Home » Posts tagged 'biotechnology'

Tag Archives: biotechnology

#TEK Tek Capital PLC – US Salt forms Strategic Partnership with MicroSalt

6th February 2023 / Leave a comment

Tekcapital Plc (AIM: TEK), (OTCQB: TEKCF) the UK intellectual property investment group focused on creating valuable products that can improve people’s lives, is pleased to announce that MicroSalt has entered into an agreement with US Salt LLC (“US Salt”) for the distribution and delivery of MicroSalt’s low-sodium solutions.

“We are proud to work with US Salt in their efforts to offer low-sodium solutions to their customer base. US Salt as a leader in salt distribution, offering lower sodium as an active option in its ingredient listing. Excess sodium intake is one of the world’s leading health concerns, and we believe that partnerships like this are a great way to expand our efforts to address the sodium reduction challenge.” Said Rick Guiney, CEO of MicroSalt”

“US Salt is looking forward to working with MicroSalt® to help with our low-sodium initiatives. Sodium is a worldwide concern in the food industry, and we believe Rick and his team are the industry leaders that can help propel our future growth.” Said Bob Jordan, Vice President of Sales & Marketing of US Salt LLC.

This partnership is expected to strengthen each companies’ respective market positions as leaders in the sodium reduction effort, through expanding the customer base for MicroSalt and the product offerings for US Salt, with healthy, lower sodium alternatives.

About US Salt LLC

US Salt, LLC is currently responsible for producing and distributing over 90% of the private label, round can salt business in the United States. US Salt currently produces and packs 26-ounce private label table salt, as well as a complete portfolio of quality round can table salt items to meet all salt seasoning needs. To learn more about US Salt, visit www.ussaltllc.com.

About MicroSalt, Ltd

MicroSalt, is the developer and manufacturer of a proprietary low-sodium salt called MicroSalt®. We are passionate about improving peoples’ lives with better-for-you seasonings and snacks by taking the lead in the industry by providing the best low-sodium salt solution, based on the mechanical transformation of the salt particle itself. This solution is the only one that delivers real salt flavour because it is salt. Our new patented technology produces salt crystals that are approximately one hundred times smaller than typical table salt, delivering a powerful saltiness as the micro-grains dissolve in the mouth, with approximately 50% less sodium consumption. Additionally, the ultra-small particle size enhances product adhesion, which reduces waste and provides improved flavor consistency. MicroSalt® and SaltMe® are registered trademarks of MicroSalt Inc.

To learn more about MicroSalt please visit www.microsaltinc.com

To learn more about SaltMe! snacks please visit www.saltme.com/

Tekcapital owns 97% of the share capital of MicroSalt Ltd. and 6,034,683 shares (78%) of MicroSalt Inc., its U.S. subsidiary.

About Tekcapital plc

Tekcapital creates value from investing in new, university-developed discoveries that can enhance people’s lives and provides a range of technology transfer services to help organisations evaluate and commercialise new technologies. Tekcapital is quoted on the AIM market of the London Stock Exchange (AIM: symbol TEK) and is headquartered in the UK. For more information, please visit www.tekcapital.com.

LEI: 213800GOJTOV19FIFZ85

For further information, please contact:

Tekcapital Plc		Via Flagstaff IR
Clifford M. Gross, Ph.D.

SP Angel Corporate Finance LLP (Nominated Adviser and Broker)		+44 (0) 20 3470 0470
Richard Morrison / Charlie Bouverat (Corporate Finance) Rob Rees (Corporate Broking)
Flagstaff Strategic and Investor Communications Tim Thompson/Andrea Seymour/Fergus Mellon microsalt@flagstaffcomms.com		+44 (0)207 129 1474

#HVO hVIVO plc – Investors’ Chronicle

17th November 2022 / Leave a comment

Building on decades of experience, hVIVO is currently the only CRO focused on challenge studies, providing world class expertise and capabilities in challenge agent manufacture, a unique portfolio of established human challenge models to test a broad range of infectious and respiratory disease products, and specialist drug development and clinical consultancy services through its Venn Life Sciences subsidiary.

hVIVO contract awards Since the release of interim results in early September, hVIVO has announced a massive £13.4mn contract with a US biotechnology client, a repeat customer, to test its respiratory syncytial virus antiviral candidate using hVIVO’s established RSV Human Challenge Study Model.

Although difficult to assess the challenge study market, Liberum Capital estimates there are around 20 challenge studies conducted each year.

Using the prevailing average contract size of £6.7mn, this indicates £100mn-£135mn of challenge study work each year, excluding any additional income through manufacturing and validating bespoke challenge agent.

Around 60 per cent of hVIVO’s current order book relates to biotech customers and the balance relates to big pharma, with the group carrying out three active challenge studies for big pharma in the first half of 2022 and two full-service challenge studies with values exceeding £25mn. Moreover, hVIVO has signed up eight challenge studies with big pharma companies since 2018, 12 and all the big pharma clients are repeat customers.

Improving financials Backed by a bumper order book and having booked £9mn of group revenue in July and August 2022, house broker FinnCap expects the group’s hVIVO division, which carries out the challenge studies, to grow revenue from £29.4mn last year to £42.5mn in 2022 and account for 82 per cent of its total revenue estimate of £51.1mn. Furthermore, taking account of challenge study contract wins, revenue from Venn Life, laboratory services and non-challenge studies, the brokerage estimates that £53mn of its 2023 revenue estimate of £56mn is already covered.

SGS’s expertise is in performing influenza challenge studies, but it also has Malaria challenge, and RSV challenge models.

Tiziana Life Sciences #TILS Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers

16th September 2019 / Leave a comment

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 Announces FDA Approval to Initiate Phase I Clinical Trial with Orally Administered Foralumab in Healthy Volunteers.

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. We believe 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 diseases^1-5.

“The therapeutic approach of oral administration with Foralumab greatly enhances 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

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.
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
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
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
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 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

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

Contacts:

Tiziana Life Sciences plc

Gabriele 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

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

The Appliance of Life Science Looks Exciting for this On-the-Nose Medical Explorer.

11th September 2019 / Leave a comment

by Malcolm Stacey

Hello, Share Troopers. Previously, I’ve written on the huge potential of life science companies which explore antibodies and antibody substitutes in the fight against serious conditions like cancer. Allow me to put another such firm before you. Tiziana Life Sciences plc (TILS) is biotechnology outfit which uses antibodies to find new treatments for inflammatory diseases and cancers.

The company has just announced good news which sent the share price alight this week. The company has demonstrated that antibodies administered through the nose show promising results. The antibody, called Foralumab proved itself to be well tolerated in all sizes of dose.

I’m thick so can’t undertones the words from the company, but you may fare better. So here they are. ‘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.’ So now you know.

Apparently, this new data is consistent with the findings of numerous pre-clinical studies. This latest project was conducted at Harvard Medical School in the USA. A pretty prestigious venue, wouldn’t you agree? Nearly 30 volunteers took part. Examination of the patients showed positive immune effects.

The hope is that Foralumab might in the future be used to treat neurodegenerative diseases, including multiple sclerosis. There is now much more incentive to push on with further studies. So there is more work to be done before we reach the licensing stage. Nevertheless, the firm is pretty excited by the results. And so is the city as the share price rose by a third on the news. And when the penny drops that jolly trend could continue.

As usual with medical pioneers, investors take the risk of treatments always under strict scrutiny to fall at the last fence. And there’s rarely any dividend paid. But the rewards, especially for the treatment of serious conditions can be immense, both financially and in terms of moral satisfaction.

And now let’s celebrate the company’s success in the Punter’s Return.

View the article on ShareProphets website here

Tiziana Life Sciences #TILS Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers

10th September 2019 / Leave a comment

Tiziana Life Sciences plc

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

New York, 10 September 2019 – Tiziana Life Sciences plc (Nasdaq: 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 mg 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 mg 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 mg, 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

Cited References

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

For further enquiries:

Tiziana Life Sciences plc +44 (0)20 7495 2379 Gabriele Cerrone, Chairman and founder

Cairn Financial Advisers LLP (Nominated adviser) +44 (0)20 7213 0883

Liam Murray / Jo Turner

Shore Capital (Broker)

Andy Crossley / Antonio Bossi

+44 (0)20 7601 6125