jobynimble
2 weeks ago
https://ir.markertherapeutics.com/news-releases/news-release-details/principal-investigator-city-hope-national-medical-center-invited
PRINCIPAL INVESTIGATOR FROM CITY OF HOPE NATIONAL MEDICAL CENTER INVITED TO PRESENT CLINICAL DATA FROM MARKER THERAPEUTICS APOLLO STUDY AT 11TH GLOBAL SUMMIT ON HEMATOLOGIC MALIGNANCIES
April 8, 2024 at 7:00 AM EDT
Preliminary data from study in patients with lymphoma enrolled at City of Hope National Medical Center was presented at the 11th Global Summit on Hematologic Malignancies in Whistler, BC, Canada
Study participants tolerated initial dose level well and demonstrated durable objective responses after MT-601 treatment
Study participant with Non-Hodgkin’s Lymphoma who relapsed after anti-CD19 CAR T cell therapy remains in complete response nine months after MT-601 treatment
HOUSTON, April 08, 2024 (GLOBE NEWSWIRE) -- 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 reported that Geoffrey Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center in Duarte, CA, was invited to present his clinical experience from the APOLLO study at the 11th Global Summit on Hematologic Malignancies in Whistler, BC, Canada (April 2-7, 2024). Dr. Shouse provided an overview on the clinical observations obtained at City of Hope on Saturday, April 6, 2024.
The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, for the treatment of patients with lymphoma who have failed or are ineligible to receive anti-CD19 chimeric antigen receptor (CAR) T cell therapy. Marker previously reported that the first study participant tolerated the treatment well and achieved a complete response (CR) eight weeks after the second infusion of MT-601, which was maintained at the six months follow-up visit (PRESS RELEASE, SEPTEMBER 11, 2023). During the presentation, Dr. Shouse showed that this study participant remains in CR nine months following initial treatment with MT-601. This APOLLO participant had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy. The participant relapsed within 90 days of CAR T cell therapy yet maintained a CR for at least nine months after treatment with MT-601, suggesting that response to MT-601 was more durable compared to CAR T cells in this study participant.
Dr. Shouse’s presentation included data from two additional study participants that have been treated at City of Hope. One of the study participants had transformed follicular NHL and failed a total of 12 lines of therapy including mosunetuzumab (bispecific antibody) for follicular NHL, and Yescarta (anti-CD19 CAR T cell therapy) after transformation into DLBCL. At the time of MT-601 administration, only follicular NHL persisted after the last treatment. Eight weeks after initial infusion with MT-601, this study participant achieved a CR and remains in CR three months following treatment with MT-601. The third patient treated at City of Hope as part of the APOLLO trial presented with DLBCL with cutaneous involvement only and was not eligible for CAR T cell therapy. When evaluated at eight weeks post-treatment, the study participant was in partial response with all lesions decreasing in size including one that has completely resolved.
Dr. Shouse also reported that treatment was well tolerated among all patients with no significant treatment-related adverse events including no reports of cytokine release syndrome (CRS) or immune-effector cell associated neurotoxicity syndrome (ICANS), and that all patients will continue to be monitored closely for long-term treatment effects and durability of response.
“We are encouraged by these clinical results and the potential impact of MT-601 in patients with lymphoma who have relapsed or are ineligible for CAR T cell therapy,” said Geoffrey Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center in Duarte, CA. "Observing objective responses in three out of three patients with lymphoma treated with MT-601 at our site is a remarkable and gratifying achievement and we are encouraged by the benefits this therapy has provided to our patients. I am honored to have been invited to showcase these data on MT-601 to leading experts in the field at the 11th Global Summit on Hematologic Malignancies.”
The therapeutic potential of MT-601 is further reinforced by non-clinical data demonstrating that MT-601 is able to eradicate lymphoma cells resistant to anti-CD19 CAR T cells (PRESS RELEASE, MAY 31, 2023).
CAR T cell therapy is associated with severe adverse events such as cytokine release syndrome or neurotoxicity, as well as the potential risk of inducing secondary cancers (U.S. FOOD AND DRUG ADMINISTRATION, NOVEMBER 28, 2023). MultiTAA-specific T cell therapies have been well-tolerated in clinical trials to date. Marker believes that multiTAA-specific T cells represent a safe alternative to CAR T cells due to their non-genetically engineered approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood without the risk of mutagenesis.
“Although treatment with CD19-targeting CAR T cells is rapidly expanding among hematological malignancies, 40-60% of patients relapse within one year of therapy,” commented Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. “The sustained CR for nine months in our first study participant, who relapsed 90 days following CAR T cell treatment, indicates durable efficacy of MT-601 versus CAR T cell therapy in this participant.”
“Though the number of patients treated to date in our APOLLO study is quite small, observing objective responses in all three study participants treated at City of Hope is encouraging, and highlights the potential benefit of MT-601 in patients with lymphoma. We are continuing to enroll additional patients to hopefully reinforce these promising observations and look forward to treating more participants in this Phase 1 study,” concluded Dr. Vera.
learningcurve2020
4 weeks ago
FISCAL YEAR 2023 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025, inclusive of available drawdowns from grant funds.
R&D Expenses: Research and development expenses were $10.4 million for the year ended December 31, 2023, compared to $12.0 million for the year ended December 31, 2022.
G&A Expenses: General and administrative expenses were $7.5 million for the year ended December 31, 2023, compared to $11.3 million for the year ended December 31, 2022.
Net Loss: Marker reported a net loss of $8.2 million for the year ended December 31, 2023, compared to a net loss of $29.9 million for the year ended December 31, 2022.
jobynimble
2 months ago
March 1st, the same day as the other news, I missed the 8-K alert so here it is…
https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1094038/000110465924029638/tm247674d1_8k.htm
ITEM 1.02. TERMINATION OF A MATERIAL DEFINITIVE AGREEMENT
On February 29, 2024, Marker Therapeutics, Inc. (the “Company”) delivered notice to Lincoln Park Capital Fund, LLC, an Illinois limited liability company (“LPC”), terminating the Purchase Agreement, dated December 12, 2022 (the “Purchase Agreement”), with LPC effective March 1, 2024 (the “Termination Date”). The Company projects a financial runway through the fourth quarter of 2025 and does not anticipate an immediate need for capital acquisition. The Purchase Agreement provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company had the right to sell to LPC up to $25 million of shares of the Company’s common stock, par value $0.001 per share (“Common Stock”), over the 24-month term of the Purchase Agreement. The Purchase Agreement provided the Company could terminate the Purchase Agreement for any reason or for no reason with one business day notice to LPC, however, certain provisions in the Purchase Agreement survive termination, as more fully described in the Purchase Agreement. In consideration for entering into the Purchase Agreement, the Company issued to LPC 1,804,098 shares of the Company’s Common Stock (the “Commitment Shares”). There are no early termination penalties attributable the Purchase Agreement. There were no material relationships between the Company, or any of the Company’s affiliates, and LPC other than with respect to the Purchase Agreement and Registration Rights Agreement, described below.
Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with LPC (the “Registration Rights Agreement”), pursuant to which the Company agreed to file a Form S-1 registration statement (the “Registration Statement”), as permissible and necessary under the Securities Act of 1933, as amended (the “Securities Act”), to register the sale of the shares of the Company’s Common Stock that may be sold to LPC under the Purchase Agreement, as well as the Commitment Shares. On January 3, 2023, the Company filed a Prospectus Supplement to the Registration Statement dated December 23, 2022 and declared effective on December 30, 2022 with the Securities and Exchange Commission registering the resale of all the shares of Common Stock that may be offered to LPC from time to time under the Purchase Agreement. From December 12, 2022 through the Termination Date, the Company sold 12,500 shares of Common Stock under the Purchase Agreement generating proceeds of approximately $33,000. The Company has no further obligations under the Purchase Agreement.
The descriptions of the Purchase Agreement and the Registration Rights Agreement contained in this Current Report on Form 8-K do not purport to be complete and are qualified in their entirety by reference to the copies of the Purchase Agreement and the Registration Rights Agreement filed as Exhibit 10.1 and Exhibit 10.2, respectively, to the Current Report on Form 8-K filed on December 13, 2022.
jobynimble
2 months ago
Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601
January 22, 2024 07:30 ET
| Source: Marker Therapeutics
HOUSTON, Jan. 22, 2024 (GLOBE NEWSWIRE) -- 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 tumors, announced today that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “neldaleucel” as the nonproprietary (generic) name for MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product candidate for the treatment of patients with lymphoma.
The USAN Council in close collaboration with the WHO established INN expert committee select and assign a single unique name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical, ensuring clear identification, safe prescription and dispensing of medicines to patients. Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics. Their use is normally required by national and international legislations. The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing. The Company recently provided a clinical update on the Phase 1 study investigating MT-601 in CAR relapse patients with lymphoma, demonstrating clinical safety and durability in the first study participant, suggesting the clinical benefit of neldaleucel (Press Release, Dec 11, 2023).
“The assignment of the nonproprietary name to MT-601 represents a significant milestone as we advance this potential treatment for patients with lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “The INN and USAN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. The USAN and WHO INN approval of neldaleucel allows us to establish a universally recognized and conflict-free nonproprietary drug name for MT-601 and represents an important step in our path to ultimately market the drug.”