- Under the Agreement, Dr. Reddy’s will obtain commercialization
rights for COYA 302 in the United States, Canada, the European
Union and the United Kingdom, for patients with ALS
- COYA will be responsible for development, including the conduct
of the Phase 2 clinical trial and for obtaining regulatory approval
in the United States
- COYA 302 is an investigational combination biologic for
subcutaneous administration, comprised of low-dose IL-2 and
CTLA4-Ig (abatacept). COYA 302 has a dual mechanism of action
intended to suppress the chronic and sustained inflammation
underlying certain neurodegenerative diseases.
- In early 2023, Coya entered into an in-licensing agreement with
Dr. Reddy’s to license its proposed biosimilar abatacept for the
development and commercialization of COYA 302
Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr.
Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY,
NSEIFSC: DRREDDY, along with its subsidiaries together referred to
as “Dr. Reddy’s”), and Coya Therapeutics, Inc. (NASDAQ: COYA)
(“Coya”), today announced that they have entered into a development
and license agreement (the “Agreement”) for the development and
commercialization of COYA 302, an investigational combination
therapy for the treatment of Amyotrophic Lateral Sclerosis
(ALS).
Under the terms of the Agreement, Coya has granted Dr. Reddy’s
an exclusive license to commercialize COYA 302, a proprietary
co-pack kit containing combination of low dose IL-2 and CTLA-4 Ig
(abatacept) in the United States, Canada, the European Union and
the United Kingdom for ALS. This Agreement is in addition to the
in-licensing agreement with Dr. Reddy’s signed in early 20231. Coya
retains the right to commercialize COYA 302 for patients with
amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each
country in South America. Coya will have responsibility for the
clinical development of COYA 302 and for seeking regulatory
approval for COYA 302 for patients with ALS in the United
States.
Dr. Reddy’s will make a USD 7.5 million upfront payment to Coya.
Upon the first FDA acceptance of an investigational new drug (IND)
application for COYA 302 for the treatment of ALS, Dr. Reddy’s will
pay Coya an additional USD 4.2 million. Upon dosing of the first
patient in the first Phase 2 trial of COYA 302 for the treatment of
ALS in the United States, Dr. Reddy’s will pay Coya an additional
USD 4.2 million. Coya anticipates that the IND filing will be made
in the first half of 2024. The Agreement also includes development
and regulatory milestones up to USD 40 million should all such
development and regulatory milestones be achieved. Additionally,
Coya is eligible to receive sales-based milestone payments of up to
USD 677.25 million linked to tiers of cumulative net sales being
achieved over several years (over the term of the agreement subject
to product commercial exclusivity). In addition, Dr. Reddy’s will
pay Coya royalties based on a percentage net sales of COYA 302
ranging from low to middle teens. Coya is not a related party to
Dr. Reddy’s or its promoters/promoter group.
Marc Kikuchi, Chief Executive Officer of Dr. Reddy’s North
America, said: “Patients with ALS, commonly known as Lou
Gehrig’s disease, have very few treatment options. We are pleased
to partner with Coya Therapeutics on this investigational therapy
which may have a unique place in treating patients with this
progressive neurodegenerative disease. With this promising biologic
product, we hope to reach many more patients around the world in
keeping with our aim of serving over 1.5 billion patients by 2030.
Dr. Reddy’s biosimilars/biologics business is part of our key
strategic initiatives expected to drive both near-term and
long-term growth.”
Dr. Howard Berman, Chief Executive Officer of Coya
observed: “The Coya team is delighted to enter this exciting
partnership with Dr. Reddy’s, a world class organization that
defines excellence in innovation and commercialization. While the
agreement provides the financial resources to execute on the Phase
2 clinical program for COYA 302 in ALS, the strategic value of the
partnership contributes much more than capital. We will benefit
from and leverage Dr. Reddy’s manufacturing expertise and growing
commercial infrastructure both in the USA and worldwide as we plan
together for the future of COYA 302 in ALS, a devastating disease
with a high unmet need.”
COYA 302 was developed out of the multi-year translational
research collaboration between Coya and Houston Methodist in the
laboratory of Dr. Stanley Appel, an internationally renowned
researcher and clinician. Houston Methodist is one of the leading
hospital and academic research facilities.
About Coya 302:
COYA 302 is an investigational and proprietary biologic
combination therapy with a dual immunomodulatory mechanism of
action intended to enhance the anti-inflammatory function of
regulatory T cells (Tregs) and suppress the inflammation produced
by activated monocytes and macrophages. COYA 302 is comprised of
proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig, and is
being developed for subcutaneous administration for the treatment
of patients with ALS. These mechanisms may have additive or
synergistic effects.
In February of 2023 Coya announced results from a
proof-of-concept, open-label clinical study evaluating LD IL-2 and
CTLA-4 Ig in small cohort of patients with ALS, conducted at the
Houston Methodist Research Institute (Houston, Texas) by Stanley
Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D.
This study was the first-of-its-kind evaluating this dual-mechanism
immunotherapy for the treatment of ALS. Patients in the study
received investigational treatment for 48 consecutive weeks and
were evaluated for safety and tolerability, Treg function, serum
biomarkers of oxidative stress and inflammation, and clinical
functioning as measured by the ALSFRS-R scale.
During the 48-week treatment period, the therapy was well
tolerated. The most common adverse event was mild injection-site
reactions. No patient discontinued the study, and no deaths or
other serious adverse events were reported.
Patients' disease progression was measured using the ALSFRS-R
scale, a validated rating tool for monitoring the progression of
disability in patients with ALS. The mean (±SD) ALSFRS-R scores at
week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of
treatment were not statistically different compared to the ALSFRS-R
score at baseline (33.5 ±5.9), suggesting significant amelioration
in the progression of the disease over the 48-week treatment
period.
Treg suppressive function, expressed as percentage of inhibition
of proinflammatory T cell proliferation, showed a statistically
significant increase over the course of the treatment period and
was significantly reduced at the end of the 8-week washout
post-treatment period. Treg suppressive function at 24 weeks
(79.9±9.6) and 48 weeks (89.5±4.1) were significantly higher
compared to baseline (62.1±8.1) (p<0.01), suggesting enhanced
and durable Treg suppressive function over the course of treatment.
In contrast, Treg suppressive function (mean ±SD) was significantly
decreased at the end of the 8-week washout period compared to
end-of-treatment at week 48 (70.3±8.1 vs. 89.5±4.1, p
<0.05).
The study also evaluated serum biomarkers of inflammation,
oxidative stress, and lipid peroxides. The available data up to 16
weeks after initiation of treatment suggest a decrease of these
biomarker levels, which is consistent with the observed enhancement
of Treg function. The evaluation of the full biomarker data is
ongoing.
Coya 302 is an investigational product not yet approved by the
U.S. Food and Drug Administration or any other regulatory
agency.
About Dr. Reddy’s biosimilars/biologics programme:
A part of its key strategic initiatives, it is expected to drive
both near-term and long-term growth. Over the last 20 years, the
team has developed into a fully integrated organisation with robust
capabilities in the development, manufacture and commercialisation
of a range of biosimilar products in oncology and immunology. The
portfolio currently has six commercial biosimilar products marketed
in India and over 27 Emerging Markets. In addition, there are
several products in the pipeline in oncology and auto-immune
diseases in various stages of development for global launches
across regulated as well as emerging markets. Coya has successfully
completed the Phase 2 study and initiated the Phase 3 study of
DRL_TC, its proposed biosimilar of tocilizumab via both the
subcutaneous and intravenous routes, for global markets. Dr.
Reddy’s proposed rituximab biosimilar application has been accepted
for review by the USFDA, EMA and MHRA. Coya has also ramped up
manufacturing capacity to support its global expansion plans.
About Dr. Reddy’s Laboratories Limited:
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, it is
committed to providing access to affordable and innovative
medicines. Driven by its purpose of ‘Good Health Can’t Wait’, the
company offers a portfolio of products and services including APIs,
generics, branded generics, biosimilars and OTC. Its major
therapeutic areas of focus are gastrointestinal, cardiovascular,
diabetology, oncology, pain management and dermatology. Its 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, Dr. Reddy’s continues to plan
and invest in the businesses of the future. As an early adopter of
sustainability and ESG actions, we released its first
Sustainability Report in 2004. Its 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: https://www.drreddys.com/.
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.
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.
1
https://www.businesswire.com/news/home/20230317005028/en/Coya-Therapeutics-Inc.-Announces-an-Agreement-with-Dr.-Reddy%E2%80%99s-Laboratories-Ltd.-to-License-its-proposed-biosimilar-Abatacept-for-the-Development-and-Commercialization-of-COYA-302-for-the-Treatment-of-Neurodegenerative-Diseases
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231206037106/en/
Coya Therapeutics, Inc.:
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR James Carbonara 646-755-7412
James@haydenir.com
Media Contact Anna Marie Imbordino
annamarie@quantum-corp.com 917-680-8765
Dr. Reddy’s Laboratories
Limited:
Investor Contact Richa Periwal
richaperiwal@drreddys.com
Media Contact Usha Iyer ushaiyer@drreddys.com
Dr Reddys Laboratories (NYSE:RDY)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Dr Reddys Laboratories (NYSE:RDY)
Historical Stock Chart
Von Mai 2023 bis Mai 2024