Calithera Biosciences Announces First Patient Enrolled in Phase 2 Clinical Trial of Mivavotinib in Relapsed/Refractory non-GCB (ABC) Diffuse Large B-Cell Lymphoma
June 23 2022 - 4:05PM
Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage,
precision-oncology biopharmaceutical company, announced that the
first patient has been enrolled in a multicenter phase 2 clinical
trial evaluating its spleen tyrosine kinase (SYK) inhibitor
mivavotinib (CB-659) in patients with relapsed/refractory
non-germinal center B-cell like (non-GCB) diffuse large B-cell
lymphoma (DLBCL), a DLBCL subpopulation that primarily comprises
patients with activated B-cell like disease (ABC).
In a retrospective analysis of prior phase 1/2 studies in
patients with DLBCL, patients with non-GCB DLBCL who received
mivavotinib had a response rate of 53%, as compared to a response
rate of 22% in patients with GCB DLBCL. Additionally, recent
preclinical studies have shown enhanced SYK activity, and greater
sensitivity to SYK inhibition, in DLBCL tumor-cell lines with
mutations in MYD88 and CD79b genes. A significant fraction of
patients with non-GCB DLBCL have tumors that harbor these
mutations, and this subset of patients is known to have poorer
outcomes with standard-of-care therapies.
“Mivavotinib has demonstrated potential to be a first-to-market
approach for non-GCB DLBCL, including the genetic subset of
patients harboring MYD88 and/or CD79 mutations,” said Susan
Molineaux, PhD, president and chief executive officer of Calithera.
“This study will advance understanding of how our novel
biomarker-driven approach could help address this high unmet
therapeutic need, and we look forward to sharing data by the first
quarter of 2023.”
The phase 2 clinical trial (NCT05319028) is an open-label study
of mivavotinib monotherapy in patients with relapsed/refractory
non-GCB DLBCL. The main study objectives are to confirm previously
seen single-agent activity in non-GCB DLBCL patients, evaluate
activity according to MYD88/CD79b mutational status, and refine
dose/schedule in this patient population. Approximately 50 non-GCB
DLBCL patients, with or without MYD88/CD79b mutations, will be
randomized 1:1 to one of two oral dose/schedule cohorts: a
continuous dosing schedule (100 mg QD) or an induction dosing
schedule (120 mg QD x 14 days, then 80 mg QD starting Day 15).
Centrally assessed ctDNA-based liquid next-generation sequencing
(NGS) will be performed after randomization to ascertain
MyD88/CD79b mutation status. The primary endpoints of the study are
overall response rate as assessed by an independent radiology
review committee and safety. Key secondary endpoints include
duration of response, progression-free survival, and complete
response.
Data from the trial could position Calithera to initiate a study
with registrational intent in biomarker-specific DLBCL
populations.
About Calithera
Calithera Biosciences is a clinical-stage, precision oncology
biopharmaceutical company developing targeted therapies to redefine
treatment for biomarker-specific patient populations. Driven by a
commitment to rigorous science and a passion for improving the
lives of people impacted by cancer and other life-threatening
diseases, Calithera is advancing a robust pipeline of
investigational, small-molecule oncology compounds with a
biomarker-driven approach that targets genetic vulnerabilities in
cancer cells to deliver new therapies for patients suffering from
aggressive hematologic and solid tumor cancers for which there are
currently limited treatment options.
Calithera is headquartered in South San Francisco, California.
For more information about Calithera, please visit
www.calithera.com.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as "may," "will," "expect," "anticipate,"
"estimate," "intend," "poised" and similar expressions (as well as
other words or expressions referencing future events, conditions,
or circumstances) are intended to identify forward-looking
statements. These statements include those related to the safety,
tolerability and efficacy of Calithera’s product candidates, the
overall advancement of Calithera’s product candidates in
preclinical development and clinical trials, including Calithera’s
plan to share data from its mivavotinib trial by the first quarter
of 2023, Calithera’s ability to potentially initiate a
registrational study in biomarker-specific DLBCL populations and
the unmet need in the treatment of patients with advanced disease.
Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or
implied by such forward-looking statements. The potential product
candidates that Calithera develops may not progress through
clinical development or receive required regulatory approvals
within expected timelines or at all. In addition, clinical trials
may not confirm any safety, potency or other product
characteristics described or assumed in this press release. Such
product candidates may not be beneficial to patients or be
successfully commercialized. The failure to meet expectations with
respect to any of the foregoing matters may have a negative effect
on Calithera's stock price. Additional information concerning these
and other risk factors affecting Calithera's business can be found
in Calithera's periodic filings with the Securities and Exchange
Commission at www.sec.gov. These forward-looking statements are not
guarantees of future performance and speak only as of the date
hereof, and, except as required by law, Calithera disclaims any
obligation to update these forward-looking statements to reflect
future events or circumstances.
CONTACTS:Stephanie Wong
ir@Calithera.com650.870.1063
INVESTORS:Burns McClellanLee
Roth212.213.0006lroth@burnsmc.com
MEDIA:Sam Brown, Inc.Hannah
Hurdle805.338.4752hannahhurdle@sambrown.com
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