TScan Therapeutics, Inc. Common Stock H.C. Wainwright 4th Annual Cell Therapy Virtual Conference

Review the key takeaways and the transcript of this earnings call.

PeriodFY 0Duration27 minParticipants2

Key takeaways

Complete donor chimerism refers to the state in which patient cells are no longer detectable, indicating that the product is working effectively.
When patient cells are eliminated, the risk of relapse is reduced, and early achievement of complete donor chimerism has been identified as an important predictor of long-term benefit.
Both the Phase 1 study and external studies have shown that early achievement of donor chimerism is associated with reduced relapse risk.
Cohort A is a mature data set with more than 3 years of follow-up, showing a 3-year relapse-free survival of 100%, outperforming the control group.
Cohort C is a nascent data set produced using commercial manufacturing processes, and its early donor chimerism data are predictive of long-term benefit.
The main difference between Cohort A and Cohort C is the manufacturing process: Cohort C shortened the manufacturing time from 17 days to 12 days and reduced costs by using a drug-selection marker instead of magnetic beads.
Cohort C products demonstrate higher proliferative capacity and activation markers and are therefore evaluated as a superior product.
Although there were more MRD-positive patients in Cohort C, there have been no relapse cases to date, suggesting benefits for not only high-risk patients but all transplant recipients.
An important trial design feature is the use of biological allocation based on A0201 genotype; in consultation with the FDA, it was demonstrated that there is no difference in outcomes between the two groups.
The clinical trial focuses on AML and MDS patients and allows for various donor types and the use of maintenance therapies to align with real-world treatment settings.
The primary endpoint is relapse-free survival, and secondary endpoints include event-free survival and overall survival.
Sensitive chimerism analyses are being collected as exploratory endpoints to evaluate the potential use of chimerism as a surrogate endpoint in future studies.
The company has secured operating funds through the second half of 2027 and is targeting Phase 3 topline data by mid-2028.
Financing will be pursued through the capital markets and business development opportunities, and updates on Cohort C and new study data will be provided to investors on an ongoing basis.

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Transcript

Preview the first five paragraphs, organized by speaker.

Ashley VanderbeckAnalyst0:00

참여해 주신 모든 분들께 환영의 인사를 드립니다. 저는 애슐리 밴더벡이며, H.C. 웨인라이트에서 어소시에이트로 일하고 있습니다. 저와 함께한 분은 TScan Therapeutics의 CEO이자 이사회 멤버인 가빈 맥비스 박사님입니다. 가빈 님, 환영합니다. 함께 하게 되어 매우 기쁩니다.

Gavin MacBeathCEO0:20

감사합니다. 초대해 주셔서 감사합니다.

Ashley VanderbeckAnalyst0:24

아주 간단하고 기본적인 질문부터 시작해 보겠습니다. TScan에 익숙하지 않은 투자자분들을 위해 회사와 파이프라인 자산에 대해 간략히 소개해 주시면 정말 도움이 될 것 같습니다.

Gavin MacBeathCEO0:37

네, 감사합니다. TScan은 임상 단계의 완전 통합형 TCR T세포 치료제 회사입니다. 2018년에 설립되었으며, 그동안 암 치료를 위한 다양한 TCR 엔지니어드 T세포 치료제 파이프라인을 구축해 왔습니다. 저희의 주력 프로그램은 혈액암 분야에 있으며, 골수 이식을 받는 환자들을 대상으로 이식 후 잔존 질환을 표적으로 하여 재발을 방지하는 치료를 진행하고 있습니다. 이것이 가장 진전된 프로그램입니다. 약 3년간 진행해 온 1상 임상시험인 ALLOHA 연구를 운영하고 있습니다. 최근 FDA와 중대한 임상시험 설계에 합의했으며, 이번 달에 3상 시험을 시작할 예정입니다. 추가로 고형암 분야에도 프로그램이 있습니다.

Gavin MacBeathCEO1:26

여기서는 체내에서 직접 T세포를 엔지니어링하는 전략을 취하고 있으며, PRAME, MAGE-A4 등 다양한 암 특이 항원을 TCRT로 표적합니다. 이때 렌티바이러스 입자를 환자에게 직접 주입하여 체내에서 T세포를 조작합니다. 이 프로그램은 현재 중후기 전임상 개발 단계에 있으며, 내년 중반에 임상 진입을 목표로 하고 있습니다.

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