– Detailed characterization of an oral
inhibitor of CDK7 demonstrates potent activity against multiple
hematologic and solid tumor cell lines, as monotherapy and in
combination with chemotherapies –
Exelixis, Inc. (Nasdaq: EXEL) and Aurigene Discovery
Technologies Limited (Aurigene) today disclosed new preclinical
data showing that AUR102 has potent anti-tumor activity in a large
panel of cancer cell lines. AUR102 is a potent, selective, and
orally bioavailable covalent inhibitor of cyclin-dependent kinase 7
(CDK7), which is an important regulator of the cellular
transcriptional and cell cycle machinery. Exelixis has an exclusive
option for AUR102 under its July 2019 exclusive collaboration,
option and license agreement with Aurigene. The new data will be
presented in a poster (Abstract 170) at the 32nd EORTC-NCI-AACR
(ENA) Symposium, which is being held virtually on October 24-25,
2020.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20201009005115/en/
“CDK7 plays a critical role in regulating cellular transcription
and cell cycle machinery, making it an exciting target for cancer
therapy,” said Murali Ramachandra, Ph.D., Chief Executive Officer
of Aurigene. “The data to be presented at ENA 2020 demonstrate that
AUR102 effectively engages CDK7 and inhibits a key mediator of the
cell cycle and transcription. The ability to inhibit CDK7 activity
with an orally available therapeutic such as AUR102 holds great
potential to improve care and outcomes for patients with diverse
cancer indications, including breast cancer, prostate cancer,
leukemia and lymphoma.”
The abstract provides a summary of results from a detailed
characterization of AUR102 in cancer cell lines and animal tumor
models. Additional data will be presented in the poster. Key
findings included in the abstract are:
- AUR102 exhibited potent anti-proliferative activity in a large
panel of cell lines with induction of cell death in cell lines
derived from multiple cancer types.
- The observed anti-proliferative activity correlated with
cellular CDK7 target engagement and decreased levels of P-Ser5
RNAPII, a key mediator of transcription.
- AUR102 studies showed synergy when used in combination with
multiple chemotherapies.
- Oral dosing with AUR102 resulted in dose-dependent anti-tumor
activity, including complete tumor regression in diffuse large
B-cell lymphoma, acute myeloid leukemia, and triple-negative breast
cancer xenograft models.
- Inhibition of tumor growth was accompanied by complete target
engagement as demonstrated in a parallel PK-PD study.
- AUR102 significantly impacts several pathways and key cancer
driver and immune-response genes.
The study authors conclude that the data support clinical
evaluation of AUR102 as a single agent and in combination with
chemotherapies for the treatment of cancer.
“The exciting AUR102 data to be presented at ENA 2020 provide
further validation of our partnering strategy, which gives us
multiple opportunities to build a pipeline of best-in-class cancer
therapies,” said Peter Lamb, Ph.D., Executive Vice President of
Scientific Strategy and Chief Scientific Officer of Exelixis.
“AUR102 could be the subject of an Investigational New Drug filing
later this year, which would be an important value driver for the
program itself and for our collaboration with Aurigene. We commend
the Aurigene team on their ongoing success in building a robust
body of data supporting the broad clinical potential of
AUR102.”
Under the terms of the July 2019 agreement, Exelixis made an
upfront payment of $10 million for exclusive options to license
three preexisting programs from Aurigene. In addition, Exelixis and
Aurigene initiated three Aurigene-led drug discovery programs on
mutually agreed upon targets, in exchange for additional upfront
option payments of $2.5 million per program. Exelixis is also
contributing research funding to Aurigene to facilitate discovery
and preclinical development work on all six programs. As the
programs mature, Exelixis will have the opportunity to exercise an
exclusive option for each program up until the time of
Investigational New Drug (IND) filing acceptance. If Exelixis
decides to exercise an option, it will make an option exercise
payment to Aurigene and assume responsibility for that program’s
future clinical development and commercialization including global
manufacturing. Aurigene will be eligible for clinical development,
regulatory, and sales milestones, as well as royalties on sales.
Under the terms of the agreement, Aurigene retains limited
development and commercial rights for India and Russia.
About Aurigene
Aurigene is a development stage biotech company engaged in
discovery and clinical development of novel and best-in-class
therapies to treat cancer and inflammatory diseases and a wholly
owned subsidiary of Dr. Reddy’s Laboratories Ltd. (BSE: 500124,
NSE: DRREDDY, NYSE: RDY). Aurigene is focused on
precision-oncology, oral immune checkpoint inhibitors, and the
Th-17 pathway. Aurigene’s programs currently in clinical
development include an oral ROR-gamma inhibitor AUR101 for moderate
to severe psoriasis in phase 2 under a U.S. FDA IND and a PD-L1/
VISTA antagonist CA-170 for non-squamous non-small cell lung cancer
in phase 2b/3 in India. Additionally, Aurigene has multiple
compounds at different stages of pre-clinical development. Aurigene
has also partnered with several large and mid-pharma companies in
the United States and Europe and has multiple programs in clinical
development. For more information, please visit Aurigene’s website
at www.aurigene.com.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in
model system genetics, we established a broad drug discovery and
development platform that has served as the foundation for our
continued efforts to bring new cancer therapies to patients in
need. Our discovery efforts have resulted in four commercially
available products, CABOMETYX® (cabozantinib), COMETRIQ®
(cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO®
(esaxerenone), and we have entered into partnerships with leading
pharmaceutical companies to bring these important medicines to
patients worldwide. Supported by revenues from our marketed
products and collaborations, we are committed to prudently
reinvesting in our business to maximize the potential of our
pipeline. We are supplementing our existing therapeutic assets with
targeted business development activities and internal drug
discovery - all to deliver the next generation of Exelixis
medicines and help patients recover stronger and live longer.
Exelixis is a member of Standard & Poor’s (S&P) MidCap 400
index, which measures the performance of profitable mid-sized
companies. For more information about Exelixis, please visit
www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis,
Inc. on Facebook.
Exelixis Forward-Looking Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’ and
Aurigene’s plans to present preclinical data in support of the
continued development of AUR102 in a poster as part of the 32nd ENA
Symposium; the potential for AUR102 to improve care and outcomes
for patients with diverse cancer indications, including breast
cancer, prostate cancer, leukemia and lymphoma; the potential for
AUR102 to be the subject of an Investigational New Drug filing
later in 2020; Exelixis’ potential future financial and other
obligations under the exclusive collaboration, option and license
agreement with Aurigene; and Exelixis’ plans to reinvest in its
business to maximize the potential of the company’s pipeline,
including through targeted business development activities and
internal drug discovery. Any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements and are based upon
Exelixis’ current plans, assumptions, beliefs, expectations,
estimates and projections. Forward-looking statements involve risks
and uncertainties. Actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: the availability of data at the
referenced times; the level of costs associated with Exelixis’
commercialization, research and development, in-licensing or
acquisition of product candidates, and other activities;
uncertainties inherent in the drug discovery and product
development process; Exelixis’ dependence on its relationship with
Aurigene, including Aurigene’s adherence to its obligations under
the exclusive collaboration, option and license agreement and the
level of Aurigene’s assistance to Exelixis in completing clinical
trials, pursuing regulatory approvals or successfully
commercializing partnered compounds in the territories where they
may be approved; the continuing COVID-19 pandemic and its impact on
Exelixis’ research and development operations; complexities and the
unpredictability of the regulatory review and approval processes in
the U.S. and elsewhere; Exelixis’ and Aurigene’s continuing
compliance with applicable legal and regulatory requirements;
Exelixis’ and Aurigene’s ability to protect their respective
intellectual property rights; market competition; changes in
economic and business conditions; and other factors affecting
Exelixis and its product pipeline discussed under the caption “Risk
Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on August 6, 2020, and in
Exelixis’ future filings with the SEC. All forward-looking
statements in this press release are based on information available
to Exelixis as of the date of this press release, and Exelixis
undertakes no obligation to update or revise any forward-looking
statements contained herein, except as required by law.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a
registered Japanese trademark.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201009005115/en/
Exelixis Investors Contact: Susan Hubbard Executive Vice
President, Public Affairs & Investor Relations (650) 837-8194
shubbard@exelixis.com
Exelixis Media Contact: Hal Mackins For Exelixis, Inc.
(415) 994-0040 hal@torchcommunications.com
Aurigene Media Contact: Subir Dubey Vice President and
Head of Business Development Aurigene Discovery Technologies
Limited +91 9611811733 subir_d@aurigene.com
Exelixis (NASDAQ:EXEL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Exelixis (NASDAQ:EXEL)
Historical Stock Chart
From Apr 2023 to Apr 2024