CytomX Therapeutics, Inc. (NASDAQ: CTMX, President, Chief Executive
Officer and Chairman: Sean McCarthy, D. Phil. “CytomX”) and
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa,
Ph.D., “Astellas”) today announced they have entered into a
strategic collaboration agreement focused on the discovery,
research, development and commercialization of novel T-cell
engaging bispecific antibodies targeting CD3 and tumor cell surface
antigens for the treatment of cancer. The parties will
utilize CytomX’s Probody® therapeutic technology platform, as well
as its proprietary bispecific formats and CD3 modules.
“This collaboration with Astellas leverages
CytomX’s deep expertise in targeting multiple antibody modalities
to the tumor microenvironment,” said Sean McCarthy, D. Phil.,
President, Chief Executive Officer and Chairman of CytomX. “We are
excited about the use of our technology to assist Astellas in
unlocking the potential of T-cell engaging bispecifics in the
treatment of solid tumors, building on the growing proof of concept
we have established for our platform.”
“At Astellas, immuno-oncology is a Primary Focus
of our research and development strategy, and we are working on the
development of next-generation cancer immuno-therapy using new
modalities/technologies,” stated Naoki Okamura, Representative
Director Corporate Executive Vice President, Chief Strategy Officer
and Chief Financial Officer, Astellas.“We look forward to the
collaboration with CytomX, which will enable us to leverage both
companies capabilities and expand our next-generation
immuno-oncology therapeutic pipeline as we continue to dedicate our
efforts to deliver innovative treatments for diseases with high
unmet medical needs.”
Probody® therapeutics are designed to remain
inactive until they are activated by proteases in the tumor
microenvironment. As a result, Probody® therapeutics are designed
to bind selectively to tumors and minimize binding to healthy
tissue, thereby reducing toxicities and potentially creating safer,
more effective therapies. Probody T-cell engaging bispecifics are
antibody constructs capable of directing cytotoxic T-cells to tumor
microenvironments, leading to cell-mediated anti-cancer
activity.
Under the agreement, CytomX and Astellas will
collaborate on several initial programs. CytomX will lead
research and discovery activities, up to clinical candidate
selection, that will be funded by Astellas. Astellas will lead and
fund preclinical and clinical development and commercialization
activities. Astellas will make an upfront cash payment of $80
million to CytomX with CytomX eligible to receive future
preclinical, clinical and commercial milestones of over $1.6
billion. CytomX is also eligible to receive tiered royalties on
global net sales that range from high-single digits to
mid-teens.
For a specified number of targets, prior to the
initiation of the first pivotal clinical trial for a product
directed toward such target, CytomX may exercise an option to
co-fund a pre-determined portion of clinical development costs. For
these products, CytomX is eligible to receive a pre-specified
portion of profits in the United States and tiered low-double digit
to mid-teen percentage royalties on net sales outside of the United
States. CytomX may later elect to co-commercialize the products
directed toward such targets in the United States.
About CytomX TherapeuticsCytomX
is a clinical-stage, oncology-focused biopharmaceutical company
with a vision of transforming lives with safer, more effective
therapies. We are developing a novel class of investigational
antibody therapeutic candidates, based on our Probody technology
platform, for the treatment of cancer. As leaders in the field, our
innovative technology is designed to turn previously undruggable
targets into druggable targets and to enable more effective
combination therapies. CytomX and its partners, comprised of
leading biotechnology and pharmaceutical companies, have developed
a robust pipeline of potential best-in-class immunotherapeutic
candidates against clinically validated targets and potential
first-in-class therapeutic candidates against novel, difficult to
drug targets. Five novel drug-candidates utilizing our Probody
technology are in the clinic, with three in Phase 2 studies and two
in Phase 1 studies. These clinical programs include cancer
immunotherapeutic candidates against validated targets such as a
PD-L1-targeting Probody therapeutic wholly owned by CytomX (CX-072)
and a CTLA-4-targeting Probody therapeutic partnered with
Bristol-Myers Squibb (BMS-986249). The CytomX clinical stage
pipeline also includes first-in-class Probody drug conjugate
product candidates against previously undruggable targets,
including a CD166-targeting Probody drug conjugate wholly owned by
CytomX (CX-2009) and a CD71-targeting Probody drug conjugate
partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer
targets that are considered to be inaccessible to conventional
antibody drug conjugates due to their presence on many healthy
tissues. In addition to its wholly owned programs, CytomX has
strategic collaborations with AbbVie, Amgen, Astellas and
Bristol-Myers Squibb. For additional information about CytomX
Therapeutics, visit www.cytomx.com and follow us on LinkedIn and
Twitter.
About AstellasAstellas Pharma
Inc., based in Tokyo, Japan, is a company dedicated to improving
the health of people around the world through the provision of
innovative and reliable pharmaceutical products. For more
information, please visit our website at
https://www.astellas.com/en
CytomX Therapeutics Forward-Looking
StatementsThis press release includes forward-looking
statements. Such forward-looking statements involve known and
unknown risks, uncertainties and other important factors that are
difficult to predict, may be beyond our control, and may cause the
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied in such statements. In particular, clinical
progress is based on preliminary data from ongoing clinical trials
and anticipated future disclosures of data are based on assumptions
of clinical trial enrollment in our clinical trials and the
clinical trials of our collaborative partners. Accordingly, you
should not rely on any of these forward-looking statements,
including those relating to the potential benefits, safety and
efficacy of CytomX’s or any of its collaborative partners’ product
candidates, administered separately or in combination, the
potential benefits or applications of CytomX’s Probody platform
technology, CytomX’s ability to develop and advance product
candidates into and successfully complete clinical trials,
including the ongoing clinical trials of CX-072 and CX-2009. Risks
and uncertainties that contribute to the uncertain nature of the
forward-looking statements include: the unproven nature of CytomX’s
novel Probody Platform technology; five product candidates under
CytomX’s Probody platform are in the initial stages of clinical
development and its other product candidates are currently in
preclinical development, and the process by which preclinical and
clinical development could potentially lead to an approved product
is long and subject to significant risks and uncertainties,
including the risk that enrollment in clinical trials may take
longer than expected; the possibility that the results of early
clinical trials may not be predictive of future results; the
possibility that CytomX’s clinical trials will not be successful;
the possibility that current pre-clinical research may not result
in additional product candidates; CytomX’s dependence on the
success of CX-072, CX-2009, CX-2029, BMS-986249 and BMS-986288;
CytomX’s reliance on third parties for the manufacture of the
company’s product candidates; and possible regulatory developments
in the United States and foreign countries. Additional
applicable risks and uncertainties include those relating to our
preclinical research and development, clinical development, and
other risks identified under the heading "Risk Factors" included in
CytomX’s Annual Report on Form 10-K filed with the SEC on February
27, 2020. The forward-looking statements contained in this press
release are based on information currently available to CytomX and
speak only as of the date on which they are made. CytomX does not
undertake and specifically disclaims any obligation to update any
forward-looking statements, whether as a result of any new
information, future events, changed circumstances or otherwise.
Probody is a U.S. registered trademark of CytomX
Therapeutics, Inc.
Astellas Cautionary Notes In
this press release, statements made with respect to current plans,
estimates, strategies and beliefs and other statements that are not
historical facts are forward-looking statements about the future
performance of Astellas. These statements are based on management’s
current assumptions and beliefs in light of the information
currently available to it and involve known and unknown risks and
uncertainties. A number of factors could cause actual results to
differ materially from those discussed in the forward-looking
statements. Such factors include, but are not limited to: (i)
changes in general economic conditions and in laws and regulations,
relating to pharmaceutical markets, (ii) currency exchange rate
fluctuations, (iii) delays in new product launches, (iv) the
inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas’
intellectual property rights by third parties.
Information about pharmaceutical products
(including products currently in development) which is included in
this press release is not intended to constitute an advertisement
or medical advice.
Contacts for inquiries or additional
information:
CytomX Therapeutics, Inc. Christopher Keenan VP, Investor
Relations and Corporate Communications ckeenan@cytomx.com TEL:
650-383-0823
Astellas Pharma Inc. Corporate Communications TEL:
+81-3-3244-3201 FAX: +81-3-5201-7473
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