About QSAM

QSAM Therapeutics, Inc. (“QSAM”), a wholly-owned subsidiary of QSAM Biosciences, Inc. (OTCQB: QSAM), is developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions.

QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical​ from IsoTherapeutics Group, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation.

CycloSam® has already demonstrated safety and efficacy in animal studies and a human trial performed at the prestigious Cleveland Clinic. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelate that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.

CycloSam® is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020.

What is CycloSam®?

CycloSam® is a bone seeking therapy designed to safely and specifically deliver targeted radiation therapy in the form of the radioisotope Samarium-153 (Sm-153) to areas of bone formation by employing the proposed superior chelant (a molecule that binds to positively charged metal ions) — DOTMP.

  • Sm-153 emits beta and gamma radiation and kills nearby cancer cells​
  • Unlike other radiopharmaceuticals on the market, CycloSam® uses DOTMP, a proposed superior chelant to EDTMP used with Quadramet®
  • CycloSam® uses the same Sm-153 radioisotope as Quadramet®, an FDA-approved and commercially released drug, but due to the proposed improved chelant, efficacy and safety are expected to be significantly improved.

Initial research has identified four initial potential indications for CycloSam®.

CycloSam

CycloSam® Indications

QSAM Leadership Team

The QSAM leadership team is made up of experts in the pharmaceutical, biotech, and medical devices industries.

Douglas BaumDouglas R. Baum has 28+ years of experience serving in a number of executive management and business development positions within the drug development and life sciences industries. Currently, he serves as the CEO, President and Director of QSAM and its subsidiary, QSAM Therapeutics, Inc., a company he co-founded in 2019. QSAM is an Austin, Texas based clinical stage specialty pharmaceutical company developing a pipeline of radiopharmaceuticals focused on various bone and solid tumor cancers.

Previously, Doug was the President and CEO of Xeris Pharmaceuticals Inc. (NASDAQ: XERS) a specialty pharmaceutical company focused on developing drugs for diabetes and related metabolic diseases. Prior to Xeris he served as the COO of MacuCLEAR, a specialty pharmaceutical company developing novel treatments for retinal diseases of the eye. Prior to MacuCLEAR, Doug served as the Vice President, Global Corporate Development at Premier Research Group (PRG), Inc. a global contract research organization serving the pharmaceutical, biotechnology and medical device industries. In 2007 PRG acquired SCIREX Corporation where Doug served as Executive Vice President & General Manager, Early Drug Development. He also serves on the Board of Directors of Regent Technologies, Inc. and previously served on the boards of Xeris, MacuCLEAR, Halsa Pharmaceuticals, Inc. and the Texas Medical Device Alliance.

Doug obtained his Bachelor’s of Business Administration degree and his Master’s of Science in Technology Commercialization degree from the University of Texas at Austin.

C. Richard PiazzaC. Richard Piazza, Ph.D. is a career healthcare executive with 48 years of experience in medical devices as well as the pharmaceutical/biotechnology sectors. Included in this is 44 years in general management positions in both public and private international companies including Ohmeda, Smith & Nephew Pharmaceuticals, Marquest & VitaGen (world’s first bioartifical liver). In 2019 he co-founded QSAM Therapeutics, Inc. with Doug Baum and currently serves as its Executive Chairman.

Richard has gained a reputation of not only introducing new technologies and driving them to success but recruiting and motivating “world class,” highly focused management teams. In addition to a highly successful business career, Richard has served on industry association boards & committees (Advamed, Biocomm, BioHouston etc.) and was an industry representative working with the FDA and the Congress to craft the FDA Modernization Act for Medical Devices. His Board experience also includes numerous directorships and Chairman roles in both public and private healthcare companies. In addition to industry affiliations, Richard remains committed to working with well-known medical pioneers to identify and advance new technologies. He acts as an advisor to some of world’s leading institutions. These include MD Anderson Cancer Center, Baylor College of Medicine, University of California San Diego, University of Chicago & Kings College Hospital (London.) Richard has been a guest Lecturer in Sales & Marketing strategy at numerous Universities including Rice University School of Management, UCLA, University of Wisconsin, CAL Tech-MIT forum, University of British Columbia & University of California San Diego.

Richard obtained a BS in Economics and a BS in Speech Pathology from the State University of New York and MA & PhD in Economics from the University of Buffalo and Leeds University.

Barry SugarmanBarry Sugarman is a Senior Executive Generalist with over 30 years of experience spanning public and private companies in the pharmaceutical, medical device, dietary supplement, and cosmetic industries. Barry has considerable direct experience in pharmaceutical product development, manufacturing, clinical trials, regulatory affairs, FDA and government relations, marketing, and distribution.

Barry possesses broad experience in clinical trial operations and management, mergers, acquisitions, turnarounds, startups, reorganization, process improvements, and sales management and a very strong knowledge of Good Manufacturing Practices (GMP’s), Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), and International Conference for Harmonization (ICH) requirements. He is an author and co-author of numerous FDA filings and approvals including Investigational New Drug Applications (IND’s), New Drug Applications (NDA’s), Abbreviated New Drug Applications (ANDA’s), and Medical Device Applications 510(k)’s.

Barry is a member of the Regulatory Affairs Professional Society (www.raps.org), American Association of Pharmaceutical Scientists (www.aaps.org), Association of Clinical Research Professionals (www.acrpnet.org), and the National Association of Corporate Directors (www.nacdonline.org). He is a co-author of “Prompt, Accurate Diagnosis of Pediatric Cancer and Leukemia for Pediatricians, Orthopedists, and Family Practitioners” – Paperback (Aug. 28, 2007) by Andrew Pendleton, Jennifer Minigh, Lainie Shapiro, and Barry Sugarman.

Keith Frank

Dr. R. Keith Frank

Dr. Jim Simon

Dr. Jim Simon
  • Over 30 years experience each with Dow Chemical leading R&D efforts in Radiopharmaceuticals & Chelators
  • Developed Quadramet®
  • Founded IsoTherapeutics in 2005 performing contract R&D for Big Pharma with emphasis on radiolabeling
  • Authored/co-authored more than 100 scientific papers & publications
  • Recognized as leading authorities in radiopharmaceuticals
  • 60+ Patents
  • Internationally recognized experts in radiopharmaceuticals
  • Extensive interaction with research institutions, investigators and hospitals