Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced filing of a new patent application relating to composition and methods for combining GLP-1ra and foralumab, a fully human anti-CD3 antibody, to achieve further reductions in systemic and vascular inflammation associated with Type 2 Diabetes (T2D) and also in a separate population of patients with non T2D obesity.
Effectiveness of GLP-1ra non T2D obesity was recently shown in the >17,600 patient SELECT trial by Novo Nordisk (N Engl J Med 2023; 389:2221-2232(NCT03574597). SELECT showed a 20% reduction of major adverse cardiovascular events (MACE) such as heart attack, stroke, and peripheral vascular disease, with semaglutide. The risk of adverse cardiovascular events could be reduced further by the combination of intranasal foralumab and a GLP-1ra. The patent application describes the potential for foralumab to provide additional risk reduction for heart attack, stroke, and peripheral vascular disease. Foralumab given with GLP-1ra may contribute importantly to further risk reduction in this at-risk patient population.
“The GLP-1ra’s have revolutionized the treatment of obesity and type 2 diabetes. Obesity and type 2 diabetes are associated with inflammation in the liver, adipose and vascular tissue. This inflammation contributes to the pathogenesis of stroke,” commented Howard L. Weiner M.D. from Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System and Professor of Neurology. “Although effective, GLP-1ra’s do not completely mitigate the disease process and are associated with various side effects. Intranasal foralumab, a fully human anti-CD3, has shown efficacy in attenuating inflammation in humans with multiple sclerosis and COVID. Because intranasal foralumab induces regulatory T cells in a physiologic fashion, foralumab has novel anti-inflammatory properties that make it applicable to multiple disease conditions. Furthermore, it has had minimal side effects in both human and animal studies. We have now discovered intranasal anti-CD3’s positive effect in models of diet-induced obesity related to mitigating its complications. Intranasal anti-CD3 therapy also dramatically decreases inflammation and metabolic changes. Thus, we believe it has the potential to be an ideal therapy to be given in combination with the class of GLP-1ra approved drugs.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences said, “I believe that our commitment to improving patient outcomes by using anti-CD3, or foralumab, in risk mitigation for MACE could be another exciting indication for foralumab. We hope our efforts will give a new therapeutic option to patients afflicted with Type 2 Diabetes and non T2D obesity that are receiving GLP-1 receptor antagonists. We believe the risk reduction could be substantial with com
Yes, correct FiveCandles, they tried to raise last year and didn't get enough interest. This looks like last chance saloon for them................so people should be aware and not blindly follow others into here. It's a massive risk
Watch out for those scammers who claim RENE has £5m in cash. It doesn't. That's what it had in September. With cash burn, it needs to raise before April if no new revenues. It's clearly stated in the interims, for those who are too dumb to research:
At 30 September 2023, the Group had cash, cash equivalents and bank deposits of £5.1 million with the Group's latest internal projections (assuming no new revenues or funding) showing a cash runway to April 2024, ahead of which point further revenues and/or a capital injection will be required.
Don’t think there’s a leak. ETX is accustomed to having these spikes due to the low free float. There appears to be a general rise in interest in bio pharmas again. C4XD followed a similar path to ETX down and has risen sharply, as has N4P today
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS). Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm. The primary endpoint of the trial will be the change in microglial activation based on PET scans. Clinical evaluations include the Expanded Disability Status Scale (EDSS), QoL assessments, and the Modified Fatigue Impact Scale (MFIS), which assess parameters that are essential to a patient’s everyday life. Novel immuno-biomarkers will be measured also and assessed for predictive relevance. Central review of PET scans and images is an integral component of this study.
"The successful consenting, screening, completion of the baseline PET scan, and dosing of our first patient in the intranasal foralumab Phase 2a trial has occurred seamlessly,” said Tanuja Chitnis, M.D., the Principal Investigator at Brigham and Women’s Hospital, a founding member-hospital of Mass General Brigham Healthcare System, and Professor of Neurology at Harvard Medical School. “My anticipation is this randomized placebo-controlled trial is the first step in bringing this potential treatment to patients that have na-SPMS, a disease with no approved therapy. Our experience in the Expanded Access Program provides sustainable hope for relief of symptoms in these patients with an unmet medical need.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences said, “I believe that our dosing of the first patient confirms Tiziana’s ability to execute on its commitments and potential to advance our fully human intranasal anti-CD3 mAb, foralumab, using novel imaging methods and clinically relevant endpoints. We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease. Currently, there are no FDA approved treatments for na-SPMS.”
Matthew W. Davis, MD, RPh, Chief Operating Officer and Chief Medical Officer of Tiziana, added, “I am very pleased the first patient has been dosed and our team is committed to remaining on track with our milestones. We are poised to accelerate enrollment and anticipate data readout in Q4 2024. I believe the study results will reveal important aspects for optimizing clinical management of na-SPMS - particularly the potential for a reduction in MFIS scores.”
https://www.tizianalifesciences.com/news-item?s=2023-12-19-tiziana-life-sciences-doses-first-patient-in-phase-2a-trial-of-intranasal-foralumab-in-multiple-sclerosis
Hi Volmer - interested in the background to the analysis of the below that you posted:
Ondo broker's research note estimates pre-tax losses of £3.3m in 2023 followed by £3.4m, £3.1m and breakeven in 2026. Net cash/debt is estimated at -£6m, -£6.2m, -£7.5m and -£7.2m in 2026. This indicates a continuing drain on cash in line with the business model. Also, it does not reflect the loan and interest due to be repaid from 31.3.2025.
With ONDO being a fairly capital light company, I would have expected break even ahead of 2026 and less cash drain. This concerns me, so I'm wondering what the basis for these predications are and what assumptions were factored in - ie. expected level of business growth. Does this factor in the large US contract or other potential new contracts?
Very little to dislike about that RNS. Reassuring and positive, everything going according to plan and more. Exciting times ahead. Next steps are further commercial agreements being finalised, Mistral being actively deployed and funding arrangements. 2024 should be transformative
Thanks Jim, great overview.
I'm sure they're under strict NDAs with Tier 1 clients which limits what they can disclose. Also, reaching contractual agreement with large companies can take a very long time - 6 months+ often just to go through the legal counsels.
All sounds very positive though