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
October 2023
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 October 18, 2023, Tiziana Life Sciences LTD (the “Company”) issued a press release, announcing a significant milestone in the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab, a groundbreaking treatment developed by Tiziana Life Sciences. Delivery Device Training materials have been developed and refined in collaboration with the FDA, and patients will be trained in the use of the nasal device in accordance with these materials.
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.
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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: October 18, 2023 | By: | /s/ Keeren Shah | |
| Name: | Keeren Shah | ||
| Title: | Chief Financial Officer | ||
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EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | News Service Announcement, dated October 18, 2023 |
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Exhibit 99.1
Tiziana Life Sciences Announces Allowance By FDA For At-Home Dosing Of Intranasal Foralumab For Multiple Sclerosis Treatment
| ● | Patients In the Intermediate Size Patient Population Expanded Access (EA) Program Will Receive Intranasal Foralumab As Part of the At-Home Dosing Initiative | |
| ● | Greater Than 1 year Safety Exposure to anti-CD3 Foralumab Has Been Well-Tolerated | |
| ● | At-Home Dosing Likely to Improve Patient Compliance to Treatment and Outcomes |
NEW YORK, October 18, 2023 --Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, is pleased to announce a significant milestone in the treatment of multiple sclerosis. The U.S. Food and Drug Administration (FDA) has allowed multiple sclerosis patients to take home and self-administer Intranasal Foralumab, a groundbreaking treatment developed by Tiziana Life Sciences. Delivery Device Training materials have been developed and refined in collaboration with the FDA, and patients will be trained in the use of the nasal device in accordance with these materials.
Intranasal Foralumab, a novel biologic therapy, has demonstrated remarkable potential in the management of multiple sclerosis. The FDA's decision to allow patients to self-administer this treatment at home marks a significant advancement in the accessibility and convenience of care for those living with this challenging condition.
“Traditionally, MS patients have had to visit healthcare facilities for treatment, which could be inconvenient and burdensome. The FDA's approval for home dosing of Foralumab will transform the way patients manage their condition, offering them greater control over their treatment schedules and the convenience of receiving care in their familiar environment” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences on this landmark decision, saying, "We are elated with the FDA's allowance for home dosing of Intranasal Foralumab. This step significantly aligns with our mission to make innovative therapies more accessible to patients and ultimately improve their quality of life. We believe that this treatment approach will revolutionize the way multiple sclerosis patients manage their condition."
Dr. William A. Clementi, Chief Development Officer of Tiziana commented “Since the beginning of the na-SPMS EA program, patients have been going to the MS clinic at Mass General Brigham to receive their 3-times a week dosing. Now, these patients will only need to go to the clinic once every 3 weeks. This dosing and medical evaluation schedule will also be mirrored in our Phase 2a double-blind study, which is due to start in November.”
“Frequent visits to the clinic for dosing is very difficult for my patients with MS,” noted Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School (HMS) and senior neurologist at Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System. “The ability for patients to dose themselves at home is truly welcome.”
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 is expected to start screening 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 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
+1 646 970 4681
ikoffler@lifesciadvisors.com
| 1 | https://www.pnas.org/doi/10.1073/pnas.2220272120 |
| 2 | https://www.pnas.org/doi/10.1073/pnas.2309221120 |