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Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers

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NEW YORK–(BUSINESS WIRE)–

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE EU MARKET ABUSE REGULATION (596/2014). UPON PUBLICATION OF THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.Tiziana Life Sciences plc (TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to report Phase 1 clinical data demonstrating that nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), was well-tolerated at all doses. Importantly, the treatment showed significant positive effects on the biomarkers for activation of mucosal immunity, which is capable of inducing site-targeted immunomodulation to elicit anti-inflammatory effects. These clinical data are consistent with the findings from numerous pre-clinical studies.1-3

REPORT: This Biotech Stock Could Hold the Key for a Multi-Billion Dollar Market Shake-up!

This Phase 1 trial, conducted at the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind, placebo-controlled, dose-ranging study with nasally administered Foralumab at 10, 50 and 250 µg per day, consecutively for 5 days in healthy volunteers for the treatment of progressive multiple sclerosis (pMS). 18 subjects received Foralumab treatment and 9 patient received placebo. All nasal doses were well tolerated. Biomarker analysis showed significant positive immune effects, that were most prominent in the 50 μg cohort with minimal immunomodulatory effects at the 10 µg and 250 µg doses.

Major Highlights

  • Treatment was well-tolerated and no drug-related safety issues were reported at any of the doses.
  • No drug-related changes were observed in vital signs among subjects at predose, during treatment and at discharge. The mean blood pressure (BP) during the 5 days of treatment were; Cohort A (10 µg/d):124/73, Cohort B (50 µg/d): 119/67 and Cohort C (250 µg/d):113/65 compared to placebo:118/67). Heart rates, respiratory rates and oral temperatures were unchanged among the 3 cohorts compared to the placebo.
  • Nasally administered Foralumab at the 50 µg dose suppressed cytotoxic CD8+ as well as perforin secreting CD8+ cells, which have been implicated in neurodegeneration in multiple sclerosis (MS).
  • Treatment at 50 μg stimulated production of anti-inflammatory cytokine IL-10 and suppressed production of pro-inflammatory cytokine IFN-γ.
  • Taken together, these results suggest stimulation of Tregs that are needed to provide clinical benefits

“Nasal administration of Foralumab is a revolutionary approach to treat patients with neurodegenerative diseases such as progressive MS (pro-MS) and amyotrophic lateral sclerosis (ALS). Extensive data from animal studies with intranasal delivery of anti-CD3 demonstrate that this route of administration induces anti-inflammatory and immunomodulatory effects. This study demonstrates for the first-time that nasally administered Foralumab, at the identified optimal dose of 50 μg, induces immunomodulatory effects capable of providing clinical benefit to treated subjects. This is a major accomplishment providing the scientific rationale to move forward with further clinical development of nasally administered Foralumab in patients with neurodegenerative diseases,” commented Dr. Howard L. Weiner, a member of scientific advisory board of Tiziana Life Sciences. He added that “both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying immunomodulation. Our immediate focus is on developing Foralumab for treatment of pro-MS.”

“The demonstration of the positive immunomodulatory effects provides the scientific rationale to move forward with further studies in the pro-MS population, stated Dr. Tanuja Chitnis, the study PI at the Brigham and Women’s Hospital.

“We are very pleased with what we believe is the first-ever demonstration that nasally administered Foralumab is not only well-tolerated, but it also exhibited significantly positive immunomodulatory effects that are indicative of stimulation of Tregs. We are excited as these results provide the scientific rationale for the nasal and oral treatment with Foralumab, our core proprietary platform technologies which could potentially revolutionize treatment with antibodies” stated Kunwar Shailubhai, CEO & CSO of Tiziana.

The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

About Foralumab

Foralumab (formerly NI-0401), 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-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs 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 Tregs.

Preclinical studies on nasal and oral administration with Anti-CD3 mAbs

Preclinical and clinical studies have shown that mucosal induction of Tregs by oral or nasal administration of anti-CD3 mAbs is an innovative approach to treat autoimmune and anti-inflammatory diseases (Kuhn and Weiner 2016)4. Nasally administered anti-CD3 mAbs were shown to ameliorate disease in an animal model of multiple sclerosis by inducing IL-10+LAP+ (latency-associated peptide) T cells3, demonstrating nasal anti-CD3 mAbs as a new approach to treat progressive forms of multiple sclerosis and other types of chronic CNS inflammation. Additionally, nasally administered anti-CD3 mAbs suppressed lupus in lupus-prone mice (BWF1) by inducing IL-10 and TGF-β dependent mechanisms associated with a suppression of IL-17 and IL-21 pro-inflammatory cytokines5.

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 in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), crohn’s disease, 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.

Cited References

  1. Weiner HL et al. Oral tolerance. Immunol Rev. 2011; 241(1):241-259
  2. Ochi H, Abraham M, Ishikawa H et al. New immunosuppressive approaches: Oral administration of CD3-specific antibody to treat autoimmunity. J Neurol Sci 2008; 274(1- 2):9-12
  3. Mayo, L et al. IL-10-dependent TrI cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation. Brain. 2016: 139; 1939-1957
  4. Kuhn C. and Weiner HL. Therapeutic anti-DC3 monoclonal antibodies: from bench to bedside. Immunotherapy 2016; 8(8):889-906
  5. Wu, H.Y, Quintana, F.J and Weiner, H.L. Nasal Anti-CD3 Antibody Ameleorates Lupus by Inducing an IL-10-Secreting CD4+CD25-LAP+ Regulatory T cell and Is Associated with Down-Regulation of IL-17+CD4+ICOS+CXCR5+ Follicular Helper T Cells. J Immunol 2008; 181:6038-6050

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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 Small-Cap Biotech Stocks To Watch In Coming Weeks

Joe Samuel

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stock market today

Biotech has been one of the hottest sectors for investors for as long as it has existed and the reasons are self-evident. It is a sector that uses cutting edge technology and comes up with treatments for a wide range of diseases.

Moreover, the fact that biotech companies often improve on existing treatments, makes them a far more attractive target for a range of investors. Here is a look at three biotech stocks to watch during the last few weeks of the quarter.

PharmaCyte Biotech (PMCB)

There has been no lack of attention on biotech penny stocks this year.  At the beginning of August, one small biotech stock broke to highs of over $10 from a starting price below $2 a share after releasing news. PharmaCyte Biotech (PMCB) focuses on ways to effectively deliver treatments to patients with diseases ranging from cancer to diabetes. 

The company’s proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®is the platform that the company uses to develop its therapy delivery methods.  For most of the quarter, shares of PMCB stock have traded between $0.033 and $0.04 with volume recently surging.

On September 19, PharmaCyte saw more than 6 million shares trade; well above its daily average. Most of the attention surrounding the company has been on two things. First, its progress with Cell-In-A-Box and the application for Pancreatic cancer has continued to progress. The company brought on Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.

What To Watch For

This week PharmaCyte (PMCB) will host a call designed to update all shareholders and the investment community simultaneously of material developments. The call will cover PharmaCyte’s preparations for submission of its Investigational New Drug application (IND) to the U.S. FDA to treat locally advanced, inoperable pancreatic cancer. It will also cover developments related to PharmaCyte’s product pipeline. PharmaCyte has been working on these and will discuss things not yet reported in a press release.

Catalyst Pharmaceuticals (CPRX)

The first one to watch is Catalyst Pharmaceuticals Inc (NASDAQ:CPRX). It is a small-cap stock engaged in developing medicines for rare diseases. Catalyst managed to get an approval for one of its products from the FDA earlier this year.

Since the approval of the Lambert-Eaton myasthenic syndrome (LEMS treating medicine Firdapse, Catalyst stock went on a massive rally from January to April. The approval of a rival drug halted the rally. Only after a civil suit from Catalyst did the stock stabilize somewhat.

Last week, Catalyst stock received a fresh boost after the company announced that it was going to make a secondary offering. However, the company decided to pull the offering the very next day and that affected the stock price once again.

What To Watch For

Analysts believe that pulling the secondary offering was the right long term decisions and this stock could be heading for another rally soon.

Eyepoint Pharmaceuticals (EYPT)

The biotech stock that could prove to be a major winner in the biotech sector this month is that of Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT). There are two factors at play. The company revenues are going to rise significantly in the coming years due to the commercial launch of two medicines.

The first one is Yutiq, which is meant for the treatment of chronic non-infectious uveitis and the other one is Dexycu, which is meant for postoperative ocular inflammation.

What To Watch For

The company is currently trading at only double that of its future revenue and that is a very attractive multiple. EYPT stock has caught the attention of analysts on Wall Street. Guggenheim has set a 12-month target price of $4, which reflects 116% gains during the period.

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Disclaimer: 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 – 9/12/2019. 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. Click Here For Full Disclaimer

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Biotechnology

Acadia (ACAD) Stock Price is up 60% This Month; Bullish Signal For Biotechs?

Joe Samuel

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One sector that has always been a favorite of investors of all varieties is the pharmaceutical sector and all investors like a turnaround story. Over the years, ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) had been one of the better-known strugglers in the industry. That was reflected in the stock price as well. But recent developments have breathed new life in the stock, which could be an indicator for the biotech industry at large.

Biotech Stocks To Watch: PharmaCyte Biotech (PMCB)

There has been no lack of attention on biotech penny stocks this year.  At the beginning of August, one small biotech stock broke to highs of over $10 from a starting price below $2 a share after releasing news. PharmaCyte Biotech (PMCB) focuses on ways to effectively deliver treatments to patients with diseases ranging from cancer to diabetes. 

The company’s proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®is the platform that the company uses to develop its therapy delivery methods.  For most of the quarter, shares of PMCB stock have traded between $0.033 and $0.04 with volume recently surging.

On September 12, PharmaCyte saw more than 4 million shares trade; well above its daily average. Most of the attention surrounding the company has been on two things. First, its progress with Cell-In-A-Box and the application for Pancreatic cancer has continued to progress. The company brought on Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.

Second, the company has been ramping up for a much-anticipated shareholder update call on September 20. The call will cover PharmaCyte’s preparations for submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to treat locally advanced, inoperable pancreatic cancer and developments related to PharmaCyte’s product pipeline on which PharmaCyte has been working and that have not yet been reported in a press release.

Acadia (ACAD) Stock Price: Important Developments

People who had held on to the stock through the barren years got a nice boost recently. This came after Acadia’s well-known medicine Nuplazid recorded better than expected sales. In addition to that, there were encouraging results from a dementia-driven psychosis study. Hence, it is important to figure out whether it is perhaps time to buy the stock.

While the signs are no doubt encouraging, it is important to note that data reveals that around 60,000 people in the United States are diagnosed with Parkinson’s every year. Out of those, a large proportion (50% to 80%) suffers from dementia. Hence it can be argued that the market is simply not too big for Acadia’s Nuplazid.

Moreover, different types of dementia are brought on by Alzheimer’s disease, which is why all of it might not actually fall into Acadia’s lap. That being said, it is also well known that antipsychotic drugs have only been approved for the treatment of Parkinson’s and hence the Alzheimer’s market is already out of the question.

Market Potential

Projections suggest that the sale of Nuplazid could grow to more than $1 billion in 2023 from $224 million in 2018. While that is encouraging, it is also important to note that the growth has been priced into the Acadia stock price.

However, if Acadia’s plans for growth somehow run into any trouble, then there is every chance of the stock price plummeting once again. The company is recovering and there is some time before the patient population for Nuplazid can be expanded sufficiently. In the meantime, investors need to be a bit more patient.

Shares of ACAD are up over 60% over the past week and made a new multi-year high of $43.98.

biotech stock price
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 – 9/12/2019. 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. Click Here For Full Disclaimer.

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Biotechnology

Top Biotech Stocks To Watch This Week

Joe Samuel

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best biotech stocks to watch

Biotech stocks rarely perform well during the summer months, and 2019 has proven to be no exception in regards to this historical pattern. The iShares Nasdaq Biotechnology ETF, for example, has fallen by nearly 2% since the official start of summer.

The values of biotech equities, however, do generally start to pick up as the year winds down. The underlying reason is that the latter part of the year is chock-full of key data readouts, regulatory decisions, and thousands of scientific conferences across the globe. 

Biotech Stocks To Watch

GT Biopharma (GTBP)

Earlier this quarter GT Biopharma, Inc. (GTBP) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager announced that Jeffrey Miller, M.D. has been hired by the Company as its Consulting Chief Medical Officer.

Further to this, the company confirmed that it had notified FDA that it was commencing enrollment in its first-in-human GTB-3550 Phase I/II clinical trial. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick.

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE™) product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15.

Since making the announcement, shares of GTBP are up by 13.2%.

NewLink Genetics Corp (NASDAQ:NLNK)

NewLink Genetics Corp (NASDAQ:NLNK) said the FDA has accepted partner Merck & Co., Inc. (NYSE:MRK)’s BLA for its investigational Ebola vaccine, according to the application priority review status. The PDUFA goal date has been set for March 14, 2020.

Potential approval of the vaccine will trigger issuance of a priority review voucher, owned by Merck and in which NewLink has a substantial economic interest. NewLink can then monetize its share of interest in the voucher. The vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed to NewLink.

vTv Therapeutics Inc (NASDAQ:VTVT)

vTv Therapeutics Inc (NASDAQ:VTVT) is scheduled to present at the European Association for the Study of Diabetes 55th annual meeting being held in Barcelona, Spain with a new Phase 1/2 Simplici-T1 study of liver-selective glucokinase activator TTP399 as an adjunctive treatment for Type 1 diabetes.

Biotech IPO To Watch

IGM Biosciences priced its IPO of 10.938 million shares at $16, the midpoint of the estimated price range of $15-$17 per share. The shared of the preclinical and clinical-stage immuno-oncology biotech will be listed on the Nasdaq under the ticker symbol “IGMS.”

best biotech stocks to watch
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $15,000 per month for 6 months by GT Biopharma (GTBP) for a period from September 4, 2019 to March 4, 2020. We may buy or sell additional shares of GT Biopharma (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 (GTBP). Click Here For Full Disclaimer.

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