Full Press Release Details
National Stock Exchange of India Ltd. (Stock Code: DRREDDY-EQ)
BSE Limited (Stock Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Please find enclosed a Press Release on "Coya
Therapeutics, Inc. and Dr. Reddy's Laboratories enter into an Exclusive Collaboration for Development and Commercialization of COYA
302, an Investigational Combination Therapy for Treatment of Amyotrophic Lateral Sclerosis (ALS)"
This is for your information and record.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer &
Coya Therapeutics, Inc. and Dr. Reddy's
Laboratories enter into an Exclusive Collaboration for Development and Commercialization of COYA 302, an Investigational Combination Therapy
for Treatment of Amyotrophic Lateral Sclerosis (ALS)
HOUSTON, TEXAS; HYDERABAD, INDIA; BASEL, SWITZERLAND.
December 6, 2023 - 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 2023[1]. 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."
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.
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
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
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
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/.
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About Coya Therapeutics, Inc.