss of $14.2 million for the 2021 Quarter.

Full Year 2022 Financial Results

As of December 31, 2022, TScan Therapeutics had cash and cash equivalents of $120.0 million excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2024.

Revenue for the year ended December 31, 2022, was $13.5 million, compared to $10.1 million for the year ended December 31, 2021 (2021 Period). This increase is due to the timing of research activities related to the Novartis Agreement.

Research and development expenses for the year ended December 31, 2022, were $59.8 million, compared to $45.0 million for the 2021 Period. The increase of $14.8 million was primarily driven by an increase in personnel expense, expansion of leased facilities, preclinical activities to support solid tumors, and Phase 1 study start-up activities for TSC-100 and TSC-101.

General and administrative expenses for the year ended December 31, 2022, were $20.4 million, compared to $13.8 million for the 2021 Period. The increase of $6.5 million in general and administrative expenses was primarily driven by increased personnel and facilities related costs to support the progress of the company into the clinic

For the year ended December 31, 2022, TScan Therapeutics reported a net loss of $66.2 million, compared to a net loss of $48.6 million for the 2021 Period

As of December 31, 2022, the Company had issued and outstanding a combined total of 24,225,954 shares of voting common stock and non-voting common stock.