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Clinical Stage Stocks Benefit From New Biotech Advancements

|Includes: Affimed N.V. (AFMD), AMGN, CELG, GILD, GTBP, INSY, IOVA, NVS, TRPX
Summary

Typically the stock market slows down toward the end of summer but this year that has not been the case.

Big pharma is weighing in on clinical stage companies as smaller biotechnology companies are benefiting.

Moves by the FDA have brought even more attention to the industry.

The recent collaboration between Affimed (AFMD) and Roche (RHHBY)/Genentech showed the market that tens of millions of dollars, $96M upfront along with $5B in milestone/royalty payments to be exact, are starting to flow into a new concept in the biotech sector.

The NK cell hypothesis has not only become validated by this new development but more specifically of the NK cell - engager concept. Itself. Prior to this, companies like Juno, which was purchased by Celgene (CELG) as well as Novartis (NVS), Gilead (GILD), Iovance (IOVA) and Amgen (AMGN) have been applauded for their use of T-cell therapies. This has, in true form opened up the next step for further advancements focused on immunotherapies.

The NK cell field, much like the T-cell field did some years ago, is beginning to see rapid advances. This is from both the science and the clinical development directions. Though the NK concept is still young, Affimed isn’t the only company focused on developing this further.

GT Biopharma (OTCQB:GTBP), since its inception on September 1, 2017 has been focusing on this area as well. By working, along with its colleagues at the Masonic Cancer Center, GT Biopharma is working on its TriKE and TetraKE NK cell-engager platforms in order to bring thee through the regulatory pathway and into clinical development.

For those new to this treatment platform, there are a number of similarities as well as a few distinctive differences between both Affimed and GT Biopharma. As far as similarities go, both companies use fusion proteins with one of the ends binding to NK cells. The other end targets a tumor antigen. But this is where the similarities end.

GT Biopharma has focused on a different way that proteins are built and how these proteins address the activation & generation of NK cells. In similar fashion to some of the first CAR-T, cells break down without a specific stimulatory agent with numbers declining. GT Biopharma’s NK cell-engager platforms use a strong activator and generator of NK cells called IL-15. Affimed’s, nor any other NK cell technology has these attributes according to GT Biopharma.

The company announced this week that it would be initiating a combination trial of its OXS-1550 and multi-billion dollar oncology drug, owned by a major Pharmaceutical Company. This effort is headed by Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics at the Masonic Cancer Center, University of Minnesota.

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GTBP data by YCharts

According to GT Biopharma, preliminary in vitro experiments in the initial preclinical work suggest a much greater effect when OXS-1550 is given with this drug. “We are very excited about our progress with GT's OXS-1550 (DT2219) combined with ibrutinib, a potent small molecule Bruton Tyrosine Kinase (BTK) inhibitor which is already an established chemotherapeutic agent,” said Dr. Daniel Vallera in response to these new events.

Continuing strong industry news, INSYS Therapeutics, Inc. (INSY), announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.


Shares of the company jumped during early morning hours of the market to highs of $9.50. This was up by nearly 20% from its previous closing price. INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products by using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids.

Israeli-based Therapix Biosciences Ltd. (TRPX) has also begun to trade higher on Thursday. Last month the company announced positive results in its pre-clinical studies evaluating THX-160, a novel pharmaceutical CB2 Receptor agonist for the treatment of pain. The company also reported its financial summary - second quarter 2018 vs. second quarter 2017.

In it the company reported that its Phase IIa clinical study for THX-110 in TS at Yale University was completed. Sixteen patients were enrolled in the study. The Company recently reported top line results, and the results were further presented at the annual meeting of the European Society for the Study of Tourette Syndrome by principal investigator Dr. Michael Bloch.

Furthermore, a pre-clinical study evaluating the effect of the THX-130, proprietary ultra-low-dose THC, in a rodent model for cognitive impairment related to traumatic brain injury (NYSE:TBI) was initiated in Dalhousie University, Halifax, Canada. Results are expected by the second half of this year.

Please note that there is a disclaimer associated with one of the companies mentioned in this article: Pursuant to an agreement between GT Biopharma and Midam Ventures LLC, Midam has been paid $200,000 from the company and ZERO shares of GT Biopharma Inc. for a duration beginning July 16, 2018, and ending August 16, 2018. Midam Ventures has been paid an additional $200k by GT Biopharma and has extended its marketing period through Sept 16, 2018. Midam may buy or sell additional shares of (OTCQB:GTBP) in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.