TScan Therapeutics Inc (TCRX)

[FACT-MASTER]

TCRX: Renting additional square footage beginning in the 4th quarter/24

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001783328/000119312524249124/d891090d8k.htm


Item?1.01
Entry into a Material Definitive Agreement

Effective October 28, 2024, TScan Therapeutics, Inc. (the “Company”) entered into a second amendment (the “Second Amendment”) to its existing lease with PPF OFF 828-830 Winter Street LLC (the “Landlord”), dated August 13, 2019, as amended by the first amendment thereto dated November 8, 2023 (as amended the “Existing Lease”), with respect to 25,472 rentable square feet of space (the “Existing Premises”) in certain premises located at 830 Winter Street, Waltham, Massachusetts.

Under the terms of the Second Amendment, the Company has agreed to lease approximately an additional 25,628 rentable square feet of space (the “Expansion Premises”) in the premises located at 830 Winter Street, Waltham, Massachusetts to support its operations, for a term commencing in the fourth quarter 2024 to October 31, 2029, subject to any permitted renewal pursuant to the Existing Lease. The Company will be obligated to pay the Landlord an additional base rent for the Expansion Premises at the monthly rate of $163,378.50, commencing two months after the start of the term for the Expansion Premises, for the first 12-month period, $168,279.86 for the second 12-month period, $173,328.25 for the third 12-month period, $178,528.10 for the fourth 12-month period, and $183,883.94 for the final 12-month period, which may be prorated for any partial year, in addition to the base rent for the Existing Premises as set forth in the Existing Lease.

Under the terms of the Second Amendment, the Landlord has agreed to provide to the Company a tenant improvement allowance of up to approximately $2,681,540.

The forgoing summary of the material terms of the Second Amendment is qualified in its entirety by reference to the complete text of the Second Amendment, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

[FACT-MASTER]

Buy rating issued from Barclay's Oct.29/14

https://www.tipranks.com/news/blurbs/tscan-therapeutics-tcrx-gets-a-buy-from-barclays

[FACT-MASTER]

TCRX: Blackrock increased their TCRX holdings in the 3rd quarter to 4,633,276 shares from 4,462,352 reported as of June 30/24

https://www.sec.gov/Archives/edgar/data/1783328/000201238324000954/us89854m1018_102124.txt

Position as of June 30/24

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

[Monksdream]

TCRX under $6

[FACT-MASTER]

TCRX: TScan Therapeutics Announces Upcoming Presentations at the Society for Immunotherapy of Cancer 39th Annual Meeting

https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-announces-upcoming-presentations-society

[Monksdream]

TCRX under $7

[FACT-MASTER]

TCRX: TScan Therapeutics to Participate in Upcoming Investor Conferences

TScan Therapeutics, Inc.
WALTHAM, Mass., Aug. 29, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology 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 Company will participate in the following upcoming investor conferences:

Morgan Stanley 22nd Annual Global Healthcare Conference; the fireside chat will be held at the New York Marriott Marquis on Thursday, September 5, 2024 at 8:30 a.m. ET


H.C. Wainwright 26th Annual Global Investment Conference; the presentation will be held at the Lotte New York Palace Hotel on Tuesday, September 10, 2024 at 9:00 a.m. ET

Webcasts of the fireside chat and presentation will be available on the “Events and Presentations” section of the Company’s website at ir.tscan.com. An archived replay of the webcasts will be available on the Company’s website for 90 days following the events.

About TScan Therapeutics, Inc.

TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy 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 ALLOHA Phase 1 heme trial). The Company is also developing TCR-T therapy 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 TCR-T therapies for patients with a variety of cancers.

Contacts

Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
[e-mail]

Maghan Meyers
Argot Partners
212-600-1902
[e-mail]

[FACT-MASTER]

TCRX: Article of interest

https://beyondspx.com/2024/08/02/tscan-therapeutics-inc-nasdaqtcrx-a-promising-biotech-tackling-cancer-with-innovative-tcr-t-therapies/

[Monksdream]

TCRX under $8

[Monksdream]

TCRX under $10

[FACT-MASTER]

TCRX: TScan Therapeutics Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for its Two Lead TCR-T Therapy Candidates for the Treatment of Heme Malignancies

https://finance.yahoo.com/news/tscan-therapeutics-receives-fda-regenerative-110000336.html

TScan Therapeutics, Inc.
RMAT designation granted for both TSC-100 and TSC-101 for the treatment of patients with AML, ALL, and MDS undergoing allogeneic HCT with reduced intensity conditioning

WALTHAM, Mass, May 29, 2024 (GLOBE NEWSWIRE) -- 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 U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TSC-100 and TSC-101, the Company’s two lead TCR-T therapy candidates for the treatment of heme malignancies (NCT05473910).

“We are delighted to receive FDA RMAT designation for both candidates in our heme program designed to treat patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning, based on encouraging initial data from the ALLOHA trial,” said Chrystal U. Louis, M.D., Chief Medical Officer. “This is an important milestone that recognizes the transformative potential of our engineered TCR-T therapy candidates, TSC-100 and TSC-101, in multiple difficult-to-treat cancers. We look forward to working closely with the FDA in our ongoing commitment to deliver life-changing therapies to patients.”

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including gene and cell therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such a disease or condition. Like Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of an Investigational New Drug (IND) application, and other opportunities to expedite development and review.

TScan has developed two lead TCR-T therapy candidates, TSC-100 and TSC-101, that target minor histocompatibility antigens HA-1 and HA-2, respectively. TScan is prospectively selecting HLA A*02:01-positive transplant patients who are either HA-1- or HA-2-positive, with donors who are negative for these antigens. In this context, TSC-100 and TSC-101 are designed to eliminate all recipient hematopoietic cells, including malignant, pre-malignant or normal cells, that persist post-transplant, while leaving donor-derived cells unaffected. Approximately 40% of patients with AML, ALL, and MDS who undergo allogeneic haploidentical HCT with reduced intensity conditioning relapse within two years of transplant, at which point there are limited treatment options and poor prognosis. The goal of this program is to increase the cure-rate for patients receiving HCT.

On May 13, 2024, the Company provided an update on its Phase 1 heme malignancies program. The update included additional follow-up on all eight treatment-arm patients as well as data on two additional control-arm patients. With a median follow-up of >10 months, all eight patients treated with TSC-100 or TSC-101 remain relapse-free with no detectable disease. No dose-limiting toxicities were observed. In contrast, two of eight control-arm patients relapsed approximately six months post-transplant and one of these patients died approximately three months later. A third control-arm patient required clinical intervention because of concerns of impending relapse, and a fourth control-arm patient died post-transplant.

[Monksdream]

TCRX under $10

[FACT-MASTER]

TCRX: TScan Therapeutics (NASDAQ:TCRX) Earns Buy Rating from Analysts at BTIG Research

https://www.americanbankingnews.com/2024/05/19/tscan-therapeutics-nasdaqtcrx-earns-buy-rating-from-analysts-at-btig-research.html

[FACT-MASTER]

TCRX: May/24 Company Presentation - MUST READ

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

Slide 13, notice the word "cure" (amazing, imo)
Slide 17,18 - amazing data
Slide 21 - mrd negativity
Slide 22 - PRICELESS
Solid Tumour Program - Tscan

Thank you

[FACT-MASTER]

TCRX: Abstract # 798

https://ir.tscan.com/static-files/90ee000a-09ec-4ab5-8edf-f4688e7b63b4

[FACT-MASTER]

Interesting FDA approval for Amgen today - Bispecific T-cell Engager

https://finance.yahoo.com/news/fda-approves-imdelltra-tarlatamab-dlle-224500427.html

Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor

IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study

Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT

THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9246451-fda-approves-imdelltra-tarlatamab-dlle-the-first-and-only-t-cell-engager-therapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer/

"The FDA's approval of IMDELLTRA marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE®) molecule. IMDELLTRA offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."

"Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years," said David P. Carbone, M.D., Ph.D., professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center.1 "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."

IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient's own T cells to attack DLL3-expressing tumor cells.2

"After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available," said Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer. "Today's FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease."

The FDA accelerated approval of IMDELLTRA is based on results from the Phase 2 DeLLphi-301 clinical trial that evaluated IMDELLTRA in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. Results from the study found that IMDELLTRA at the 10 mg Q2W dose (N=99) demonstrated a robust objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.3

The IMDELLTRA label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. The most common (> 20%) adverse reactions reported among patients were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%), and nausea (22%). Permanent discontinuations due to treatment-emergent adverse events (TEAEs) were infrequent (7%). CRS was largely confined to the first and second dose, predominantly grade 1 or 2, and was generally managed with supportive care. Details of the Important Safety Information are included below.

Amgen's Commitment to Patient Support
Amgen is committed to supporting patients with ES-SCLC and to helping ensure appropriate patients with access to IMDELLTRA. Patients, caregivers, and physicians who need support, tools, or resources can contact Amgen® SupportPlus. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including for uninsured or under-insured patients through the Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by Amgen that helps qualifying patients access Amgen medicines at no cost.

Amgen to Webcast Investor Call on IMDELLTRA FDA Approval
Amgen will host a webcast call for the investment community on Monday, May 20, 2024 at 1:00 p.m. PT (4:00 p.m. ET). Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen, Murdo Gordon, executive vice president of Global Commercial Operations, and other members of the Amgen team will participate.

Live audio of the investor call will be simultaneously broadcast over the internet and will be available to members of the news media, investors, and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability, and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

About IMDELLTRA™ (tarlatamab-dlle)
IIMDELLTRA is a first-in-class immunotherapy engineered by Amgen researchers that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.2,4 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.3,5

IMDELLTRA™ (tarlatamab-dlle) U.S. Indication
IMDELLTRA™ (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

[FACT-MASTER]

TCRX: Institutional holders as of March 31/24

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

[FACT-MASTER]

TCRX: Tscan reports Q1/24

https://www.sec.gov/ix?doc=/Archives/edgar/data/1783328/000095017024058198/tcrx-20240331.htm

[FACT-MASTER]

TCRX: TScan Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating TCR-T Therapy for the Treatment of Solid Tumors

https://finance.yahoo.com/news/tscan-therapeutics-announces-first-patient-110000594.html

TScan Therapeutics, Inc.
Patient dosed with TSC-203-A0201 targeting cancer-associated antigen PRAME

On-track to report initial data from the solid tumor clinical trial in 2024

WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- 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.

[FACT-MASTER]

TP53 articles of interest:


https://www.genecards.org/cgi-bin/carddisp.pl?gene=TP53

https://www.nature.com/articles/s41588-023-01480-1

https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(23)00028-5/abstract

[FACT-MASTER]

TCRX: April / 24 Company Presentation - a MUST READ

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

SLIDE 22 = PRICELESS

[FACT-MASTER]

Wish i had time to attend ASCO and listen in, this could be very interesting, (and seems early for results, imo)

Initial data from a phase 1, first-in-human clinical trial for T-Plex, a multiplexed, enhanced T cell receptor-engineered T cell therapy (TCR-T) for solid tumors https://meetings.asco.org/abstracts-presentations/233898

Given the initial results data from the TSC-100 / TSC-101, the above data, if similar imo, .. would be a major breakthrough.

Was just reviewing the paper you referenced on TScan II :

https://www.cell.com/cell/fulltext/S0092-8674(23)01175-3

[FACT-MASTER]

Thank you for that clarification.

I'm sensing ( but could be wrong) that these presentations could be related to TScan II / cytokinin pathways.

[jondoeuk]

Upcoming at ASCO https://finance.yahoo.com/news/tscan-therapeutics-announces-upcoming-presentations-200500617.html

Initial data from a phase 1, first-in-human clinical trial for T-Plex, a multiplexed, enhanced T cell receptor-engineered T cell therapy (TCR-T) for solid tumors https://meetings.asco.org/abstracts-presentations/233898

A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation https://meetings.asco.org/abstracts-presentations/238322

The majority of abstracts will be released on the 23rd, at 5:00 PM (ET).

[jondoeuk]

No, these will be preclinical. I know they will also give an oral presentation (at ASGCT) as well. From memory, around a quarter are selected for this.

[Monksdream]

TCRX under $10

[FACT-MASTER]

Upcoming Poster Presentations include 2 Non-Clinical Presentations:

Question: Does this mean that they these therapies do not need FDA approval ?

Title: Nonclinical Development of T-Plex Component TSC-204-A0101: A Natural TCR-T Cell Therapy for the Treatment of MAGE-A1- and HLA-A*01:01-Positive Cancers
Presenter: Shazad Khokhar, Ph.D.
Abstract Number: 834
Session Title: Wednesday Posters: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Session Date/Time: Wednesday, May 8; 12:00 p.m. Eastern Time
Location: Exhibit Hall

Title: Non-Clinical Development of T-Plex Component TSC-201-B0702: A TCR-T Cell Therapy Directed to a Novel HLA-B*07:02 Restricted MAGE-C2 Epitope for the Treatment of Solid Tumors
Presenter: Hannah Bader, Ph.D.
Abstract Number: 835
Session Title: Wednesday Posters: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Session Date/Time: Wednesday, May 8; 12:00 p.m. Eastern Time
Location: Exhibit Hall

[FACT-MASTER]

TCRX: TScan Therapeutics Announces Upcoming Presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting

https://finance.yahoo.com/news/tscan-therapeutics-announces-upcoming-presentations-210100850.html

TScan Therapeutics, Inc.
WALTHAM, Mass., April 22, 2024 (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 the acceptance of one abstract for oral presentation and four abstracts for poster presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11 in Baltimore, MD as well as virtually.

Oral Presentation Details:

Title: Discovery of Tumor Reactive TCRs and Their Cognate Antigenic Targets via High-Throughput Functional Screening
Presenter: Candace Perullo
Abstract Number: 419
Session Title: Targeted Gene and Cell Therapy II
Session Date/Time: Saturday, May 11; 10:15 a.m. - 12:00 p.m. Eastern Time
Presentation Time: 11:15 - 11:30 a.m. Eastern Time
Location: Room 318-323

Poster Presentation Details:

Title: Nonclinical Development of T-Plex Component TSC-204-A0101: A Natural TCR-T Cell Therapy for the Treatment of MAGE-A1- and HLA-A*01:01-Positive Cancers
Presenter: Shazad Khokhar, Ph.D.
Abstract Number: 834
Session Title: Wednesday Posters: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Session Date/Time: Wednesday, May 8; 12:00 p.m. Eastern Time
Location: Exhibit Hall

Title: Non-Clinical Development of T-Plex Component TSC-201-B0702: A TCR-T Cell Therapy Directed to a Novel HLA-B*07:02 Restricted MAGE-C2 Epitope for the Treatment of Solid Tumors
Presenter: Hannah Bader, Ph.D.
Abstract Number: 835
Session Title: Wednesday Posters: Immune Targeting and Approaches with Genetically-Modified Cells and Cell Therapies
Session Date/Time: Wednesday, May 8; 12:00 p.m. Eastern Time
Location: Exhibit Hall

Title: Trial in Progress: A Phase 1, First in Human Clinical Trial for T-Plex, a Multiplexed, Enhanced T Cell Receptor-Engineered T Cell Therapy (TCR-T) for Solid Tumors
Presenter: Dawn Pinchasik, M.D.
Abstract Number: 1900
Session Title: Friday Posters: Cell Therapy and Cell-Based Gene Therapy Trials
Session Date/Time: Friday, May 10; 12:00 p.m. Eastern Time
Location: Exhibit Hall

Title: Trial in Progress: A Phase 1 Trial of TSC-100 and TSC-101, Engineered T Cell Therapies That Target Minor Histocompatibility Antigens to Eliminate Residual Disease After Hematopoietic Cell Transplantation
Presenter: Michelle Matzko, M.D., Ph.D.
Abstract Number: 1901
Session Title: Friday Posters: Cell Therapy and Cell-Based Gene Therapy Trials
Session Date/Time: Friday, May 10; 12:00 p.m. Eastern Time
Location: Exhibit Hall

A copy of the presentation materials will be added to the “Publications” section of the Company’s website at tscan.com once presentations have concluded.

[FACT-MASTER]

TCRX: TScan Therapeutics Announces Closing of Upsized Public Offering

https://www.biospace.com/article/releases/tscan-therapeutics-announces-closing-of-upsized-public-offering/

Published: Apr 19, 2024

WALTHAM, Mass., April 19, 2024 (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 the closing of an underwritten public offering of 2,472,581 shares of its voting common stock at a public offering price of $7.1300 per share, which was equal to the closing price of its voting common stock on the Nasdaq Global Market on April 16, 2024, and pre-funded warrants to purchase up to an aggregate of 18,577,419 shares of its voting common stock at a price to the public of $7.1299 per pre-funded warrant to purchase one share of the voting common stock, which represents the per share public offering price for the voting common stock less the $0.0001 per share exercise price for each such pre-funded warrant. In addition, TScan has granted the underwriters a 30-day option to purchase up to an additional 3,157,500 shares of its voting common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to TScan from this offering were approximately $150.1 million, prior to any exercise of the underwriters’ option to purchase additional shares of voting common stock and before deducting underwriting discounts and commissions and other estimated offering expenses payable by TScan.

Morgan Stanley and TD Cowen acted as joint book-running managers for the offering. LifeSci Capital acted as lead manager, and BTIG, H.C. Wainwright & Co. and Needham & Company acted as co-managers for the offering.

The Company intends to use the net proceeds from the offering for general corporate purposes. Following this offering, and excluding any additional proceeds from the underwriters’ exercise of their over-allotment option, the Company expects its cash, cash equivalents and marketable securities will fund its current operating plan into the fourth quarter of 2026.

A registration statement on Form S-3 (File No. 333-277699) relating to these securities was filed with the Securities and Exchange Commission (the SEC) on March 6, 2024, and was declared effective by the SEC on April 12, 2024. The offering was made only by means of a preliminary prospectus supplement and accompanying filed with the SEC. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC. These documents are available for free on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, telephone: [phone] or by emailing [e-mail], or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at [phone] or by email at [e-mail].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

[FACT-MASTER]

TCRX: TScan Therapeutics Provides Clinical Pipeline Update and Highlights Near-Term Priorities - April 16/24

https://finance.yahoo.com/news/tscan-therapeutics-provides-clinical-pipeline-200100396.html

TScan Therapeutics, Inc.
Over 40 solid tumor patients have completed all biomarker testing in the screening protocol; ~60% of these patients qualify for at least one TCR-T in the ImmunoBank and ~30% are eligible for multiplex therapy

Patients identified across all six TCR-T cohorts in solid tumor program with dosing of first three expected in early May

All eight patients in the heme program treated with TSC-100 or TSC-101 remain relapse-free with no detectable cancer to date; median follow-up of >10 months

WALTHAM, Mass., April 16, 2024 (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 provided an update on its solid tumor and heme malignancies clinical programs.

“We continue to make meaningful progress across both our solid tumor and heme malignancies Phase 1 clinical programs. As we rapidly approach dosing the first patients in the solid tumor program, I am pleased to share that over 40 patients have completed all biomarker testing in the screening protocol, with the majority qualifying for at least one TCR-T in our ImmunoBank and many qualifying for multiplex therapy. This should allow for rapid enrollment into the treatment protocol over the course of the year,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “With respect to the heme program, we are encouraged to see continued positive data with all treatment-arm patients remaining relapse-free with no detectable cancer to date, now with a median follow-up of over 10 months.”

Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of therapeutic TCR-Ts that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-Ts to overcome tumor heterogeneity and prevent resistance that may arise from either target or HLA loss (screening protocol: NCT05812027; treatment protocol: NCT05973487).

Phase 1 solid tumor clinical study has been initiated; first three patients expected to be dosed in early May 2024.

More than 40 patients have completed all biomarker testing in the screening protocol across a broad array of tumor types. 60% of patients qualify for at least one TCR-T in the ImmunoBank and approximately 30% are eligible for multiplex therapy (T-Plex), potentially enabling rapid enrollment into the treatment protocol upon disease progression.

Patients have been identified across all six TCR-T cohorts with dosing expected to commence early May.

Initial data on patients from both singleplex and multiplex cohorts expected in the second half of 2024.

Additional IND filings planned to continue to expand the ImmunoBank.

Long-term duration of response data for multiplex therapy anticipated in 2025.

Heme Malignancies Program: TScan’s two lead TCR-T cell therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) (NCT05473910).

All eight patients treated with TSC-100 or TSC-101 remain MRD negative, relapse-free with no detectable cancer to date in either bone marrow biopsies or peripheral blood (median follow-up of >10 months) and no dose limiting toxicities observed to date.

To date, all but one patient has exhibited complete donor chimerism in all subsets of blood cells at all time-points, indicating that only donor-derived cells are present in these patients following treatment with either TSC-100 or TSC-101. One patient with T-ALL who was treated with TSC-100 at the lowest dose level exhibited minimally detectable (<0.3%) mixed donor chimerism at 10.5 months and 12 months post-transplant.

No detectable mixed chimerism was observed in the malignant cell lineage (CD3+ T-cells) for this patient; mixed chimerism was only observed in healthy nonmalignant blood cells (CD33+ myeloid cells)

In contrast, for the control arm (transplant alone), eight patients have now been enrolled and only one has achieved and maintained complete donor chimerism to date. Two patients relapsed approximate six months post-transplant and one of these patients died approximately three months later. A third patient required clinical intervention on day 133 because of concerns of impending relapse, and a fourth died 21 days post-transplant.

Opening of expansion cohorts at the recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints is planned for the third quarter of 2024.

Completion of Phase 1 enrollment and reporting of one-year clinical and translational data on initial patients is anticipated in the second half of 2024.

Expects to initiate registration trial pending feedback from regulatory authorities and report two-year relapse data in 2025.

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 multiplex 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 TCR-T candidates for patients with a variety of cancers.

[FACT-MASTER]

TCRX: Proposes $125 million public offering - voting common stock

https://finance.yahoo.com/news/tscan-therapeutics-announces-launch-125-202500975.html

[FACT-MASTER]

TScan Therapeutics Announces Upcoming Presentation at the 23rd Annual Needham Virtual Healthcare Conference

https://finance.yahoo.com/news/tscan-therapeutics-announces-upcoming-presentation-110000220.html

[FACT-MASTER]

TCRX: Article of interest:

https://finance.yahoo.com/news/hedge-funds-investors-control-50-124841101.html

[FACT-MASTER]

Nice AH close! $ 8.21

Look closely at AH trading

https://www.nasdaq.com/market-activity/stocks/tcrx/after-hours-trades

(middle trade = mm signal flash, imo)

[Monksdream]

TCRX new 52 hi

[FACT-MASTER]

TCRX: S-3 Shelf Registration $300,000,000

https://www.sec.gov/Archives/edgar/data/1783328/000119312524060718/d778597ds3.htm

Excerpt 1

Common Stock and Non-Voting Common Stock

As of March 1, 2024, we had outstanding 43,605,608 shares of voting common stock and 4,276,588 shares of non-voting common stock, held of record by over 70 stockholders (which number does not include beneficial owners whose shares are held by nominees in street name). As of March 1, 2024, we also had outstanding Pre-Funded Warrants to purchase up to 47,010,526 shares of our Voting Common Stock, at a price of $1.9999 per warrant with an exercise price of $0.0001 per share.


Fully diluted is close to 100 million shares outstanding.

Nothing under $10.00 would be fair, imo.

It would be interesting to see who steps up to the plate for the eventual offering, imo.

[FACT-MASTER]

TCRX: TSCAN THERAPEUTICS, INC. 2021 EQUITY INCENTIVE PLAN

TSCAN THERAPEUTICS, INC. 2021 EMPLOYEE STOCK PURCHASE PLAN

https://www.sec.gov/Archives/edgar/data/1783328/000119312524060705/d781311ds8.htm

[FACT-MASTER]

TCRX: Form 10-K/23 - filed March 6/24

https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001783328/000095017024026875/tcrx-20231231.htm

[FACT-MASTER]

TCRX: February 26/24 press release:

https://finance.yahoo.com/news/tscan-therapeutics-presents-promising-updated-120000487.html


TScan Therapeutics, Inc.
All eight (100%) treatment-arm patients are relapse-free and have achieved and maintained complete donor chimerism following treatment with TSC-100 or TSC-101

Patient with high-risk, TP53-mutated MDS is relapse-free for over one year following treatment with TSC-101

Patient with AML converted from detectable to undetectable disease following treatment with TSC-101

Data presented at TANDEM meeting suggests complete donor chimerism is an early indicator of treatment success

Company to host virtual KOL event today, Monday, February 26, at 8:00 a.m. ET, to discuss the data presented at the 2024 Tandem Meetings

WALTHAM, Mass., Feb. 26, 2024 (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 an oral presentation at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®). The oral presentation, selected for the plenary session as a Best Abstract, highlights updated data from the Phase 1 multi-arm clinical trial evaluating TSC-100 and TSC-101, designed to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL) (NCT05473910).

“We are excited to report updated data from our heme program, with eight patients across our treatment arms and six patients in our control arm. We remain encouraged to see that no relapses have occurred to date in treated patients, four of whom have been on the study for over ten months. One patient with high-risk, TP53-mutated MDS has now reached the one-year mark following treatment with TSC-101, a meaningful milestone as the likelihood of relapse decreases significantly over time, leading to an improved quality of life,” said Debora Barton, M.D., Chief Medical Officer. “We have also enrolled six patients in the control arm, receiving transplant alone. To date, two control-arm patients relapsed following transplant, at days 161 and 180, and one of these patients succumbed to the relapse at day 265. A third patient required clinical intervention at day 133 because of concerns of impending relapse.”

“Sustained complete donor chimerism may be the most valuable indicator of treatment success,” added Gavin MacBeath, Ph.D., Chief Executive Officer. “HCT is currently the best treatment option for many patients suffering from AML, MDS, and ALL, as approximately 60% of patients are cured by this treatment. Unfortunately, roughly 40% of patients relapse following HCT, at which point there are limited treatment options and a poor prognosis. Donor chimerism measures any remaining patient-derived hematopoietic cells that could potentially lead to relapse. We are using a high-sensitivity next-generation sequencing assay to track donor chimerism in all patients in our study. We are encouraged to see that all eight patients treated with our cell therapy products achieved and maintained complete donor chimerism at every time-point, with four of these patients past the 10-month mark. This is a very good sign for these patients, and we look forward to sharing follow-up data, as well as data on additional patients, as the study continues to enroll in 2024.”

The Phase 1 trial is a multi-arm dose escalation study evaluating TSC-100 and TSC-101, which are designed to treat residual disease and prevent relapse following HCT in patients with AML, ALL or MDS undergoing haploidentical donor allogeneic HCT with reduced intensity conditioning. Primary endpoints include safety and dose-finding, and secondary and exploratory endpoints include relapse rates versus standard-of-care (HCT alone) as well as supportive surrogates of efficacy, including donor chimerism and minimal residual disease (MRD). MRD identifies any residual disease-related DNA present in a patient, and chimerism measures any remaining recipient-derived hematopoietic cells in a patient following HCT (NCT05473910).

Key Presentation Highlights Include:

TSC-100 treatment arm (N=4: T-ALL, AML, AML, MDS)

4/4 patients treated with TSC-100 achieved complete donor chimerism with no relapse.

TSC-101 treatment arm (N=4: TP53-mutated MDS, AML, B-ALL, B-ALL)

4/4 patients treated with TSC-101 achieved complete donor chimerism with no relapse, including a patient with high-risk, TP53-mutated MDS who has reached one year of follow-up.

One patient with AML was MRD-positive following HCT and converted to and maintained MRD-negative status following treatment with TSC-101 (most recent measurement at day 180).

TSC-100 and TSC-101 persistence noted for prolonged periods:

Persistence of TSC-100 and TSC-101 was observed at all time points after dosing, with the longest follow-up of over 9 months.

Repeat dosing (dose levels 2 and 3) led to a 3-fold increase in circulating TSC-100 and TSC-101 levels compared to single dosing (dose level 1) at the same time points.

Six control arm patients (MDS, MDS, MDS, AML, AML, AML) have been enrolled and received standard of care HCT alone:

One control-arm patient with high-risk, TP53-mutated MDS evolved with MRD positivity and worsening mixed chimerism, experienced clinical relapse approximately six months post-transplant, and succumbed to relapse approximately nine months post-transplant.

One control-arm patient with MDS experienced clinical relapse approximately five months post-transplant.

One control-arm patient with MDS developed worsening mixed chimerism requiring early termination of immunosuppression, resulting in complete donor chimerism but with grade 1 skin graft-versus-host disease.

One control-arm patient never achieved complete donor chimerism, with more than four months follow-up post-transplant.

2/6 control-arm patients achieved complete donor chimerism following HCT.

Virtual KOL Event

The Company will host a virtual KOL event featuring:

Monzr M. Al Malki, M.D., Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the Unrelated Donor Bone Marrow Transplant and Haploidentical Transplant Programs at City of Hope

Ran Reshef, M.D., M.Sc., Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center

The conference call will be held today, February 26, at 8:00 a.m. ET, to discuss the data presented at the Tandem Meetings. Details for attending the live event can be found here. A replay will be made available on the “Events and Presentations” section of the Company’s investor relations website at ir.tscan.com.

[FACT-MASTER]

TCRX: February 14/24 Press Release

https://finance.yahoo.com/news/tscan-therapeutics-host-virtual-kol-120000958.html

TScan’s abstract selected by the Tandem Meetings to receive a Best Abstracts Award

Company to discuss the potential implications of initial data from a large prospective clinical trial assessing the relationship between donor chimerism and risk of relapse

WALTHAM, Mass., Feb. 14, 2024 (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 the Company will host a virtual key opinion leader (KOL) event to discuss updated results from its Phase 1 heme malignancies study and highlights from its oral presentation at the 2024 Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®) on Monday, February 26, 2024, at 8:00 a.m. ET.

The event will provide an in-depth review of the oral presentation related to TScan’s ongoing Phase 1 multi-arm clinical trial evaluating TSC-100 and TSC-101, which are designed to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL) (NCT05473910). The Company will also discuss the potential implications of initial data from a large prospective clinical trial assessing the relationship between donor chimerism and risk of relapse.

Featured speakers include:

Monzr M. Al Malki, M.D., Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the Unrelated Donor Bone Marrow Transplant and Haploidentical Transplant Programs at City of Hope

Ran Reshef, M.D., M.Sc., Professor of Medicine and Director of the Cellular Immunotherapy Program at Columbia University Irving Medical Center

Gavin MacBeath, Ph.D., Chief Executive Officer, TScan Therapeutics

Debora Barton, M.D., Chief Medical Officer, TScan Therapeutics

Shrikanta Chattopadhyay, M.D., M.M.Sc., Senior Vice President of Medical and Translational Medicine, TScan Therapeutics

Registration for the live event can be found here. A replay will be made available on the “Events and Presentations” section of the Company’s investor relations website at ir.tscan.com.

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 therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic cell transplantation. The Company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to build its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplexed TCR-T therapies for patients with a variety of cancers.

[FACT-MASTER]

Question: Given the results published thus far on the TSC-100 / TSC-101 trial, and knowing this is second line treatment post HCT, as per the approved trial NCT05473910;

When would TSC-100 / TSC-101 go into a first line treatment scenario trial?

Is that even possible in the current trial or would a new trial (IND) need to be initiated / approved.

When analysing the donor chimerism data on the February Presentation - slide 14 and additional abstract results...

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

...it demonstrates imo, that TSC-100 / TSC-101 should be first line treatment.

[FACT-MASTER]

Just my opinion....

predict RMAT / BTD soon ( by end of February 2024, imo)

[FACT-MASTER]

TCRX: NCT05473910 updated February 5/24 - minor changes

https://classic.clinicaltrials.gov/ct2/history/NCT05473910?A=1&B=11&C=merged#StudyPageTop

[FACT-MASTER]

TCRX: Press Release February 6/24

https://finance.yahoo.com/news/tscan-therapeutics-expands-clinical-team-120000514.html

TScan Therapeutics, Inc.
WALTHAM, Mass., Feb. 06, 2024 (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 the appointment of Dawn Pinchasik, M.D., M.S., as Vice President, Clinical Development. Dr. Pinchasik brings to TScan over a decade of experience in clinical development across the pharmaceutical and biotechnology industry.

“We are pleased to welcome Dawn to TScan at such an exciting time in the Company’s evolution,” said Debora Barton, M.D., Chief Medical Officer. “Her expertise in cell and gene therapy clinical development and experience with regulatory interactions, most recently at ElevateBio, will be crucial as we advance our clinical-stage pipeline across heme malignancies and solid tumors. We remain on track to dose the first patient in the Phase 1 solid tumor study in the first quarter of 2024, and I look forward to working closely with Dawn as we advance this program through the clinic.”

“I am excited to join the TScan team as we work towards our mission of delivering life-changing therapies to patients battling a variety of solid tumors and heme malignancies,” added Dr. Pinchasik. “I am eager to harness my past experiences and work closely with the clinical team to advance this scientifically compelling pipeline and improve patient outcomes through the development of these novel therapies.”

Prior to joining TScan, Dr. Pinchasik was the Senior Director, Early Development at ElevateBio, LLC, where she supported the internal pipeline and partnered programs for ElevateBio and the wholly owned subsidiary, Life Edit Therapeutics Inc. Before joining ElevateBio, Dr. Pinchasik was a Senior Medical Director at Rubius Therapeutics, Inc., where she supported all clinical-stage pipeline products for the company’s cell therapy platform, including the launch of its first two clinical trials. Prior to that, Dr. Pinchasik was the Medical Director at Aileron Therapeutics, Inc., where she worked closely with the chief medical officer and led the development of protocols and regulatory documents. Earlier in her career, Dr. Pinchasik held roles of increasing responsibility at Onyx Pharmaceuticals, Inc. (Onyx) and later at Amgen, Inc., following its acquisition of Onyx in 2014. She completed a fellowship in pediatric hematology/oncology at Cincinnati Children’s Hospital Medical Center in 2013 and residency in pediatrics at Children’s Hospital of Pittsburgh in 2010. Dr. Pinchasik holds an M.D. from Drexel University College of Medicine, and an M.S., Clinical and Translational Research, from the University of Cincinnati.

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 therapy candidates, TSC-100 and TSC-101, are in development for the treatment of patients with hematologic malignancies to eliminate residual disease and prevent relapse after allogeneic hematopoietic cell transplantation. The Company is also developing multiplexed TCR-T therapy candidates for the treatment of various solid tumors. The Company has developed and continues to build its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplexed TCR-T therapies for patients with a variety of cancers.

[FACT-MASTER]

I sense further collaboration with Amgen.

re: Sjögren's disease (SjD)
https://www.cell.com/cell/fulltext/S0092-8674(23)01175-3

Very interesting read.

[FACT-MASTER]

imho,

... a masterpiece.

Thank you for posting and congratulations to all the authors, investigators, and TScan mgmt.

All the best to the TScan team at the Tandem meetings.

[jondoeuk]

The abstract https://tandem.confex.com/tandem/2024/meetingapp.cgi/Paper/23846

[jondoeuk]

(OT) TScan-II: A genome-scale platform for the de novo identification of CD4+ T cell epitopes https://www.cell.com/cell/fulltext/S0092-8674(23)01175-3

They developed a platform to enable high-throughput identification of CD4+ T-cell epitopes. This enables screens to discover antigens recognised by CD4+ T-cells in cancer, infectious diseases, and autoimmunity.

[jondoeuk]

How do they decide the dosages? IHC scores?

Based on the nonclinical data generated.

Does each combo require a BLA?

A primary IND was filed and subsequent TCRs are added as secondary INDs. Each TCR will need to clear two dose levels before it can be combined with another.

[FACT-MASTER]

I'm getting back to your question ( even though you are asking jd), because imo, the public reporting on TCRX have missed a critical detail and/or TCRX management may have not been clear enough. I'm referencing the press release of January 23 2023 here:

https://ih.advfn.com/stock-market/NASDAQ/tscan-therapeutics-TCRX/stock-news/90036699/tscan-gets-fda-clearance-for-three-investigational

TScan Gets FDA Clearance for Three Investigational New Drug Apps

TScan Therapeutics Inc. said Monday that the Food and Drug Administration has cleared its investigational new drug applications for T-Plex, TSC-204-A0201 and TSC-204-C0702.

The Massachusetts-based clinical-stage biopharmaceutical company said T-Plex would now be the primary investigational new drug and TSC-204-A021 and TSC-204-C0702 the secondary investigational new drugs for its solid-tumor program.

The company said T-Plex allows patients to customize combinations of T-cell receptor-engineered T-cell therapies (TCR-T), chosen from its proprietary bank of TCRs, to treat cancers based on their specific markers. TSC-204-A0201 and TSC-204-C0702 target cancers associated with melanoma-associated antigen-1, a cancer-associated antigen overexpressed in head, neck, melanoma, cervical, and non-small cell lung cancers.

A Phase-1 clinical trial with a screening protocol expected to begin in the second quarter would assess repeat-dosing of TCR-Ts, and a secondary investigational new drug application would be filed for each unique TCR-T referencing the T-Plex application, TScan said.

The trial would evaluate each TCR-T as a singleplex therapy at two successive dose levels, the company said. Once single-agent safety is established, each TCR would become eligible for multiplexing, or combining it with any other TCR that has passed this threshold, the company said.

The above press release, imo is not clear, especially with the headline reading " TScan Gets FDA Clearance for Three Investigational New Drug Apps"

It may be 3 apps, but only 2 studies.

1. Screening protocol study as the primary investigational new drug application: ( imo, this is where TScan technology of Target Scan / Receptor Scan / Safety Scan - is utilized for patient eligibility and prevent off targets, which is a concern of the FDA.)
This study, imo is the all important starting point for a patient prior to entering any of the additional treatment trials, and maps their oncologous condition - not sure if that is the right term,

https://classic.clinicaltrials.gov/ct2/history/NCT05812027?A=1&B=11&C=merged#StudyPageTop

"Brief Summary: TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific human leukocyte antigen Human Leukocyte Antigen (HLA) molecules. The purpose of this screening study is to collect samples to conduct HLA genotyping, HLA LOH Loss of Heterozygosity (LOH) and expression of tumor antigens Tumor-associated Antigens (TAA) testing. These results will be used to determine if subjects meet the eligibility criteria for these parameters and could potentially be enrolled in a TScan clinical treatment study.
Detailed Description: This multicenter screening study will be conducted to determine a subject's tumor antigen expression profile, HLA genotype and HLA LOH for TScan sponsored clinical treatment study(s). No treatment intervention will occur as part of this screening study.
Subjects will be required to provide a buccal swab to assess their HLA status. If they are positive for certain types of HLA, they will return for a subsequent visit to provide a saliva sample to assess HLA loss of heterozygosity. In parallel, archival tissue (less than 6 months old) will be needed to assess for tumor antigen expression. If archival tissue is older than six months, a fresh tumor biopsy will be required at the time of the second visit.

If eligible, subjects will be referred to appropriate available interventional trial(s) at the discretion of the Investigator.

2. TSC-204-A0201 / TSC-204-C0702

https://classic.clinicaltrials.gov/ct2/history/NCT05973487?A=1&B=5&C=merged#StudyPageTop

Brief Summary: TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules.
This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.

Detailed Description: Participants will be screened in a separate screening study, TSCAN-003 (NCT05812027), to assess their HLA type, tumor-associated antigen (TAA) expression and loss of heterozygosity (LOH) status. The results of these tests will be used to determine initial eligibility in this study.
Depending on the genetic type, participants will be assigned to one of the following study groups:

( imo, the dosage part you are asking about is one of the experimental aspects of the trials, the eligibility is related to the above 2 studies.)
All imo.