- COYA 302 is an investigational combination biologic for
subcutaneous administration, comprised of COYA 301 and CTLA4-Ig
(Abatacept). COYA 302 has a dual mechanism of action intended to
suppress the chronic and sustained inflammation underlying certain
neurodegenerative diseases.
- COYA 301 is an investigational immunomodulatory cytokine for
subcutaneous administration intended to enhance regulatory T cell
(Treg) function in vivo, and Abatacept is a fusion protein that
binds to antigen-presenting cells and downregulates T effector
cells and other pro-inflammatory cells.
- As part of the development of the combination product COYA 302,
Coya will source CTLA4-Ig from Dr. Reddy’s
- Under the terms of the agreement, Coya retains exclusive rights
to develop and commercialize COYA 302 across multiple
neurodegenerative diseases in multiple territories, including North
and South America, the EU, United Kingdom, and Japan.
- Dr. Reddy’s obtains exclusive rights to commercialize COYA 302
across multiple neurodegenerative disease conditions in areas
outside of Coya’s territory.
- Results from a proof-of-concept clinical study for COYA 302
evaluating pharmacodynamic, biomarker, safety, and preliminary
efficacy parameters in patients with Amyotrophic Lateral Sclerosis
(ALS) will be presented by Dr. Stanley Appel at the MDA Conference
in Dallas, Texas on March 21, 2023.
Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
multiple therapeutic platforms intended to enhance Treg function,
including biologics and cell therapies, today announced a worldwide
agreement with Dr. Reddy’s Laboratories Limited. (BSE: 500124, NSE:
DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr.
Reddy’s”), a global pharmaceutical company. Under this agreement,
Coya will in-license the proposed Abatacept biosimilar of Dr.
Reddy’s for the development of Coya’s combination product for
neurodegenerative diseases, COYA 302. It is a dual biologic
intended to suppress neuroinflammation via multiple
immunomodulatory pathways, for the treatment of neurodegenerative
conditions.
COYA 302 is comprised of two components – COYA 301 and CTLA4-Ig.
Coya will develop COYA 301. Under the terms of the Agreement, Coya
has been granted an exclusive, royalty-bearing license to Dr.
Reddy’s proposed biosimilar Abatacept for the development and
commercialization of Coya 302 for the treatment of certain
neurological diseases for sale in multiple territories including
North and South America, the EU, United Kingdom, and Japan. As
consideration for the license, Coya will pay a one-time
non-refundable upfront fee to Dr. Reddy’s. In addition, Coya will
owe tiered payments to Dr. Reddy’s based upon Coya’s achievement of
certain developmental milestones. Coya will also owe royalties to
Dr. Reddy’s on Net Sales of Coya 302 within its licensed territory
on a tiered basis. The Agreement does not preclude Dr. Reddy’s from
launching its proposed biosimilar Abatacept globally for approved
indications post regulatory approval.
Coya anticipates that it will file an IND for COYA 302 in the 2H
of 2023 with the goal of initiating a phase 1b/2 trial in ALS
(Amyotrophic Lateral Sclerosis) soon thereafter.
The Agreement also provides for the license of Coya 301, Coya’s
low dose IL-2 to Dr. Reddy’s to permit the commercialization by Dr.
Reddy’s of Coya 302 in territories not otherwise granted to Coya.
Coya will receive royalties on Net Sales by Dr. Reddy’s in their
territories based on the same tiered structure as Coya owes Dr.
Reddy’s. The Agreement also allows Dr. Reddy’s and Coya to enter
into a mutually satisfactory commercial supply agreement at an
appropriate time.
“This is a landmark agreement for Coya in our efforts to develop
COYA 302. To partner with such a high-caliber pharmaceutical
company like Dr. Reddy’s is what every emerging biotechnology
company strives for, and we believe that the combined resources of
both organizations strengthens our chances to bring this
therapeutic modality to patients with neurodegenerative diseases if
approved by regulatory authorities,” commented Howard H Berman,
Ph.D., CEO of Coya Therapeutics.
Adrian Hepner, M.D., Ph.D. and CMO of Coya added, “We believe
that the COYA 302 proof-of-concept clinical data in ALS patients is
encouraging and sets the foundation to advance our development
program. Our combination therapy approach has been designed to
address the multiple pathophysiological pathways leading to chronic
and sustained inflammation that drives the progression of serious
neurodegenerative diseases. We plan to file an IND in the second
half of this year and work closely with the regulatory authorities
to initiate our clinical studies soon thereafter.”
Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s
commented, “We are very happy to collaborate with Coya in this
effort to advance therapies that address critical unmet needs for a
variety of neuro-degenerative diseases. As a global biosimilars
developer, we believe our proposed Abatacept biosimilar will be
valuable in the development of this innovative combination therapy.
We continue to look for ways to use our scientific capabilities and
product portfolio to serve patients around the world.”
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq:
COYA) is a clinical-stage biotechnology company developing
proprietary treatments focused on the biology and potential
therapeutic advantages of regulatory T cells (“Tregs”) to target
systemic inflammation and neuroinflammation. Dysfunctional Tregs
underlie numerous conditions including neurodegenerative,
metabolic, and autoimmune diseases, and this cellular dysfunction
may lead to a sustained inflammation and oxidative stress resulting
in lack of homeostasis of the immune system. Coya’s investigational
product candidate pipeline leverages multiple therapeutic
modalities aimed at restoring the anti-inflammatory and
immunomodulatory functions of Tregs. Coya’s therapeutic platforms
include Treg-enhancing biologics, Treg-derived exosomes, and
autologous Treg cell therapy. Coya’s 300 Series product candidates,
COYA 301 and COYA 302, are biologic therapies intended to enhance
Treg function and expand Treg numbers. COYA 301 is a cytokine
biologic for subcutaneous administration intended to enhance Treg
function and expand Treg numbers in vivo, and COYA 302 is a
biologic combination for subcutaneous and/or intravenous
administration intended to enhance Treg function while depleting T
effector function and activated macrophages. These two mechanisms
may be additive or synergistic in suppressing inflammation. For
more information about Coya, please visit
www.coyatherapeutics.com
About Dr. Reddy’s
Laboratories
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company
headquartered in Hyderabad, India. Established in 1984, we are
committed to providing access to affordable and innovative
medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we
offer a portfolio of products and services including APIs,
generics, branded generics, biosimilars and OTC. Our major
therapeutic areas of focus are gastrointestinal, cardiovascular,
diabetology, oncology, pain management and dermatology. Our major
markets include – USA, India, Russia & CIS countries, China,
Brazil and Europe. As a company with a history of deep science that
has led to several industry firsts, we continue to plan ahead and
invest in businesses of the future. As an early adopter of
sustainability and ESG actions, we released our first
Sustainability Report in 2004. Our current ESG goals aim to set the
bar high in environmental stewardship; access and affordability for
patients; diversity; and governance. For more information, log on
to: www.drreddys.com.
Forward-Looking Statements
This press release contains “forward-looking” statements that
are based on our management’s beliefs and assumptions and on
information currently available to management. Forward-looking
statements include all statements other than statements of
historical fact contained in this presentation, including
information concerning our current and future financial
performance, business plans and objectives, current and future
clinical and preclinical development activities, timing and success
of our ongoing and planned clinical trials and related data, the
timing of announcements, updates and results of our clinical trials
and related data, our ability to obtain and maintain regulatory
approval, the potential therapeutic benefits and economic value of
our product candidates, competitive position, industry environment
and potential market opportunities. The words “believe,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,”
and similar expressions are intended to identify forward-looking
statements.
Forward-looking statements are subject to known and unknown
risks, uncertainties, assumptions and other factors including, but
not limited to, those related to risks associated with the impact
of COVID-19; the success, cost and timing of our product candidate
development activities and ongoing and planned clinical trials; our
plans to develop and commercialize targeted therapeutics; the
progress of patient enrollment and dosing in our preclinical or
clinical trials; the ability of our product candidates to achieve
applicable endpoints in the clinical trials; the safety profile of
our product candidates; the potential for data from our clinical
trials to support a marketing application, as well as the timing of
these events; our ability to obtain funding for our operations;
development and commercialization of our product candidates; the
timing of and our ability to obtain and maintain regulatory
approvals; the rate and degree of market acceptance and clinical
utility of our product candidates; the size and growth potential of
the markets for our product candidates, and our ability to serve
those markets; our commercialization, marketing and manufacturing
capabilities and strategy; future agreements with third parties in
connection with the commercialization of our product candidates;
our expectations regarding our ability to obtain and maintain
intellectual property protection; our dependence on third party
manufacturers; the success of competing therapies or products that
are or may become available; our ability to attract and retain key
scientific or management personnel; our ability to identify
additional product candidates with significant commercial potential
consistent with our commercial objectives; and our estimates
regarding expenses, future revenue, capital requirements and needs
for additional financing.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. Moreover, we
operate in a very competitive and rapidly changing environment, and
new risks may emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of
all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances discussed
herein may not occur and actual results could differ materially and
adversely from those anticipated or implied in the forward-looking
statements. Although our management believes that the expectations
reflected in our forward-looking statements are reasonable, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances described in the
forward-looking statements will be achieved or occur. We undertake
no obligation to publicly update any forward-looking statements,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230317005028/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara (646)-755-7412 James@haydenir.com
Media Contact Jessica Starman
media@coyatherapeutics.com
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