0001094038
false
0001094038
2023-09-11
2023-09-11
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
September 11, 2023
Date of Report (Date of earliest event reported)
MARKER THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
001-37939 |
45-4497941 |
(State or other jurisdiction of
incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
9350 Kirby Drive, Suite 300
Houston, Texas |
|
77054 |
(Address of principal executive offices) |
|
(Zip Code) |
(713) 400-6400
Registrant’s telephone number, including
area code
N/A
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
MRKR |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
On September 11, 2023, Marker Therapeutics,
Inc. (the “Company”) issued a press release announcing preliminary results for the first patient treated with
MT-601, its multi-tumor associated antigen (multiTAA)-specific T cell product targeting six TAAs, in the Phase 1 multicenter APOLLO clinical
trial. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Marker Therapeutics, Inc. |
|
|
|
Dated: September 11, 2023 |
By: |
/s/ Juan Vera |
|
|
Juan Vera |
|
|
President and Chief Executive Officer |
Exhibit 99.1
Marker Therapeutics Announces Complete Response
in First Lymphoma Patient Treated with MT-601 after CAR T Relapse
Marker Therapeutics reports clinical updates
in APOLLO trial for the treatment of lymphoma patients who have relapsed after anti-CD19 CAR T cell therapy
Patient with Non-Hodgkin’s
Lymphoma who relapsed after anti-CD19 CAR T cell therapy tolerated initial dose level well and achieved complete response after MT-601
treatment
Houston,
TX – September 11, 2023 – Marker Therapeutics, Inc. (Nasdaq: MRKR) is a clinical-stage immuno-oncology
company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid
tumor indications. Today Marker is announcing the preliminary results of the first participant treated with MT-601, its multi-tumor associated
antigen (multiTAA)-specific T cell product targeting 6 TAAs, in the Phase 1 multicenter APOLLO clinical trial. The APOLLO trial is investigating
the safety and efficacy of MT-601 for the treatment of patients with lymphoma who have either failed or are ineligible to receive anti-CD19
CAR T cell therapy.
This first APOLLO study participant had diffuse
large B cell lymphoma (DLBCL) and was enrolled into the Phase 1 dose escalation stage of the trial (Press Release, June 12, 2023)
after failing 4 prior lines of therapy, including anti-CD19 CAR T cell therapy.
After relapse following anti-CD19 CAR T cell
therapy, the participant was treated with 2 doses of MT-601 at the 200 million cell dose level without prior lymphodepletion. MT-601
treatment was well tolerated with no reports of higher than Grade 1 treatment-related adverse events. The tolerability at this initial
dose level is consistent with the favorable clinical safety profile and tolerability previously reported for other multiTAA-specific
T cell products. Eight weeks after the 2nd infusion of MT-601, the participant demonstrated complete metabolic response based
on PET-CT scans.
Marker previously reported non-clinical proof-of-concept
data that showed that MT-601 has the potential to eliminate lymphoma cells that are resistant to anti-CD19 CAR T cells, highlighting
the therapeutic potential of MT-601 in vitro (Press Release, May 31, 2023).
“We are delighted to announce that the
first study participant treated in the APOLLO trial achieved a complete response after treatment with MT-601,” said Monic Stuart,
M.D., Chief Medical Officer of Marker Therapeutics. “This is a significant initial step forward in our Phase 1 clinical trial and
highlights the potential benefit of MT-601 in patients who have relapsed after anti-CD19 CAR T cell therapy. The patient will remain
under close observation as we continue to monitor long-term treatment effects and the durability of response.”
“The complete response we have observed
in this CAR T relapsed patient with lymphoma marks a remarkable milestone for Marker and our technology,” said Juan F. Vera, M.D.,
President and Chief Executive Officer of Marker Therapeutics. “Our APOLLO trial is an important area for MT-601 assessment, as
up to 60% of patients treated with anti-CD19 CAR T therapies relapse within one year. While a complete response in our first patient
treated with MT-601 is certainly encouraging, the focus of the APOLLO study is to continue to treat and evaluate additional participants
in this Phase 1 study.”
About MT-601
MT-601 utilizes a novel non-genetically modified
approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2,
MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897)
for the treatment of lymphoma patients who are relapsed/refractory after or ineligible to anti-CD19 CAR T cell therapies.
About APOLLO
The APOLLO trial (clinicaltrials.gov Identifier:
NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with
relapsed or refractory lymphoma who either received anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are ineligible for anti-CD19
CAR T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary
efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, eight clinical sites across the United States
will cumulatively enroll up to approximately 30 participants during the dose escalation phase.
About multiTAA-specific T cells
The multi-tumor associated antigen (multiTAA)-specific
T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s
blood capable of recognizing a broad range of tumor antigens. Clinical trials that enrolled more than 180 patients with various hematological
malignancies and solid tumors showed that autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated
durable clinical responses, and consistent epitope spreading. The latter is typically not observed with other T cell therapies and enables
the potential contribution to a lasting anti-tumor effect.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage
immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological
malignancies and solid tumor indications. The T cell therapy technology developed by Marker is based on the selective expansion of non-engineered,
tumor-specific T cells that recognize tumor associated antigens (i.e., tumor targets) and kill tumor cells expressing those targets.
This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s
immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer the T cells, Marker believes
that its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered
CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio
of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
To
receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.
Forward-Looking Statements
This
release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance,
and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters,
are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations
relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range
of application and potential curative effects and safety in the treatment of diseases; the timing, conduct and success of our clinical
trials of our product candidates, including MT-601 for the treatment of patients with lymphoma.
Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to
differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks
set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings
which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation
to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press
release except as may be required by law.
Contacts
TIBEREND STRATEGIC ADVISORS, INC.
Investors
Daniel Kontoh-Boateng
(862) 213-1398
dboateng@tiberend.com
Media
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com
v3.23.2
Cover
|
Sep. 11, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Sep. 11, 2023
|
Entity File Number |
001-37939
|
Entity Registrant Name |
MARKER THERAPEUTICS, INC.
|
Entity Central Index Key |
0001094038
|
Entity Tax Identification Number |
45-4497941
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
9350 Kirby Drive, Suite 300
|
Entity Address, City or Town |
Houston
|
Entity Address, State or Province |
TX
|
Entity Address, Postal Zip Code |
77054
|
City Area Code |
713
|
Local Phone Number |
400-6400
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common
Stock, par value $0.001 per share
|
Trading Symbol |
MRKR
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
false
|
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Marker Therapeutics (NASDAQ:MRKR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Marker Therapeutics (NASDAQ:MRKR)
Historical Stock Chart
From Jul 2023 to Jul 2024