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
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.
- 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.
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.
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.
- Weiner HL et al. Oral tolerance. Immunol Rev. 2011; 241(1):241-259
- 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
- Mayo, L et al. IL-10-dependent TrI cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation. Brain. 2016: 139; 1939-1957
- Kuhn C. and Weiner HL. Therapeutic anti-DC3 monoclonal antibodies: from bench to bedside. Immunotherapy 2016; 8(8):889-906
- 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
Biotech Stocks To Watch This Week
With Biotech Continuing Higher, Are These Buys Or Sells This Week?
Biotech penny stocks have proven to be one of the best sectors for investments. That’s as far as the stock market is concerned. If experts are to be believed then it may continue to be among the best options in the years to come. That being said, it does not mean that investing in biotech stocks is an easy ride.
An investor needs to conduct a lot of research and also watch the market closely. Similar to other high-risk industries, volatility is a big factor. At any given point in time, a bad report could send stocks plummeting. Similarly, one good DA report can trigger a monster move. Here is a quick look at a few biotech penny stocks which made moves recently. Will they be better stocks to buy or avoid this month?
GT Biopharma Inc. (GTBP)
This company’s stock made new 3 month highs on October 22. GT Biopharma (GTBP) announced that its solid tumor targeting TriKE killed a non-small cell lung cancer tumor cell. This is a major development news for the company’s TriKE platform because the market potential for non-small lung cancer is big.
Non-small lung cancer accounts for 84% of all lung cancer diagnoses. Shareholders clearly felt this way, which may have been why GT Biopharma’s stock shot up by more than 25%.
There could be another potential reason why stockholders are reacting this way to the recent news. Earlier in October, the company announced that the design of HIV-TriKE was able to successfully target the HIV-Env protein.
This would allow the company’s TriKE technology to eliminate replicating HIV infected cells. Because of the success of TriKE with lung cancer cells, investors might feel that the company will be able to successfully destroy HIV cells. For more on GT Biopharma’s novel treatment pipeline and progress, click here.
Pieris Pharmaceuticals (PIRS)
The first stock to consider in the biotech sector with regards to the latest movements is that of Pieris Pharmaceuticals Inc (NASDAQ:PIRS). Back on November 5, the company announced that dose escalation monotherapy data with regards to one of its products is going to be presented at the Immunotherapy of Cancer (SITC) Annual Meeting that is going to be held at National Harbor, Maryland.
The medicine in question is PRS-343, which is meant for treating HER2-positive solid tumors. It goes without saying that it is a positive development and the Pieris stock has reacted positively to the news as well. Since the news broke, the stock has gained as much as 10%.
Foamix Pharmaceuticals (FOMX)
The other biotech stock that has been on a tear for much of the week is the Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) stock. Back on October 18, the company announced that one of its products known as AMZEEQ has been approved by the United States Food and Drug Administration. The medicine in question is a topical foam and is meant for treating inflammatory lesions in both adults as well as pediatric patients, who are older than 9. That was the initial trigger for the rise in the stock price.
Last week, the company also published a peer review of the long term open-label safety of AMZEEQ and that proved to be the trigger for the rally. During the course of the week so far, the Foamix stock has soared by as much as 60%. This is a stock that should definitely be tracked by investors.
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (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 (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.
3 Biotech Stocks To Watch Now After Big Market News
When it comes to stock market investments, an investor needs to make sure that he has his money in some of the high growth sectors. The biotech sector has been among the higher growth sectors for quite some time and hence, it is a prudent move to be invested in this particular sector.
Small-cap biotechs have been screaming recently. This space is consistently on the Street’s radar as a single catalyst such as a positive FDA advisory committee (AdCom) outcome or promising trial results can send shares through the roof. For example, Agile Therapeutics (AGRX) saw share prices skyrocket 223% in just one day after an FDA AdCom vote resulted in an approval recommendation for its Twirla contraceptive patch.
However, the reverse also holds true meaning that biotech stocks carry their fair share of risk. When it comes to choosing the actual stocks, an investor needs to be vigilant about the market and do research diligently. Only then will they be able to choose stocks that might generate returns. On that note, here is a look at a few biotech stocks that have turned heads following key updates.
Sernova (SVA) (SEOVF) Gains Ground On New Leadership
Sernova (SVA) (SEOVF) recently announced that Mr. David Swetlow, CPA, CA, has joined Sernova as Chief Financial Officer. Mr. Swetlow is a veteran of the high tech and life sciences industries with over 20 years in various senior management, board, and advisory roles for start-up, acceleration, and high-growth stage companies, including multiple TSX and Nasdaq listed biotech companies amongst them QLT Inc. and Protox Therapeutics Inc.
What sets Sernova as a company apart from the rest of the pack is the company’s technology. In a push to revolutionize drug delivery, the company has been developing a novel option that it calls the CellPouch. Nearly 100 years after the discovery of insulin, Sernova (TSX:SVA) (OTC:SEOVF) is advancing the treatment for type 1 diabetes. Its implantable Cell Pouch™ technology received FDA clearance and is currently intrials in the US.
Sernova’s Cell Pouch™, combined with its immune protection technology, offers therapeutic cells local protection from immune system attack. At a very basic level, this creates an effective, safe, long-term and convenient therapeutic option for patients with chronic disease. But this is no basic technology and it could set a stage to change the lives of millions of people dramatically.
What Are Analysts Saying? With the current climate of biotech, analysts are watching sector stocks closely, Sernova included. Echelon Wealth Partners analyst Douglas Loe thinks Sernova (TSX:SVA) (OTC:SEOVF) has massive upside [SOURCE]. Not only did the analyst give a $1 price target for the stock he also backed up his “Speculative Buy” rating with a clear explanation of the company’s future prospects.
IVERIC bio (ISEE) soars 350% in a Week
The first biotech stock to consider in this regard is that of IVERIC bio Inc (NASDAQ:ISEE), which managed to go on a remarkable rally after the company made a major announcement last Monday. Last Monday, the company published a highly positive top-line from a clinical study of its product Zimura.
The medicine in question is a variant of a C5 inhibitor and it is believed that it could be used to treat dry age-related macular degeneration (AMD). Patients had been administered with the medicine for a period of 12 months and not only were the top-line data positive.
Zimura had also been tolerable for patients. The Iveric stock soared on the back of the announcement last Monday and since then it has gained as much as 350%.
Inovio Pharmaceuticals (INO) Jumps On FDA Data
The other biotech stock which has made a strong move is that of Inovio Pharmaceuticals Inc (NASDAQ:INO). Today the company released highly positive interim data from its clinical study of its T cell-activating immunotherapy named INO-5401.
As many as 80% of the patients who had been methylated did not show any progression in 6 months. Also, 75% showed no progress when it came to the non-methylated ones and naturally, the stock climbed this morning.
The stock rose as much as 6.30% on Tuesday. It came on the back of the news and could be a top biotech stock to watch this month.
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.
Top Biotech Stocks Making Big Moves This Week
One of the few sectors that have managed to consistently grow is the biotech sector and experts believe that it continues to do so in the foreseeable future. In such a situation, it is imperative for investors to keep one or more biotech stocks in their portfolios.
However, when it comes to picking the right stock, one needs to conduct his research thoroughly and that is a constant even if the sector is a high growth one. On that note, here is a lock at three biotech stocks that should be watched closely by investors.
PharmaCyte Biotech (PMCB)
Biotech has always been one of the best performing sectors in the market. A number of biotech stocks have produced life-changing returns because of their treatments and opportunities. Pharmacyte Biotech (PMCB) has a storied past with big progress toward 1 goal: commercializing its Cell In A Box technology.
The latest series of events leading up to Tuesday may show some of the most important milestones in company history. For starters, Pharmacyte announced in mid-October that it had completed the first of its two staggered and back to back manufacturing runs for the production of PharmaCyte’s clinical trial product.
Why was this important? The company needs to generate the data required to complete the FDA’s Investigational New Drug application – IND. This week the company reported the second manufacturing runs for the production of PharmaCyte’s clinical trial product. With both completed, what comes next?
“Once the information from that testing is available, it will be incorporated into our Investigational New Drug application (IND) for submission to the FDA.”PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner
Bellicum Pharmaceuticals (BLCM)
The first biotech stock that should go into investors’ watch lists is that of Bellicum Pharmaceuticals Inc (NASDAQ:BLCM). The company made a significant announcement on Thursday, October 31 with regards to its natural killer cell chimeric antigen receptor (CAR) program and since then the stock has taken off.
The company announced that a part of the preclinical investigation into the program is going to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, which is going to be held from November 6th to November 10th. The news resulted in a major rally and over the past two trading sessions, the stock has gained as much as 60%.
Agile Therapeutics (AGRX)
The other biotech stock that has been soaring since last Thursday is the Agile Therapeutics Inc (NASDAQ:AGRX) The women’s healthcare company announced on October 31 that its contraceptive product Twirla has been given a favorable vote by an advisory committee of the United States Food and Drugs Administration.
Soon after the announcement, the trading volume of its shares zoomed to as much as 46.3 million shares and that is significantly higher than its average trading volume of 2.3 million shares. Since then, the stock has soared by as much as 400% and it goes without saying that this is a stock that should definitely be tracked by investors.
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 – 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. Click Here For Full Disclaimer.
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