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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.
TCRX financing news:
https://finance.yahoo.com/news/tscan-therapeutics-announces-pricing-140-043700771.html
Haven't had time to do dd on pre-funded warrants etc,
Let's see how much of the over-allotment the underwriters subscribe for.
No, but there could be merit in using the (TCR) approach in a select population of patients who unable to undergo an HSCT.
In AML that would be patients at a high risk of relapse, as defined by CR following induction, but are MRD+, and/or with incomplete recovery of neutrophil (CRi) or platelet counts (CRp). In that group more than 80% will relapse within the first year no matter what is (currently) done after induction therapy https://ascopubs.org/doi/full/10.1200/JCO.2014.58.3518
The wisdom of your response above, is duly understood.
The prognosis for the condition you have outlined above is very poor, ( lost a friend and business colleague to pretty much exactly this condition in 2022).
One factor that i've thought about though, is the possibility of a "mutational footprint " left by some induction therapies and if that would effect the TScan tech. From the recent display of data, it doesn't appear to be an issue.
The other articles you posted are highly informative, imo - still reading
yeah, got like 50 biotechs on my watchlist, powerful volume this month,, what is cash position to fund future operations etc all that bs gay stuff
https://www.stockscores.com/charts/charts/?ticker=tcrx
No, but there could be merit in using the (TCR) approach in a select population of patients who unable to undergo an HSCT.
In AML that would be patients at a high risk of relapse, as defined by CR following induction, but are MRD+, and/or with incomplete recovery of neutrophil (CRi) or platelet counts (CRp). In that group more than 80% will relapse within the first year no matter what is (currently) done after induction therapy https://ascopubs.org/doi/full/10.1200/JCO.2014.58.3518
I also know of a PhI/II trial testing auto CD8+ (central memory vs. naïve phenotype) T-cells transduced using a viral vector to target WT1. Of seven treated, four are NED, with the other three relapsing. There are data from two (the third declined additional treatment before passing away) showing one was due to WT1 negative disease and the other was due to failure of T-cells.
WT1 is an oncogene and also expressed on leukemic stem cells https://www.nature.com/articles/nature22993
Looking at the patient who was WT1 negative, their disease was found to express CCNA1, so could be targeted with a different TCR https://ashpublications.org/bloodadvances/article/4/2/387/440610/Evaluation-of-cyclin-A1-specific-T-cells-as-a
As for the second, immunosuppressive and rapid proliferation of the disease were likely the reason, so other modifications to T-cells will be needed to address both, such as this https://ashpublications.org/blood/article/130/22/2410/36564/A-CD200R-CD28-fusion-protein-appropriates-an
The short interest doesn't appear to be of any concern, so no squeeze, imo.
The Finra dark pool data is of concern. From whence these shares became, and traded between whom, and for what purpose? - are all questions that come to mind. And suggests shares outstanding may now be higher. This wouldn't surprise as i recall an offering a while back atm - i'll see if i can find that.
Markets are strange sometimes.
imo, the recent data is awesome, and the hope for the cancer patient has never looked better. The Tscan approach is highly sophisticated, imo, and if positive data continues, somehow i would hope this remains USA technology.
Thanks for the post and link.
I'll continue to be long term here at TCRX and not concerned about the present price spasms.
Shares Outstanding 24.23M
Shares Float 17.61M
Institutional Ownership 63.50%
Short Float 0.51%
https://www.shortablestocks.com/?TCRX
They are having a Replay you could listen it was all positive IMO looking to end of 2023 for another milestone
Would there be any merit to TCRX utilizing TSC100/TSC101 pre HCT? (ie as new SOC)/
Would that probably require study change / FDA approval?
Thank you in advance.
Did anybody ask about the far right 3 slides here:(re TSC101)
https://www.tscan.com/wp-content/uploads/2023/05/ASGCT-poster-2023.pdf
in relation to Slide 44 of the May TCRX Corporate presentation here, where they use the word "CURE"
https://ir.tscan.com/static-files/1d066354-1ed3-4f4f-b97b-28806d9da9f5
Thank you in advance.
Good to hear, I would have loved to attended- just couldn't get away.
Was there much discussion on the TSC101 CD4*CD8* part of the trial.
From the poster presentation this looks most interesting ( far right slides - TSC101 CD4*CD*/ UD Chimerism/ TP53
https://www.tscan.com/wp-content/uploads/2023/05/ASGCT-poster-2023.pdf
Key Poster Highlights:
Phase 1 umbrella clinical trial evaluating TSC-100 and TSC-101 targeting MiHAs HA-1 and HA-2, respectively, to treat residual disease and prevent relapse following HCT using RIC in patients with AML, MDS or ALL
Two control arm patients have been enrolled and received standard of care (SOC) (HCT alone):
Both control arm patients have medium-risk MDS and experienced incomplete donor chimerism (presence of patient-derived cells) following transplant
One patient is now in early stages of relapse: after 100 days, patient-derived cells are still observed and increasing
TSC-101 treatment arm (n=1 high-risk MDS with p53 mutation):
DL1 administered 21 days after transplant Engineered T cells showed expansion between 14-21 days after infusionDetectable markers of activation and proliferation observed
Twenty-one days after treatment and 42 days after transplant, donor chimerism was at 100% (no detectable patient-derived hematopoietic cells with sensitivity limit of 0.13%)
Minimal residual disease (MRD) assessment: p53 mutation was not detected post-transplant in bone marrow and peripheral blood samples, with sensitivity limit of 0.01%
No DLTs observed
Study advancing to DL2
TSC-100 treatment arm (n=1 T-cell ALL):
DL1 administered 28 days after transplant
T cell expansion occurred on Day 7 with detectable markers of T cell activation and proliferation
Two assays are used to detect the action of T cells:
MRD: SOC assays measuring remaining malignant cells use flow cytometry, which has a sensitivity of ~0.1% High sensitivity assay based on next-generation sequencing (NGS) and droplet digital PCR is also used in this study, with a sensitivity of 0.01%
Chimerism: SOC STR assays have ~1% sensitivity Study is using the high-sensitivity NGS-based Alloheme assay, with a sensitivity of ~0.13%
A copy of the poster can be accessed on the “Publications” section of the Company’s website at www.tscan.com.
https://www.otcmarkets.com/stock/TCRX/news/story?e&id=2531529
Very Good TCRX Presentation well run and informational from all involved
Meeting is in one Hour I signed in
The poster https://www.tscan.com/wp-content/uploads/2023/05/ASGCT-poster-2023.pdf
PR https://www.globenewswire.com/news-release/2023/05/17/2670856/0/en/TScan-Therapeutics-Presents-Preliminary-Phase-1-Clinical-Results-on-TSC-100-and-TSC-101-at-the-American-Society-of-Gene-Cell-Therapy-26th-Annual-Meeting.html
NEWS TScan Therapeutics Presents Preliminary Phase 1 Clinical Results on TSC-100 and TSC-101 at the American Society of Gene & Cell Therapy 26th Annual Meeting
Poster highlights Phase 1 results following treatment with TSC-100 and TSC-101 after hematopoietic cell transplantation
https://www.otcmarkets.com/stock/TCRX/news/story?e&id=2531529
Company to host a virtual KOL event featuring Monzr M. Al Malki, M.D., to discuss highlights from the meeting and preliminary data today, Wednesday, May 17th at 5:30 p.m. ET
WALTHAM, Mass., May 17, 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 highlighting preliminary data from the Phase 1 umbrella clinical trial evaluating TSC-100 and TSC-101 targeting minor histocompatibility antigens (MiHA) HA-1 and HA-2, respectively, to treat residual disease and prevent relapse following hematopoietic cell transplantation (HCT) using reduced intensity conditioning (RIC) in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL) at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting 2023.
TScan has developed two lead TCR-T cell therapy candidates, TSC-100 and TSC-101, that express TCRs targeting MiHAs HA-1 and HA-2, respectively, both presented by HLA-A*02:01. The goal is to select HCT patients who are HA-1 or HA-2 positive, with donors who are mismatched on either the MiHA or HLA-A*02:01. In this context, TSC-100 and TSC-101 are designed to eliminate all recipient hematopoietic cells, including malignant cells, that persist post-transplant, while leaving donor-derived cells unaffected. Both products are being developed in patients with AML, ALL, and MDS undergoing allogeneic haploidentical HCT with RIC, with the goal of preventing disease relapse. Approximately 42% of patients with these diseases relapse within two years of RIC transplant, at which point there are limited treatment options and poor prognosis. The longer-term objective is to enable more patients to maintain prolonged remission after receiving HCT with RIC, which is a more tolerable conditioning regimen than myeloablative conditioning.
“We continue to make meaningful progress in our Phase 1 umbrella trial with preliminary data presented at ASGCT demonstrating notable differences following treatment with both of our TCR-T cell therapy candidates,” said Debora Barton, M.D., Chief Medical Officer. “In a p53-mutated MDS patient who received TSC-101 infusion, we observed T cell expansion between 14 and 21 days post-treatment and observed markers of T cell activation and proliferation. Particularly encouraging, this patient had 100% donor chimerism post-transplant with no detectable patient-derived hematopoietic cells with sensitivity limit of 0.13%, and no dose-limiting toxicities. Our Phase 1 study is rapidly enrolling and TSC-101 is advancing into the second dose level. We are on track to reach the recommended Phase 2 dose for TSC-100 and TSC-101 and report interim clinical data for the program by the end of 2023.”
Gavin MacBeath, Ph.D., acting Chief Executive Officer and Chief Scientific and Operating Officer added: “We are very excited to progress to the second dose level for TSC-101 after seeing encouraging results from the patient at this first dose level. We are hopeful to continue to produce robust clinical outcomes as we progress our Phase 1 trial and remain excited about the potential clinical benefits our engineered T cells may have in difficult-to-treat patient populations.”
The Phase 1 umbrella trial is a multi-arm, i3+3 study evaluating TSC-100, TSC-101, and standard of care HCT alone (control arm) in patients with AML, ALL or MDS. Patients enrolled in Dose Level 1 (DL1) receive either TSC-100 or TSC-101 upon count recovery after HCT at approximately day 21. Patients enrolled in Dose Level 2 (DL2) will 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, provided there are no safety issues. The trial design also includes a third dose level (DL3), where the second dose is escalated 4-fold.
Key Poster Highlights:
Phase 1 umbrella clinical trial evaluating TSC-100 and TSC-101 targeting MiHAs HA-1 and HA-2, respectively, to treat residual disease and prevent relapse following HCT using RIC in patients with AML, MDS or ALL
Two control arm patients have been enrolled and received standard of care (SOC) (HCT alone):
Both control arm patients have medium-risk MDS and experienced incomplete donor chimerism (presence of patient-derived cells) following transplant
One patient is now in early stages of relapse: after 100 days, patient-derived cells are still observed and increasing
TSC-101 treatment arm (n=1 high-risk MDS with p53 mutation):
DL1 administered 21 days after transplant Engineered T cells showed expansion between 14-21 days after infusionDetectable markers of activation and proliferation observed
Twenty-one days after treatment and 42 days after transplant, donor chimerism was at 100% (no detectable patient-derived hematopoietic cells with sensitivity limit of 0.13%)
Minimal residual disease (MRD) assessment: p53 mutation was not detected post-transplant in bone marrow and peripheral blood samples, with sensitivity limit of 0.01%
No DLTs observed
Study advancing to DL2
TSC-100 treatment arm (n=1 T-cell ALL):
DL1 administered 28 days after transplant
T cell expansion occurred on Day 7 with detectable markers of T cell activation and proliferation
Two assays are used to detect the action of T cells:
MRD: SOC assays measuring remaining malignant cells use flow cytometry, which has a sensitivity of ~0.1% High sensitivity assay based on next-generation sequencing (NGS) and droplet digital PCR is also used in this study, with a sensitivity of 0.01%
Chimerism: SOC STR assays have ~1% sensitivity Study is using the high-sensitivity NGS-based Alloheme assay, with a sensitivity of ~0.13%
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 share highlights from its poster presented at ASGCT, featuring Monzer M. Al Malki, M.D, Associate Profession, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, on Wednesday, May 17th at 5:30 p.m. ET to discuss the presentation and results from the ongoing Phase 1 study of TSC-100 and TSC-101 to treat residual disease and prevent relapse following HCT using RIC in patients with AML, MDS and ALL. To register for the event, please click here. A replay will be available on the “Events and Presentations” section of the Company’s 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 solid tumors.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, and timing relating to the Company’s hematologic malignancies program, including patient enrollment, reaching recommended Phase 2 dose for TSC-100 and TSC-101, and interim clinical data; the structure, timing and success of the Company’s planned preclinical development and clinical trials; the potential benefits of any of the Company’s proprietary platforms, multiplexing, or current or future product candidates in treating patients; and the Company’s goals, focus, and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “advance,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy candidates; TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; TScan’s approved INDs and enrollment of patients in its study being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the partnership with Amgen being indicative or predictive of the value of TScan’s target discovery platform outside of oncology; the timing of the launch, initiation, progress and expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s timeline regarding its filing of INDs for its TCRs throughout the year, TScan’s ability to enroll patients for its clinical trials within its expected timeline, TScan’s plans relating to developing and commercializing its TCR-T therapy candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.
Contacts
Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
hsavelle@tscan.com
Joyce Allaire
LifeSci Advisors, LLC
Managing Director
617-435-6602
jallaire@lifesciadvisors.com
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Source: TScan Therapeutics, Inc.
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AW 1 d419056daw.htm AW TSCAN THERAPEUTICS, INC. May 16, 2023
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F. Street N.E.
Washington, D.C. 20549
Re:
TScan Therapeutics, Inc. (CIK 0001783328)
Request to Withdraw Pre-Effective Amendment No. 1 to Registration Statement (Reg No. 333-268260) on Form S-3 (Accession No. 0001193125-23-145261)
Ladies and Gentlemen:
Pursuant to Rule 477 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), TScan Therapeutics, Inc. (the “Company”) hereby requests the immediate withdrawal of the Company’s Amendment No. 1 to Registration Statement on Form S-3 referred to above (the “Amendment”), which was filed on May 16, 2023, together with all exhibits thereto, with Accession No. 0001193125-23-145261. No securities were sold pursuant to this Amendment.
Two Amendments No. 1 to the Registration Statement on Form S-3 were filed under the EDGAR submission header for Reg No. 333-268260.
The Company is requesting the immediate withdrawal of the Amendment No. 1 that references Reg. No. 333-268261 (Accession No. 0001193125-23-145261).
The Company is not seeking the withdrawal of the Amendment No. 1 that references Reg. No. 333-268260 (Accession No. 0001193125-23-145259).
Thank you for your assistance in this matter. If you have questions regarding this request, please contact the Company’s legal counsel, William D. Collins, Esq., of Goodwin Procter LLP, at (617) 570-1447.
Very truly yours,
/s/ Brian Silver
Chief Financial Officer
cc:
Zoran Zdraveski, Esq. (Chief Legal Officer at TScan Therapeutics, Inc.)
William D. Collins, Esq. (Goodwin Procter LLP)
David Li, Esq. (Goodwin Procter LLP)
Insight source
https://quantisnow.com/insight/4513795
$TCRX Amgen and Novartis are involved with TCRX enough said
https://www.otcmarkets.com/stock/TCRX/news/story?e&id=2522538
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