QSAM BIOSCIENCES INC Stock Price, News & Analysis

QSAM Biosciences (OTCQB: QSAM) announced a clinical milestone with the commencement of treatment for the first patient in its Phase 1 trial evaluating CycloSam® for metastatic bone cancer. The trial aims to assess safety, tolerability, and preliminary efficacy after receiving FDA clearance for its Investigational New Drug (IND). CycloSam® targets both primary and secondary bone cancer and was developed to provide better treatment options for patients with limited prognosis. The company emphasizes the urgency of addressing this significant medical need.

QSAM Biosciences has announced a significant milestone with the Japan Patent Office granting a patent for its treatment technology utilizing Samarium-153-DOTMP (CycloSam^®) for bone cancer in children and adults. This patent enhances QSAM's growing intellectual property portfolio, now totaling 14 patents across three families. The patented method improves dosing regimens by reducing impurities, potentially increasing clinical efficacy in treating both primary and metastatic bone cancers. QSAM is currently advancing its FDA-cleared Phase 1 clinical trial for CycloSam^®.

QSAM Biosciences, Inc. announced a 1-for-40 reverse stock split effective March 10, 2022, approved by its Board of Directors. This action aims to facilitate the company's application for listing on the NASDAQ Capital Market. Post-split, the outstanding shares will reduce to approximately 1,686,321, excluding additional convertible shares. A new CUSIP number will be assigned, and a 'D' will be added to the ticker symbol for 20 business days. No fractional shares will be issued, and stockholders are advised to consult their brokers for further details.

QSAM Biosciences has received Rare Pediatric Disease Designation from the FDA for its clinical-stage drug, CycloSam, aimed at treating osteosarcoma, a severe bone cancer primarily affecting children and young adults. This designation may expedite market access, providing potential incentives, including a Priority Review Voucher upon FDA approval. QSAM also holds Orphan Drug Designation for CycloSam, which offers additional benefits, such as tax credits and seven years of market exclusivity if approved. The company plans a clinical trial focused on primary bone cancers in the upcoming year.

On January 25, 2022, QSAM Biosciences announced the appointment of Adriann Sax to its Board of Directors. Ms. Sax, with over 30 years in biotech, will also serve on the Audit Committee and chair the Nomination and Governance Committee. Previously, she held leadership roles at Kadmon Corp and Bristol Myers Squibb, showcasing her experience in oncology. Executive Chairman C. Richard Piazza expressed confidence in Sax’s contribution to QSAM's value and growth. Sax aims to leverage her expertise to further QSAM's goals, focusing on the potential of its CycloSam® technology in treating bone cancer.

QSAM Biosciences Inc. has activated its first clinical trial site and begun patient enrollment for a Phase 1 trial of CycloSam®, targeting multiple bone cancer types. The trial's objective is to establish the maximum tolerated dose and evaluate early efficacy indicators. Around 400,000 new cases of malignant bone metastasis are reported annually in the U.S. with a notable lack of advancements in primary bone cancer treatments over 40 years. CycloSam® has received Orphan Drug Designation for osteosarcoma, highlighting its potential for significant impact.

QSAM Biosciences has received FDA clearance for its investigational new drug (IND) application, allowing it to initiate Phase 1 clinical trials for CycloSam, a novel treatment for bone cancer. This marks a significant milestone for the company, which aims to establish the optimal dosage for future pivotal Phase 2/3 trials. CycloSam is designed to deliver targeted radiation to treat primary and secondary bone cancers, leveraging advanced manufacturing and chelation technologies. QSAM is positioned to advance its pipeline in oncology, validating its approach in drug development.

QSAM Biosciences has received FDA approval for Orphan Drug Designation of CycloSam® for treating osteosarcoma. This designation offers seven years of market exclusivity, crucial given the high unmet need for effective treatments in this area, particularly for children and young adults. CycloSam is anticipated to improve patient outcomes through a novel radiopharmaceutical approach. The company emphasizes its commitment to advancing oncology drug development as a means to provide better therapeutic options for patients suffering from osteosarcoma.

QSAM Biosciences has secured patents in Japan and Canada for its innovative technology, CycloSam®, which uses high purity Samarium-153 for cancer treatment. This follows a similar patent granted by the USPTO last year. The patents cover low specific activity Samarium-153, which minimizes impurities, enhancing the potential for efficient production and delivery. Douglas R. Baum, CEO, highlighted the significance of expanding their intellectual property portfolio, which now includes 15 patents across three families, positioning CycloSam® as a promising therapy for bone cancer.