Verastem Oncology to Present Scientific Data Supporting Immuno-Oncology Applications of Duvelisib & Defactinib at the 3rd Ann...
May 21 2018 - 4:05PM
Business Wire
Verastem, Inc. (NASDAQ: VSTM) (Verastem Oncology or the
Company), focused on developing and commercializing drugs to
improve the survival and quality of life of cancer patients, today
announced that Jonathan Pachter, PhD, the Company’s Chief
Scientific Officer, will give an oral presentation and moderate a
roundtable discussion at the 3rd Annual Advances in Immuno-Oncology
Congress being held May 24-25, 2018 in London, UK.
“The data that will be presented at the Immuno-Oncology Congress
demonstrate the unique potential of duvelisib, as a dual inhibitor
of PI3K-delta and PI3K-gamma, to enhance the efficacy of immune
checkpoint and co-stimulatory antibodies in preclinical models of
both hematological malignancies and solid tumors,” said Dr.
Pachter. “These results support continued research and lend
particular importance as we move toward the commercialization of
duvelisib, Verastem’s lead candidate an oral, dual inhibitor of
PI3K-delta and PI3K-gamma. The duvelisib New Drug Application (NDA)
is currently under review by the U.S. Food and Drug Administration
(FDA) for the treatment of patients with relapsed or refractory
CLL/SLL, and accelerated approval for the treatment of patients
with relapsed or refractory follicular lymphoma. I will also give
an update on the scientific rationale and clinical progress of our
FAK inhibitor defactinib in combination with PD-1 and PD-L1
inhibitors in solid tumors.”
Details for the presentation and round table discussion at
the Congress are as follows:
Oral Presentation Title: Immunological Effects of
Clinical Stage FAK & PI3K-Delta/Gamma InhibitorsSession:
Translational Immuno-OncologyDate and time: Thursday, May
24, 2018 at 5:40 – 6:10 PM BST
Round Table Discussion Title: Novel Checkpoint Pathways
& Strategies for Combined Modality TreatmentDate and
time: Friday, May 25, 2018 at 7:30 – 8:00 AM BST
A copy of the oral presentation will be available here
following the presentation.
About DuvelisibDuvelisib is a first-in-class
investigational oral, dual inhibitor of phosphoinositide 3-kinase
(PI3K)-delta and PI3K-gamma, two enzymes known to help support the
growth and survival of malignant B-cells and T-cells. PI3K
signaling may lead to the proliferation of malignant B- and T-cells
and is thought to play a role in the formation and maintenance of
the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated
in late- and mid-stage extension trials, including DUO™, a
randomized, Phase 3 monotherapy study in patients with relapsed or
refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL),4 and DYNAMO™, a single-arm, Phase 2 monotherapy study in
patients with refractory indolent non-Hodgkin lymphoma (iNHL).5
Both DUO and DYNAMO achieved their primary endpoints. Verastem
Oncology’s New Drug Application (NDA) requesting the full approval
of duvelisib for the treatment of patients with relapsed or
refractory CLL/SLL, and accelerated approval for the treatment of
patients with relapsed or refractory follicular lymphoma (FL) was
accepted for filing by the U.S. Food and Drug Administration (FDA),
granted Priority Review and assigned a target action date of
October 5, 2018. Duvelisib is also being developed by Verastem
Oncology for the treatment of peripheral T-cell lymphoma (PTCL),
and is being investigated in combination with other agents through
investigator-sponsored studies.6 Information about duvelisib
clinical trials can be found on www.clinicaltrials.gov.
About DefactinibDefactinib is an investigational
inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine
kinase that mediates oncogenic signaling in response to cellular
adhesion and growth factors.7 Based on the multi-faceted roles of
FAK, defactinib is used to treat cancer through modulation of the
tumor microenvironment and enhancement of anti-tumor immunity.8,9
Defactinib is currently being evaluated in three separate clinical
collaborations in combination with immunotherapeutic agents for the
treatment of several different cancer types including pancreatic
cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and
mesothelioma. These studies are combination clinical trials with
pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck
KGaA, respectively.10,11,12 Information about these and additional
clinical trials evaluating the safety and efficacy of defactinib
can be found on www.clinicaltrials.gov.
About Verastem OncologyVerastem, Inc. (Nasdaq:VSTM),
operating as Verastem Oncology, is a biopharmaceutical company
focused on developing and commercializing drugs to improve the
survival and quality of life of cancer patients. Verastem Oncology
is currently developing duvelisib, a dual inhibitor of PI3K-delta
and PI3K-gamma, which has successfully met its primary endpoint in
a Phase 2 study in indolent Non-Hodgkin Lymphoma (iNHL) and a Phase
3 clinical trial in patients with chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL). Verastem Oncology’s
New Drug Application (NDA) requesting the full approval of
duvelisib for the treatment of patients with relapsed or refractory
CLL/SLL, and accelerated approval for the treatment of patients
with relapsed or refractory follicular lymphoma (FL) was accepted
for filing by the U.S. Food and Drug Administration (FDA), granted
Priority Review and assigned a target action date of October 5,
2018. In addition, Verastem Oncology is developing the FAK
inhibitor defactinib, which is currently being evaluated in three
separate clinical collaborations in combination with
immunotherapeutic agents for the treatment of several different
cancer types, including pancreatic cancer, ovarian cancer,
non-small-cell lung cancer (NSCLC), and mesothelioma. Verastem
Oncology’s product candidates seek to treat cancer by modulating
the local tumor microenvironment and enhancing anti-tumor immunity.
For more information, please visit www.verastem.com.
References1 Winkler D.G., Faia K.L., DiNitto J.P. et al.
PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates immune
responses and suppresses activity in autoimmune and inflammatory
disease models. Chem Biol 2013; 20:1-11.2 Reif K et al. Cutting
Edge: Differential Roles for Phosphoinositide 3 kinases, p110-gamma
and p110-delta, in lymphocyte chemotaxis and homing. J Immunol
2004:173:2236-2240.3 Schmid M et al. Receptor Tyrosine Kinases and
TLR/IL1Rs Unexpectedly activate myeloid cell PI3K, a single
convergent point promoting tumor inflammation and progression.
Cancer Cell 2011;19:715-727.4 www.clinicaltrials.gov, NCT020045225
www.clinicaltrials.gov, NCT018828036 www.clinicaltrials.gov,
NCT02783625, NCT021580917 Schaller M.D. and Parsons J.T. Focal
adhesion kinase: an integrin-linked protein tyrosine kinase. Trends
Cell Biol. 1993 3: 258-62.8 Jiang H et al. Targeting focal adhesion
kinase renders pancreatic cancers responsive to checkpoint
immunotherapy. Nat Med 2016: Aug 22(8) 851-60.9 Sulzmaier F.J. et
al. FAK in cancer: mechanistic findings and clinical applications.
Nature Rev Cancer. 2014 14: 598-610.10 www.clinicaltrials.gov,
NCT0254653111 www.clinicaltrials.gov, NCT0294331712
www.clinicaltrials.gov, NCT02758587
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version on businesswire.com: https://www.businesswire.com/news/home/20180521006003/en/
Verastem Oncology, Inc.Marianne M. Lambertson, +1
781-292-4273Vice President, Corporate CommunicationsInvestor
Relations/Public Relationsmlambertson@verastem.com
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