|Over a month ago|
Marker Therapeutics to establish cGMP manufacturing facility in Houston, TX » 07:0606/3006/30/20
Marker Therapeutics announced that it has executed a lease agreement to establish a cGMP manufacturing facility in Houston, TX, in an area near the George Bush Intercontinental Airport. The facility will allow production according to U.S. FDA guidelines and is designed to be scalable using modular processes. The facility is expected to be completed by year-end and operational in 2021. The facility has approximately 48,500 feet and will provide space for clinical manufacturing and quality functions upon completion. Marker will continue to manufacture its MultiTAA-specific T cell therapy at the Baylor College of Medicine to support the company-sponsored AML trial until the in-house cGMP manufacturing facility is operational.
Marker Therapeutics announces USAN approves zelenoleucel as generic name » 07:0206/2306/23/20
Marker Therapeutics announced that the U.S. Adopted Names, or USAN, Council has approved "zelenoleucel" as the nonproprietary name or generic for MT-401, a multi-tumor-associated antigen, or MultiTAA,-specific T cell product candidate for the treatment of patients with acute myeloid leukemia following allogeneic stem cell transplant in both adjuvant and active disease settings. "The USAN approval of zelenoleucel as the generic name for MT-401 is another step forward for continued advancement of our therapy," said Peter L. Hoang, President & CEO of Marker Therapeutics. "MT-401, which received Orphan Drug designation from the U.S. FDA in April, has shown clinical benefit in patients with acute myeloid leukemia post stem cell transplant in an investigator-sponsored trial. We are excited about the continued clinical development of zelenoleucel and look forward to initiating our Company-sponsored Phase 2 study in patients with AML following transplant."
Marker Therapeutics reports results from MultiTAA-specific T cell therapy » 08:1605/2905/29/20
Marker Therapeutics announced updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the company's MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma. Between June 2018 and December 2019, 13 patients have been treated, each of whom received up to 6 monthly infusions of 1x107 MultiTAA-specific T cells/m2 in conjunction with ongoing first-line chemotherapy and without prior protocol-associated lymphodepletion. For 12 of the 13 patients, sufficient cells for all six planned doses were generated; two doses were available for the remaining patient. Out of the 13 evaluable patients: 4 patients experienced objective responses after administration of MultiTAA cells; 1 patient experienced a radiographic complete response occurring at month 9 after starting chemotherapy; 3 patients experienced partial responses per RECIST occurring at 6-9 months after starting chemotherapy;6 patients experienced stable disease; 1 patient experienced a mixed response (some lesions increased in size and others decreased for a net zero change in size of tumor lesions); 2 patients experienced disease progression; For 9 of the 13 patients, the cancer was controlled for a period longer than historical controls relative to the type of chemotherapy used; 5 patients enrolled in the study were not administered MultiTAA-specific T cells, either because of disease progression (4 patients) which made them ineligible for treatment, or because insufficient starting material from the patient was available for manufacturing (1 patient); Evidence of epitope-spreading was observed in all responders, suggesting that the MultiTAA T cell therapy triggered the recruitment of a broader endogenous immune system response for improved anti-tumor activity; No infusion-related reactions, cytokine release syndrome or neurotoxicity was observed.
Fly Intel: Top five analyst downgrades » 10:1305/1205/12/20
CNP, ON, MRKR, QDEL, ALB
Catch up on today's…
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. CenterPoint Energy (CNP) downgraded to Neutral from Buy at Goldman Sachs with analyst Insoo Kim saying the company's $1.4B private placement announced last week quelled its equity needs, but he is concerned that the upfront share dilution and the demand impact related to COVID-19 will see the utility's annualized earnings growth rate through 2022 below its 5%-7% target range. 2. ON Semiconductor (ON) downgraded to Outperform from Strong Buy at Raymond James with analyst Chris Caso citing March quarter results. 3. Marker Therapeutics (MRKR) downgraded to Neutral from Overweight at Piper Sandler with analyst Edward Tenthoff saying Marker has delayed the initiation of the safety lead-in of the Phase II acute myeloid leukemia study of MultiTAA with the legacy reagent in three patients. 4. Quidel (QDEL) downgraded to Underweight from Neutral at JPMorgan with analyst Tycho Peterson saying ith the shares trading at a 34.6 times 2021 price-to-earnings ratio, Quidel's valuation more than factors in a best case scenario. 5. Albemarle (ALB) downgraded to Neutral from Buy at Goldman Sachs with analyst Robert Koort saying with the growing ramifications of the COVID-19 pandemic, the anticipated ascension of the lithium cycle will be further delayed. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
Marker Therapeutics downgraded to Neutral from Overweight at Piper Sandler » 04:5405/1205/12/20
Piper Sandler analyst…
Piper Sandler analyst Edward Tenthoff downgraded Marker Therapeutics to Neutral from Overweight with a price target of $2.50, down from $5. Marker has delayed the initiation of the safety lead-in of the Phase II acute myeloid leukemia study of MultiTAA with the legacy reagent in three patients, Tenthoff tells investors in a research note. The analyst cites further study delays for the downgrade.
Marker Therapeutics reports Q1 EPS (14c), consensus (11c) » 16:2105/1105/11/20
At March 31, Marker had…
At March 31, Marker had cash and cash equivalents of $40.3M. The company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into Q2 of 2021.
|Over a quarter ago|
Marker Therapeutics' Acute Myeloid Leukemia candidate designated Orphan Drug » 16:2304/2904/29/20
Marker Therapeutics' MT-401, a multi-tumor-associated antigen-specific T cell product for the treatment of patients with acute myeloid leukemia has been granted Orphan Drug designation by the FDA's Office of Orphan Products Development.
Fly Intel: Pre-market Movers » 09:0404/1304/13/20
ATHX, MRKR, MUR, BCRX, BA, TXN, ACB, NXPI, CAT
Check out this morning's…
Marker Therapeutics receives EUA from FDA for D2000 Adsorption Cartridge » 08:3004/1304/13/20
Terumo BCT and Marker…
Terumo BCT and Marker Therapeutics announced that the FDA has issued Emergency Use Authorization, or EUA, for the use of Terumo BCT's Spectra Optia Apheresis System combined with Marker Therapeutics' D2000 Adsorption Cartridge to treat patients 18 years of age or older with confirmed coronavirus admitted to the intensive care unit, or ICU, with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels. The devices work together by reducing the number of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell's immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a "cytokine storm" that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
Marker Therapeutics sees cash runway extending beyond 2Q21 16:0903/1203/12/20