Tiziana Life Sciences Granted FDA Fast Track Designation
Tiziana Life Sciences (NASDAQ: TLSA) has received FDA Fast Track designation for its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, to treat non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This designation expedites the review process and increases FDA interaction. Intranasal foralumab aims to modulate the immune system and reduce neuroinflammation in neurodegenerative diseases.
The company is currently conducting a Phase 2a trial for na-SPMS and has an Expanded Access Program showing promising results. However, Tiziana faces a potential Nasdaq delisting due to not maintaining a minimum bid price of $1.00. The company plans to appeal this decision and present its compliance plan to the Nasdaq Hearings Panel.
Tiziana Life Sciences (NASDAQ: TLSA) ha ricevuto la designazione Fast Track della FDA per il suo foralumab intranasale, un anticorpo monoclonale anti-CD3 completamente umano, per trattare la Sclerosi Multipla Secondaria Progressiva Non Attiva (na-SPMS). Questa designazione accelera il processo di revisione e aumenta l'interazione con la FDA. Il foralumab intranasale mira a modulare il sistema immunitario e ridurre la neuroinfiammazione nelle malattie neurodegenerative.
L'azienda sta attualmente conducendo uno studio di Fase 2a per la na-SPMS e ha un Programma di Accesso Espanso che mostra risultati promettenti. Tuttavia, Tiziana affronta una potenziale delisting da Nasdaq per non aver mantenuto un prezzo minimo di offerta di $1.00. L'azienda prevede di appellarsi a questa decisione e presentare il suo piano di conformità al Nasdaq Hearings Panel.
Tiziana Life Sciences (NASDAQ: TLSA) ha recibido la designación Fast Track de la FDA para su foralumab intranasal, un anticuerpo monoclonal anti-CD3 completamente humano, para tratar la Esclerosis Múltiple Secundaria Progresiva No Activa (na-SPMS). Esta designación acelera el proceso de revisión y aumenta la interacción con la FDA. El foralumab intranasal busca modular el sistema inmune y reducir la neuroinflamación en enfermedades neurodegenerativas.
La empresa está llevando a cabo actualmente un ensayo de Fase 2a para la na-SPMS y tiene un Programa de Acceso Ampliado que muestra resultados prometedores. Sin embargo, Tiziana enfrenta una posible delistado de Nasdaq por no mantener un precio mínimo de oferta de $1.00. La empresa planea apelar esta decisión y presentar su plan de cumplimiento al Nasdaq Hearings Panel.
Tiziana Life Sciences (NASDAQ: TLSA)는 비활성 2차 진행성 다발성 경화증(na-SPMS) 치료를 위한 완전 인간 항-CD3 단클론 항체인 비강용 포랄루맙에 대해 FDA 신속 승인을 받았습니다. 이 지정은 리뷰 프로세스를 가속화하고 FDA와의 상호작용을 증가시킵니다. 비강용 포랄루맙은 면역 체계를 조절하고 신경 퇴행성 질환에서 신경 염증을 줄이는 것을 목표로 합니다.
현재 회사는 na-SPMS를 위한 2a상 시험을 진행 중이며, 유망한 결과를 보이는 확대 접근 프로그램을 보유하고 있습니다. 그러나 Tiziana는 $1.00의 최소 호가 가격을 유지하지 못해 나스닥 상장 폐지의 위험에 직면해 있습니다. 회사는 이 결정에 대해 항소하고 나스닥 청문위에 준수 계획을 제출할 계획입니다.
Tiziana Life Sciences (NASDAQ: TLSA) a reçu la dénomination Fast Track de la FDA pour son foralumab intranasal, un anticorps monoclonal anti-CD3 entièrement humain, pour traiter la Sclérose en Plaques Secondaire Progressive Non Active (na-SPMS). Cette désignation accélère le processus d'examen et augmente l'interaction avec la FDA. Le foralumab intranasal vise à moduler le système immunitaire et à réduire la neuroinflammation dans les maladies neurodégénératives.
La société mène actuellement un essai de Phase 2a pour la na-SPMS et dispose d'un Programme d'Accès Élargi montrant des résultats prometteurs. Cependant, Tiziana fait face à un potentiel delisting du Nasdaq en raison de l'incapacité à maintenir un prix d'offre minimum de 1,00 $. L'entreprise prévoit de faire appel de cette décision et de présenter son plan de conformité au Nasdaq Hearings Panel.
Tiziana Life Sciences (NASDAQ: TLSA) hat die FDA Fast Track-Designierung für sein intranasales Foralumab, einen vollständig humanen Anti-CD3-Monoklonalen Antikörper, zur Behandlung der nicht aktiven sekundären progressiven Multiplen Sklerose (na-SPMS) erhalten. Diese Designierung beschleunigt den Prüfungsprozess und erhöht die Interaktion mit der FDA. Intranasales Foralumab zielt darauf ab, das Immunsystem zu modulieren und die Neuroinflammation bei neurodegenerativen Erkrankungen zu reduzieren.
Das Unternehmen führt derzeit eine Phase-2a-Studie für na-SPMS durch und hat ein erweitertes Zugangsprogramm, das vielversprechende Ergebnisse zeigt. Tiziana sieht sich jedoch einer möglichen Delistung von Nasdaq gegenüber, da der Mindestgebotspreis von $1.00 nicht aufrechterhalten wurde. Das Unternehmen plant, gegen diese Entscheidung Berufung einzulegen und seinen Konformitätsplan dem Nasdaq Hearings Panel vorzulegen.
- FDA granted Fast Track designation for intranasal foralumab in na-SPMS treatment
- Fast Track designation provides benefits like more frequent FDA meetings and potential Rolling Review of NDA
- Early clinical data shows therapeutic benefits with a favorable safety profile
- 10 na-SPMS patients in Expanded Access Program showed improvement or stability within 6 months
- FDA allowed enrollment of additional 20 patients in the Expanded Access Program
- Ongoing Phase 2a trial for intranasal foralumab in na-SPMS
- Received notice from Nasdaq for potential delisting due to not maintaining minimum bid price of $1.00
- Company faces delisting from Nasdaq Capital Market on July 29, 2024, unless appeal is successful
Financial Implications: The FDA Fast Track designation for Tiziana Life Sciences' intranasal foralumab is a significant milestone that could affect the stock positively. Fast Track designation often leads to quicker regulatory reviews, which could expedite time-to-market, enhancing revenue projections sooner than later. This designation also signals strong regulatory confidence in the potential efficacy and safety of foralumab, which is important for investor sentiment. However, it's also important to monitor cash burn rates during accelerated R&D phases and ensure that the balance sheet can support the likely increase in operational costs.
Medical and Clinical Insights: Fast Track designation for intranasal foralumab in treating non-active Secondary Progressive Multiple Sclerosis (na-SPMS) is a notable achievement. This status is granted to therapies that potentially meet critical unmet medical needs, indicating the innovative nature of Tiziana's approach. Intranasal delivery is particularly compelling because it could offer a new pathway to modulate the immune system and reduce neuroinflammation—a key factor in neurodegenerative diseases. However, until more robust Phase 2 and 3 clinical trial data become available, investors should remain cautiously optimistic.
Market Positioning and Competitive Landscape: The Fast Track designation can significantly enhance Tiziana's competitive edge in the biopharmaceutical sector, especially in the neurodegenerative disease market. This market is currently under-served, with few effective treatments available for conditions like Multiple Sclerosis (MS). The designation could make foralumab an attractive partnership or acquisition target, further boosting investor confidence. However, the company faces a delisting risk from Nasdaq, which could dampen investor sentiment if not adequately addressed. This duality of positive drug development news and financial instability must be carefully balanced.
NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).
The Fast Track designation is a significant milestone for Tiziana Life Sciences, providing an expedited review process and increased interaction with the FDA. This designation is intended to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Only four Fast Track designations have been granted in 2024 by FDA’s Center for Drug Evaluation and Research as of March 31, 2024.
"We are thrilled to receive Fast Track designation from the FDA for intranasal foralumab for the treatment of Multiple Sclerosis," said Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. "This designation underscores the potential of foralumab to address critical unmet needs in the treatment of neurodegenerative diseases. We are committed to advancing this promising therapy as quickly as possible to benefit patients."
The Fast Track designation provides several benefits, including more frequent meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA).
"Receiving Fast Track designation is a testament to the innovative approach we are taking with foralumab," said Dr. William Clementi, Chief Development Officer of Tiziana Life Sciences. "We believe that the intranasal delivery method offers a novel way to effectively target neuroinflammation, and we look forward to working closely with the FDA to bring this therapy to patients in need."
Intranasal foralumab is designed to modulate the immune system and reduce neuroinflammation, which is a key factor in the progression of neurodegenerative diseases such as Multiple Sclerosis, Alzheimer’s Disease and Amyotrophic Lateral Sclerosis (ALS). Early clinical data have shown that intranasal Foralumab can deliver therapeutic benefits with a favorable safety profile. The company aims to accelerate these programs and capitalize on opportunities to address significant unmet medical needs.
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).
Receipt of Notice from Nasdaq and Plan to Appeal
On July 19, 2024, the Company received written notice (the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company did not maintain a minimum bid price of at least
As a result of the foregoing, the Staff informed the Company that its ordinary shares would be subject to delisting from The Nasdaq Capital Market on July 29, 2024, unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). Accordingly, the Company intends to timely request a hearing before the Panel, which request will stay any delisting action by Nasdaq at least pending the issuance of the Panel’s decision following the hearing and the expiration of any additional extension period granted by the Panel following the hearing. At the hearing, the Company will present its plan to evidence compliance with the minimum bid price requirement.
About Foralumab
Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2]
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com
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 further inquiries:
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
email: ikoffler@lifesciadvisors.com
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120
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