RCS - PureTech Health PLC - FDA Grants PRTC's LYT-200 Orphan Drug Designation

Puretech HealthAnnouncement

13/03/2024 11:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240313:nRSM6057Ga&default-theme=true

RNS Number : 6057G  PureTech Health PLC  13 March 2024

13 March 2024

PureTech Health plc

 

PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid
Leukemia

 

LYT-200 is being advanced in hematological malignancies such as acute myeloid
leukemia (AML) and high-risk myelodysplastic syndrome (MDS), and locally
advanced/metastatic solid tumors, including head and neck cancers

 

Phase 1b clinical trial evaluating LYT-200 in relapsed/refractory AML and MDS
patients is ongoing

 

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 orphan
drug designation to LYT-200 for the treatment of AML.

 

"The current long-term survival rates of patients with relapsed or refractory
AML are very poor, and there remains a tremendous unmet need for more
effective therapies," said Amir Fathi, MD, Director of the Leukemia Program at
Massachusetts General Hospital and lead investigator of the trial.

 

LYT-200 is a fully human IgG4 monoclonal antibody (mAb) targeting galectin-9,
a potent oncogenic driver in leukemia cells and an immunosuppressive protein.
LYT-200 has demonstrated direct cytotoxic, anti-leukemic effects through
multiple mechanisms and is being developed as a potential novel treatment for
hematological malignancies, such as relapsed/refractory AML and high-risk MDS,
as well as locally advanced/metastatic solid tumors that have poor survival
rates, including head and neck cancers. LYT-200 is currently being evaluated
in an ongoing Phase 1b clinical trial in relapsed/refractory AML and MDS, both
as a single agent and in combination with standard-of-care venetoclax and
hypomethylating agents (HMA). Initial findings from this trial were announced
in 2023
(https://news.puretechhealth.com/news-releases/news-release-details/puretech-year-end-update-and-outlook-2024)
, and additional data are expected to be presented in a scientific forum in
2024.

 

"Orphan drug designation from the FDA validates our belief that targeting
galectin-9 with LYT-200 is a novel, promising approach that may offer patients
a better tolerated, more effective treatment," notes Aleksandra Filipovic, MD,
PhD, Head of Oncology at PureTech.

 

The FDA grants orphan drug designation to novel drug and biologic products for
the treatment, diagnosis, or prevention of conditions affecting fewer than
200,000 persons in the U.S. Orphan drug designation qualifies PureTech for
incentives under the Orphan Drug Act, including tax credits for some clinical
trials and eligibility for seven years of market exclusivity in the U.S., if
the drug is approved for AML.

 

About LYT-200

LYT-200 is a fully human IgG4 monoclonal antibody targeting galectin-9 for the
potential treatment of hematological malignancies, such as acute myeloid
leukemia (AML) and high-risk myelodysplastic syndrome (MDS), as well as
locally advanced/metastatic solid tumors that have poor survival rates,
including head and neck cancers. Galectin-9 is a potent oncogenic driver and
immunosuppressor, and in AML it has been described to work via cytotoxic CD8 T
cells and natural killer cells. A wide variety of preclinical data underscores
the importance of galectin-9 as a target and suggests a potential opportunity
for biomarker development. These data demonstrate high expression of
galectin-9 across various blood cancers and solid tumor types and show that
galectin-9 levels correlate with poor survival in several cancers.

 

LYT-200 has demonstrated direct cytotoxic, anti-leukemic effects through
multiple mechanisms, as well as synergy with standard of care chemotherapy and
venetoclax in preclinical models. In the ongoing, Phase 1b clinical trial
evaluating LYT-200 as a single agent in AML and MDS, LYT-200 has demonstrated
a favorable safety and tolerability profile as well as early signals of
potential clinical activity. This trial is ongoing, in addition to a Phase 1/2
adaptive design trial for the potential treatment of advanced/metastatic solid
tumors. Consistent with its hub-and-spoke model, PureTech intends to advance
LYT-200 via its Founded Entity Gallop Oncology.

 

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 28 therapeutics and therapeutic candidates,
including two (Plenity® and EndeavorRx®) that have received both US
FDA clearance and European marketing authorization and a third (KarXT) that
has been filed for FDA approval. 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 the LYT-200 development program
and the timing for results from ongoing clinical trials of LYT-200, 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, 2022 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

 Investor Relations

 IR@puretechhealth.com

 EU Media

 Ben Atwell, Rob Winder

 +44 (0) 20 3727 1000

 ben.atwell@FTIconsulting.com

 U.S. Media

 Nichole Bobbyn

 +1 774 278 8273

 nichole@tenbridgecommunications.com

 

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAGPUBAWUPCPWP