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Tiziana Life Sciences (TLSA) Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers

Joe Samuel

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A breakthrough approach for treatment of autoimmune and inflammatory diseases

London, 16 September, 2019 – Tiziana Life Sciences plc (NASDAQ:TLSA and AIM: TILS), a clinical stage biotechnology company focused on developing targeted drugs for cancer and inflammatory diseases, is pleased to announce (further to the announcement made on 1 May 2019) that the U.S. Food and Drug Administration (FDA) has allowed the initiation of a Phase I clinical trial in healthy volunteers using a novel oral enteric-coated capsule formulation of Foralumab, a fully human monoclonal antibody (mAb), in collaboration with the Brigham and Women’s Hospital (BWH), Harvard Medical School, Boston, MA. This is the first clinical trial in which Foralumab will be administered orally to healthy subjects. Our objective is to develop orally administered Foralumab for treatment of autoimmune and inflammatory diseases.

The scientific rationale for this approach was originally discovered by Dr. Howard Weiner, professor at the Brigham and Women’s Hospital, Harvard Medical School. Dr. Weiner discovered that oral or nasal administration of anti-CD3 mAb induces mucosal tolerance to upregulate T regulatory cells (Tregs) capable of providing site-targeted immunomodulation to suppress inflammation. Therefore, this scientific concept could be effective for the treatment of a variety of autoimmune and inflammatory diseases1-5.

“The therapeutic approach of oral administration with Foralumab should greatly enhance our ability to treat neurodegenerative and inflammatory diseases. We have also explored the nasal administration of Foralumab for the treatment of progressive MS. We believe nasal and oral administration with Foralumab opens innovative avenues to treat inflammatory and autoimmune diseases by inducing different classes of Tregs. Thus, mucosal activation stimulating Tregs is a physiological mechanism which we think might be safer than other treatment approaches,” commented Dr. Weiner.

Cited References

  1. 1. Wu HY, Maron R, Tukpah AM, Weiner HL. Mucosal anti-CD3 monoclonal antibody attenuates collagen-induced arthritis that is associated with induction of LAP+ regulatory T cells and is enhanced by administration of an emulsome-based Th2-skewing adjuvant. J Immunol. 2010; 185(6):3401-3407.
  2. 2. Ochi, H.,et al., Oral CD3-specific antibody suppresses autoimmune encephalomyelitis by inducing CD4+CD25-LAP+ T cells. Nature Medicine 2006: 12: (6); 627-635
  3. 3. Lior Mayo, Andre Pires Da Cunha, Asaf Madi, Vanessa Beynon, Zhiping Yang,Jorge I. Alvarez, Alexandre Prat, Raymond A. Sobel, Lester Kobzik, Hans Lassmann, Francisco J. Quintana and Howard L. Weiner. IL-10-dependent Tr1 cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation. Brain 2016: 139; 1939–1957
  4. 4. Chantal Kuhn, Rafael M. Rezende, Andre Pires da Cunha, Fabrice Valette, Francisco J. Quintana, Lucienne Chatenoud, Howard L. Weiner. Mucosal administration of CD3-specific monoclonal antibody inhibits diabetes in NOD mice and in a preclinical mouse transgenic for the CD3 epsilon chain. Journal of Autoimmunity (2016) 76: 1-8
  5. 5. Ogura M, et al., Prevention of human xenograft rejection with oral anti-CD3 mAb. Clinical Immunology 183: 2017; 240-246

About Howard Weiner

Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women’s Hospital in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer’s disease, amyotrophic lateral sclerosis, stroke and brain tumours. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T cells for the treatment of these diseases.

About Harvard Medical Centre

Brigham and Women’s Hospital (BWH, “The Brigham”) is located adjacent to Harvard Medical School, of which it is the second largest teaching affiliate. It is the largest hospital of the Longwood Medical and Academic Area in Boston, Massachusetts, USA. With Massachusetts General Hospital, it is one of the two founding members of Partners HealthCare, the largest healthcare provider in Massachusetts. Brigham and Women’s Hospital conducts the second largest hospital-based research program in the world, with an annual research budget of more than $630 million. Pioneering milestones include the world’s first successful heart valve operation and the world’s first solid organ transplant.

About Autoimmune Diseases and Foralumab

Autoimmune diseases constitute a major medical problem and include diseases such as multiple sclerosis, type 1 diabetes, rheumatoid arthritis and inflammatory bowel disease. Other diseases, that have inflammatory components include diseases such as NASH, atherosclerosis and stroke. The induction of regulatory cells at mucosal surfaces by the oral or nasal administration of antigens has been shown to treat a large variety of autoimmune and inflammatory diseases in animal models with minimal toxicity. Foralumab was developed by Novimmune and has been acquired by Tiziana Life Sciences PLC. Foralumab (formerly NI-0401) is thus far the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn’s disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of foralumab.

In a humanized mouse model (NOD/SCID IL2γc-/-) developed in Dr Kevan Herold’s laboratory, it was show that while targeting the T cell receptor, orally administered foralumab modulates immune responses of the T cells, enhances regulatory T cells and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of regulatory T cells.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to milciclib, the Company is also developing foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody known to the company in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ’seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority

For more information go to http://www.tizianalifesciences.com

View Original Source: https://www.tizianalifesciences.com/news-item?s=2019-09-16-tiziana-life-sciences-announces-fda-approval-to-initiate-phase-i-clinical-trial-with-orally-administered-foralumab-in-healthy-volunteers

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Contacts:

Tiziana Life Sciences plcGabriele Cerrone, Chairman and founder+44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)Liam Murray / Jo Turner+44 (0)20 7213 0883
Shore Capital (Nominated brokers)Antonio Bossi / Andy Crossley+44 (0)20 7408 4050

Disclaimer: Pursuant to an agreement between Midam Ventures LLC and Tiziana Life Sciences plc (TLSA), Midam has been paid $150,000 by Tiziana Life Sciences plc (TLSA) for a period from August 22, 2019 to September 22, 2019. We may buy or sell additional shares of Tiziana Life Sciences plc (TLSA) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Tiziana Life Sciences plc (TLSA). Full Disclaimer Click Here

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Biotechnology

3 Penny Stocks Looking To Change The Biotech Industry

Jon Phillip

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biotechnology stocks

The world of biotech investing can be tricky. That’s particularly true when it comes to small-cap stocks in the industry. These companies often have terrific science, but no profits and little revenue; if any at all. But biotech stocks can offer true potential for investors who know what to look for.

Perhaps the best strategy for gaining exposure to this space is to look at early-stage, small-cap biotechs. By doing so, you put yourself at the front-line for cutting edge, experimental companies that could one day hit it big. Given this, here are 3 small-cap biotechs working to evolve in the biotech industry.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, INVESTORS & THE WORLD

GT Biopharma Inc. (GTBP)

One company making groundbreaking developments in the biotechnology field is GT Biopharma Inc. (GTBP). GT Biopharma Inc. is an immune-oncology biotech company determined to create new treatments for cancer. In order to do this, the company leverages its proprietary TriKE technology to develop its pipeline. As of now, GT Biopharma has 6 treatment plans undergoing the clinical trial process.

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So, what exactly is this TriKE technology platform? TriKE is actually an acronym for tri-specific killer engagers that are made to target NK’s or natural killer and tumor cells. Once they target NK cells, it binds to the CD16 receptor which makes a longer and stronger response compared to current treatment methods.

TriKE Therapy

One use of TriKE has been to develop a way to target the HIV-Env protein. The design to do this is known as HIV-TriKE. As a matter of fact, the company recently announced data that showed the effectiveness of HIV-TriKE. It was shown that it enhanced NK cell cytokine production and effectively killed infected targets with HIV-Env.

“We are pleased to see how the TriKE™ technology is able to be extended to the treatment of infectious disease and is able to kill HIV in the reservoir.”  Mr. Cataldo further stated, “We believe the HIV-TriKE™ will become part of a scalable and curative therapeutic strategy,” expressed Anthony Cataldo, CEO and Chairman of GE Biopharma.

Conatus Pharmaceuticals Inc. (CNAT)

This next biotechnology company is known as Conatus Pharmaceuticals Inc. (CNAT). This company’s focus is different compared to GT Biopharma. It aims to treat chronic diseases that have a large unmet need. Its lead product candidate CTS-2090, inhibits IL-1β which treats inflammatory diseases.

biotechnology stocks to watch

In terms of news releases, the company has been slightly lackluster over the last two months. However, in early August Conatus released its Q2 financials which showed some profitability promise in its income statement.

Revenues increased and expenses decreased in Q2 2019 compared to Q2 2018 which significantly reduced the company’s net loss by $3.8 million. One potential hindrance factor in the financials could be Conatus’ consistently declining free cash flow.

Nuvectra Corporation (NVTR)

To top things off, we have a neurostimulation company known as Nuvectra Corporation (NVTR). The company has a commercial product called Algovita Spinal Cord Stimulation which treats chronic pain of the trunk and limbs. In addition to this, Nuvectra is awaiting FDA pre-market approval for its Virtis Sacral Neuromodulation which treats chronic urinary retention and overstive bladders.

breakthrough biotech stocks to watch

Compared to Conatus, Nuvectra has produced recent news that investors can sink their teeth into. First off, the company appointed Jennifer Kosharek as CFO around a month ago. This is a strong appointment thanks to her 15+ years of accounting experience and other leadership positions with Nuvectra.

Furthermore, the company recently submitted its supplementary chemical composition and biocompatibility data to the FDA to support Virtis’ pre-market approval.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, INVESTORS & THE WORLD

biotechnology stocks

Pursuant to an agreement between Midam Ventures LLC and GT Biopharma Inc. (GTBP), Midam has been paid $100,000 for a period from October 1, 2019 to November 15, 2019. We may buy or sell additional shares of GT Biopharma Inc. (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma Inc. (GTBP). Full Disclaimer Click Here

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Biotechnology

Are These Biotech Names On Your October Watch List?

Joe Samuel

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Over the past two decades, the biotech sector has been one of the best sectors to watch. If experts are to be believed, then it is likely to continue to be a hot sector for the foreseeable future. However, biotech stocks require research and that can help when it comes to making a list of biotech stocks.

Once that is done, the investor needs to track the companies closely. Then it’s easier to decide upon the best course of action. Here is a look at three biotechnology penny stocks this month.

Biotech Stocks To Watch: PharmaCyte Biotech (PMCB)

If you’re looking at PharmaCyte Biotech (PMCB) at this exact moment, you’re seeing it before the company begins clinical trials and just as it’s preparing to complete its Investigational New Drug Application for the FDA.  Whether you’re new to biotech stocks or a seasoned vet, you should understand how important milestones like this are for a company.

best biotechnology stocks to buy now

David A. Judd, a cellular biologist and a member of PharmaCyte’s Medical and Scientific Advisory Board, was recently interviewed. Right now, PharmaCyte Biotech (PMCB) is putting together the necessary material for its planned clinical trial for inoperable pancreatic cancer, one of the most deadly forms of cancer today. Though there has been a targeted focus on Pancreatic cancer with PharmaCyte, its diabetes application may also have promise according to Judd.

“I think diabetes is where this type of technology really lends itself to the application. The key is to develop the right type of cell line to treat Type 1 and insulin-dependent Type 2 diabetes. There are several cell lines being explored by PharmaCyte simultaneously to do this. Selecting the right cell line to become our leading product candidate to treat diabetic patients in need of insulin is key to the success of PharmaCyte’s Diabetes Program.”

Over the last week, shares of PMCB stock have jumped from $0.0319 to highs of $0.0367 on Friday.

Biotech Stocks To Watch: Hepion Pharmaceuticals (HEPA)                                           

The next biotech stock to watch is Hepion Pharmaceuticals Inc (NASDAQ:HEPA). The company is involved in manufacturing medicines meant for liver conditions emanating from non-alcoholic reasons. The company announced that its research article has been published by the highly influential peer-reviewed journal, the Journal of Pharmacology and Experimental Therapeutics.

The paper in question is titled “A Pan-Cyclophilin Inhibitor, CRV431, Decreases Fibrosis and Tumor Development in Chronic Liver Disease Models.” The study shows that Hepion’s product CRV431 could well be a solution for treating chronic diseases of the liver. The paper also stated that the medicine is suited to address a range of therapeutic needs.

Once the news broke, the company’s stock started soaring and soared over 43% at $3.58, well off the session high of $5.59.

Biotech Stocks To Watch: Protalix Biotherapeutics (PLX)

The other biotech stock that broke out more this week is Protalix Biotherapeutics Inc (NYSE:PLX). The company released data from the BRIDGE Phase 3 clinical study of its product PRX-102 and the revelations have proven to be highly encouraging. Out of a total of 22 patients who had been enrolled for the study, the data was gleaned from 16 of them.

The patients in question had been treated with PRX-102 for 12 months. The medicine is meant for treating Fabry disease and it has been revealed that there was an improvement in the function of kidneys in the patients. The stock soared by as much as 75% on Thursday and should definitely be on the watch lists of most investors.

list of healthcare stocks to watch

Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 10/15/2019. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 10/16/2019 – 11/15/2019.We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Full Disclaimer Here.

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Stock Price Newsletter – October 18, 2019

Joe Samuel

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Biotech ETF’s Just Hit New Highs: 3 Stocks To Watch

The biotech sector has a plethora of stocks though. Therefore, an investor needs to put in the necessary research. On that note, here is a look at three biotech stocks to watch as sector stocks enjoy a bull run in October.

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In Case You Missed It: Sernova (SVA) (SEOVF) Finds C-Peptide In Phase I/II Fasting Patient

Sernova Corp. (SVA) (SEOVF) has detected enduring levels of C-peptide (measured up to 30 days and continuing), a biomarker of transplanted beta cell insulin production, in the bloodstream of a fasting patient in its continuing phase I/II Cell Pouch United States clinical study of type-1 diabetes.

Read More Here


These Healthcare & Biotech Stocks Deserve Your Attention This Month

The positive results provided a break for the sector. Furthermore, healthcare stocks have risen by 5.7% this year. The entire index has seen a nearly 20 percent gain, according to The Wall Street Journal. With this in mind, healthcare and biotechnology stocks are in focus this month.

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top biotechnology stocks to watch today

Disclaimer: Pursuant to an agreement between Midam Ventures LLC and Sernova (TSX:SVA) (OTC:SEOVF), Midam has been paid $350,000 for a period from September 23, 2019 to September 22, 2020. We may buy or sell additional shares of Sernova (TSX:SVA) (OTC:SEOVF) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Sernova (TSX:SVA) (OTC:SEOVF). Click Here For Full Disclaimer.

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