C4 Therapeutics Announces Positive Data from CFT7455 Phase 1 Trial in Relapsed/Refractory Multiple Myeloma
12 Diciembre 2023 - 3:01PM
C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation science to develop a new generation of small-molecule
medicines and transform how disease is treated, today presented
clinical data from the ongoing Phase 1 dose escalation portion of
its Phase 1/2 clinical trial of CFT7455, a MonoDAC™ degrader of
IKZF1/3, for the potential treatment of multiple myeloma (MM) and
non-Hodgkin’s lymphomas (NHL). These data include results from
CFT7455 as a monotherapy for relapsed/refractory (R/R) MM patients,
which has completed dose escalation, and interim results from
CFT7455 in combination with dexamethasone for R/R MM patients,
which continues to enroll patients. C4T also continues to enroll
patients in the Phase 1 dose escalation trial exploring CFT7455 as
a monotherapy for NHL patients.
“We are excited CFT7455 monotherapy is showing promising signs
of anti-myeloma and immunomodulatory activity and anti-myeloma
activity when combined with dexamethasone, particularly in patients
who have undergone numerous lines of prior therapy for multiple
myeloma, including BCMA therapies,” said Len Reyno, M.D., chief
medical officer of C4 Therapeutics. “We have established 14 days
on/14 days off as the optimal dosing schedule, which is consistent
with our preclinical data supporting CFT7455 as a rationally
designed IKZF1/3 degrader with the potential to offer a new therapy
for patients with relapsed/refractory multiple myeloma.”
CFT7455 Phase 1 Dose Escalation The goal of the
CFT7455 Phase 1 dose escalation trial is to define the safety
profile of CFT7455, determine the maximum tolerated or administered
dose, and identify signs of anti-tumor activity in R/R MM and R/R
NHL. The Phase 1 dose escalation portion of the trial includes
three arms: CFT7455 as a monotherapy for R/R MM patients, which is
complete; CFT7455 in combination with dexamethasone for R/R MM
patients, which continues to advance through dose escalation; and
CFT7455 as a monotherapy for NHL patients, which also continues to
advance through dose escalation. The Phase 1 dose escalation
portion of the ongoing Phase 1/2 trial has utilized a 14 days on/14
days off dosing schedule within which both daily dosing and
Monday/Wednesday/Friday (MWF) dosing were explored.
CFT7455 as a Monotherapy for R/R MM Patients
Monotherapy dose escalation is complete. As of the November 28,
2023 data cutoff date, 22 patients had received CFT7455 as a
monotherapy. The maximum dose administered was 75 µg daily for 14
days on/14 days off. A maximum tolerated dose was not defined.
Patients were heavily pretreated, with a median of seven prior
therapies. The majority of patients (n=12) received prior CAR-T or
T-cell engager therapy.
Pharmacokinetic and Pharmacodynamic Results
- Clearance of CFT7455 is consistent with a 48-hour
half-life.
- Daily dosing (14 days on/14 days off) resulted in deep IKZF1/3
degradation.
- After day 14, as plasma concentrations of CFT7455 begin to
decline, degraded proteins recover through day 28, enabling
neutrophil recovery.
Safety and Evidence of Anti-Tumor Effect
- CFT7455 was well tolerated.
- 22 patients were evaluable for safety. The most common adverse
events (AEs) Grade 3 or above were neutropenia (n=11), anemia (n=4)
and leukopenia (n=4).
- No dose-limiting toxicities (DLTs) resulted in discontinuation
of therapy.
- As of the November 28, 2023 data cutoff date, 20 patients were
evaluable for evidence of anti-tumor effect.
- Four patients received the maximum dose administered of 75 µg
daily. Three patients were refractory to BCMA therapies. Responses
were measured in accordance with the International Myeloma Working
Group (IMWG) criteria for multiple myeloma. All four patients
achieved Stable Disease (SD) or better and one patient achieved a
Partial Response (PR).
Immunomodulatory Results
- CFT7455 induced CD8+ T-cell activation by increasing the
effector memory T-cell subset, as required for effective adaptive
immunity.
- T-cell activation was observed at well tolerated monotherapy
doses, supporting the potential use of CFT7455 in combination with
bi-specific T-cell engagers and monoclonal antibody therapies.
CFT7455 in Combination with Dexamethasone for R/R MM
Patients As of the November 28, 2023 data cutoff date,
nine patients had received CFT7455 in combination with
dexamethasone across two initial dose escalation cohorts (50 µg MWF
for 14 days on/14 days off; or 37.5 µg daily for 14 days on/14 days
off). Patients were heavily pretreated, with a median of six prior
therapies. The majority of patients (n=5) received prior CAR-T or
T-cell engager therapy. This arm is ongoing; patients are currently
enrolling in either the 62.5 µg escalation cohort or the 37.5 µg
expansion cohort.
Safety and Evidence of Anti-Tumor Effect
- CFT7455 in combination with dexamethasone is well tolerated to
date.
- The most common AEs Grade 3 or above were consistent with the
monotherapy safety signal.
- No AEs have led to dose reductions, discontinuations or
DLTs.
- All three patients evaluable for efficacy at 37.5 μg daily
achieved SD or better according to IMWG criteria. These assessments
include:
- One patient achieved a Stringent Complete Response (sCR), after
initially achieving a Very Good Partial Response (VGPR). This
patient was refractory to BCMA therapies.
- One patient achieved a PR. This patient was refractory to BCMA
therapies.
- One patient achieved SD.
Upcoming Data Presentations for CFT7455C4T
expects to present the following data on CFT7455 in 2024:
- Complete Phase 1 dose escalation data from the ongoing Phase
1/2 clinical trial in R/R MM.
- Complete Phase 1 dose escalation data from the ongoing Phase
1/2 clinical trial in NHL.
C4T Webcast for Analysts and Investors C4T will
host an investor webcast today, December 12, 2023, at 4:30 pm
Eastern Time, to discuss the CFT7455 Phase 1 clinical data in
relapsed/refractory multiple myeloma. To join the webcast, please
visit this link or the “Events & Presentations” page of the
Investors section on the company’s website at
www.c4therapeutics.com. A replay of the webcast will be archived
and available following the event.
About C4 TherapeuticsC4 Therapeutics (C4T)
(Nasdaq: CCCC) is a clinical-stage biopharmaceutical company
dedicated to delivering on the promise of targeted protein
degradation science to create a new generation of medicines that
transforms patients’ lives. C4T is leveraging its
TORPEDO® platform to efficiently design and optimize
small-molecule medicines that harness the body’s natural protein
recycling system to rapidly degrade disease-causing proteins,
offering the potential to overcome drug resistance, drug
undruggable targets and improve patient outcomes. C4T is advancing
multiple targeted oncology programs to the clinic and expanding its
research platform to deliver the next wave of medicines for
difficult-to-treat diseases. For more information, please
visit www.c4therapeutics.com.
About CFT7455CFT7455 is an orally bioavailable
MonoDAC™ degrader designed to be highly potent and selective
against its intended targets of Ikaros (IKZF1) and Aiolos (IKZF3)
and overcome shortcomings of currently approved therapies to treat
multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). Initial
clinical data show CFT7455 is well tolerated, demonstrates
anti-myeloma activity and displays evidence of immunomodulatory
effects. The optimal dosing schedule for CFT7455 is 14 days on/14
days off. Dose escalation continues in cohorts exploring CFT7455 in
combination with dexamethasone for relapsed/refractory MM patients
and as a monotherapy for NHL patients. More information about this
trial may be accessed at www.clinicaltrials.gov (identifier:
NCT04756726).
Forward-Looking StatementsThis press release
contains “forward-looking statements” of C4 Therapeutics, Inc.
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, but may not
be limited to, express or implied statements regarding our ability
to develop potential therapies for patients; the design and
potential efficacy of our therapeutic approaches; the predictive
capability of our TORPEDO® platform in the development of
novel, selective, orally bioavailable BiDAC™ and MonoDAC™
degraders; the potential timing, design and advancement of our
preclinical studies and clinical trials, including the potential
timing for and receipt of regulatory authorization related to
clinical trials and other clinical development activities including
clinical trial commencement; our ability and the potential to
successfully manufacture and supply our product candidates for
clinical trials; our ability to replicate results achieved in our
preclinical studies or clinical trials in any future studies or
trials; our ability to replicate interim or early-stage results
from our clinical trials in the results obtained when those
clinical trials are completed or when those therapies complete
later stage clinical trials; regulatory developments in the United
States and foreign countries; the potential timing for updates on
our clinical and research programs; and our ability to fund our
future operations. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: uncertainties related to the initiation,
timing, advancement and conduct of preclinical and clinical studies
and other development requirements for our product candidates; the
risk that any one or more of our product candidates will cost more
to develop or may not be successfully developed and commercialized;
and the risk that the results of preclinical studies and/or
clinical trials will or will not be predictive of results in
connection with future studies or trials. For a discussion of these
and other risks and uncertainties, and other important factors, any
of which could cause our actual results to differ from those
contained in the forward-looking statements, see the section
entitled “Risk Factors” in C4 Therapeutics’ most recent Annual
Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed
with the Securities and Exchange Commission. All information in
this press release is as of the date of the release and C4
Therapeutics undertakes no duty to update this information unless
required by law.
Contacts:Investors: Courtney SolbergSenior
Manager, Investor RelationsCSolberg@c4therapeutics.com
Media: Loraine Spreen Senior Director, Corporate
Communications & Patient
Advocacy LSpreen@c4therapeutics.com
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