tion of each Phase II dose-ranging study, and prior to initiation of
the Phase III study, Novartis will be able to exercise its option to
license and commercialize each drug.
BOLSTERING THE IMMUNO-ONCOLOGY PIPELINE
At the start of 2015 Novartis launched a new immuno-oncology
research team led by cancer vaccine pioneer Glenn Dranoff. In a
short period of time, the team built a broad portfolio of clinical
and pre-clinical programs focused on stimulating the body’s immune system to combat cancers through targeting critical regulatory steps in the anti-tumor immune response.
Today the company’s immuno-oncology portfolio includes
novel checkpoint inhibitors, chimeric antigen receptor T-cell
(CART) technology, myeloid cell targeting agents, the T-cell
stimulating factor IL- 15, STING agonists that enhance immune
recognition of cancers, and adenosine receptor antagonists and
TGF-beta blocking antibodies that overcome immunosuppres-sion in the tumor microenvironment.
During the year, Novartis made a series of acquisitions and
strategic collaborations between itself and biotech companies
that have helped bolster its immuno-oncology pipeline. It continued to grow the pipeline through a collaboration and licensing
agreement with Surface Oncology that gave Novartis access to
four preclinical programs that target regulatory T cell populations,
inhibitory cytokines, and immunosuppressive metabolites in the
Novartis also added bispecific antibodies to its immuno-oncology portfolio through a collaboration and licensing agreement with
Xencor. Traditional monoclonal antibodies target and bind to a single
antigen. Bispecific antibodies are engineered to recognize and target
two different antigens, which makes them potentially more effective
in targeting complex diseases. A T-cell engaging bispecific antibody
is able to bind an antigen on a tumor cell with one arm and engage
T-cells capable of their destruction with the other.
Novartis has the right to develop four additional bispecific an-
tibodies and to use other Xencor proprietary antibody engineering
technology for up to ten additional biotherapeutic programs across
the Novartis R&D portfolio. In addition, the companies will col-
laborate to co-develop Xencor’s two bispecific T-cell engaging an-
tibodies targeting CD3xCD123 and CD3xCD20 for the treatment
of acute myeloid leukemia and B-cell malignancies.
Novartis also signed an exclusive option, collaboration and
license agreement with Conatus Pharmaceuticals, a biotech focused on the development of novel medicines to treat liver disease. This agreement enables Novartis and Conatus to jointly
develop emricasan, an investigational, first-in-class, oral, pan-caspase inhibitor for the treatment of NASH with advanced fibrosis (scarring) and cirrhosis. This collaboration has the potential to expand treatment options for people in various stages of
fatty liver disease, where no approved medicines currently exist.
In terms of new drug approvals, two of Novartis’ drugs for which
regulatory decisions are expected soon include LEE011, an investigational drug in combination with letrozole for the treatment
of HR+/HER2- advanced breast cancer, and PKC412, an investigational drug for the treatment of acute myeloid leukemia. Both
drugs have been granted priority review designations by the FDA.
Other regulatory decisions are expected for biosimilars.
Novartis is also going to submit new drug applications for
CTL019, an investigational drug for the treatment of acute lymphoblastic leukemia in children, and AMG334, an investigational
drug for the treatment of migraines, developed in partnership
During the year Novartis’ Cosentyx (secukinumab) was approved by the FDA for two new indications, active ankylosing
spondylitis (AS) and active psoriatic arthritis (PsA). Both are
life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. Cosentyx is now the first and only
interleukin-17A (IL-17A) antagonist approved for AS, as well as
moderate to severe plaque psoriasis and PsA, which impacts as
many as 30% of patients with psoriasis. CP
NOVARTIS BUYS BLOOD DISEASE DRUG MAKER FOR $665M
Purchase of Selexys complements and broadens hematology pipeline
Novartis acquired Selexys Pharmaceuticals, a drug maker specializing in development of therapeutics in certain hematologic and inflammatory disorders. Novartis exercised its right to acquire Selexys following receipt of results of the SUSTAIN study,
a Phase II trial evaluating the use of SelG1, an anti-P-selectin antibody, in the reduction of vaso-occlusive pain crises in patients with
sickle cell disease (SCD).
Novartis obtained the exclusive right to acquire Selexys and SelG1 in 2012. Prior to the acquisition, Selexys Pharmaceutical Corporation was a privately held biopharmaceutical company headquartered in Oklahoma City, Oklahoma. Terms of the deal could total up to
$665 million in upfront, acquisition and milestone payments.
“Sickle cell disease affects millions of people around the world and there are limited therapies available for treatment of vaso-occlusive
pain crises, a very common complication of the disease,” said Bruno Strigini, chief executive officer, Novartis Oncology. “With this ac-
quisition, Novartis is able to leverage its leadership in hematology research to advance development of a potential new treatment option
for patients living with this debilitating condition.”
“We would like to extend our gratitude to all of the dedicated patients, physicians and nurses who participated in the SUSTAIN study
of SelG1 in sickle cell disease,” said Dr. Scott Rollins, former president and chief executive officer, Selexys Pharmaceuticals. “Further, the
acquisition of Selexys by Novartis represents an important step in the continued development of SelG1, a novel, potential first-in-class
therapy for patients with this underserved life-threatening disease.”