TIDMPRTC
PureTech Health PLC
07 December 2023
7 December 2023
PureTech Health plc
PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting
Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress
2023
LYT-200 demonstrates favorable safety profile and anti-tumor
activity in combination with anti-PD-1 agent, tislelizumab
Three out of four patients treated so far with head and neck
cancers experienced disease control, with one complete response and
one partial response observed in the first subset of patients
Initial results are promising, particularly for patients with
head and neck cancers, where historical outcomes are poor with
response rates of less than 20 percent on current standard-of-care
treatments(1)
PureTech Health plc (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 a poster presentation with results from the Phase 1
portion of the Phase 1/2 dose escalation and expansion clinical
trial of LYT-200 at the ESMO Immuno-Oncology Congress 2023. LYT-200
is an anti-galectin-9 antibody being evaluated as a monotherapy and
in combination with tislelizumab, an anti-PD-1 antibody developed
by BeiGene, in metastatic solid tumors, including urothelial and
head and neck cancers. LYT-200 is also in development for the
treatment of hematological malignancies, such as acute myeloid
leukemia.
The data being presented from an ongoing study including all
evaluable patients demonstrate that LYT-200 has a favorable safety
profile in all cohorts, including the monotherapy and combination
arms, and shows disease control and initial anti-tumor activity in
combination with tislelizumab. In the combination cohort,
anti-tumor activity was observed in patients with relapsed or
refractory head and neck squamous cell carcinoma, a patient
population that has historically demonstrated a low response rate
to anti-PD-1 agents of around 20 percent and 10 percent with
chemotherapy(1) .
"Galectin-9 is thought to play a foundational role in
suppressing immune-mediated activity against tumor cells, and
increases in galectin-9 expression have been shown to correlate
with aggressive disease and higher mortality, as is seen in
patients with head and neck and urothelial cancers," said Julie
Krop, M.D., Chief Medical Officer at PureTech Health. "LYT-200 is
the most advanced clinical program against this target, and we are
very encouraged by the initial results and look forward to
completing this study and advancing this program into late-stage
development."
The Phase 1/2 clinical trial includes a dose finding/dose
escalation phase (part 1) and an expansion cohort phase (part 2) in
patients with relapsed and refractory, locally advanced/metastatic
solid tumors. In the monotherapy cohort, 20 patients received
LYT-200 across seven escalation doses, with dose levels of 0.2
mg/kg to 16 mg/kg once every two weeks or 10 mg/kg once a week.
LYT-200 was well-tolerated with no observed dose-limiting
toxicities and only low-grade adverse events, as well as long-term
disease stabilization exceeding one year in patients with heavily
pre-treated pancreatic cancer and in one patient with colorectal
cancer. The monotherapy arm of the trial has been completed, and
the clinically relevant dose was selected for the Phase 2 portion
of the trial.
In the combination arm, 11 patients have been dosed, and the
initial subset of all evaluable patients treated so far includes
four patients with head and neck cancers and two patients with
urothelial cancer. In the evaluable patients with head and neck
cancers, disease control was observed in three of the four
patients, with one patient experiencing a complete response for
nine months, one patient with a deepening partial response for
eight months, and one patient with disease stabilization for four
months, and treatment in these patients remains ongoing. The two
evaluable patients with urothelial cancer experienced disease
stabilization for seven months and three months, and both remain on
treatment. The combination arm continues to enroll patients with
urothelial and head and neck cancers.
"Galectin-9 is a promising target for the treatment of solid
tumors, and the initial results from the LYT-200 Phase 1 trial
support its clinical potential," said Zev Wainberg, M.D., Professor
of Medicine at UCLA and Co-director of the UCLA GI Oncology
Program, and the lead primary investigator of the study.
The poster titled " Phase 1/2 Trial of Galectin-9 Antibody
LYT-200 +/- Tislelizumab" will be presented today at The ESMO
Immuno-Oncology Congress 2023, which is taking place in Geneva,
Switzerland.
About LYT-200
LYT-200 is a fully human IgG4 monoclonal antibody targeting a
foundational immunosuppressive protein, galectin-9, for the
potential treatment of metastatic/locally advanced solid tumors,
including urothelial and head and neck cancers, with otherwise poor
survival rates. A wide variety of preclinical data supports the
potential clinical efficacy of LYT-200 and the importance of
galectin-9 as a target and suggests 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 that 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
cancer in vivo models. LYT-200 is currently being evaluated in a
Phase 1/2 adaptive design trial for the potential treatment of
advanced solid tumors and in a Phase 1b clinical
trial for the potential treatment of acute myeloid leukemia (AML) .
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 27 therapeutics and therapeutic candidates,
including two (Plenity(R) and EndeavorRx(R)) 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 or connect
with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding 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 those
related to our expectations around the design of and the timelines
and key milestones associated with clinical trials for LYT-200,
including the initial results from the Phase 1 portion of the Phase
1/2 dose escalation and expansion clinical trial in solid tumors,
our expectations regarding the potential treatment indications, and
PureTech's 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.
(1) Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A,
Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F,
Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A,
Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in
head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27.
doi: 10.1056/NEJMoa0802656. PMID: 18784101.
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
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