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QSAM Biosciences Inc. (QSAM)

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Last Post: 5/19/2022 11:40:45 AM - Followers: 16 - Board type: Free - Posts Today: 2

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

"" rel="nofollow" target="_blank">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: Current Report Filing (8-k) 05/17/2022 05:01:32 AM
QSAM News: Withdrawal of Registration Statement (rw) 05/17/2022 02:04:50 AM
QSAM News: Quarterly Report (10-q) 05/16/2022 12:10:03 PM
QSAM News: QSAM Biosciences files to uplist shares to Nasdaq, hold $12M IPO 04/04/2022 01:29:31 PM
QSAM News: Securities Registration Statement (s-1/a) 04/04/2022 03:01:40 AM
PostSubject
#875   Still fresh today. see dates of Chucks accurate post. bobbyknobb 05/19/22 11:40:45 AM
#874   IMAC is a winner in this space. qsam bobbyknobb 05/19/22 11:39:12 AM
#872   GREETINGS!! well kids currently crashed down 15%. bobbyknobb 05/17/22 02:10:38 PM
#871   HOWDY !!! CURRENTLY CRASHED DOWN ONLY 29%. after bobbyknobb 05/16/22 02:57:30 PM
#870   Hey Chuck...good post. so currently this pump and bobbyknobb 05/05/22 02:43:20 PM
#869   Hey Bobby don't forget, this is the second ChuckFinley305 04/23/22 12:28:44 PM
#868   ok OK 1 share given....40 taken RS. You bobbyknobb 04/21/22 01:12:46 PM
#867   QSAM Biosciences, Inc. – Follow-On Offering Televet 03/21/22 07:22:05 PM
#866   https://www.otcmarkets.com/filing/conv_pdf?id=15647553&guid=moFwkKDQe9wOB3h Televet 03/21/22 07:20:30 PM
#865   QSAM one for 40 reverse split: Renee 03/09/22 06:33:39 PM
#864   Nice Fai 2 02/02/22 11:53:39 AM
#863   $QSAM Very big step today. Priority Review Vouchers, Wrangler1 02/02/22 09:26:19 AM
#862   https://finance.yahoo.com/news/qsam-biosciences-receives-rare-pediatric-13300062 Wrangler1 02/02/22 09:21:12 AM
#861   I understand your negative bias. Losing money leaves RandyKCMO 01/12/22 10:56:55 AM
#860   A reverse split of 20:1 would be required ChuckFinley305 01/12/22 07:32:01 AM
#859   I believe they stated that the reverse would RandyKCMO 01/11/22 04:28:17 PM
#858   Reverse split to get the share price higher, ChuckFinley305 01/11/22 03:03:12 PM
#857   Hi Randy, Televet 01/06/22 11:55:56 PM
#856   Management Authorized to do reverse split in conjunction RandyKCMO 01/06/22 08:21:34 PM
#855   Down on a 100,000+ share trades.. back up ChuckFinley305 12/28/21 01:00:18 PM
#854   MARKETS AT RECORD HIGHS. this just lost 1/3rd. bobbyknobb 12/27/21 05:49:53 PM
#853   Thanks for posting… I hadn’t seen this. I’ve RandyKCMO 12/18/21 09:18:13 PM
#852   I have family long in this one.. GLTA Newdie999 12/17/21 05:51:23 PM
#851   4:57 pm ET *DJ QSAM Biosciences, Now on Newdie999 12/17/21 05:44:11 PM
#850   News on TOS Platform after the bell... Newdie999 12/17/21 05:41:38 PM
#849   Guess that means we are officially have a RandyKCMO 12/02/21 08:32:50 PM
#848   QSAM Biosciences Activates Clinical Sites and Opens Enrollment Televet 12/02/21 05:53:12 AM
#847   Looks like they just sold off $555,000 of ChuckFinley305 11/16/21 06:40:17 AM
#846   There is a difference between not being successful ChuckFinley305 11/16/21 06:32:49 AM
#845   Must have been the other mod then. ChuckFinley305 11/16/21 06:26:18 AM
#844   Your theory is pretty clear. Chris Nelson RandyKCMO 11/12/21 01:05:21 PM
#843   So yes... the previous company has been rescued... RandyKCMO 11/12/21 12:57:53 PM
#842   I have no idea what you're talking about. RandyKCMO 11/12/21 12:35:00 PM
#841   I see you removed the Chris Nelson information ChuckFinley305 11/12/21 08:02:08 AM
#840   Randy, Cyclone also had what seemed like a very ChuckFinley305 11/12/21 07:58:04 AM
#839   Good stuff Randy. I spoke with Chris Televet 11/12/21 04:37:21 AM
#838   WAIT... THERE'S MORE!! R.KEITH FRANK RandyKCMO 11/11/21 01:34:35 PM
#837   Any Slouches? nope NOT HERE>>> Barry Sugarman is RandyKCMO 11/11/21 01:32:46 PM
#836   Yes, there's more... Dr. Charles J Link is RandyKCMO 11/11/21 01:30:43 PM
#835   Want some more talent... well here's more: C. RandyKCMO 11/11/21 01:28:48 PM
#834   For Example: Douglas R. Baum has 28+ years RandyKCMO 11/11/21 01:27:52 PM
#833   The website details the new officers and board RandyKCMO 11/11/21 01:26:33 PM
#832   If you visit QSAM's website and read what RandyKCMO 11/11/21 01:24:59 PM
#831   Decided to re-establish a position in QSAM. I RandyKCMO 11/11/21 01:18:37 PM
#830   Greeting ya' all. How's it goin. Well bobbyknobb 11/11/21 03:12:45 AM
#829   How did your talk go with management? Would Wrangler1 11/05/21 02:36:24 PM
#827   0.29 ? -0.02 (-6.45%) ChuckFinley305 11/04/21 03:26:19 PM
#826   I highly doubt he will even get to ChuckFinley305 11/04/21 10:33:01 AM
#825   Greetings Televet, Please ask C. Nelson about bobbyknobb 11/03/21 09:08:20 PM
#824   Greetings Televet, Please ask C. Nelson about bobbyknobb 11/03/21 09:08:16 PM
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