TScan Therapeutics Inc (TCRX)

[dinogreeves]

Sounds even better, now that you are in also. 7-8 is my first target, then 14-15, actually sooner that I thought, 3-4 months.

[dinogreeves]

Baker Brothers is going to take them for a nice ride.

[Awl416]

Gotta imagine huge intraday short percentage yesterday

[crazy horse 0]

Sounds good

Baker Brothers top institutional investors, they know where this is going in due time, just like they did with every biotech before them, just like MDG*L. 150 million in the bank already and huge back bone from Amgen and Baker Brothers.

[dinogreeves]

Baker Brothers top institutional investors, they know where this is going in due time, just like they did with every biotech before them, just like MDG*L. 150 million in the bank already and huge back bone from Amgen and Baker Brothers.

[dinogreeves]

Price targets 14-15 within the next 6-9 months. Take it for what it is worth, this is not even considering more data coming out mid year till fall.

[jondoeuk]

Not sure if these TIP presentations include any trial data.

It might contain preliminary safety and/or biomarker data. Interim clinical data for the program is expected by the end of the year, so maybe ASH.

An update on the Novartis collaboration would be appropriate, imo, since, if i am not mistaken, that was to end this past March 31/23.

I agree, but we might have to wait for a filing.

[jondoeuk]

Multi-year partnership with AMGN https://www.prnewswire.com/news-releases/amgen-and-tscan-therapeutics-announce-collaboration-to-identify-novel-targets-in-crohns-disease-301818552.html

Per the terms, TCRX will receive $30M upfront in addition to preclinical, clinical, regulatory, and commercial milestones worth over $500M and tiered single-digit royalties. "TScan's platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs," Raymond Deshaies, AMGN's SVP of Global Research, said.

[Capitalvaluetrade]

TCRX Excellent Move

[dinogreeves]

Baker Brothers, going to annihilate the shorts.

[surf1944]

https://stockcharts.com/h-sc/ui?s=TCRX&p=D&yr=0&mn=6&dy=0&id=p38090673899

https://www.barchart.com/stocks/quotes/TCRX/technical-chart?plot=CANDLE&volume=total&data=DO&density=ML&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;SMA(20);SMA(50);SMA(100);SMA(200);CHKMF(20)&sym=SYSX&grid=1&height=210&studyheight=100

https://www.barchart.com/stocks/quotes/TCRX/opinion

Open gap $2.25

[Invest-in-America]

TCRX: If this puppy doesn't Close today at circa $20+ per share, well, then it simply ain't a REAL Universe within which we all reside, my Fellow Amerikanoes. (Is it possible to have any BETTER news than what TCRX had today??)
https://www.marketwatch.com/story/tscan-therapeutics-stock-soars-after-amgen-collaboration-on-crohns-disease-treatment-that-could-bring-in-more-than-500-million-5ada4b

[Triple nickle]

Booomer

[Awl416]

Damn

[FACT-MASTER]

https://ca.finance.yahoo.com/news/tscan-therapeutics-announces-upcoming-trial-204200459.html

Not sure if these TIP presentations include any trial data.

An update on the Novartis collaboration would be appropriate, imo, since, if i am not mistaken, that was to end this past March 31/23.

[jondoeuk]

They plan to begin enrolling patients for screening by the middle of the year, with patient dosing expected to commence in Q3. Initial safety and biomarker data for the most advanced single-agent TCRs could be presented by the end of the year, with initial multiplex therapy data for the first combination of TCRs expected in the first half of 2024. Also, will test redosing and explore three-TCR combinations.

In addition, as the programs advance, they intend to introduce additional elements, including features designed to increase the infiltration of TCR-T cells into solid tumours, with the aim of keeping those cells active for a longer time and rendering them more impervious to different immunosuppressive tumour microenvironments.

[jondoeuk]

The solid tumour screening study is up https://www.clinicaltrials.gov/ct2/show/NCT05812027

[jondoeuk]

Upcoming TIP poster https://annualmeeting.asgct.org/program/agenda-details?agendaId=26372

[jondoeuk]

No reason given https://www.globenewswire.com/news-release/2023/03/31/2638587/0/en/TScan-Therapeutics-Announces-CEO-Transition.html

[jondoeuk]

The first patient has been dosed in its PhI umbrella trial. They were treated with TSC-101.

[FACT-MASTER]

Fourth Quarter 2022/Year end financials

https://www.globenewswire.com/news-release/2023/03/08/2622885/0/en/TScan-Therapeutics-Reports-Fourth-Quarter-and-Full-Year-2022-Financial-Results-and-Highlights-Upcoming-Milestones.html

[FACT-MASTER]

Last at $3.30 - nice close!!

on a blood red market day all over the place.

Thanks Jerome

[FACT-MASTER]

TCRX: February 2023 Corporate Presentation

https://ir.tscan.com/static-files/1d066354-1ed3-4f4f-b97b-28806d9da9f5

Current Phase 1 clinical trials TSC-100 and TSC-101

https://clinicaltrials.gov/ct2/show/NCT05473910

[glenn1919]

TCRX........................................https://stockcharts.com/h-sc/ui?s=TCRX&p=W&b=5&g=0&id=p86431144783

[harry crumb]

Hidden gem here that could run

[FACT-MASTER]

Pre-market volume/price ON FIRE!

Are you still here bro?

[FACT-MASTER]

TCRX: IND NEWS

https://ca.finance.yahoo.com/news/tscan-therapeutics-announces-fda-clearance-120000100.html

[FACT-MASTER]

Interesting development - Thermo Fisher

https://www.precisiononcologynews.com/sequencing/fda-approves-thermo-fisher-hla-typing-test-cdx-immunocore-uveal-melanoma-therapy#.Y5JifLg6BBE

" Dec 07, 2022 | staff reporter

NEW YORK – Thermo Fisher Scientific said on Wednesday that its SeCore CDx HLA Sequencing System was granted de novo classification by the US Food and Drug Administration as a companion diagnostic to Immunocore’s Kimmtrak (tebentafusp-tebn) therapy for uveal melanoma.

Kimmtrak is the only T-cell receptor therapy approved by the FDA for metastatic or unresectable uveal melanoma, a rare but deadly eye cancer, and is indicated for adults who are human leukocyte antigen (HLA)-A*02:01 positive. The marketing authorization makes the SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic, Thermo Fisher said.

“Clinicians can now use the SeCore CDx HLA Sequencing System to identify individuals who may benefit from this breakthrough immunotherapy,” Nicole Brockway, Thermo Fisher’s president of transplant diagnostics, said in a statement. “We look forward to continuing to partner with leading-edge companies to develop and commercialize immunotherapies that address unmet needs in a variety of disease areas.”

The interest from TMO bodes well for TCRX, imo. re:Tscan/Receptor scan/safetyscan etc

Both TMO and TCRX recently attended Evercore ISI HealthConx Conference this past November.

[FACT-MASTER]

Boston Globe Article - TCRX

https://flashalert.me/?symbol=TCRX&source=PR&referer=https://twitter.com/&url=https://www.globenewswire.com/news-release/2022/12/01/2565881/0/en/TScan-Therapeutics-Named-the-Highest-Placed-Midsize-Biotechnology-Company-in-The-Top-Places-to-Work-for-2022-by-The-Boston-Globe.html&s3=TCRX/2022-12-01/08-03-05_000000/glob/6615b141ea2585b5106240ded6167463/TScan-Therapeutics-Named-the-Highest-Placed-Midsize-Biotechnology-Company-in-The-Top-Places-to-Work-for-2022-by-The-Boston-Globe.html

https://news.beeken.io/news-preview?utm_content=newsfeed-Healthcare-TCRX&content=U2FsdGVkX19ZXXYJs7m%2Fupohdh5oJ0uXewj8BZkuLLwyhsIlY6mRHMb13o5JUKk2FpeyrVY7%2BFdDuKOrds7dYYy%2B8ufp%2Btv6FcdPCtcOneQyAo5ox5tVz7rINho02loQ0nlcJI6HuHRoMOvwosGZeNGZ3sOnr7dg7EJqkJC012i2UtNcOljQCYpqb1cQr4wodawTUp05iQKJQVgAS3syKPKjFCUf2WZzRyvtl%2BDXf9HDdvlYUPo%2BX3EhTuMQlmLF2W5tkMwEo%2Fdt7GUH3upBgilTNWYYxq%2BQU%2FGpjfkcwYODGC%2Fg2HPWRBvdtl19R7IsqNifdy69%2B%2FMhfg67h%2F6lPkJBh1KEGg9WOdXxPWb%2FjWMwm2kV29ufi9Evo62mH%2FvHNlTwaEIHaVH%2FIlLgup4wAzDS%2BiztUDyLiFrqOhlYUb3pyLWot4W1CC3n9aiyEdd4xkxmJ%2BvKRkf1TRx6DvO0c8ngNaVGCfiTLg912vCrJC1caocFSwI5CmbOHeDFl%2FyFHp7Nux2K%2Fs1uub3bqs2lkrqCIDen5dhkC6AOAq8RJDxm2nSSMnY3OoiTCbWkGOWdZKqH5jV7LhTfm8yqUDjiLrot7sCDbzCDP8cjT5g3Bu7yAIKW8UF7MKcI%2BKfmC0t7Hy%2BeR9GiQdOz6dmjRsP9iib7MSTCfb4keMAOoSZSTc878glPgB%2BlxdBJ1LtA3ZxDkgtdB8i5nbX09uFzABPp3SSWWnzc%2FzBqQ8ZpnPPHKk0NA82rgDRL2U3WaXIhxto5TPgfryDpC1xE6Lfg9xeqaCh3a0DdNYYhtqMJpbXRzvJMIJZZ7BapyS850JaM2TUoRYpdqLLb2IllabP3Z5xcuKo7NNYfQk%2FnwpcdyDp6dLqEhWBF2Idu7nqMsAweYpMK1VMzfMe7bfWhpUTdeTaHySKgPoHBp2ZlLplybXzP99itA8ediO2rpA20n1ZbJZpp%2BfkXXcpxpr2B6rzuFZGCTkn6jTAAkT%2FdWRK7oED2GbnItYWd6uMPGvrJUfKJIrkt6nbXw8v2xqh70xO6GgDMY913qhCdNS4MraublJHbvxYWhpQ7BPlF2drzly1A0WbxAa9SysHYP%2BmvyZ4I6MW0J%2F%2BULqKY81sO9RA0HNt%2FYLtwFg%2FOx0MlwLNGtd%2BfYH5byrvpmeFYmOnHYb1TreLnfdNtgO3K3w4cOBTcPVH28MBudwnTUvVa9YXKxYI12va1lY6Y8kDoXEl6r0FNvNsI%2BgNB6EvJ0nDwpmlB1kz8Diy4lN0BMO7wsRoPUhsubnKOGQVjUXObStnG2GEeWxNqyyDKnCqQRzeu1vX9LuJM7SLMLyc9jcYlbn4EVjBIFJgMo70mEhOrHKMUgyU4mMQwrITQw7oyToGW1iDt%2BFcECYjNO%2FaKH87shfh4BoG2x%2FBaiiaXTbPBCIoQs9GaP%2Fpc%2FwGZl99lvfq5uf8ppHHskeN9462ZK%2FVus86SYwNQjJXFncQCpG6ryF54T0XgiTRk9er%2BYQtnSydO%2FQq6iPD69BLlYs0BVrcAqPzLBv1ewNF9doCZAL3yTtMq4FD3WcvtM%2FJ4Ms6gebXlKvN5jk34EpVdWaC1GOwIUWOIRK1E%2BRmXmqNqmvsoD5eQM06iNPcaVMiyRuhnfe3BnQtbXsCJLYNucTCz21Y444r8EakSxBBNJzo3IjjNLV4eNPvY4HMoZC67WBtOZM8h7zBTHvOphdRp6k8374ArHSn42W7rAHWDoeA0khcqeGcj9Ig5vlrODGLl0i9I%2BXZ1%2F7ZK8kuNUeAVtV9vnacAMTsjXd139uXzQMSAMOwagLaleZ21aPHeRgLmbaBwuLgfMKiMzRDucF%2F%2FqO7coWUoCuJPLTtI4WWe&utm_source=dlvr.it&utm_medium=twitter

[FACT-MASTER]

TScan presenting at 5th Annual Evercore ISI HealthCONx Conference:

https://www.biospace.com/article/releases/tscan-therapeutics-to-participate-in-the-5th-annual-evercore-isi-healthconx-conference/

"

Published: Nov 22, 2022

WALTHAM, Mass., Nov. 22, 2022 (GLOBE NEWSWIRE) -- 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, today announced that management will participate in a virtual fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on Tuesday, November 29, 2022 at 10:55 a.m. ET.

A webcast of the fireside chat will be available on the “Events and Presentations” section of the Company’s website at ir.tscan.com. An archived replay of the webcast will be available on the Company’s website for 90 days following the event."

[FACT-MASTER]

TCRX top 5 Institutional Holdings

OWNER NAME / DATE / SHARES HELD

BAKER BROS. ADVISORS LP 09/30/2022 2,784,792
BLACKROCK INC. 09/30/2022 1,513,815
DEER MANAGEMENT CO. LLC 09/30/2022 1,245,505
ALPHABET INC. 09/30/2022 1,077,080
DC FUNDS, LP 09/30/2022 630,000


https://www.nasdaq.com/market-activity/stocks/tcrx/institutional-holdings

[FACT-MASTER]

TScan's multiplexed TCR-T targeting both Mage and Prame simultaneously appears well thought out / researched. ( Nice presentations and slides).

Targeting the heterogeneity aspects ( for me i think of that as cancer dark matter) means thinking ahead to the mutations and stopping the cancer metastasis.

BMS is in deep over at IMTX, if i recall correctly Novartis deal with TCRX expires soon, if results come in decent i could see BMS interested here, imo.

TCRX is hard to read stock wise, undervalued imo, results at ASH might attract more respect.

TCRX management - upper echelon, imo.

[jondoeuk]

Slides https://ir.tscan.com/static-files/e37317c4-d6a7-48c3-9071-c11d7cfd222c

[jondoeuk]

Posters

https://www.tscan.com/wp-content/uploads/2022/11/2022-SITC-poster-multiplexing.pdf

https://www.tscan.com/wp-content/uploads/2022/11/2022-SITC-poster-PRAME.pdf

[FACT-MASTER]

The ASH sure knows how to pick the place for an expo in December.

New Orleans - sweet

https://www.hematology.org/meetings/annual-meeting

[FACT-MASTER]

Study NCT05473910: link below

https://clinicaltrials.gov/ct2/show/NCT05473910?term=TScan&draw=2&rank=

excerpt:

"The primary endpoints are: (1) incidence of dose-limiting toxicities (DLTs), and (2) incidence of adverse events (AEs) and serious AEs (SAEs) of TSC-100 and TSC-101 combined with the standard of care (SOC) compared with the SOC alone at 2 years of follow-up. The study will also investigate the efficacy of TSC-100 and TSC-101 combined with the SOC compared with that of the SOC alone to treat the study population and assess the immunogenicity of TSC-100 and TSC-101."

Theoretically, successful involvement of TSC-100 and TSC-101 in SOC would truly be a breakthrough. Monumental potential, if results warrant inclusion in SOC.

[FACT-MASTER]

From previous post:

"The Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 is open for enrollment, and the Company will provide a progress update at the 64th American Society of Hematology (ASH) Annual Meeting:"

https://ash.confex.com/ash/2022/webprogram/Paper167707.html

3325 Trial in Progress: A Phase 1 Umbrella Study of TCR-Engineered T Cells That Target HA-1 (TSC-100) and HA-2 (TSC-101) to Treat Residual Leukemia after Hematopoietic Cell Transplantation
Program: Oral and Poster Abstracts
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Hematology Disease Topics & Pathways:
Research, clinical trials, Biological therapies, Translational Research, Clinical Research, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Therapies, Immunotherapy
Sunday, December 11, 2022, 6:00 PM-8:00 PM

Ran Reshef, MD1*, Hyung C. Suh, MD, PhD2*, Monzr M. Al Malki, MD3, Aasiya Matin, MD4*, Ashish S Kothari, MD, MS5, Allison Bell, PharmD6*, Antoine J Boudot, Ph.D.7*, Yun Wang, PhD7*, Nina Abelowitz, NP7*, James Murray7*, Gavin Macbeath, PhD7*, Debora Barton, MD7* and Shrikanta Chattopadhyay, MD7

1Columbia University Medical Center, New York, NY
2John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ
3Department of Hematology/HCT, City of Hope, Duarte, CA
4Department of Oncology, Blood and Marrow Stem Cell Transplant Program, Karmanos Cancer Institute/Wayne State University, Detroit, MI
5Clinical Development, CareDx, Inc., Brisbane, CA
6CareDx, Inc., Brisbane, CA
7TScan Therapeutics, Waltham, MA
Background:

Engineered T cell therapies targeting the lineage-specific antigens CD19 (B cells) or BCMA (plasma cells) are highly effective in patients with lymphoid malignancies and feasible because depleting normal B cells or plasma cells can be tolerated by patients. Targeting lineage antigens in myeloid malignancies is not feasible, however, since depleting normal myeloid cells like neutrophils would lead to serious complications such as febrile neutropenia. To address myeloid malignancies with T cell therapies, one solution is to target antigens that are expressed on the hematopoietic cells of patients undergoing allogeneic hematopoietic cell transplantation (HCT), but not expressed on their donor’s cells. Hematopoietic lineage-specific minor histocompatibility antigens (MiHAs) can be targeted by T cell receptors (TCRs), but not chimeric antigen receptors, because they most frequently represent single-amino acid changes in intracellular proteins that are presented on the cell surface by human leukocyte antigen (HLA) binding. TScan has developed the engineered T cell products TSC-100 and TSC-101 that express TCRs targeting MiHAs HA-1 and HA-2 respectively, both presented by HLA-A*02:01. By choosing HCT patients who are HA-1 or HA-2 positive and donors who are mismatched on either the MiHA or HLA-A*02:01, TSC-100 and TSC-101 can eliminate all recipient hematopoietic cells while leaving donor hematopoietic cells untouched. These products are being developed in patients with AML, ALL and MDS undergoing HCT to eliminate any residual hematopoietic cells after HCT and prevent disease relapse that affect ~40% of patients. We describe the clinical trial design and translational assays to generate early evidence of biological activity. Preliminary clinical safety and translational data will be presented.

Study Design and Methods:

Study NCT05473910 is a multi-center, multi-arm, non-randomized controlled Phase 1 umbrella study evaluating the feasibility, safety and preliminary efficacy of TSC-100 and TSC-101. Key inclusion criteria include adult patients with AML, MDS or ALL who are eligible for reduced intensity conditioning (RIC)-based haploidentical donor transplantation. HLA-A*02:01-positive patients are assigned to the treatment arms, undergo HA-1/ HA-2 testing and receive either TSC-100 or TSC-101 in addition to standard HCT. HLA-A*02:01-negative patients are assigned to the control arm and receive standard HCT alone. Donors in treatment arms undergo two rounds of leukapheresis, one to manufacture TSC-100/101 and one after mobilization to collect stem cells. Patients undergo RIC, peripheral blood stem cell infusion followed by post-transplant cyclophosphamide. Upon count recovery, patients begin treatment with TSC-100 or TSC-101. In Dose Level 1, patients receive a single dose of 5x106 cells/kg. In Dose Level 2, patients receive two doses of 5x106 cells/kg given 40 days apart. In Dose Level 3, patients receive one dose of 5x106 cells/kg and a second dose of 2x107 cells/kg given 40 days later. Primary endpoints include adverse event profiles of TSC-100/ 101 and dose limiting toxicities. Secondary endpoints measure efficacy including relapse rates, disease-free survival and overall survival. Exploratory endpoints include persistence of TSC-100/ TSC-101, surrogates of efficacy including minimal residual disease (MRD) rates before/ after transplantation, donor chimerism kinetics and rates post-transplantation and markers of T cell activation on TSC-100/ 101.

Novel translational assays have been developed for the exploratory endpoints. TSC-100/ 101 persistence is measured by flow cytometry with lower limit of quantification <0.1% of total T cells. MRD is measured by flow cytometry and next-generation sequencing (NGS) the combination of which detects MRD with greater sensitivity than either assay alone. Donor chimerism is measured by standard STR-based assays with a limit of detection of 1-2% and a novel NGS-based assay called Alloheme with a limit of detection of 0.04%. T-cell activation markers on TSC-100/ 101 are measured by flow cytometry, cytokine profiling and single-cell RNA sequencing. Together these translational assays measure elimination of the target hematopoietic cell population, malignant or normal, and provide evidence of potential biological activity well before frank clinical relapses occur.

[FACT-MASTER]

Excellent update here:

https://www.abc4.com/business/press-releases/globenewswire/8692169/tscan-therapeutics-reports-third-quarter-2022-financial-results-and-provides-business-update/

WALTHAM, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- 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, today reported financial results and provided a business update for the third quarter ended September 30, 2022.

“We continued to make meaningful progress across the entirety of our pipeline during the third quarter and look forward to providing an update on our Phase 1 clinical trial by the end of this year. We plan to commence clinical development for the solid tumor program with multiple TCRs next year,” said David P. Southwell, President and Chief Executive Officer. “On the financing side, we are pleased to have secured a debt facility for up to $60 million with K2 HealthVentures during the third quarter. The initial $30 million that we drew at the close provides TScan with a cash runway into the second quarter of 2024.”

Debora Barton, M.D., Chief Medical Officer added: “Based on recent FDA interactions, we have a clear path to file INDs for multiple solid tumor TCRs and to conduct a Phase 1 umbrella trial which will enable us to bring our ImmunoBank of highly selective TCRs to patients. We look forward to sharing further details on our solid tumor program development plans during a virtual event later this month.”

Recent Corporate Highlights

During the quarter TScan announced the closing of a convertible debt facility for up to $60 million with K2 HealthVentures (K2HV). The initial $30 million provided at close, in addition to the current cash on hand, extends the Company’s cash runway into the second quarter of 2024. The Company has the option to draw the remaining tranches subject to certain conditions and by mutual agreement of TScan and K2HV to further support development of additional programs and/or business development.

TScan will present two posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting:

Multiplexed TCR-T cell therapy targeting MAGE-A1 and PRAME enhances the activity of adoptive T cell therapy in pre-clinical models; Thursday, November 10, 2022, from 9:00am-9:00pm ET, Exhibition Hall C

Discovery of TSC-203-A02: A PRAME-specific TCR-T cell therapy candidate for the treatment of solid tumors; Friday, November 11, 2022, from 9:00am-8:30pm ET, Exhibition Hall C

TScan has successfully completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plans for its solid tumor program. The FDA has provided feedback to TScan regarding T-Plex, its customized TCR-T cell product mixture, a collection of two to three TCRs selected from the ImmunoBank based on a patient’s tumor antigen positivity and HLA expression.

The Company is hosting a virtual investor event Monday, November 14, 2022, at 5:00 p.m. ET to provide an in-depth review of the poster presentations at the SITC Annual Meeting related to solid tumor TCR-T candidates, clinical development plans, and TScan’s approach to multiplexed therapy as a way to potentially overcome antigen heterogeneity and HLA loss. Registration for the live event can be found here. A replay will be available on the “Events and Presentations” section of the Company’s website at ir.tscan.com.

Anticipated Near-Term and Upcoming Catalysts

Hematologic Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, to prevent relapse in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS) patients undergoing allogeneic haploidentical hematopoietic cell transplantation (HCT) with reduced intensity conditioning (RIC). Up to 40% of patients who receive HCT with RIC relapse within two years after the transplant, at which point there are limited treatment options and poor prognosis. The longer-term objective is to enable more patients to maintain prolonged remission after HCT using RIC, a more tolerable chemotherapy than the myeloablative conditioning, followed by TScan’s TCR-T.

The Phase 1 umbrella trial (NCT05473910) for TSC-100 and TSC-101 is open for enrollment, and the Company will provide a progress update at the 64th American Society of Hematology (ASH) Annual Meeting:

Trial in Progress: A Phase 1 Umbrella Study of TCR-Engineered T Cells That Target HA-1 (TSC-100) and HA-2 (TSC-101) to Treat Residual Leukemia After Hematopoietic Cell Transplantation; Sunday, December 11, 2022, from 6:00-8:00pm CT, Ernest N. Morial Convention Center, Hall D

The Company expects to enroll the first two cohorts in this trial in the first half of 2023 and plans to report interim data for this study by the end of 2023.

Solid Tumor Programs: TScan’s TCR-T therapy candidates for solid tumors include a combination of validated targets, such as MAGE-A1 (TSC-204), HPV16 E7 (TSC-200), and PRAME (TSC-203), as well as novel targets for TCR-T therapy, such as those for TSC-201 and TSC-202. To address resistance that can arise from HLA loss and to provide therapeutic options for a diverse patient population, TScan is also developing TCRs for multiple HLAs across all of its targets.

The Company plans to progress IND-enabling studies for its solid tumor programs and submit IND applications for two MAGE-A1 TCRs (TSC-204-A2 and TSC-204-C7) by the end of 2022.

The Company plans to file INDs for HPV (TSC-200-A2) and PRAME (TSC-203-A2) in the first half of 2023 with two additional INDs to be filed by the end of 2023. The Company expects to release preliminary clinical safety data for the most advanced TCRs by the end of 2023.

Third Quarter 2022 Financial Results

As of September 30, 2022, TScan Therapeutics had cash and cash equivalents of $137.3 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 third quarter ended September 30, 2022, was $3.4 million, compared to $2.4 million for the third quarter ended September 30, 2021 (2021 Quarter). This increase is due to research activities related to TScan’s collaboration agreement with Novartis Institutes for Biomedical Research, which commenced in September 2020.

Research and development expenses for the third quarter ended September 30, 2022, were $15.0 million, compared to $14.2 million for the 2021 Quarter. The increase of $0.8 million was primarily driven by increased personnel expense and an increase in clinical study expenses as the Company advances its trials, partially offset by a decrease in preclinical expenses as the Company shifts its focus towards clinical development.

General and administrative expenses for the third quarter ended September 30, 2022, were $4.9 million, compared to $4.0 million for the 2021 Quarter. The increase of $0.9 million in general and administrative expenses was primarily driven by an increase in personnel expense related to growth to support the business.

For the third quarter ended September 30, 2022, TScan Therapeutics reported a net loss of $16.2 million, compared to a net loss of $15.8 million for the 2021 Quarter.

As of September 30, 2022, the Company had issued and outstanding shares of 24,074,927.

[FACT-MASTER]

"We plan to seek a Breakthrough Therapy designation for our current
or future product candidates and may seek Breakthrough Therapy
designation for some or all of our future product candidates. A
breakthrough therapy is defined as a drug or biologic that is
intended, alone or in combination with one or more other drugs or
biologics, to treat a serious or life-threatening disease or
condition and preliminary clinical evidence indicates that the
drug, or biologic, may demonstrate substantial improvement over
existing therapies on one or more clinically significant endpoints,
such as substantial treatment effects observed early in clinical
development. For product candidates that have been designated as
breakthrough therapies, interaction and communication between the
FDA and the sponsor of the trial can help to identify the most
efficient path for clinical development while minimizing the number
of patients placed in ineffective control regimens. Biologics
designated as breakthrough therapies by the FDA may also be
eligible for other expedited approval programs, including
Accelerated Approval.




Designation as a breakthrough therapy is within the discretion of
the FDA. Accordingly, even if we believe one of our product
candidates meets the criteria for designation as a breakthrough
therapy, the FDA may disagree and instead determine not to make
such designation. In any event, the receipt of a Breakthrough
Therapy designation for a product candidate may not result in a
faster development process,review or licensure compared to candidate products considered for
licensure under non-expedited FDA review procedures and does not
assure ultimate approval by the FDA. In addition, even if one or
more of our product candidates qualify as breakthrough therapies,
the FDA may later decide that the product no longer meets the
conditions for qualification. Thus, even though we intend to seek
Breakthrough Therapy designation for some or all of our current or
future product candidates for the treatment of various cancers,
there can be no assurance that we will receive breakthrough therapy
designation."

https://ih.advfn.com/stock-market/NASDAQ/tscan-therapeutics-TCRX/stock-news/89506739/quarterly-report-10-q

[jondoeuk]

The company will hold an investor event on Nov 14, at 5:00 PM ET https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MjExOA==

[jondoeuk]

ASH abstract

3325 Trial in Progress: A Phase 1 Umbrella Study of TCR-Engineered T Cells That Target HA-1 (TSC-100) and HA-2 (TSC-101) to Treat Residual Leukemia after Hematopoietic Cell Transplantation https://ash.confex.com/ash/2022/webprogram/Paper167707.html

[jondoeuk]

SITC titles

Multiplexed TCR-T cell therapy targeting MAGEA1 and PRAME to enhance TCR-T therapeutic efficacy

Discovery of TSC-203-A02: A PRAME-specific TCR-T cell therapy candidate for the treatment of solid tumors

[jondoeuk]

The company knows that targeting a single antigen isn't going to be sufficient to eliminate all cancer cells, as it allows any lacking it to escape. Also, targeting a single HLA allele, such as HLA-A*02, could result in loss through commonly observed loss of heterozygosity (HLA LOH) mechanisms. So they have developed a screening strategy to select patients and TCRs, which is designed to prevent resistance arising from either antigen loss and/or HLA LOH.

They will select two different TCRs that target intact antigens and HLA alleles, which should result in deeper and more durable responses over the current TCR-T cell therapies. Now they are designing trials to test this hypothesis clinically.

Long-term, the vision is to expand ImmunoBank, analyse the tumour for each patient to determine which antigens are expressed at high levels, and select up to three TCRs.

As for predicting responses to current SOC, the same team published a previous study, in which they developed machine learning that could predict responses to chemotherapy in patients with gastric or bladder cancer. A new study has shown that artificial intelligence using the interactions between genes in a biological network could successfully predict the patient response to not only chemotherapy, but also immunotherapy in multiple types https://www.nature.com/articles/s41467-022-31535-6

[FACT-MASTER]

Nice update here on TCRX from Simply Wall St.

https://ca.finance.yahoo.com/news/forecasts-heres-analysts-think-future-100835524.html

[FACT-MASTER]

TScan Therapeutics to Participate in the 13th Annual Wedbush PacGrow Healthcare Conference

https://newsfilter.io/a/207b8d5e0a18b5443beede0ec457308c

[FACT-MASTER]

Target/Receptor scan as a more accurate biomarker for cancer/other diseases diagnosis.

Not 100% sure if i'm on the right train of thought.

[FACT-MASTER]

Impressive roster of presenters - good company to be networking with.

I sense your knowledge of biotechnology is far above my self researching / logical investigative analysis.

Here's a question i have that perhaps you may have insight on.

Could TScan's TargetScan and ReceptorScan be potentially used, as a standard of care procedure, to first determine what antigens the patient's cancer has? Wouldn't this provide insight into what treatment the patient would be most suitable for?

I ask this because of certain processes i have seen individuals go through, only to pass away.

Here's an example: patient is diagnosed with metastasized cancer and is prescribed chemo+Keytruda. 4 months later it is determined that nothing is working, Keytruda had no benefit ( no receptor/antigen match, imo) chemo weakens patient/cancer gains strength/patient dies.

TScan's Target/Receptor scan approach to cancer treatment makes logical sense, imo.

I'm not exactly sure on the standard of care procedures for cancer that are already in place, however if TScan's Target/Receptor Scan were to become standard of care procedure, this would certainly be an incredibly vital asset for TCRX.

[jondoeuk]

The TSC-100/101 trial is now listed https://www.clinicaltrials.gov/ct2/show/NCT05473910

[jondoeuk]

Dr. Wang will present at this https://www.genscript.com/gene-cell-engineering-virtual-summit.html

I've registered so will try and post the video (if it becomes available).

[FACT-MASTER]

Publication - peer reviewed article TCRX

https://www.stocktitan.net/news/TCRX/t-scan-therapeutics-announces-publication-in-cell-highlighting-the-le4i74bn6zkm.html