Clovis to acquire rights to discovery
program for three additional targets for radionuclide
therapy
- Clovis to pay approximately $12 million in upfront payments to
3B Pharmaceuticals
- Clovis currently planning to file an IND for FAP-targeted
radiopharmaceutical therapy in 2H 2020
- FAP highly expressed in multiple tumor types; Clovis to pursue
broad and accelerated clinical development program
Clovis Oncology, Inc. (NASDAQ: CLVS) has entered into a global
licensing and collaboration agreement with 3B Pharmaceuticals GmbH
(3BP), a private German biotechnology company developing targeted
radiopharmaceutical drugs and diagnostics for oncology indications
with a high unmet medical need. The initial focus is on developing
a peptide-targeted radionuclide therapy (PTRT) and imaging agent
targeting fibroblast activation protein alpha (FAP). FAP is highly
expressed in many epithelial cancers, including more than 90
percent of breast, lung, colorectal and pancreatic carcinomas.1
Clovis will conduct global clinical trials and has obtained U.S.
and global rights, excluding Europe (inclusive of Russia, Turkey
and Israel), where 3BP retains rights. The parties have also agreed
to collaborate on a discovery program directed at three additional
targets for radionuclide therapy, to which Clovis will have global
rights.
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Terms of the transactions include approximately $12 million in
upfront payments to 3BP. Upon achievement of certain development
and regulatory milestones, additional potential milestone payments
and single- to low-double-digit commercial royalties would be paid
to 3BP by Clovis. Clovis will be responsible for a limited number
of 3BP full-time employees (FTEs) and external costs during the
pre-clinical development. Research and development expense guidance
provided by Clovis on its August 1 financial results call does not
change as a result of today’s announcement.
“We are extremely enthusiastic about the opportunity to develop
this novel class of targeted radiopharmaceutical therapies, with an
initial focus on fibroblast activation protein alpha. Targeted
radiopharmaceutical therapy represents a next frontier in oncology
drug development, with potential application across multiple tumor
types. In particular, FAP represents a very compelling target given
its overexpression across numerous tumor types and limited
expression in healthy tissue,” said Patrick J. Mahaffy, President
and CEO of Clovis Oncology. “Additionally, as a result of our
discovery collaboration, Clovis intends to further expand its
pipeline with additional targeted radiopharmaceutical candidates
that result from the discovery program using 3BP’s technology
platform. We are delighted to work with 3BP given their leadership
in the discovery and development of peptide-targeted radionuclide
therapies.”
The collaboration is initially focused on the development of an
FAP-targeted preclinical candidate identified by 3BP’s technology
platform. FAP is highly expressed in cancer-associated fibroblasts
(CAFs) which are found in the majority of cancer types and play an
intricate role in driving tumor growth. Targeting CAFs with an FAP
radiopharmaceutical is believed to have multiple modes of
anti-tumor action, but principally relies on the induction of DNA
damage in tumor cells by ionizing radiation emitted locally from
neighboring CAFs targeted by the therapy.
Clovis and 3BP also announced their intention to enter into a
collaboration for the discovery and development of
radiopharmaceuticals for three additional targets using 3BP’s
technology platform. 3BP will be responsible for discovery
activities for the three targets. Once lead molecules have been
identified, responsibilities will transition to Clovis for
Investigational New Drug (IND)-enabling studies.
“We have focused for many years on developing a peptide
technology platform for the discovery and development of innovative
radiopharmaceuticals, which we believe represents the best means of
selectively delivering potent radiation to tumors,” said Dr. Ulrich
Reineke, Managing Director of 3BP. “As we are approaching clinical
development, we are very enthusiastic about partnering with Clovis
Oncology to move our FAP-targeted product forward and to
collaborate further on building a portfolio of targeted
radiopharmaceutical therapeutics. We believe this is an ideal
partnership for the rapid clinical development of our
radiopharmaceuticals for the benefit of patients with many
different types of cancer.”
About Fibroblast Activation Protein Alpha (FAP)
Fibroblast activation protein alpha, or FAP, is highly expressed
in cancer-associated fibroblasts (CAFs) which are found in the
majority of cancer types, potentially making it a suitable target
across a wide array of solid tumors. FAP is highly expressed in
many epithelial cancers, including more than 90 percent of breast,
lung, colorectal and pancreatic carcinomas.1 CAFs are highly
prevalent in the tumor microenvironment of many cancers and persist
through all malignant stages of a tumor, from primary tumor to
metastasis. FAP has limited expression on normal fibroblasts,
reducing the potential for effects in normal tissue.
About Peptide-Targeted Radionuclide Therapy (PTRT)
Peptide-targeted radionuclide therapy involves a small amount of
radioactive material (radionuclide) that is combined with a
cell-targeting moiety peptide for the treatment of cancer; PTRT is
considered a form of radiopharmaceuticals. The targeting peptide is
able to recognize and bind to specific features of tumors, such as
antigens and cell receptors. When injected into the patient’s
bloodstream, the peptide attaches to cancer cells or
cancer-associated stromal cells, delivering a high dose of
radiation to the tumor while sparing normal tissues.
About FAP-Targeted Radiopharmaceuticals
Clinical studies of small molecule imaging agents targeting FAP
have validated this target in a diverse number of cancer
indications and support the further evaluation of peptide-targeted
radionuclide therapy. FAP-targeted radiopharmaceuticals have at
least two potential modes of anti-tumor activity: radiation
crossfire, in which tumor cells are irradiated due to their close
proximity to CAFs; and depletion of CAFs, disrupting the
communication between the tumor cells and the tumor stroma. In
addition, in certain tumor types, such as sarcoma and mesothelioma,
FAP is expressed on the tumor cells themselves, and in those
tumors, FAP-targeted radiopharmaceuticals may have a direct
antitumor effect.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer
agents in the U.S., Europe and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners, for
those indications that require them, diagnostic tools intended to
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado, with additional office locations in the U.S. and
Europe. Please visit www.clovisoncology.com for more
information.
About 3B Pharmaceuticals
3B Pharmaceuticals is a German biotechnology company developing
targeted radiopharmaceutical drugs and diagnostics for oncology
indications with a high unmet medical need. As a leader in peptide
discovery and optimization, 3B Pharmaceuticals has built a
technology platform extending from hit identification to early
clinical development. 3BP was founded in 2008 by a team of renowned
experts in peptide drug discovery and nuclear medicine from Berlin,
Bern and Basel. The company is owned by its founders and
management. For more information on 3B Pharmaceuticals, visit
www.3b-pharma.com.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management. Examples of forward-looking
statements contained in this press release include, among others,
statements regarding our future financial and operating
performance, business plans or prospects, including expectations
concerning our research and development expenses, our intentions
regarding our development and discovery programs, including the
expansion of our development pipeline, in connection with the
collaboration with 3BP, the timing and pace of our pre-clinical
development. Such forward-looking statements involve substantial
risks and uncertainties that could cause Clovis Oncology’s actual
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in drug discovery and pre-clinical and clinical
development, including the outcome of pre-clinical studies, whether
future study results will be consistent with previous study
findings, including pre-clinical studies, whether additional
studies not originally contemplated are determined to be necessary,
the timing of initiation, enrollment and completion of planned
studies. Clovis Oncology undertakes no obligation to update or
revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to the business of the company in general,
see Clovis Oncology’s Annual Report on Form 10-K, Quarterly Reports
on Form 10-Q and its other reports filed with the Securities and
Exchange Commission.
_____________________________ 1 Rettig, 1993, Cancer
Research
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Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: U.S. Lisa Guiterman,
301.217.9353 clovismedia@sambrown.com or Christy Curran,
615.414.8668 clovismedia@sambrown.com
EU Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
3B Pharmaceuticals Media Contact: Dr. Jan Michel Director
Finance & Corporate Development Tel.: +49 (30) 6392-4317 Fax.:
+49 (30) 6392-4316 E-mail: jan.michel@3b-pharma.com
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