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QSAM Biosciences Inc. (QSAM)

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QSAM Biosciences

9442 Capital of Texas Hwy N
Plaza 1 Suite 500
Austin, TX 78759
United States
512 343 4558
https://qsambio.com 

Sector(s): Healthcare
Industry: Biotechnology
Full Time Employees: 5

QSAM Biosciences SEC Filings https://www.sec.gov/cgi-bin/browse-edgar?CIK=1310527&owner=exclude
QSAM Biosciences Press Releases https://www.globenewswire.com/en/Search?organization=QSAM%20Biosciences%20Inc.
Goldman Small Cap Research Report on QSAM Biosciences, Inc. (QSAM) https://bit.ly/3nGUocI


QSAM Biosciences, Inc. 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? developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc.

CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelant 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 initiated 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.
 


The overall market for Radiopharmaceuticals is expected to exceed US$6.1 billion. The rising prevalence of cancer and cardiovascular diseases are the main factors driving the radiopharmaceuticals market.

QSAM Biosciences, Inc. (“QSAM”) is comprised of industry experts formed to acquire the rights to and seek commercialization of Samarium-153 DOTMP, aka CycloSam®, a bone targeting radiopharmaceutical? from IsoTherapeutics Group.

IsoTherapeutics’ scientists, leaders in the development of radiopharmaceuticals, also developed FDA approved and commercially released Quadramet® (Samarium-153 EDTMP), indicated for pain palliation.

CycloSam® shares the same FDA approved radioisotope as Quadramet®, but utilizes a novel chelate that had demonstrated preliminary increased efficacy and decreased side effects in animal models.

CycloSam® is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis.

The study protocol, Principal Investigator, 1 clinical site and manufacturing plan are all finalized and the clinical trial is ready to commence. Additional sites are proposed to be coming online in the coming months to participate in the clinical trial.

CycloSam® is also cleared by the FDA under a second single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T).

Fifteen (15) patents under prosecution in the US and internationally; two of which have been issued.

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®. that represent a large, multi-billion-dollar market. This includes osteosarcoma, metastatic bone cancers from the breast, prostate and lungs, bone marrow ablation, and the reduction in external radiation. Later this year, QSAM plans to commence a new, multi-site clinical trial in the US to further the development of the therapy. 

 
CycloSam
 

 

 

 

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.

Charles J. Link, M.D. – Medical Director

https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web-150x150.jpg 150w, https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web-200x200.jpg 200w, https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web-300x300.jpg 300w, https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web-400x399.jpg 400w, https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web-600x599.jpg 600w, https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web-768x767.jpg 768w, https://qsambio.com/wp-content/uploads/2021/02/Chuck-Link-Web.jpg 790w" style="border-style:none; box-sizing:border-box; display:inline; float:left; height:auto; margin-right:15px; max-width:100%; vertical-align:top; width:200px">Dr. Link is an accomplished physician scientist and experienced executive with decades of biotech and drug development experience. Previously, Dr. Link founded NewLink Genetics, a NASDAQ-listed immunotherapy company focused on developing novel immuno-oncology product candidates. He served as Chairman, CEO and Chief Scientific Officer of NewLink Genetics until his retirement in 2019. During his tenure at NewLink, Dr. Link led a series of collaborative transactions totaling hundreds of millions of dollars with Merck, Roche and the United States government. He also supervised the collaboration between NewLink and Merck to develop EVERBO, the first and only Ebola vaccine to receive FDA and EMA approval.

Dr. Link has been a practicing oncologist for over 30 years and has authored more than 150 peer-reviewed papers. He is inventor on numerous patents in the field of cancer immunotherapy. He previously received academic funding from the National Institute of Health, the National Cancer Institute, the American Cancer Society, Susan G. Komen Foundation, and others. Dr. Link attended the US Air Force Academy before graduating from the Stanford University School of Medicine. He completed his residency in Internal Medicine at the University of California, San Francisco, and fellowship training in medical oncology at the National Cancer Institute in Bethesda, Maryland, where he also served as an attending physician.

He also currently serves on the Board of Directors at NovaScan Inc., a clinical-stage company focused on cancer detection; and is the founder and President of biotech startup Syncromune.

Barry Sugarman – Senior Advisor

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.

R. Keith Frank, Ph.D. and Jim Simon, Ph.D. – Scientific Advisory Board

Keith Frank

Dr. R. Keith Frank

Dr. Jim Simon

Dr. Jim Simon
 
Charles J. Link Jr, M.D. - Board of Directors and Medical Director

Dr. Link brings decades of biotech and drug development experience to QSAM. He currently serves on the executive committee of the Board of Directors at NovaScan Inc., a clinical-stage company focused on cancer detection; and is the founder and President of biotech startup Syncromune. Previously, Dr. Link was the CEO, CSO, Chairman, and founder of NewLink Genetics, a NASDAQ-listed immunotherapy company focused on developing novel immuno-oncology product candidates.

During his tenure at NewLink, Dr. Link led a series of collaborative transactions totaling hundreds of millions of dollars with Merck, Roche and the United States government. He also oversaw the collaboration with Merck to develop EVERBO, the first Ebola vaccine to receive FDA approval.

Prior to founding NewLink Genetics, Dr. Link was an attending physician at the National Cancer Institute. He has authored more than 150 peer-reviewed papers. He previously received funding from the National Institute of Health, the National Cancer Institute, the American Cancer Society, and others. Dr. Link received an M.D. from Stanford University, and he attended the Air Force Academy.
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QSAM News: QSAM Biosciences Inc. reports Q1 results 05/25/2021 09:42:32 AM
QSAM News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 05/17/2021 04:10:21 PM
QSAM News: Current Report Filing (8-k) 04/20/2021 04:01:03 PM
QSAM News: Annual Report (10-k) 04/15/2021 04:29:30 PM
QSAM News: Notification That Annual Report Will Be Submitted Late (nt 10-k) 04/01/2021 06:02:26 AM
PostSubject
#715  Sticky Note in addition to a Payroll Protection Program ChuckFinley305 05/26/21 07:44:51 AM
#557  Sticky Note WHY I THINK QSAM HAS A BRIGHT FUTURE! RandyKCMO 10/26/20 10:45:39 PM
#729   The Dr.s on board have gone through FDA copleybmt 07/26/21 02:37:55 PM
#728   congrats Nice move I also bought heavy after copleybmt 07/26/21 02:34:19 PM
#727   Yeah I think the time for building a RandyKCMO 07/26/21 11:02:34 AM
#726   Agreed. Before and After the reverse I had RandyKCMO 07/26/21 11:01:36 AM
#725   This wound so tight I can feel it copleybmt 07/26/21 10:57:26 AM
#724   Randy we seem to find a few gems copleybmt 07/26/21 10:53:19 AM
#723   I agree paper drying up or gone! copleybmt 07/26/21 10:48:30 AM
#722   Must be close to getting IND cleared through Wrangler1 07/26/21 10:40:09 AM
#721   I think you’re right. QSAM is found a RandyKCMO 07/17/21 09:44:23 PM
#720   Looks as if the paper has been eaten copleybmt 07/16/21 02:28:55 PM
#719   When you realize this is a tradable company ChuckFinley305 07/02/21 07:27:06 AM
#718   Someone wake this stock up Rip Van Sleeper! copleybmt 06/08/21 01:51:55 PM
#717   I was bid shopping to clean up the copleybmt 05/26/21 08:26:10 AM
#716   This aged well... stock price was $0.85 ChuckFinley305 05/26/21 08:04:01 AM
#715   in addition to a Payroll Protection Program ChuckFinley305 05/26/21 07:44:51 AM
#714   QSAM Biosciences Issues Letter from CEO on Successful Televet 05/25/21 05:15:38 PM
#713   Agreed... Tell progress being made on a drug RandyKCMO 05/19/21 08:41:10 AM
#712   The high dosage medicine VERSES the side effect copleybmt 05/18/21 04:06:42 PM
#711   No doubt they could benefit kids and anyone Wrangler1 05/17/21 04:28:07 PM
#710   I took your advice and reached out to Notabadguy 05/17/21 03:42:54 PM
#709   It looks like there are one or two Notabadguy 05/17/21 03:36:53 PM
#708   Thanks for the input. Good to hear. Is Wrangler1 05/14/21 11:36:04 AM
#707   I looked at the product and the people copleybmt 05/14/21 10:47:36 AM
#706   tired of waiting I slapped the ask. copleybmt 05/14/21 10:46:53 AM
#705   If you have any questions, recommend reaching out Wrangler1 05/12/21 12:32:57 PM
#704   https://www.linkedin.com/in/davidkugelman/ Televet 05/12/21 04:29:22 AM
#703   Thanks. I own quite a few shares. Televet 05/12/21 04:07:53 AM
#702   Had some back and forth email communication with Wrangler1 05/11/21 12:28:50 PM
#701   I put up a fat bid for anyone copleybmt 05/10/21 03:12:54 PM
#700   Whoa! QSAM Biosciences Announces Submission of IND Application Notabadguy 05/04/21 10:02:34 AM
#699   I'm very optimistic near-term. Even more optimistic longer term. Notabadguy 04/29/21 04:33:29 PM
#698   Time to load up here at $0.40. Notabadguy 04/29/21 12:05:48 AM
#697   Dr. Burt, a world renowned stem cell and Wrangler1 04/28/21 01:19:09 PM
#696   $QSAM Biosciences Appoints Richard K. Burt, M.D., Rob~daBanca 04/28/21 09:54:40 AM
#695   Thanks Solong!! I missed this newfound released. It's RandyKCMO 04/19/21 08:19:58 PM
#694   $QSAM - letter out from the CEO solong 04/19/21 09:41:07 AM
#693   Sounds like a winning strategy. I've done the same. RandyKCMO 04/11/21 08:21:39 PM
#692   So don't buy the stock? If you really Notabadguy 04/11/21 08:16:40 PM
#690   For those who want to ignore the man ChuckFinley305 04/01/21 08:23:54 AM
#689   Thanks. It's seems he's finally putting his credentials RandyKCMO 03/23/21 12:52:11 AM
#688   36 is considerably higher than "4 or 5".. ChuckFinley305 03/22/21 01:06:37 PM
#687   BRIEF-Sun Pacific Holding Corp Announces MOU With Atlas bunda 03/21/21 11:58:28 AM
#686   Not sure about your math. I counted 36 RandyKCMO 03/17/21 08:24:52 PM
#685   Not sure about your math. I counted 36 RandyKCMO 03/17/21 08:24:50 PM
#684   Stock is down 10% on the largest trading ChuckFinley305 03/17/21 05:18:42 PM
#683   Visit there or call. You can't talk to ChuckFinley305 03/17/21 05:16:15 PM
#682   I just pulled this off their website. SageCaptain 03/17/21 02:35:50 PM
#681   QSAM keeps adding links into the chain to RandyKCMO 03/17/21 12:37:44 PM
#680   News Release Today: QSAM Biosciences Seeks to Expand RandyKCMO 03/17/21 12:35:12 PM
#679   4 or 5? I count 50 on the ChuckFinley305 03/17/21 09:47:18 AM
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