MRKR Marker Therapeutics Inc

 

  

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

 

December 17, 2024

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.)

 

2450 Holcombe Blvd, Suite BCM-A, MS: BCM251 Houston, Texas		77021
(Address of principal executive offices)		(Zip Code)

 

(713) 400-6400

Registrant’s telephone number, including area code

 

(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. ¨

 

 

 

Item 8.01.

Other Information

 

On December 17, 2024, Marker Therapeutics, Inc. (the “Company”) issued a press release announcing that the Company was awarded a $9.5 Million Grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of MT-601 in patients with pancreatic cancer. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.	Description
99.1	Press release, dated December 17, 2024.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

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: December 17, 2024	By:	/s/ Juan Vera
		Juan Vera
		President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

 

Marker Therapeutics Awarded $9.5 Million Grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to Support the Investigation of MT-601 in Patients with Pancreatic Cancer

 

 

Houston, TX – December 17, 2024 – Marker Therapeutics, Inc. (Nasdaq: MRKR), 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 announced that the Company has been awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer.

 

The CPRIT grant is intended to support the Company’s Phase 1 PANACEA study (clinicaltrials.gov Identifier: NCT06549751) evaluating the safety and tolerability of MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, in patients with metastatic pancreatic cancer.

 

The Company’s lead asset, MT-601, is currently being studied in patients with CD19-CAR relapsed lymphoma as the primary indication (clinicaltrials.gov identifier: NCT05798897). Marker previously reported that one of the Principal Investigators presented preliminary safety and efficacy with sustained objective responses observed in three study participants treated at City of Hope National Medical Center (Press Release, April 8, 2024). MT-601 recognizes multiple targets within six tumor-specific antigens that are highly expressed among different cancer indications. Due to the broad target recognition profile of MT-601, the Company plans to investigate its potential application beyond lymphoma in patients with solid tumors.

 

The use of MT-601 in solid tumors is supported by preliminary efficacy data of a previous study conducted at Baylor College of Medicine investigating multiTAA-specific T cells in patients with pancreatic cancer who received treatment in conjunction with frontline chemotherapy (Phase 1 Trial in Pancreatic Adenocarcinoma (TACTOPS), June 1, 2020; clinicaltrials.gov identifier: NCT03192462). In this study, the multiTAA-specific T cell product targeted five of the six tumor-antigens used in MT-601. In the 13 patients treated, administration of multiTAA-specific T cells was associated with a favorable safety profile and durable cancer control, including 1 complete response, 3 partial responses and 6 patients with stable disease. Notably, measurable tumor responses were observed in 4 patients, and 9 patients exceeded the median overall survival of historical controls of patients receiving chemotherapy alone.

 

“We are pleased to receive $9.5 million from CPRIT to explore MT-601 in our Phase 1 study in patients with pancreatic cancer,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “The CPRIT application underwent multiple rounds of review by expert panels, and being awarded this grant underscores the innovation behind our therapy and recognizes the potential impact of our study.”

 

Including this CPRIT grant, the Company has been awarded over $30 million in non-dilutive funding from governmental institutions including FDA, NIH and CPRIT. Most recently, the Company was awarded a $2 million grant from the NIH Small Business Innovation Research (SBIR) program to support the investigation of MT-601 in patients with pancreatic cancer. Together with the $9.5 million from CPRIT, Marker will use these funds to advance MT-601 in pancreatic cancer and anticipates clinical program initiation in 2025.

 

 

 

 

Dr. Vera added: “Being awarded with a total of $9.5 million from CPRIT and $2 million from the NIH SBIR program to advance our lead asset, MT-601, beyond lymphoma to pancreatic cancer is an important acknowledgement of our work and reflects the reviewers’ confidence in our study. With the support of these highly competitive grants from CPRIT and NIH, we will be able to advance MT-601 in pancreatic cancer without affecting operations in the ongoing study of MT-601 in patients with lymphoma.”

 

About the Cancer Prevention and Research Institute of Texas (CPRIT)

 

Created by the Texas Legislature and approved by a statewide vote in 2007, the Cancer Prevention and Research Institute of Texas (CPRIT) leads the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to support CPRIT with an additional $3 billion, for a total $6 billion investment in cancer research and prevention. To date, the agency has awarded more than $3.7 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has also recruited 324 distinguished researchers to Texas, supported the establishment, expansion, or relocation of 74 companies to Texas, and supported 10.1 million prevention services reaching all 254 counties in Texas.

 

About MT-601

 

The Company’s lead product, MT-601, is a multi-tumor associated antigen (multiTAA)-specific T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in cancer cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGE-A4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or where CD19 CAR-T cell therapy is not an option. The broad target recognition profile of MT-601 allows its potential application in indications other than lymphoma, including solid tumors such as pancreatic cancer.

 

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. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits.

 

 

 

 

About Marker Therapeutics, Inc.

 

Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research.

 

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 or with pancreatic cancer. 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

 

Investors

TIBEREND STRATEGIC ADVISORS, INC.

Jonathan Nugent

205-566-3026

jnugent@tiberend.com

 

 

v3.24.4

Cover	Dec. 17, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 17, 2024
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	2450 Holcombe Blvd
Entity Address, Address Line Two	Suite BCM-A
Entity Address, Address Line Three	MS: BCM251
Entity Address, City or Town	Houston
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	77021
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

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