RCS - PureTech Health PLC - PRTC Presents LYT-200 Phase 1b Data in AML at ASH

Puretech HealthAnnouncement

09/12/2024 07:00

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RNS Number : 2342P  PureTech Health PLC  09 December 2024

9 December 2024

PureTech Health plc

 

PureTech Presents Data for LYT-200 (anti-galectin-9 monoclonal antibody) for
Relapsed/Refractory AML/MDS at the 2024 ASH Annual Meeting

 

LYT-200 is generally safe and well-tolerated as a single agent as well as in
combination with standard-of-care venetoclax and hypomethylating agents

 

LYT-200 demonstrates clinical benefit as a single agent, with two partial
responses and 59% of evaluable patients achieving stable disease or better

 

In combination, two complete responses were seen and 80% of evaluable patients
achieved stable disease or better 1 

 

Data support LYT-200 as a potential first-line treatment for AML/MDS patients

 

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,
presented data from the dose escalation phase of its ongoing Phase 1b trial
evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in
patients with relapsed or refractory acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS) at the 2024 American Society of Hematology
(ASH) Annual Meeting in San Diego, California.

 

LYT-200 is currently being evaluated both as a monotherapy and in combination
with the standard-of-care venetoclax and hypomethylating agents (HMA) for
patients whose disease is relapsed/refractory to at least one line of prior
treatment. It targets galectin-9, a glycan-binding protein that is
significantly upregulated in AML and MDS and plays a key role in disease
development, progression, immune interference and drug resistance. Initial
results show a favorable safety profile across both arms and all dose levels
with no dose limiting toxicities, as well as evidence of response,
hematological improvement and sustained disease management.

 

"Relapsed/refractory acute myeloid leukemia is one of the most dire cancer
diagnoses, with 50% of patients non-responsive to or relapsing after initial
treatment and a median survival time of less than six months, 2 " said Luba
Greenwood, J.D., Entrepreneur-in-Residence at PureTech who is leading the
Gallop Oncology work. "We are encouraged to see that LYT-200 achieved
responses as well as long-term disease stabilization in heavily pre-treated
patients, and we look forward to progressing LYT-200 as a critical therapeutic
option with the potential to treat most AML patients."

 

In the monotherapy arm, patients received LYT-200 at five dose levels (2.0
mg/kg to 16.0 mg/kg). Across all dose levels, LYT-200 induced clinical benefit
and responses in heavily pre-treated, relapsed/refractory AML/MDS patients,
even in those with complex cytogenetics and mutations such as KRAS, NRAS, BRAF
as well as patients previously fully refractory to standard of care. Out of 22
evaluable patients who received monotherapy, 59% achieved stable disease or
better with two partial responses. The mean duration on treatment is greater
than two months, which exceeds the standard overall survival of approximately
1.7 months in venetoclax/HMA-refractory patients. 3 

 

When administered in combination with venetoclax/HMA, results demonstrate that
LYT-200 may enhance the efficacy of standard-of-care therapies, even in
relapsed or refractory patients. In the combination arm, patients received
LYT-200 across three dose levels (4.0 mg/kg to 12.0 mg/kg) with
venetoclax/HMA. Out of 15 evaluable patients who received combination therapy,
80% achieved stable disease or better, with two experiencing complete
responses and one patient achieving a morphologic leukemia free state
(MLFS).(1) The combination regimen has also demonstrated clinical benefit in
patients with KRAS/NRAS mutations and the mean duration on treatment up until
the point of data cut-off is greater than two months.

 

"Galectin-9 is an essential driver of both disease proliferation and immune
suppression in AML that has not yet been addressed therapeutically," said
Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at PureTech. "LYT-200
represents a novel approach for treating AML via a two-gear mode of action
that kills cancer cells directly via apoptosis and DNA damage, as well as by
re-activating central anti-cancer effectors of the immune system. We are
excited by these Phase 1 data that demonstrate the transformative potential of
this dual mechanism of LYT-200, both as a single agent and in combination with
existing standard-of-care treatments."

 

Pharmacodynamic assessments of treated patients, using gene and protein
analyses of patient cells, validate the LYT-200 dual mode of action, and
reveal AML cellular pathways as well as specific immune cell types which may
be most critical for response.

 

Based on these data, LYT-200 will continue development in relapsed/refractory
AML/MDS towards a Phase 2 clinical trial. 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 preclinical 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

+1-609-578-7230

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

(( 1 ))Data as of November 4, 2024, were presented at ASH 2024. Figure
reflects additional data generated through November 20, 2024.

 2 Miyamoto K, Minami Y. Cutting Edge Molecular Therapy for Acute Myeloid
Leukemia. Int J Mol Sci. 2020;21(14):5114. Published 2020 Jul 20.
doi:10.3390/ijms21145114

 3 Maiti A, Rausch CR, Cortes JE, et al. Outcomes of relapsed or refractory
acute myeloid leukemia after frontline hypomethylating agent and venetoclax
regimens. Haematologica. 2021;106(3):894-898. Published 2021 Mar 1.
doi:10.3324/haematol.2020.252569

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