0001213900-24-035983.txt : 20240425 0001213900-24-035983.hdr.sgml : 20240425 20240425100003 ACCESSION NUMBER: 0001213900-24-035983 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20240425 FILED AS OF DATE: 20240425 DATE AS OF CHANGE: 20240425 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Tiziana Life Sciences Ltd CENTRAL INDEX KEY: 0001723069 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: D0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38723 FILM NUMBER: 24873435 BUSINESS ADDRESS: STREET 1: 3RD FLOOR, 11-12 ST. JAMES'S SQUARE CITY: LONDON, ENGLAND STATE: X0 ZIP: SW1Y 4LB BUSINESS PHONE: 0044(0) 207-495-2379 MAIL ADDRESS: STREET 1: 3RD FLOOR, 11-12 ST. JAMES'S SQUARE CITY: LONDON, ENGLAND STATE: X0 ZIP: SW1Y 4LB FORMER COMPANY: FORMER CONFORMED NAME: Tiziana Life Sciences plc DATE OF NAME CHANGE: 20171116 6-K 1 ea0204650-6k_tizianalife.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

April 2024

 

 

 

Commission File Number:  001-38723

 

 

 

Tiziana Life Sciences LTD

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

9th Floor

107 Cheapside

London

EC2V 6DN

(Address of registrant’s principal executive office)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒    Form 40-F ☐

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

On April 25, 2024, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, Positive 3-Month Neuroimaging Scores in Multiple Sclerosis Patients Receiving Intranasal Foralumab for the first time, quantitative data showing improvement in White Matter Z scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain., a copy of which is furnished as Exhibit 99.1

 

The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  TIZIANA LIFE SCIENCES LTD
       
Date: April 25, 2024 By: /s/ Keeren Shah
    Name:  Keeren Shah
    Title: Chief Financial Officer

 

2

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Tiziana Life Sciences LTD Press Release, dated April 25, 2024

 

 

3

 

EX-99.1 2 ea020465001ex99-1_tiziana.htm TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED APRIL 25, 2024

Exhibit 99.1

 

 

Tiziana Life Sciences Reports Positive 3-Month Neuroimaging Scores in Multiple Sclerosis Patients Receiving Intranasal Foralumab

 

NEW YORK, April 25, 2024 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced for the first time, quantitative data showing improvement in White Matter Z scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.

 

Tarun Singhal, MBBS, M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, stated, “Last week at the American Academy of Neurology annual meeting, we presented, for the first time, quantitative [F18]PBR06-PET data showing the dampening of microglial activation, an indicator of brain inflammation, in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) receiving intranasal foralumab. These data came from the open-label intermediate-sized patient population Expanded Access (ISPPEA) program. We calculated White Matter Z-scores to measure the effect of intranasal foralumab on microglial activation at baseline and then after foralumab treatment for three months. We saw reductions of 28% to 48%, indicating improvement in 5 out of 6 patients, and a 36% median reduction in White Matter Z-scores compared to baseline (see Figure 1). A peer-reviewed journal has published our recent work with newer [F18]PBR06-PET quantitation approaches.”[1].

 

The full publication in Clinical Nuclear Medicine can be found here: https://journals.lww.com/nuclearmed/fulltext/9900/glial_activity_load_on_pet_reveals_persistent.1077.aspx

 

“I am grateful for Dr. Singhal’s work advancing our intranasal foralumab program and the insight his work provides into the foralumab’s effect on brain inflammation. We are seeing this additional, encouraging evidence of intranasal foralumab’s effect after reporting that it attenuated microglial activation in na-SPMS patients with progression independent of relapse activity (PIRA) at 3 months as evaluated by [F-18]PBR06-PET and was associated with clinical symptom improvement or stability. Based on these positive results, a double-blind, placebo-controlled, dose-ranging study (NCT06292923) of intranasal foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint with clinical measures of EDSS (disability) and MFIS (fatigue) is currently underway. I welcome the publication of Dr. Singhal’s [F18]PBR06-PET research paper, highlighting these combined findings in Clinical Nuclear Medicine,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences.

 

[1]https://journals.lww.com/nuclearmed/fulltext/9900/glial_activity_load_on_pet_reveals_persistent.1077.aspx

 

 

Figure 1*

 

 

 

*EA5 showed a worsening in their White Matter Z-Score at three months during a pseudo-exacerbation of the patient’s trigeminal neuralgia.

 

About Foralumab

 

Activated T cells play an essential 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 began screening patients in November 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treating neuroinflammatory and neurodegenerative human diseases.[2],[3]

 

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, 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 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
ikoffler@lifesciadvisors.com

 

[2]https://www.pnas.org/doi/10.1073/pnas.2220272120

 

[3]https://www.pnas.org/doi/10.1073/pnas.2309221120

 

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