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 24, 2019
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 7.01 Regulation FD Disclosure.
A copy of an investor presentation that the Company intends to use in investor meetings beginning on September 24, 2019 is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference.
The information in this Item 7.01 of this Current Report on 8-K (including Exhibit 99.1) is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, whether made before or after today’s date, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific references in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description |
| 99.1 | Investor Presentation. |
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 24, 2019 | By: | /s/ Anthony Kim | |
| Anthony Kim | |||
| Chief Financial Officer | |||
Exhibit 99.1
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6 LYMPHOMA PHASE I TRIAL (TACTAL) Group A: Active disease (15 patients) • 7 complete responses (CR) • Durable for 4 months -- >5 years • No patient achieving a CR has subsequently relapsed • 8 stable disease (SD) • Durable for 4 -- >12 months) • 2 patients subsequently achieved CR with confounding factors Group B: Adjuvant ( 17 patients*) • 14/17 currently remain in remission • Range 9 months -- >4 years • Mean time in CCR is 29 months • 3 relapses occurred between 8 - 33 months Presented at Society of Hematology Oncology (SOHO) Sept 2019 Autologous MultiTAA T cells for adult patients with lymphoma *1 patient treated twice after initial relapse Group A Monotherapy for patients with active disease Group B Maintenance therapy for patients in remission from prior therapy Dose escalation (n=11) Dose escalation (n=14) Antigen escalation (n=3) Antigen escalation (n=4)
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9 AML & MDS PHASE I TRIAL (ADSPAM) Group B: Active Disease (All AML) (6 patients ⴕ ) • 1 CR: Duration 13 months • Survived 2.5 years; died of heart attack • 1 partial response (PR): Duration 4 months • Significant reduction in circulating tumor blasts • Tumor reduction from 50% to 15% and 70% to 40% • 3 patients responded sufficiently to qualify for a subsequent therapy for which they were previously ineligible • Overall survival ranged from 4 months to 30 months Group A: Adjuvant (11 AML, 2 MDS) (13 patients) • 11/13 patients remain alive (range 6 weeks to 2.5 years post - infusion) • 9 never relapsed and remain in CR (durable for 6 weeks to 2.5 years) • 2 patients had relapse in CNS treated with local therapy, 1 patient had extramedullary relapse treated in Group B with CR for 13 months Presented at American Society of Blood and Marrow Transplantation (ASBMT) Annual Meeting Feb 2019 Dose Escalation DL1 5x10 6 cells/m 2 DL2 1x10 7 cells/m 2 DL3 2x10 7 cells/m 2 DL4* 5x10 7 cells/m 2 DL5* 1x10 8 cells/m 2 Allogeneic MultiTAA T cells ≥30 days post allo - HSCT Group A Maintenance therapy for AML/MDS patients who are disease - free after transplant Group B Monotherapy for patients with relapsed/refractory AML/MDS post - transplant *DL4 and DL5 added during amendment, currently ongoing ⴕ 1 patient treated twice
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15 PANCREATIC PHASE I/II TRIAL (TACTOPS ARM A) • Tumor biopsies showed significant T cell infiltration within the tumor • Significant T cell expansion and epitope spreading was observed in patients responding to therapy • Limited or no significant T cell expansion and epitope spreading was seen amongst non - responders Presented at American Association for Cancer Research: Immune Cell Therapies for Cancer Meeting July 2019 Notable observations:
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17 Primary objectives are to evaluate: Relapse - free survival (RFS) (Group 1) The best overall response rate (BOR), duration of response (DOR) (Group 2) Additional objectives include: • The safety of multiple tumor associate antigen ( multiTAA ) - specific T cell therapy • OS • Graft - versus - host disease RFS (GRFS) • PFS (Group 2) • Study the expansion, persistence, and anti - tumor immune effects of the adoptively - transferred, donor - derived, multiTAA - specific T cells, as well as the presence of epitope spreading Main Entry Criteria: • Patients with AML after allogeneic HSCT (HLA - matched related donor, matched unrelated donor, or haploidentical) • Karnofsky /Lansky score of ≥ 60 • Age ≥ 18 • Life expectancy ≥ 8 weeks • Adequate organ function Immune Monitoring • Analyzed for immunological parameters at multiple timepoints PHASE 2 STUDY DESIGN FOR AML
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