Results collectively support the mechanism of
action and rationale for targeting MMSET in patients with multiple
myeloma
CAMBRIDGE, Mass., Dec. 3, 2024
/PRNewswire/ -- K36 Therapeutics, Inc. ("K36"), a
clinical-stage biotech company focused on developing its
first-in-class MMSET / NSD2 inhibitor KTX-1001 for t(4;14) multiple
myeloma, today announced upcoming poster presentations outlining
data from its KTX-1001 and KTX-1029 programs at the 66th
American Society of Hematology (ASH) Annual Meeting and Exposition
held December 6-10, 2024 in
San Diego, California.
The KTX-1001 presentations will feature the first results from
the dose escalation part of the Phase 1 study and characterization
of the asset's biochemical activity. A third poster will
characterize the in vitro and in vivo efficacy of
KTX-1029, a novel, potent, selective inhibitor of MMSET. Taken
together, the results collectively support the mechanism of action
and rationale for targeting MMSET in patients with multiple
myeloma.
"I am excited to report on the clinical progress of KTX-1001, a
potent, oral MMSET inhibitor being developed for multiple myeloma
patients with translocation t(4;14). The dose-escalation phase of
the clinical trial demonstrates an increase in KTX-1001 exposure by
dose and a corresponding decrease in H3K36me2 biomarker, reflecting
clear target engagement that is consistent with preclinical models"
said Pierre Bories, MD, PhD,
Hematologist, Early Phase Clinical Research Unit Hematology and
Clinical Research, Onco-Occitanie Network, Toulouse University
Cancer Institute Oncopole.
"We've seen significant momentum in enrollment since our first
presentation at ASH last year, highlighting the opportunity for
KTX-1001 to meet the unmet need for oral therapies in high-risk
patients," said Terry Connolly,
Ph.D., President and Chief Executive Officer of K36. "I want to
thank the patients, investigators, and their teams for their
commitment to generating crucial data from our trial. KTX-1001 has
shown a favorable tolerability profile, and promising clinical
activity reinforcing its potential as a first in class targeted
therapy for t(4;14) multiple myeloma patients who have exhausted
standard treatments."
Additional presentation details are outlined below:
Title: First Results from the Dose Escalation Part
of the Phase 1 Study of KTX1001, an Oral, First-in-Class, Potent
Inhibitor of MMSET/NSD2 for Relapsed/Refractory Multiple Myeloma
(RRMM)
Poster Number: 3370
Session Name: 654.
Multiple Myeloma: Pharmacologic Therapies: Poster II
Date & Time: Sunday, December 8, 2024, 6:00 PM-8:00 PM PST
"This trial highlights the potential of personalized oral
therapies like KTX-1001 to treat multiple myeloma with a targeted
medicine designed for high-risk patients," said Benjamin Winograd, M.D. Ph.D., K36's Chief
Medical Officer. "The safety profile of the oral therapy at
relevant doses allows us to move forward with the dose expansion
phase of the trial. In 2025, we will combine our oral
investigational drug with standard of care agents, starting with a
proteasome inhibitor and IMiDS to continue the development of
KTX-1001 for the treatment of t(4;14) patients"
Title: Characterization of the Biochemical Activity of
KTX-1001, a Selective Small Molecule NSD2 Inhibitor, in Surface
Plasmon Resonance (SPR)
Poster Number: 2205
Session Name: 802. Chemical Biology and Experimental
Therapeutics
Date & Time: Saturday, December
7, 2024, 5:30 PM-7:30 PM
PST
- Describes a novel method for utilizing surface plasmon
resonance (SPR) to interrogate the binding of KTX-1001 to the SET
domain of MMSET.
- These data demonstrate that one of the ways that KTX-1001
reduces H3K36me2 is by displacing S-adenosyl methionine (SAM), the
cofactor responsible for donating the methyl groups to H3K36.
Title: KTX-1029, a Potent, Selective MMSET/NSD2
Inhibitor Is Effective in t(4;14) Multiple Myeloma Preclinical
Models
Poster Number: 1878
Session Name: 651. Multiple Myeloma and Plasma Cell
Dyscrasias
Date & Time: Saturday, December
7, 2024, 5:30 PM-7:30 PM
PST
- Describes the in vitro and in vivo efficacy of
KTX-1029, a novel, potent, selective inhibitor of MMSET. KTX-1029
demonstrated efficacy in MM preclinical models as a single agent
and in combination with the proteasome inhibitors bortezomib and
carfilzomib in both PI-sensitive and -resistant settings.
- The data generated with KTX-1029 compliments the data generated
with the company's orally-available clinical candidate, KTX-1001
and adds to the body of evidence for targeting MMSET in multiple
myeloma patients with t(4;14) and for further exploration of
combination regimens with multiple myeloma standards of care.
Full abstracts can be found at the ASH Annual Meeting website
at www.Hematology.org.
About KTX-1001
KTX-1001 is a novel, first-in-class,
potent, and selective methyltransferase inhibitor of the catalytic
activity of MMSET/NSD2. It is an orally administered small molecule
developed initially for the treatment of relapsed and refractory
multiple myeloma, with a focus on patients with the t(4;14)
translocation. This inhibitor offers a promising avenue for
addressing this challenging high risk patient population.
About the KTX-1001 Phase 1 Clinical Trial
The Phase 1
clinical trial is a single-arm, open-label study in subjects with
relapsed and refractory multiple myeloma. It is a multi-part
clinical trial with dose escalation followed by an expansion cohort
in patients with the genetic translocation t(4;14) to evaluate the
safety, tolerability, and preliminary efficacy of different doses
of KTX-1001. For more information and participating centers visit
NCT05651932.
About K36 Therapeutics, Inc.
Founded in February
2021, K36 is a privately held biotech company backed by Atlas
Venture, F-Prime Capital, Eight Roads Ventures, Nextech and Bristol
Myers Squibb (NYSE:BMS). Our mission
is to translate epigenetic modulation of oncogenic pathways into
first-in-class small molecule therapeutics for the benefit of
cancer patients worldwide. For more information, please
visit www.k36tx.com and follow us on LinkedIn.
K36 COMPANY CONTACT
Soo Bang | sbang@k36tx.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/k36-therapeutics-announces-multiple-poster-presentations-highlighting-the-first-clinical-data-for-ktx-1001-and-other-developmental-compounds-at-the-66th-american-society-of-hematology-ash-annual-meeting-302320321.html
SOURCE K36 Therapeutics