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TCRX: January 4/24 Press Release
https://finance.yahoo.com/news/tscan-therapeutics-announces-2024-clinical-120000698.html
TScan Therapeutics, Inc.
Reported positive initial data from Phase 1 heme program at the 65th American Society of Hematology (ASH) Annual Meeting
Clearance of INDs for four TCR-Ts, including a TCR-T for PRAME, in support of use of multiple TCRs in combination for the solid tumor clinical trial
Entered a collaboration with Amgen to identify novel targets in Crohn’s Disease
Closed underwritten public offering with net proceeds of $140.6 million, funding operations into 2026
WALTHAM, Mass., Jan. 04, 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 its 2024 clinical pipeline plans and highlighted recent corporate achievements.
“2023 was a pivotal year for TScan, most recently marked by the Phase 1 heme malignancies data presented at the ASH Annual Meeting on six treatment arm patients and four control arm patients. We are encouraged to see complete donor chimerism and MRD negativity achieved and maintained in all six treated patients, with a median follow-up of over six months,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “Over the course of the year we also continued to build our ImmunoBank for the treatment of solid tumors. We have now cleared INDs for four TCRs, including TCRs for PRAME, HPV16, and MAGE-A1, and have regulatory clearance to treat patients with multiple TCRs sequentially in our Phase 1 study. Additionally, we submitted INDs for two additional TCRs in December and the 30-day review period with the FDA is ongoing. We look forward to dosing the first patient in the Phase 1 solid tumor clinical study in the first quarter and reporting clinical data, initially on patients treated with singleplexed therapy, and then on patients treated with multiplexed therapy, in 2024.”
“The data from our heme program presented at ASH is a true testament to the progress we made over the past year. We have now enrolled and dosed patients up to the third and final dose level with no DLTs observed to date and no safety signals thus far, indicating that the third dose level will likely be the recommended Phase 2 dose,” added Debora Barton, M.D., Chief Medical Officer. “We plan to activate additional sites and provide clinical updates at major medical meetings throughout the year. Upon establishing the recommended Phase 2 dose, we plan to open expansion cohorts at that dose to further characterize safety and evaluate translational and efficacy endpoints.”
2023 Key Achievements and Recent Company Highlights
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 hematopoietic cell transplantation (HCT) (NCT05473910).
Recently presented initial Phase 1 clinical results at the 65th American Society of Hematology (ASH) Annual Meeting. Highlights from the poster included:
No relapses have occurred in six of six treatment-arm patients, four with follow-up past six months; one of four control-arm patients relapsed at six months and two others required clinical intervention for increasing mixed chimerism.
No patient-derived hematopoietic cells were detected in six of six treatment-arm patients, indicating complete elimination of target cells, versus zero of four control-arm patients.
An AML patient with detectable disease post-transplant converted to no detectable disease following treatment with TSC-101.
Patients were enrolled up to the third and final dose level in both treatment arms with no dose limiting toxicities.
Solid Tumor Program: TScan continues to build the ImmunoBank, a collection of therapeutic TCRs that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-Ts sequentially to overcome tumor heterogeneity and prevent resistance that may arise from either target or HLA loss (screening protocol: NCT05812027) (treatment protocol: NCT05973487).
Continued to build the ImmunoBank with U.S. Food and Drug Administration (FDA) clearance of five investigational new drug applications (INDs):
T-Plex IND supports the sequential use of multiple TCRs to deliver customized, multiplexed TCR-T cell therapies based on target and HLA expression.
TSC-200-A0201 targets HPV16 on HLA type A*02:01.
TSC-203-A0201 targets PReferentially expressed Antigen in MElanoma (PRAME) on HLA type A*02:01.
TSC-204-A0201 and TSC-204-C0702 target melanoma-associated antigen 1 (MAGE-A1) on HLA types A*02:01 and C*07:02, respectively.
Filed INDs in December 2023 for TSC-201-B0702 targeting melanoma-associated antigen C2 (MAGE-C2) on HLA type B*07:02 and TSC-204-A0101 targeting MAGE-A1 on HLA type A*01:01; 30-day review period ongoing.
Presented six posters at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. Notable highlights include TScan’s solid tumor Phase 1 trial design supporting a separate screening protocol to identify patients ahead of disease progression, and the disclosure of the previously undisclosed target of TSC-201-B0702 as MAGE-C2.
Corporate and Financial Highlights:
Appointed Gavin MacBeath, Ph.D., as Chief Executive Officer and as a member of the Board of Directors.
Appointed Justin McCue, Ph.D., as Chief Technology Officer.
Appointed Barbara Klencke, M.D., and R. Keith Woods to the Board of Directors.
Entered into a collaboration with Amgen to identify novel targets in Crohn’s Disease. TScan received $30 million upfront and is eligible to earn over $500 million in success-based milestones as well as tiered single-digit royalty payments.
Closed underwritten public offering with gross proceeds of $140.6 million, funding operations into 2026.
TScan named as a Top Place to Work for two consecutive years by The Boston Globe.
Upcoming Anticipated Milestones
Heme Malignancies Program:
Plans to complete Phase 1 dosing and report clinical and translational data in 2024, and two-year relapse data in 2025.
Plans to open expansion cohorts at the recommended Phase 2 dose level to further characterize safety and evaluate translational and efficacy endpoints.
Expects to initiate registration trial in 2025.
Solid Tumor Program:
Initiated Phase 1 solid tumor clinical study and expects to dose the first patient in the first quarter of 2024.
Expects to report initial multiplexed therapy data for its first combinations of TCR-Ts under T-Plex, as well as response data for singleplex cohorts, in 2024.
Plans to continue to build ImmunoBank with additional IND filings throughout 2024.
Long-term duration data for multiplexed therapy anticipated in 2025.
Likely due to expression. While it has been reported in a wide range of tumour types, most show heterogeneous expression, with only myxoid and round cell liposarcomas and synovial sarcomas having the most homogenous expression. The market for each being small.
Ignore last message. Looks like TCR T is good for cold tumor like SS. No wonder IMCR engager failed in OV.
Thanks. Why pts lacking actionable genetic aberrations were tested? No LD? The trial was destined to fail.
Not that I'm aware. I know of a PhI/II (n=20) IIT testing an auto MAGE-C2 TCR-T in melanoma and H&N cancers with valproic acid and azacytidine https://journals.aai.org/jimmunol/article/197/6/2541/106100/MAGE-C2-Specific-TCRs-Combined-with-Epigenetic
Some years ago GSK presented this (before handing back to ADAP) https://jitc.bmj.com/content/8/Suppl_3/A60.2
Is any TCR bio testing Decitabine combo?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9568428/
Why ADAP is the only TCR T bio targeting NY-ESO?
TCRX: Article/ASH
https://csimarket.com/news/tscan_therapeutics_tsc-100_and_tsc-101_transforming_hematological_disease_treatment_clinical_trial_results_reveal_no_relapses_in_treatment_armnote_the_title_can_be_customized_based_on_the_specific_focus_or_angle_desired_2023-12-09170914
The highly anticipated phase 1 clinical trial results for TScan Therapeutics' experimental treatments, TSC-100 and TSC-101, were recently presented at the 65th American Society of Hematology Annual Meeting and Exposition. The findings exhibited unprecedented success in preventing relapses and minimizing the need for further clinical intervention.
Outline of Facts:
TScan Therapeutics proudly showcased the initial results of their groundbreaking phase 1 clinical trial at the prestigious ASH Annual Meeting. The trial involved six patients, divided into a treatment arm and a control arm. Notably, no relapses occurred in any of the six individuals in the treatment arm, including four patients who had a follow-up period exceeding six months.
Contrastingly, one out of the four patients in the control arm experienced a relapse after the six-month mark. Furthermore, two additional control-arm patients required clinical intervention during the trial. These results highlight the efficacy of TSC-100 and TSC-101 in preventing disease relapse and reducing the need for further medical intervention.
Assessment of Impact on the Company:
The groundbreaking phase 1 clinical trial results achieved by TScan Therapeutics have immense potential implications for the company. The absence of any relapses in the treatment arm, combined with the limited need for clinical intervention, underlines the remarkable success of TSC-100 and TSC-101.
These outcomes position TScan Therapeutics as a frontrunner in the development of innovative immunotherapies for hematological disorders. The impressive clinical trial results will likely bolster investor confidence, attract potential partnerships, and further solidify the company's reputation within the medical community.
By showcasing the effectiveness of their experimental treatments, TScan Therapeutics may pave the way for future advancements in the field of blood-related diseases. The findings also offer hope to patients suffering from similar conditions, assuring them that revolutionary treatments may soon become available.
In conclusion, TScan Therapeutics' presentation of the initial phase 1 clinical results for TSC-100 and TSC-101 at the American Society of Hematology Annual Meeting signifies a major breakthrough in the development of potentially game-changing treatments for hematological disorders. With no relapses occurring in the treatment-arm patients and minimal clinical intervention required, TScan Therapeutics has displayed tremendous promise in revolutionizing the treatment landscape for these diseases.
Is this the most promising TCR-T bio?
TCR-T Multiplexing CTAs seems more effective than neoantigen ACT?
I decided to wait for the poster. I agree with you about the data, but I'm still somewhat cautious based on the number treated so far.
TCRX Phase 1 data = ABSOLUTELY AWESOME!
BTD/RMAT coming soon,imo.
TCRX: Company Presentation December 2023
https://ir.tscan.com/static-files/1d066354-1ed3-4f4f-b97b-28806d9da9f5
TCRX: December 9/23 https://ir.tscan.com/node/8521/pdf
No relapses have occurred in six of six treatment-arm patients, four with follow-up past six months; one of four control-arm patients relapsed at six months and two others required clinical intervention
No patient-derived hematopoietic cells detected in six of six treatment-arm patients, indicating complete elimination of target cells, versus zero of four control-arm patients
AML patient with detectable disease post-transplant converted to no detectable disease following treatment with TSC-101
Patients enrolled up to the third and final dose level in both treatment arms with no dose limiting toxicities
Company to host virtual KOL event on Monday, December 11, at 8:00 a.m. ET to discuss the data presented at the ASH Annual Meeting and Exposition
WALTHAM, Mass., Dec. 09, 2023 (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 a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. The poster highlights initial data from the 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).
“We are excited to present initial clinical data in our heme program, with six patients in our treatment arms and four patients in our control arm. Complete donor chimerism and MRD negativity, two favorable indicators of treatment success, were achieved and maintained in all six treated patients, four of whom have been on the study for over six months. In contrast, these indicators were not achieved in any of the four control-arm patients. In addition, one of the control-arm patients relapsed at six months, and two other control-arm patients required clinical intervention due to worsening chimerism, a sign of potential future relapse,” said Debora Barton, M.D., Chief Medical Officer. “We have now enrolled and dosed patients up to the third and final dose level with no DLTs observed to date and no safety signals thus far, indicating that the third dose level will likely be the recommended Phase 2 dose. After establishing the recommended Phase 2 dose, we plan to open expansion cohorts at that dose to further characterize safety and evaluate translational and efficacy endpoints. There are currently 10 active clinical sites, and additional sites are in the process of being activated to participate in these expansion cohorts.”
“Hematopoietic cell transplantation is currently the best treatment option for many patients suffering from AML, MDS, and ALL, as approximately 60% of patients are cured by this procedure,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “Unfortunately, for patients who relapse following transplantation, the prognosis is very poor. We have designed TSC-100 and TSC-101 to address this unmet need and increase the success rate of transplantation. We are very encouraged by these early data as they indicate that our therapies are working as designed. The translational data show that our cell therapies are eliminating all residual patient-derived malignant, pre-malignant, and benign cells, which are the cells that drive relapse. We are grateful to all the patients and their families who are participating in this trial and look forward to sharing more data in 2024 as the study continues to enroll.”
The Phase 1 trial is a multi-arm dose escalation study evaluating TSC-100, TSC-101, or HCT alone in patients with AML, ALL or MDS undergoing haploidentical allogeneic HCT with reduced intensity conditioning. Patients enrolled in Dose Level 1 receive a single dose of either TSC-100 or TSC-101 approximately 21 days post-transplant. Patients enrolled in Dose Level 2 receive the same dose of TSC-100 or TSC-101 approximately 21 days post-transplant, followed by a second dose administered 40 days after the initial dose. For patients in Dose Level 3, the second dose is escalated four-fold. Primary endpoints include safety and dose-finding, and secondary and exploratory endpoints include relapse rates versus standard-of-care as well as qualitative biological readouts, including MRD and donor chimerism. MRD specifically measures malignant cells, to identify any residual disease present in a patient, and donor chimerism measures a combination of malignant, pre-malignant and normal cells, measuring any remaining patient-derived hematopoietic cells.
Key Poster Highlights:
TSC-100 treatment arm (N=3 T-ALL, AML, AML)
3/3 patients treated with TSC-100 achieved complete donor chimerism and MRD negativity.
TSC-101 treatment arm (N=3 TP53 mutated MDS, AML, B-ALL)
3/3 patients treated with TSC-101 achieved complete donor chimerism and MRD negativity, including a TP53-mutated MDS patient who remained with no detectable disease for over seven months post-HCT.
One patient with AML was MRD-positive following HCT and converted to MRD-negative following treatment with TSC-101.
Four control arm patients (MDS, MDS, TP53-mutated MDS, AML) have been enrolled and received standard of care HCT alone:
One TP53-mutated MDS control-arm patient evolved with MRD positivity and worsening mixed chimerism, finally experiencing disease relapse approximately six months after transplantation.
Two MDS control-arm patients developed worsening mixed chimerism that prompted early withdrawal of immunosuppression, which was complicated by grade 1 or grade 3 skin graft-vs-host disease.
0/4 of the control-arm patients achieved and maintained complete donor chimerism.
Higher sensitivity assays used to detect the activity of T cells:
Donor chimerism detected by high-sensitivity next-generation sequencing assay (AlloHeme) with limit of detection 0.13%.
MRD detected by next-generation sequencing with limit of detection of 0.05-0.1%.
A copy of the poster can be accessed on the “Publications” section of the Company’s website at www.tscan.com.
Virtual KOL Event
The Company will host a virtual KOL event featuring Monzr M. Al Malki, M.D., on Monday, December 11, 2023, at 8:00 a.m. ET to discuss the data presented at ASH. Dr. Al Malki is an 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. Details for attending the live event can be found here.
Interesting read.
I'm not 100% sure at the moment, however "Hematologics Inc. L" sounds familiar here with Tscan. Are they not the lab that TSCAN contracted for MRD testing?
Thought it was stated in a press release, if i find that,will post.
TCRX: https://www.globenewswire.com/news-release/2023/12/07/2792384/0/en/TScan-Therapeutics-Appoints-R-Keith-Woods-to-its-Board-of-Directors-Bringing-Expertise-in-Commercialization-and-Global-Operations.html
WALTHAM, Mass., Dec. 07, 2023 (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 R. Keith Woods to its Board of Directors. Mr. Woods has over 30 years of life science experience, with expertise in commercialization, sales, global operations, supply chain and business strategy.
“I am pleased to welcome Keith, a highly respected and experienced leader in biotechnology, as our newest member to the Board of Directors,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “In his previous position as COO of argenx, Keith successfully transitioned the company from an R&D organization to a fully integrated global biotech organization. Keith has extensive experience in operations, sales, launch readiness, and commercialization, and we look forward to working with him as we advance our clinical programs toward pivotal studies.”
“I am delighted to be joining TScan’s Board and further support the progress of this innovative company. I believe that TScan is well-positioned to deliver on its mission of bringing life-changing therapies to patients suffering from cancer and other debilitating disorders. I look forward to bringing my commercialization, operations, and biopharmaceutical industry experience to supporting the growth of TScan and advancing this compelling pipeline,” added Mr. Woods.
Mr. Woods has over three decades of experience in the biopharmaceutical sector, having served most recently as chief operating officer (COO) of argenx where he led the company through its transition from an R&D organization to a global commercial organization. During this time, he oversaw key teams in preparation for argenx’s first product launch, including sales, marketing, market access and reimbursement, business operations, patient services and medical affairs. In 2023, Mr. Woods transitioned from this role to serve as a strategic advisor to the Board of Directors of argenx. Prior to argenx, Keith served as senior vice president of North American operations for Alexion Pharmaceuticals, Inc. (Alexion), where he managed a team of several hundred people in the U.S. and Canada and was responsible for more than $1 billion in annual sales. Prior to joining Alexion, Mr. Woods held various positions of increasing responsibility within Roche, Amgen, and Eisai Co., Ltd., over a span of 20 years. He holds a Bachelor of Science in marketing from Florida State University.
No Transplant needed.
a novel approach to target PRAME using a chimeric antigen receptor (CAR) construct encoding a targeting domain based on T-cell receptor (TCR) mimic antibodies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10111362/
TCRX: https://www.globenewswire.com/news-release/2023/12/04/2790444/0/en/TScan-Therapeutics-to-Host-Virtual-KOL-Event-to-Discuss-Results-from-Ongoing-Phase-1-Trial-of-TSC-100-and-TSC-101-Presented-at-the-65th-ASH-Annual-Meeting-and-Exposition.html
WALTHAM, Mass., Dec. 04, 2023 (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 on Monday, December 11, at 8:00 a.m. ET to discuss highlights from its poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. Following the prepared remarks, the call will be opened for a live question and answer session. To submit a question, please reach out to questions@lifesciadvisors.com.
The event will provide an in-depth review of the presentation related to lead TCR-T cell therapy candidates, TSC-100 and TSC-101, designed to target HA-1 and HA-2, respectively, to treat residual disease and prevent relapse in patients with acute myeloid leukemia, acute lymphocytic leukemia or myelodysplastic syndromes undergoing allogeneic haploidentical hematopoietic cell transplantation with reduced intensity conditioning. (NCT05473910)
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
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 available on the “Events and Presentations” section of the Company’s website at ir.tscan.com.
TCRX: https://www.globenewswire.com/news-release/2023/12/04/2789885/0/en/TScan-Therapeutics-Expands-Manufacturing-Leadership-with-the-Appointment-of-Justin-McCue-Ph-D-as-Chief-Technology-Officer.html
WALTHAM, Mass., Dec. 04, 2023 (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 Justin McCue, Ph.D., as its Chief Technology Officer. Dr. McCue joins TScan with over 20 years of experience in biologics and cell therapy manufacturing, including process/analytical development, technical operations, clinical development, and commercialization of T cell therapy products.
“We are delighted to welcome Justin to TScan. His extensive expertise is a valuable addition to the Company and an important next step in the evolution of our executive team,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “Justin’s experience with clinical and commercial manufacturing will be invaluable as we continue to advance our heme program through clinical development and launch our multi-TCR-T solid tumor program.”
“I look forward to bringing my experience in the areas of technology development, technical operations, and commercial manufacturing readiness to TScan at this critical time in the Company’s trajectory,” added Dr. McCue. “I am excited to join a seasoned leadership team and support the Company in its goal to deliver life-changing therapies to patients with heme malignancies and solid tumors.”
Dr. McCue joins TScan from Avectas, a cell engineering technology company, where he most recently served as Chief Technology Officer responsible for leading technology development and scientific strategy. Prior to joining Avectas, Dr. McCue was Vice President of Technical Operations at Repertoire Immune Medicines where he led CMC development and clinical manufacturing of their multi-targeted antigen-specific T-cell platform. Before this, Dr. McCue spent more than 15 years in the cell therapy and biopharma industry, including roles at Juno/Celgene and Biogen. Dr. McCue holds a bachelor’s degree in chemical engineering from the University of California, Berkeley, and a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology.
Is this the most promising TCR-T bio? TCR-T Multiplexing CTAs seems more effective than neoantigen ACT?
TCRX: Dec.4/23 Press Release
https://finance.yahoo.com/news/tscan-therapeutics-expands-manufacturing-leadership-120000248.html
The Monday morning call (December 11/23) should be very interesting...
... just a hunch but i sense BTD or RMAT or something very significant re:FDA
https://lifescievents.com/event/tscan-2/
With AMGEN and who knows, maybe Novartis is still lurking around, this could get bought out quickly imo.
The limited data looks truly, truly amazing.
Can we call it a cure? maybe not yet but looks very promising.
Thanks for posting that.
The abstract is up https://ash.confex.com/ash/2023/webprogram/Paper187355.html
They should present on at least a few more patients with longer follow-up.
TCRX: ASH 2023 December 11/23
https://lifescievents.com/event/tscan-2/
TCRX: November / 23 Presentation
https://ir.tscan.com/static-files/1d066354-1ed3-4f4f-b97b-28806d9da9f5
TCRX: Quarterly Report
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001783328/000095017023061533/tcrx-20230930.htm
EXCERPT 1:(page 51)
We may seek designation for our TargetScan platform as a designated platform technology, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
We may seek designation for our TargetScan platform as a designated platform technology. Under the Food and Drug Omnibus Reform Act of 2022 (FDORA), a platform technology incorporated within or utilized by a biological product is eligible for designation as a designated platform technology if (1) the platform technology is incorporated in, or utilized by, a biological product approved under an BLA; (2) preliminary evidence submitted by the sponsor of the licensed biological product, or a sponsor that has been granted a right of reference to data submitted in the application for such biological product, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one biological product without an adverse effect on quality, manufacturing, or safety; and (3) data or information submitted by the applicable person indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the biological product development or manufacturing process and to the review process. A sponsor may request the FDA to designate a platform technology as a designated platform technology concurrently with, or at any time after, submission of an IND application for a biological product that incorporates or utilizes the platform technology that is the subject of the request. If so designated, the FDA may expedite the development and review of any subsequent original BLA for a biological product that uses or incorporates the platform technology. Even if we believe our TargetScan platform technology meets the criteria for such designation, the FDA may disagree and instead determine not to grant such designation. In addition, the receipt of such designation for a platform technology does not ensure that a biological product will be developed more quickly or receive FDA approval. Moreover, the FDA may revoke a designation if the FDA determines that a designated platform technology no longer meets the criteria for such designation.
TCRX Pipeline
https://www.tscan.com/pipeline/
TCRX Publication (August 4/22)
Tissue-resident memory and circulating T cells are early responders to pre-surgical cancer immunotherapy
https://www.cell.com/cell/fulltext/S0092-8674(22)00723-1
TCRX Publication (August 8/19)
T-Scan: A Genome-wide Method for the Systematic Discovery of T Cell Epitopes
https://www.cell.com/cell/fulltext/S0092-8674(19)30774-3?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0092867419307743%3Fshowall%3Dtrue
TCRX Nov. 6/23 Press release:
https://finance.yahoo.com/news/tscan-therapeutics-presents-phase-1-120000080.html
(imo, a very logical approach to cancerous treatment - see below)
TScan Therapeutics, Inc.
Solid tumor program uses separate screening protocol designed to identify patients in advance of treatment protocol; on track to enroll first patient in study this year
Company adds TSC-201-B0702 to ImmunoBank, targeting novel melanoma-associated antigen C2 (MAGE-C2)
WALTHAM, Mass., Nov. 06, 2023 (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 presentation of six posters at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting.
“Solid tumors are notoriously heterogenous, which may contribute to low response rates and limited duration of response following treatment with single-targeting TCR-T cell therapy. TScan’s solid tumor program is designed to deliver multiplexed, enhanced TCR-T cell therapy to effectively address both target heterogeneity and HLA loss,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “TScan has initiated a screening protocol to test for target expression and the presence of HLA genes in patients’ tumors. This information is then used to determine eligibility for enrollment into the treatment protocol and to guide selection of which TCR-Ts to administer to the patient. We have already screened over 30 patients in the screening protocol and expect to enroll the first patient in our treatment protocol this year.”
Product Characteristics and Clinical Trial Design for T-Plex, a Multiplexed, Enhanced T cell Receptor-Engineered T cell Therapy for Solid Tumors
TScan’s Phase 1 solid tumor clinical trial is designed to assess customized, multiplexed TCR-T as a way to overcome tumor heterogeneity and HLA loss of heterozygosity. First generation TCR-T, targeting single antigens, has shown encouraging response rates (typically 30-50%), but has often shown short durations of response (3-4 months).
TScan believes that its approach to multiplexing across targets and HLAs will result in increased response rates and increased duration of response. To make this possible, TScan is prospectively screening patients with melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, cervical cancer, ovarian cancer, and anogenital cancers for target expression and the presence of intact HLA genes. Customized treatment is made possible by the Company’s ImmunoBank, its repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types. TScan continues to prioritize populating the ImmunoBank to increase the number of addressable targets, thereby increasing the percentage of patients that are eligible to receive either singleplexed or multiplexed treatment.
In the treatment protocol, each TCR-T is first tested as singleplexed therapy at two different dose levels to assess safety. Once a TCR-T has cleared dose level two, it becomes eligible to be combined with any other TCR-T that has also cleared dose level two. As additional Investigational New Drug Applications (INDs) for TCR-Ts are cleared by the FDA and enter the ImmunoBank, they will be incorporated into the same study and follow the same dose escalation scheme, enabling a rapid path to novel multiplexed therapies.
Discovery of novel MAGE-C2 epitopes for TCR-T adoptive cell therapy from expanded T cell clones of TIL therapy products
Using TargetScan, TScan has identified a novel B*07:02-restricted epitope in the cancer/testis antigen MAGE-C2 as a promising target for TCR-T therapy. TScan is developing TSC-201-B0702, a TCR-T cell therapy that targets this epitope, with plans to file an IND by the end of the year. TCR-Ts targeting MAGE-C2 could potentially be used to treat up to 50% of melanoma patients, 25% of patients with head and neck cancers, and 50% of patients with NSCLC in the United States.
“As we expand the number of TCRs in the ImmunoBank, we expect the number of patients eligible for enrollment in our study to increase, providing a rapid and efficient path to delivering multiplexed therapy,” continued Dr. MacBeath. “In addition to filing an IND for TSC-201-B0702, we also anticipate filing an IND for TSC-204-A0101 by the end of 2023. TSC-204-A0101 targets an epitope on MAGE-A1 specific for the HLA type A*01:01.”
For additional information on all six posters presented at the SITC 38th Annual Meeting, visit the “Events and Presentations” section of the Company’s Investor Relations website at ir.tscan.com.
TCRX: Study of TSC-100 and TSC-101
History of trial changes - October 26/23
https://classic.clinicaltrials.gov/ct2/history/NCT05973487?A=1&B=4&C=Side-by-Side#StudyPageTop
History of trial changes - Oct.26/23
https://classic.clinicaltrials.gov/ct2/history/NCT05973487?A=1&B=4&C=Side-by-Side#StudyPageTop
TCRX: 3rd IND for solid tumours
https://finance.yahoo.com/news/tscan-therapeutics-announces-fda-clearance-110000990.html
Today's announcement is concerning TSC- 200 - A0201
https://www.tscan.com/pipeline/
TCRX: recent Sc13G filings:
1. Baker
https://www.sec.gov/Archives/edgar/data/1783328/000110465923067540/tm2317496d1_sc13da.htm
2. Lynx1 Capital Management LP
https://www.sec.gov/Archives/edgar/data/1783328/000090266423003397/p23-1699sc13g.htm
3. Biotechnology Value Fund, L.P.
https://www.sec.gov/Archives/edgar/data/1783328/000092189523001429/sc13g07422tcrx_06052023.htm
4.EcoR1 Capital, LLC
https://www.sec.gov/Archives/edgar/data/1783328/000093583623000439/tscan.htm
TCRX: Must read filing
https://ih.advfn.com/stock-market/NASDAQ/tscan-therapeutics-TCRX/stock-news/91234707/amended-statement-of-beneficial-ownership-sc-13d-a
It's public information now who the main recipient was, behind the pre-funded warrants.
Wow, imo
Nice breakout north of the the 50 and 200 day levels.
Closed at the high of the day at $2.81 on 600,000+ shares trading hands.
AH close at $2.90
Nice Chart! appreciate it (member marked)
https://stockcharts.com/h-sc/ui?s=tcrx&p=D&yr=0&mn=6&dy=0&id=p38090673899
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
https://www.barchart.com/stocks/quotes/tcrx/technical-chart?plot=CANDLE&volume=total&data=DO&density=M&pricesOn=1&asPctChange=0&logscale=1&indicators=BBANDS(20,2);SMA(13);PTP(50);ADX(14);SMA(50);SMACD(12,26,9);RSI(14,100);ACCUM;STOSL(14,3)&sym=CNNA&grid=1&height=500&studyheight=100
https://www.nasdaq.com/market-activity/spos
TCRX
TScan Therapeutics, Inc.
NASDAQ Global
2.00
22,989,474
5/30/2023
$45,978,948
Priced
they run then dilute then runn again weeks
Question:
Why the pre-funded warrants in this capital raise?
Is something up here?
Did anybody notice Volume a RIPP'in last Friday past 4 million shares trading hands and up some give/take 30% to close at $3.19?
imo, TScan is a one of a kind company. Amgen/Novartis/ positive data on AML Baker Bros./ Alphabet/ nuevo TCR-T tech....
Bendita aqui gente.
Let's go back to the latest 10-Q for a minute
https://www.sec.gov/ix?doc=/Archives/edgar/data/1783328/000095017023020087/tcrx-20230331.htm
As of May 5, 2023, the registrant had 19,480,729 shares of voting common stock, $0.0001 par value per share, and 4,745,225 shares of non-voting common stock, $0.0001 par value per share, outstanding.
19,480,729 + 4,745,225 = 24,225,954 (current outstanding)
and now here:
https://finance.yahoo.com/news/tscan-therapeutics-announces-pricing-140-043700771.html
WALTHAM, Mass., May 26, 2023 (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 pricing of an underwritten public offering of 22,989,474 shares of its voting common stock at a public offering price of $2.00 per share, and pre-funded warrants to purchase up to an aggregate of 47,010,526 shares of its common stock at a price to the public of $1.9999 per pre-funded warrant, 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.
From above :
24,225,954 (current outstanding) + 22,989,474 ( proposed public offering) =
47,215,428 will be the new current outstanding,and if all pre-funded warrants are exercised that brings in an additional 47,010,526 shares for a grand total of 94,225,954 shares outstanding.
TCRX Board Re: Pre-funded Warrants
Check this information out on "pre-funded warrants"
This appears imo, to be a call option that never expires.
https://www.sec.gov/Archives/edgar/data/1783328/000119312523154339/d489569d424b5.htm#suprom489569_9
DESCRIPTION OF PRE-FUNDED WARRANTS
The following is a brief summary of certain terms and conditions of the pre-funded warrants being offered by this prospectus supplement. The following description is subject in all respects to the provisions contained in the pre-funded warrants.
Form
The pre-funded warrants will be issued as individual warrant agreements to the investors. The form of pre-funded warrant will be filed as an exhibit to our Current Report on Form 8-K that we expect to file with the SEC in connection with this offering.
Term
The pre-funded warrants do not expire.
Exercisability
The pre-funded warrants are exercisable at any time after their original issuance. The pre-funded warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and by payment in full of the exercise price in immediately available funds for the number of shares of common stock purchased upon such exercise. As an alternative to payment in immediately available funds, the holder may elect to exercise the pre-funded warrant through a cashless exercise, in which the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the pre-funded warrant. No fractional shares of common stock will be issued in connection with the exercise of a pre-funded warrant. In lieu of any fractional shares that would otherwise be issuable, we will pay in cash to an exercising holder the fair market value, determined according to the terms of the pre-funded warrant, for any such fractional shares.
Exercise Limitations
Under the pre-funded warrants, we may not effect the exercise of any pre-funded warrant, and a holder will not be entitled to exercise any portion of any pre-funded warrant, which, upon giving effect to such exercise, would cause the aggregate number of shares of our common stock beneficially owned by the holder (together with its attribution parties (as defined below) to exceed 4.99% of the number of shares of our common stock that would be outstanding immediately after giving effect to the exercise. However, any holder may increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from the holder to us. For purposes of the foregoing, “attribution parties” means, collectively, the following persons and entities with respect to any holder: (i) its direct and indirect affiliates, (ii) any person acting or who could be deemed to be acting as a Section 13(d) “group” together with the holder or any attribution parties and (iii) any other persons whose beneficial ownership of our common stock would or could be aggregated with the holder and/or any other attribution parties for purposes of Section 13(d) or Section 16 of the Exchange Act.
Exercise Price
The exercise price per whole share of our common stock purchasable upon the exercise of the pre-funded warrants is $0.0001 per share of common stock. The exercise price of the pre-funded warrants and the number of shares of our common stock issuable upon exercise of the pre-funded warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common stock.
S-19
Table of Contents
Charges, Taxes and Expenses
Issuance and delivery for shares of common stock upon exercise of a pre-funded warrant will be made without charge to the holder thereof for any issue or transfer tax, transfer agent fee or other incidental tax or expense (excluding any applicable stamp duties) in respect of the issuance thereof, all of which taxes and expenses shall be paid by us. However, we are required to pay any tax that may be payable in respect of any transfer involved in the registration of any warrant shares or pre-funded warrants in a name other than that of the holder or an affiliate thereof. The holder shall be responsible for all other tax liability that may arise as a result of holding or transferring its pre-funded warrants or receiving shares upon exercise thereof.
Transferability
Subject to applicable laws, the pre-funded warrants may be assigned by the holder without our consent. The pre-funded warrants will be held in definitive form by the warrant agent. The ownership of the pre-funded warrants and any transfers of the pre-funded warrants will be registered in a warrant register maintained by the warrant agent. We will initially act as warrant agent.
Exchange Listing
We do not plan on applying to list the pre-funded warrants on The Nasdaq Global Market, any other national securities exchange or any other nationally recognized trading system.
Fundamental Transactions
In the event of a “fundamental transaction” (as described in the pre-funded warrants and generally including but not limited to any reorganization, recapitalization, spin-off or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation or merger with or into another person, the tender and acceptance for payment of shares representing more than 50% of the voting power of our capital stock pursuant to any tender or exchange offer (whether by us or another person), the acquisition by another person of more than 50% of the voting power of our capital stock pursuant to a stock purchase agreement or other business combination (except for any such transaction in which our stockholders immediately prior to such transaction maintain, in substantially the same proportions, voting power of us immediately after the transaction)), upon consummation of such a fundamental transaction, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the pre-funded warrants immediately prior to such fundamental transaction without regard to any limitations on exercise contained in the pre-funded warrants.
No Rights as a Stockholder
Except by virtue of such holder’s ownership of shares of our common stock, the holder of a pre-funded warrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises the pre-funded warrant. In the event of certain distributions, including cash dividends, if any, to all holders of our common stock for no consideration, the holder of a pre-funded warrant shall be entitled to participate in such distributions to the same extent as if such holder held the number of shares of our common stock acquirable upon exercise of its pre-funded warrant (without regard to any limitations on exercise). If such distribution would result in such holder and the other attribution parties exceeding the exercise limitations described above, a portion of such distribution shall be held in abeyance for the benefit of such holder until the earlier of such time as the ownership limitations would not be exceeded or the warrant is exercised.
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