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written by reader Questions for Doc KSS

By, July 20, 2015

Guys: Lots of people are asking KSS questions, which he’s keen to answer. But tracking/remembering them all, without constantly re-reading the whole thread, is bustin’ his balls. So the below aims to act as a queuing list. Write it up and post your associated links to assist his research. The better the starter info, the more likely an answer.
Please also help the process by reminding others who post q’s on the main bio threads, that if they want an answer, this is the place to post or likely he will NEVER respond.

This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.



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7 years ago

$TGXSF Tigenix – a Brussels based Biotech.

They have a Phase III trial for Cx601 an adipose-derived allogeneic stem cell suspension for the treatment of complex perianal fistulas in Crohn’s disease patients.

Phase II. Cx611 is an intravenous injection of allogeneic expanded adipose-derived stem cells (eASC’s) in development for the treatment of early rheumatoid arthritis and for severe sepsis.

As always, the science is over my head, but it does look interesting.

Institutional Holdings
Grifols S.A. / Gri-CEL S.A. 34,188,034 21.30%
Novartis AG/Novartis Bioventures Ltd 5,534,905 4.55%
Roche Holding AG/Roche 3%

Analyst Report
Marketing Request to EMA

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👍 1261
7 years ago

Not a question, but a follow up to a post earlier (and a mention in another) on Honig and Blauser, 2 punks that attach themselves by whatever means to many Frost plays. These two are responsible for the losses I’ve suffered in 3 of the 7 Frost plays I’ve been involved with over the years.

A hit piece in SA just destryed IDI today to the point it may not recover. How much of the aricle is fact? No way for me to know, but I run away anymore, like a scalded dog when I smell their fetid prescence show up around my “stuff”.

“IDI: Strong Sell On Fraud Lawsuits, Bankruptcy And Technology Failure, -92.4% Downside – IDI, Inc. (NYSEMKT:IDI) ”

IDI: chart

👍 778
7 years ago

Immusoft Corp
Programming Cells to Cure Disease.
I have gained much from Dr. Kss’s writings and Gummie chats on the GS boards. Although I have a technical background, it is from a more mundane field of engineering, I do not have the skills to assess the technological merits of this prospect, or any biotech for that matter, the main reason you do not hear much from me here.
However, I attended an interesting presentation by Immusoft, an (very) early stage company last week. The website provides links to the company resources, technology and pipeline status.
If the technology/prospect checks out, it may be an appropriate target for a Gummie early stage investment at pre IPO via convertible debentures or such vehicle… some Gummie interest in identifying such opportunities in thread chat last week. I would certainly be interested in participating.

This is from the Immusoft website:
Immusoft’s mission is to develop a breakthrough autologous cell therapy platform for treating a variety of human diseases through our proprietary Immune System Programming (ISP™) technology. ISP™ technology can effectively re-programming a patient’s own cells to become miniature drug factories in the body. The technology was designed to address current challenges faced with the production and delivery of conventional protein therapeutic drugs (biologics). The ISP™ platform enables safe insertion of genes encoding the correct human homolog of a missing or defective protein(s) into a patient’s immune cells using the Sleeping Beauty (SB) transposon system – a non-viral vector.
For decades, researchers have focused on gene therapy approaches to treat human diseases. Engineering viruses to insert or replace missing or defective genes with functional copies has been commonplace. However, engineered viruses require significant modification to efficiently infect target cell types, may be difficult to produce in the quantities needed for therapeutic use, most viruses’ have payload limitations, and are subject to immune clearance if seen as immunogenic (foreign to the body). Gene therapy involving viral transduction continues to be associated with real or perceived safety issues for therapeutic use in humans.
Immusoft’s ISP™ platform technology is hybrid cell/gene therapy approach, which uses a clinically validated, non-viral vector for safe, reliable insertion of functional genes into immune cells. Once administered back into the patient, a subset of ISP™ modified cells reside within survival niches in the body, continuously secreting gene-encoded protein(s). The platform’s broad utility to produce virtually any biologic drug entity, i.e. antibodies, proteins or enzymes, has the potential to disrupt the current standard of care for many diseases requiring recombinant enzyme replacement therapy, as well as, address orphan diseases with very small patient populations.

I have the slide deck from the presentation that I attended in pdf format if there is interest and a way up uploading or linking pdf’s to the Board.

I would be most interested and appreciative of Dr. KSS’s thoughts on this prospect. It’s in the queue and hopefully the good Dr. may find a moment to take a look.

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👍 24
7 years ago


MacroGenics has a diverse portfolio of product candidates focused in three therapeutic areas: oncology, autoimmune disorders and infectious diseases.

In oncology, MacroGenics is conducting Phase 2 clinical development of MGAH22 (or margetuximab). MGAH22 is the first Fc-modified anti-cancer mAb produced from the company’s proprietary Fc optimization technology and targets tumors that over-express the HER2 oncoprotein, potentially including breast, bladder and gastric cancers. In mid-2011, MacroGenics began clinical development of its second anti-cancer mAb, MGA271, which recognizes a novel target (B7-H3), which is expressed on several solid tumor types. MGA271 is a humanized, Fc-optimized mAb that is being studied for the treatment of multiple solid tumors, potentially including prostate, renal and pancreatic cancers as well as melanomas. MacroGenics’ earlier stage oncology pipeline includes multiple programs for which the company expects to select clinical development candidates over the next several years.

The company’s lead autoimmune program, teplizumab, is an anti-CD3 antibody being developed for the prevention and treatment of early onset type 1 diabetes. In June 2011, MacroGenics announced the publication in The Lancet of results from Protégé, a Phase 3 clinical study of teplizumab in type 1 diabetes. Exploratory, post-hoc analyses suggest that teplizumab, an anti-CD3 monoclonal antibody, when used in a full dose regimen may preserve C-peptide and increase the percentage of patients requiring very low doses of insulin compared to those on placebo. In addition, these analyses identified certain subpopulations to be studied in future trials.

MacroGenics is also pursuing development of its own proprietary molecules for the treatment of inflammatory disease.MacroGenics’ infectious disease portfolio includes several antibody-based therapeutics for the treatment of infectious diseases from pathogens, including Dengue, smallpox and H5N1.

Scott Koenig, M.D., Ph.D.
President and CEO and Director

Dr. Koenig has been our President and Chief Executive Officer and a director since September 2001 and was one of our co-founders. Prior to joining us, Dr. Koenig served as Senior Vice President of Research at MedImmune Inc., where he participated in the selection and maturation of their product pipeline. From 1984 to 1990, he worked in the Laboratory of Immunoregulation at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, where he investigated the immune response to retroviruses and studied the pathogenesis of AIDS. Dr. Koenig currently serves as Chairman of the Board of Directors of Applied Genetic Technologies Corporation and the Children’s Research Institute. Additionally, Dr. Koenig serves on the Board of Directors of Children’s National Medical Center, the International Biomedical Research Alliance, and the Biotechnology Industry Organization (BIO). Dr. Koenig received his A.B. and Ph.D. from Cornell University and his M.D. from the University of Texas Health Science Center in Houston. We believe that Dr. Koenig’s detailed knowledge of our company and his over 29 years in research and the biotechnology industry provide a valuable contribution to our board of directors.

Dr. Bonvini, Senior Vice President, Research
From 1985 to 2003, Dr. Bonvini was with the FDA in the Center for Biologics Evaluation and Research, or CBER, which is responsible for regulating therapeutic monoclonal antibodies and other proteins, ultimately serving as Acting Deputy Director, Division of Monoclonal Antibodies and Chief, Laboratory of Immunobiology

Dr. Wigginton Senior Vice President, Clinical Research
Dr. Wigginton was previously the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research and Executive Director, Discovery Medicine-Clinical Oncology at Bristol-Myers from October 2008 to August 2013.

Major Holders Breakdown
% of Shares Held by All Insider and 5% Owners: 27%
% of Shares Held by Institutional & Mutual Fund Owners: 44%
% of Float Held by Institutional & Mutual Fund Owners: 60%
Number of Institutions Holding Shares: 86

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👍 1261
7 years ago
Reply to  danmcco

Xencor $XNCR is similar to $MGNX. Seemingly good mgmt, partnerships, Phase II products, larger institutional/insider holdings.

Unfortunately, I have no clue as to whether mAB technology is likely to succeed. Sorry 🙁

👍 1261
7 years ago

To: Dr. KSS
Amarantus Bioscience Holdings, inc.
I would love to get your opinion of this company?

The company has two divisions, but I see it’s greatest potential in Neurodiagnostics!
IMHO, I think AMBS has the potential to become a market leader in neurodiagnostics! Which currently has a 2.2 B Market cap!
Distribution channel in place to support U.S. / EU trials
Blood-based biomarkers…
LymPro test, BIG!
Screening subjects
CLIA certification of MSPrecise and LymPro
3B- commercial market.
AMBS’s modified MANF application for retinal artery occlusion should be cleared in Europe for orphan drug designation this week.
Thank you, for any opinions you can give?

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