Marker Therapeutics Inc (MRKR) has seen a boost of 13.15% in premarket today following the announcement that the company received FDA Orphan Drug Designation. However, the last trading session concluded at $0.8396 with a decrease of 2.69%.
FDA Orphan Drug Designation – All About it
MRKR announced on 19th January 2022 that MT-601 has been given Orphan Drug designation. Marker created MT-601 which is a novel medicine that targets six tumor-associated antigens that are significantly expressed in pancreatic cancer. Moreover, the company plans to start a Phase 1 multicenter research of MT-601 in patients with locally advanced unresectable or metastatic pancreatic cancer who are receiving front-line chemotherapy. The research will recruit 20 to 25 patients and will comprise an initial antigen escalation phase followed by a dosage escalation period, according to Marker. In 2022, the company expects to submit an IND for MT-601 for the treatment of pancreatic cancer.
Appointment of Biotech Executive Katharine Knobil – How’s the decision?
On 9th December 2021, MRKR reported the appointment of Biotech Executive Katharine Knobil. Dr. Knobil is the Chief Medical Officer of Agilent Technologies, Inc. at the moment. She was formerly the Chief Medical Officer and Head of Research & Development at Kaleido Biosciences, Inc. before joining Agilent.
Not only this but she also worked at GlaxoSmithKline plc for 20 years, holding different leadership positions until becoming Chief Medical Officer. She graduated from Cornell University with a B.A. in Biology and an M.D. from the University of Texas Southwestern. Lastly, she is now a member of the Arena Pharmaceuticals, Inc. Board of Directors.
The company is delighted to welcome Dr. Knobil to the Marker Board of Directors. Her vast leadership expertise in the clinical development of innovative treatments, including 20 years at GlaxoSmithKline plc, will benefit Marker as the Company moves forward with its revolutionary cell therapies in the clinic. Last but not the least, Dr. Knobil’s advice and knowledge will be invaluable to the company.
Third Quarter 2021 results – How was the quarter?
MRKR reported third-quarter 2021 results on 10th November 2021. The company reported $48.7 million in cash and cash equivalents and research and development expenses came out to be $6.8 million. Not only this but the general and administrative expenses totaled $3.2 million, more than $2.6 million for the quarter ended September 30, 2020. Lastly, the company reported a net loss of $12.4 million.
The first patient in Marker’s Phase 2 AML trial has been dosed with the study medication. Furthermore, the company aims to enroll the trial’s first 20 patients in the fourth quarter, with the first data readout in the first quarter of 2022. Early next year, the company plans to hold a conference call and webcast to provide year-end updates.