Ayala Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of AL102 in Combination with BCMA Targeting Age...
April 21 2021 - 8:00AM
Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage
oncology company focused on developing and commercializing small
molecule therapeutics for patients suffering from rare and
aggressive cancers, today announced the dosing of the first patient
in the ongoing Phase 1 clinical trial evaluating its potent
investigational gamma secretase inhibitor (GSI), AL102, in
combination with Novartis’ investigational anti-B-cell maturation
antigen (BCMA) agent, WVT078, for the treatment of patients with
relapsed and/or refractory multiple myeloma (MM).
AL102 is an oral small molecule that inhibits gamma secretase.
Inhibition of gamma secretase prevents the cleavage and shedding of
BCMA, which are ubiquitously expressed on MM cells. Preclinical
data have demonstrated that treatment with AL102 increases
expression of membrane-bound BCMA on the surface of MM cells and
could enhance activity of WVT078.
“The dosing of the first patient in this Phase 1 trial marks an
important milestone in our collaboration with Novartis. We view
this trial, not only as a significant opportunity to explore the
clinical viability of enhancing BCMA-targeting agents with GSIs
such as AL102, but also as an important step forward in bringing a
novel treatment option to patients with MM,” said Roni Mamluk,
Ph.D., Chief Executive Officer of Ayala. “Despite numerous advances
in the treatment landscape for MM, the disease remains incurable.
BCMA is ubiquitously expressed on myeloma cells. Increasing BCMA
expression on target cells and reducing the shedding in circulation
is believed to potentially enhance therapies and increase
responses. We look forward to further evaluating this potential as
we bring this program into the clinic.”
The Phase 1, open-label, multicenter trial of AL102 in
combination with Novartis’ WVT078 is currently enrolling patients
with relapsed and/or refractory multiple myeloma who have received
two or more standard of care lines of therapy including an IMID, a
proteasome inhibitor, and an anti-CD38 agent. The first-in-human
dose escalation trial is designed to assess the safety,
tolerability and recommended dose regimen(s) of WVT078 alone and in
combination with AL102. In addition, the trial will assess
preliminary anti-MM response and characterize the pharmacokinetics
and immunogenicity of WVT078 alone and in combination with
AL102.
Under the terms of the option and license agreement established
in December 2018, Novartis is responsible for the conduct and
expenses of any trials of AL102 in combination with their
BCMA-targeting agents, as well as potential commercialization, in
multiple myeloma. Ayala retains worldwide license rights to AL102
in all other indications.
About AL102AL102 is a potent, selective and
oral gamma secretase inhibitor (GSI). AL102 is currently being
developed for the treatment of desmoid tumors, as well as in
combination with Novartis’ BCMA-targeting agents for the treatment
of multiple myeloma (MM).
About WVT078WVT078 is a bispecific antibody
that engages both BCMA and CD3, resulting in the recruitment of
cytotoxic T cells that target BCMA-positive MM cells.
About Multiple Myeloma Multiple myeloma is a
rare and aggressive blood cancer that accounts for approximately
one percent of all cancers. In the U.S., there are nearly 90,000
people living with, or in remission from, multiple myeloma.
Approximately, 26,850 Americans are diagnosed with multiple myeloma
each year and 11,240 patient deaths are reported on an annual
basis.
About Ayala PharmaceuticalsAyala
Pharmaceuticals, Inc. is a clinical-stage oncology company focused
on developing and commercializing small molecule therapeutics for
patients suffering from rare and aggressive cancers. Ayala’s
approach is focused on predicating, identifying and addressing
tumorigenic drivers of cancer through a combination of its
bioinformatics platform and next-generation sequencing to deliver
targeted therapies to underserved patient populations. The company
has two product candidates under development, AL101 and AL102,
targeting the aberrant activation of the Notch pathway with gamma
secretase inhibitors to treat a variety of tumors including Adenoid
Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell
Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple
Myeloma (MM) (in collaboration with Novartis). AL101 has received
Fast Track Designation and Orphan Drug Designation from the U.S.
FDA and is currently in a Phase 2 clinical trial for patients with
ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2
clinical trial for patients with TNBC (TENACITY) bearing Notch
activating mutations and other gene rearrangements. AL102 is
currently being advanced to a Phase 2/3 clinical trial for patients
with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1
clinical trial in combination with Novartis’ BMCA targeting agent,
WVT078, in Patients with relapsed/refractory Multiple Myeloma. For
more information, visit www.ayalapharma.com.
Contacts:
Investors:Julie SeidelStern Investor Relations,
Inc. +1-212-362-1200Julie.seidel@sternir.com
Ayala
Pharmaceuticals:+1-857-444-0553info@ayalapharma.com
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