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
April 29, 2020
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.) |
|
3200 Southwest Freeway Suite 2240 Houston, Texas |
77027 | |
| (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. ¨
| Item 8.01 | Other Events. |
On April 29, 2020, Marker Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration has granted orphan drug designation to MT-401 for the treatment of patients with acute myeloid leukemia after receiving allogeneic stem cell transplant. 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.
| Exhibit No. | Description |
| 99.1 | Press release issued on April 29, 2020 |
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: April 29, 2020 | By: | /s/ Anthony Kim | ||||
| Anthony Kim | ||||||
| Chief Financial Officer | ||||||
Exhibit 99.1
Marker Therapeutics Receives FDA Orphan Drug Designation for its Multi-Antigen Targeted T Cell Therapy for Acute Myeloid Leukemia
Houston, TX—April 29, 2020—Marker Therapeutics, Inc. (Nasdaq:MRKR), 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, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-401, a multi-tumor-associated antigen (MultiTAA)-specific T cell product for the treatment of patients with acute myeloid leukemia (AML), following allogeneic stem cell transplant.
“We are pleased that the FDA has granted orphan designation to MT-401, our novel MultiTAA-specific T cell product candidate and believe it is supportive of its potential to treat post allogeneic stem cell transplant patients with AML—a devastating and pervasive blood disease with a high medical need for a treatment. In investigator-sponsored trials, our MultiTAA-specific T cell product candidate was well- tolerated and we have observed clinical benefit across various liquid and solid tumors, suggesting the product candidate’s ability to induce a patient’s own T cells to expand for a more durable anti-tumor effect. We look forward to initiating our Company-sponsored Phase 2 study in patients with post allogeneic stem cell transplant AML,” said Peter L. Hoang, President & CEO of Marker Therapeutics.
Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax credits, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. For more information about orphan designation, please visit the FDA website at www.fda.gov.
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. Marker’s
cell therapy technology 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 its T cell therapies, we believe that our 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 Statement Disclaimer
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 potential benefits of orphan drug designation; and the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. 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 our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Marker Therapeutics, Inc.
Contacts
Investor
Solebury Trout
Chiara Russo
(617) 221-9197
crusso@soleburytrout.com
Media
Solebury Trout
Amy Bonanno
(914) 450-0349
abonanno@soleburytrout.com
##