RCS - PureTech Health PLC - PRTC's LYT-200 Gets Fast Track Designation in AML

Puretech HealthAnnouncement

09/01/2025 12:00

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RNS Number : 6677S  PureTech Health PLC  09 January 2025

9 January 2025

PureTech Health plc

 

PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid
Leukemia (AML)

 

Single agent and combination data from Phase 1b AML/MDS trial presented at ASH
2024 showed potential of LYT-200 to serve broad range of patients across
various lines of treatment

 

LYT-200 is currently being evaluated in two Phase 1/2 trials for the potential
treatment of AML/MDS and head and neck cancers

 

PureTech Health plc (https://puretechhealth.com/) (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company
dedicated to changing the lives of patients with devastating diseases, today
announced that the U.S. Food and Drug Administration ("FDA") has granted Fast
Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal
antibody, for the treatment of acute myeloid leukemia ("AML"). Fast Track
designation is a process designed to streamline the development and accelerate
the assessment of drugs that target serious conditions with unmet medical
need.

 

"Fast Track designation from the FDA reinforces our belief in the potential
for LYT-200 to address the urgent needs of AML patients," said Luba Greenwood,
J.D., Entrepreneur-in-Residence at PureTech who is leading the Gallop Oncology
work. "This milestone builds on the FDA's recognition of LYT-200's promise,
including Orphan Drug designation for AML and a second Fast Track designation
for head and neck cancers, both of which were granted last year. By targeting
galectin-9, a key driver of cancer proliferation and immune suppression,
LYT-200 represents a novel and promising approach for patients in need, and we
look forward to the continued development of this program."

 

LYT-200 exerts its therapeutic effects in AML by killing cancer cells directly
via apoptosis and DNA damage as well as reactivating central anti-cancer
effectors of the immune system. LYT-200 is the most advanced clinical program
against galectin-9 and is being evaluated in two ongoing clinical trials,
including:

 

1.    Phase 1/2 clinical trial evaluating LYT-200 as a monotherapy and in
combination with venetoclax and hypomethylating agents in hematological
malignancies, including AML and high-risk myelodysplastic syndrome (MDS). In
this trial, LYT-200 has demonstrated
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-presents-data-lyt-200-anti-galectin-9-monoclonal)
a favorable safety and tolerability profile as well as early signals of
clinical activity as single agent and in combination.

2.    Phase 1/2 trial in advanced/metastatic solid tumors, including head
and neck

cancers. In this trial, LYT-200 is being evaluated as a monotherapy and in
combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene. To
date, LYT-200 has demonstrated
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-presents-data-phase-1-trial-lyt-200-targeting-galectin)
a favorable safety profile in all cohorts, including the monotherapy and
combination arms with BeiGene's tislelizumab, and shown disease control and
suggestions of initial anti-tumor activity.

 

The FDA has also granted orphan drug designation
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-receives-orphan-drug-designation-lyt-200-acute-myeloid)
to LYT-200 for the treatment of AML as well as a separate
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-receives-fda-fast-track-designation-lyt-200-head-and)
Fast Track designation
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-receives-fda-fast-track-designation-lyt-200-head-and)
for the treatment of recurrent/metastatic head and neck squamous cell
carcinomas ("head and neck cancers"), in combination with anti-PD1 therapy.
PureTech previously announced that it intends to advance LYT-200 via its
Founded Entity, Gallop Oncology.

 

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting a foundational
oncogenic and immunosuppressive protein, galectin-9, for the potential
treatment of hematological malignancies and locally advanced metastatic solid
tumors, including head and neck cancers, with otherwise poor survival rates. A
wide variety of preclinical data support the potential clinical efficacy of
LYT-200 and the importance of galectin-9 as a target and suggest a potential
opportunity for biomarker development. PureTech has presented data
demonstrating high expression of galectin-9 across various solid tumor types
and blood cancers and has found that, in several cancers, galectin-9 levels
correlate with shorter time to disease relapse and poor survival. Preclinical
work also demonstrates single mechanistic and anti-tumor efficacy of LYT-200
in multiple animal and patient-derived tumor cell models. For example, LYT-200
outperforms anti-PD-1 in solid tumor models models as a single agent. LYT-200
also synergizes with anti-PD-1 in activating CD4 and CD8 T cells in in
vivo cancer models. LYT-200 is currently being evaluated in two ongoing
Phase 1/2 adaptive design trials for the potential treatment of AML/MDS and
head and neck cancers.

 

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving
life to new classes of medicine to change the lives of patients with
devastating diseases. The Company has created a broad and deep pipeline
through its experienced research and development team and its extensive
network of scientists, clinicians and industry leaders that is being advanced
both internally and through its Founded Entities. PureTech's R&D
engine has resulted in the development of 29 therapeutics and therapeutic
candidates, including three that have been approved by the U.S. Food and
Drug Administration. A number of these programs are being advanced
by PureTech or its Founded Entities in various indications and stages of
clinical development, including registration-enabling studies. All of the
underlying programs and platforms that resulted in this pipeline of
therapeutic candidates were initially identified or discovered and then
advanced by the PureTech team through key validation points.

 

For more information, visit www.puretechhealth.com
(http://www.puretechhealth.com/)  or connect with us on X (formerly Twitter)
@puretechh.

  

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be 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 those related to development plans for LYT-200,
potential benefits to patients, and our future prospects, developments and
strategies. The forward-looking statements are based on current expectations
and are subject to known and unknown risks, uncertainties and other important
factors that could cause actual results, performance and achievements to
differ materially from current expectations, including, but not limited to,
those risks, uncertainties and other important factors described under the
caption "Risk Factors" in our Annual Report on Form 20-F for the year
ended December 31, 2023, filed with the SEC and in our other regulatory
filings. These forward-looking statements are based on assumptions regarding
the present and future business strategies of the Company and the environment
in which it will operate in the future. Each forward-looking statement speaks
only as at the date of this press release. Except as required by law and
regulatory requirements, we disclaim any obligation to update or revise these
forward-looking statements, whether as a result of new information, future
events or otherwise.

 

Contact:

PureTech

Public Relations

publicrelations@puretechhealth.com (mailto:publicrelations@puretechhealth.com)

Investor Relations

IR@puretechhealth.com (mailto:IR@puretechhealth.com)

UK/EU Media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

puretech@fticonsulting.com (mailto:puretech@fticonsulting.com)

US Media

Justin Chen

jchen@tenbridgecommunications.com (mailto:jchen@tenbridgecommunications.com)

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