Full Press Release Details
Precision BioSciences and Tiziana Life Sciences
Announce Exclusive License Agreement to Evaluate Foralumab, a Novel, Fully Human Anti-CD3 Monoclonal Antibody, in Conjunction with Allogeneic
CAR T Candidates for Cancer Treatment
Precision Gains Access to Tiziana's Anti-CD3
Antibody, Foralumab, to Evaluate as a Lymphodepletion Agent with its Allogeneic CAR T Portfolio
Durham, N.C., New York, N.Y. and London, September 2, 2021 -
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene
correction therapies with its ARCUS genome editing platform, and Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS), a clinical
stage biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an
exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce
tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.
The Cluster of Differentiation (CD) 3 is a receptor on effector T cells
and an anti-CD3 antibody, such as foralumab, has the potential to eliminate or tolerize patient effector T cells. Precision's manufacturing
process, which uses ARCUS to knock out the TRAC gene and implements a CD3-depletion step, produces allogeneic CAR T candidates that are
>99.9% CD3-negative. Thus, an anti-CD3 antibody, such as foralumab, might be used to enable the CAR T cells to expand, proliferate,
and persist to maximize long term clinical benefits.
Under the terms of the agreement, Precision gains an exclusive license
to use foralumab as a lymphodepletion agent in conjunction with its allogeneic CAR T therapeutics for the treatment of cancers. Precision
will be responsible for the development, commercialization, and costs for use of foralumab, and Tiziana will receive upfront payment,
certain milestone payments, and royalties for foralumab.
"We are building out an allogeneic CAR T platform with editing
strategies and novel conditioning regimens, such as a lymphodepleting agent like foralumab, for a broad range of hematologic malignancies
and solid tumors," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "By combining Precision's know-how
in constructing novel CAR T products with novel conditioning regimens, we will explore this approach to potentially improve durability
of clinical responses to our therapeutic platform."
"We're pleased to offer Precision the exclusive opportunity
to explore foralumab, our fully human anti-CD3 monoclonal antibody, for use as a potential lymphodepletion strategy with their allogeneic
CAR T programs," said Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of Tiziana Life Sciences. "While
CAR T therapies have been clinically successful, relapse rates remain high, which continues to limit broad utility. We are impressed with
Precision's novel approaches to CAR T development, offering the potential for a meaningful off-the-shelf solution. Further, given
Precision's approach to manufacturing that produces CAR T cells virtually CD3-negative, we believe use of foralumab as a lymphodepletion
or tolerizing agent has the potential, either alone or in combination with other co-stimulatory molecules, to improve the long-term success
of CAR T in cancer treatment."
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION
FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU
EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN
UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.
The person responsible for arranging for the release of this announcement
on behalf of Tiziana Life Sciences plc is Dr Kunwar Shailubhai, Chief Executive Officer.
About Precision's Allogeneic CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic
CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The Company's allogeneic CAR T platform is designed to
maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived
from healthy donors as starting material, then uses its ARCUS genome editing technology to modify the cells via a single-step engineering
process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, which
is designed to create a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host
disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of na ve
and central memory CAR T cells throughout the manufacturing process and in the final product.
Foralumab (TZLS-401, formerly NI-0401), the only entirely human anti-CD3
mAb, shows reduced release of cytokines as compared to other anti-CD3 mAbs after IV administration in patients with Crohn's disease with
decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized
mouse model (NOD/SCID IL2 c-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates
immune responses of the T cells, enhances regulatory T-cells (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 Clin Immunol 183, 240-246). 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.
About Precision BioSciences, Inc.
BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS
genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery,
and control in mind. Using ARCUS, the Company's pipeline consists of multiple "off-the-shelf" CAR T immunotherapy clinical
candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments
exist. For more information about Precision BioSciences please visit www.precisionbiosciences.com.
About Tiziana Life Sciences plc
Tiziana Life Sciences plc is a dual listed
(Nasdaq: TLSA & UK LSE: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human
diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies
with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab
is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has
potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes
("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response
is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal
antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
Precision Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements
regarding the Company's agreement with Tiziana for the exploration, use, development or commercialization of foralumab as a lymphodepletion
agent in conjunction with the Company's allogeneic CAR T therapeutics for the treatment of cancers and any future milestone or royalty
payments thereunder. In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe,"
"could," "expect," "should," "plan," "intend," "estimate," "target,"
"mission," "may," "will," "would," "should," "could," "target,"
"project," "predict," "contemplate," "potential," or the negative thereof and similar
words and expressions.
Forward-looking statements are based on management's
current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of
known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the
forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability
to procure sufficient funding and requirements under our current debt instruments; our operating expenses and our ability to predict what
those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources;
our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and
development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology
and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or
our collaborators' ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and
penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape
applicable to our and our collaborators' development of product candidates; our or our collaborators' ability to obtain and
maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved
product candidate; our or our collaborators' ability to advance product candidates into, and successfully design, implement and
complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our
product candidates; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties
in our and our collaborators' ability to enroll patients; if our product candidates do not work as intended or cause undesirable