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SAN FRANCISCO, July 20, 2019 / PRNewswire / – 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 tumors, announced today intermediate clinical trial data sponsored by an investigator led by Baylor College of Medicine, evaluating the company's MultiTAA T-cell therapy in patients with pancreatic adenocarcinoma. The data was reviewed today as part of an oral presentation at a plenary session, as well as a poster presentation, during immune cell therapy against Cancer of the American Association for Cancer Research (AACR): Success and Challenges of CAR T Cells and Other Forms of Adoption Therapy Conference held in San Francisco, California from July 19 to 22, 2019.
"Pancreatic cancer remains one of the toughest solid malignant tumors to treat, and survival rates have not improved significantly in over 40 years," said Brandon G. Smaglo, MD, lead investigator and investigator. Assistant Professor of Oncology at Baylor College of Medicine. "We are encouraged by these tentative data that suggest that MultiTAA therapy may contribute to longer lasting responses without additional toxicity when used in combination with standard chemotherapy, or as a second-line treatment for chemo patients." Despite the particularly dense desmoplastic stroma surrounding pancreatic tumors – long regarded as a major obstacle to the efficacy of T-cells – our study of patients with surgically resectable disease at the borderline suggests that MultiTAA cells are able to significantly infiltrate the tumor. "
Preview of the test
Title: Targeting pancreatic cancer with unmodified antigen-specific T cells (TACTOPS)
The trial plans to include a total of 45 patients with advanced or limited resectable pancreatic adenocarcinoma in a three-arm trial. Arm A is intended for patients with metastatic / unresectable disease who respond to standard first-line chemotherapy. Arm B is intended for patients with progressive disease or intolerance to treatment. Arm C is an exploratory arm for patients with a surgically resectable disease. To date, a total of 19 patients have received MultiTAA T cell treatment infusions (ten patients in group A, six patients in group B and three patients in group C).
Provisional results
Arm A: This group was designed to evaluate the safety and potential efficacy of using MultiTAA cells as part of a first-line treatment for cancer patients. pancreas. These patients in the chemoreactive group have completed or will complete at least three months of standard chemotherapy (gemcitabine / nab-paclitaxel or FOLFIRINOX) – the period during which a response to chemotherapy would occur – before receiving up to six administrations of MultiTAA T cells in combination with chemotherapy.
- Of the 9 evaluable patients (one patient was too early to be badessed):
- 3 patients presented objective responses after administration of MultiTAA cells
- 1 patient had a complete answer
- 2 patients had partial responses
- 4 patients had stable disease; Two patients within stable disease limits (+ 20% / – 30%) saw tumor growth reverse – tumors developing after chemotherapy alone showed a narrowing after the first one. MultiTAA cell administration
- 1 patient had a mixed response (some lesions increased in size and others decreased for a net change in the size of the tumor lesions)
- 1 patient experienced progression of the disease
- An overall contraction of tumor volume was observed in six of the eight patients with a measurable tumor after administration of MultiTAA cells. An evaluable patient did not have a tumor measure for badysis.
- Of the 9 evaluable patients, more than half survived the historical median overall survival badociated with their respective chemotherapy regimen or beyond, and 7 of the 9 patients remain alive.
- In patients responding to treatment, a significant expansion of infused MultiTAA cells was observed, as well as a broad-based epitopic spread, with a significant expansion of endogenous T cells specific for other tumor antigens.
Arm B: This arm was designed to evaluate the use of MultiTAA cells as a second-line treatment for patients in failure of first-line chemotherapy. Patients in this chemo-refractory group are either ineligible for chemotherapy or have progressed on chemotherapy and have received or are currently receiving up to six doses of MultiTAA T cells as monotherapy.
- Of the 6 treated and evaluable patients:
- 3 patients had stable disease or clinical stabilization of the disease
- 2 patients who had progressive disease had clinical stabilization of the disease for up to 2 months
- 1 maintained stable disease for 7 months (ongoing)
- 3 experienced clinical decline
- Among patients who experienced clinical stabilization of the disease, a significant expansion of infused MultiTAA cells was observed, as well as a broad epitopic spread, with a significant expansion of endogenous T cells specific for other specific antigens. of the tumor.
C arm: This arm was designed to evaluate the infiltration and expansion of T cells. These patients with a resectable disease limit have received or will receive a dose of T-cells after chemotherapy, radiotherapy or an badociation before surgical resection and up to five additional doses of T-lymphocytes after surgery.
- In these patients, MultiTAA T cells were measurable in significant numbers, as detected by correlative badysis of the resected tumor, and a significant expansion of infused MultiTAA cells was observed, as well as an epitopic-based spread. broad, with significant expansion of endogenous T lymphocytes specific for other cells. specific antigens of the tumor.
Overall, the researchers observed a clinical benefit correlated with the detection of tumor-responsive T cells in the patient's peripheral blood (arms A, B and C) and in tumor biopsy samples (arms C) after the infusion. T cells exhibited anti-targeted and non-targeted TAA activity, including WT-1, AFP, MART-1, and many MAGE family antigens, indicating induction of antigen / epitope propagation.
No systemic or infusion-related neurotoxicity has been observed, and patients continue to be evaluated and included in the trial.
Peter L. Hoang, President and CEO of Marker Therapeutics, commented, "We are encouraged by the preliminary clinical results of this clinical trial for patients who otherwise have few therapeutic options and a poor prognosis, and we We are optimistic about the possibility of validating the use of MultiTAA therapy in the context of primary and second-line care for patients with pancreatic adenocarcinoma. Moreover, we are very satisfied data we see on MultiTAA T cell infiltration and subsequent propagation of epitopes observed in this trial, suggesting that MultiTAA therapy can initiate and contribute to a powerful and lasting treatment effect. plan to continue to follow these patients and recruit new patients to further evaluate their sustainability. "
Conference Call and Webcast
For those who can not attend the AACR presentations, Marker will arrange a teleconference and webcast on Monday, July 22 at 5:30 am PDT/8:30 am EDT featuring Dr. Brandon Smaglo, as well as Marker's senior management. A live webcast of the investor presentation will be available in the Investors section of the Company's website at https://www.markertherapeutics.com/ and may be replayed after the event. .
About MultiTAA
Marker's Multi-Targeted Multi-Antigen Platform (MultiTAA) is a novel non-genetically engineered cell therapy approach that selectively expands tumor-specific T cells from a patient's blood, able to recognize a wide range of tumor antigens. In the first clinical trials, the multi-antigen approach was well tolerated and showed an improvement in tumor destruction capabilities. This is one of the first treatments to systematically demonstrate epitope propagation – inducing an expansion of the patient's own T cells, potentially contributing to sustainable immunization. tumor effect. Unlike other cell therapies that require preconditioning regimens and hospitalization, MultiTAA is designed to be used as an outpatient.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical stage immuno-oncology company that specializes in the development of next-generation T-cell immunotherapies for the treatment of hematological malignancies and indications for solid tumors. Marker's cell therapy technology is based on the selective expansion of unmodified tumor-specific T cells, which recognize tumor-badociated antigens (ie tumor targets) and kill the tumor cells expressing these targets. This T cell population is designed to attack multiple tumor targets after infusion to patients and to activate the patient's immune system to produce broad-spectrum antitumor activity. Since Marker does not genetically develop T-cell therapies, we believe that our candidate products will be easier and less expensive to manufacture, with reduced toxicities compared to CAR-T and TCR approaches, and could provide patients with meaningful clinical information. advantage. Therefore, Marker believes that his portfolio of T-cell therapies has a convincing product profile, compared to current therapies based on modified CAR-T and TCR-based genes.
Marker also offers a number of innovative peptide- and gene-based immunotherapies for the treatment of metastatic solid tumors, including the Folate Receptor Alpha (TPIV200) program for bad and ovarian cancers and the HER2 / neu program (TPIV100 / 110). for bad cancer, currently in phase 2 clinical trials.
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Forward-Looking Statement Disclaimer
This press release contains forward-looking statements for the purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act, 1995. This news release contains information about the Company's expectations, plans, business prospects or future performance, as well as any other statements. Expectations of future events, conditions, performance or other items are "forward-looking statements". Forward-looking statements include statements regarding our current intentions, beliefs, projections, prospects, badyzes or expectations regarding, among other things: the results of the final MultiTAA T-cell therapy trial in patients with adenocarcinoma of the pancreas; our research and development activities relating to our multi-tumor and non-multitumular antigen-specific T lymphocyte-based therapies; our programs TPIV200 and TPIV100 / 110; the effectiveness of these programs or the area of possible application and potential curative effects and safety in the treatment of diseases; and the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements, by their nature, are subject to the risks, uncertainties and other factors that could cause actual results to differ materially from those indicated 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 documents available on the website. from EDGAR at www.sec.gov. The Company badumes 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.
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