TIDMRENX
RNS Number : 4073N
Renalytix AI PLC
20 May 2020
This announcement contains inside information
Renalytix AI plc
("RenalytixAI", the "Company")
Joint venture for scaled production of COVID-19 antibody test
kits
Renalytix AI plc (LSE : RENX ), a commercial-stage artificial
intelligence-enabled in vitro diagnostics company, focused on
optimizing clinical management of kidney disease to drive improved
patient outcomes and lower healthcare costs, announces that its
wholly-owned subsidiary, Renalytix AI, Inc. has entered into a
joint venture with the Icahn School of Medicine at Mount Sinai
("Mount Sinai"), Kantaro Biosciences, LLC ("Kantaro"), to develop
and scale production of COVID-19 antibody test kits.
Highlights
-- Mount Sinai and Renalytix AI, Inc. form joint venture,
Kantaro, to develop and scale production of covid antibody test
kits
-- Kantaro has partnered with Bio-Techne Corporation (NASDAQ:
TECH) for manufacturing and global kit distribution
-- Scaled kit production planned to enable clinical laboratories
to conduct 10M tests per month beginning July
Background to the antibody test
RenalytixAI, Inc. and Mount Sinai today announce the formation
of Kantaro, a Mount Sinai venture, to develop and scale production
and distribution of a test kit based on the Mount Sinai-developed
high-performance serologic assay for SARS-CoV-2 antibodies. Kantaro
has partnered with Minneapolis-based Bio-Techne Corporation to
develop and launch the new kit, with the goal of producing more
than ten million patient tests per month by July. The two companies
have formed a joint commercialization and distribution team to
support the rapid distribution of kits to clinical laboratories in
the US and around the world.
Kantaro's SARS-CoV-2 test kits are designed for use in any
authorized clinical testing laboratory without the need for
proprietary equipment. The technology underlying the kits was
created by a team of internationally recognized scientists and
clinicians, including members from the Departments of Microbiology
and Pathology, Molecular and Cell-Based Medicine within the Icahn
School of Medicine at Mount Sinai. The original Mount Sinai test
was validated in The Mount Sinai Hospital's Clinical Laboratories,
and has been performed on over 30,000 patient samples. The Kantaro
test kit, an enzyme-linked immunosorbent assay (ELISA), builds on
this test technology and is designed to measure the presence or
absence of anti-COVID-19 antibodies in addition to measuring the
titer (level) of antibodies a person has produced. The kit will
utilize not one, but two virus antigens, the full-length spike
protein, and its receptor binding domain, necessary for viral entry
into cells.
Mount Sinai developed the underlying assay in response to the
critical needs of thousands of patients within the hospital system,
including those who were severely ill and could potentially benefit
from convalescent plasma for emergency therapy. Mount Sinai was
issued an Emergency Use Authorization (EUA) by the U.S. Food and
Drug Administration (FDA) for clinical testing in its CLIA
certified laboratory on April 15th. Kantaro plans to seek EUA for
the test kit following final validation.
"Antibody testing will be critical to providing patients and
governments the essential information they need to help the world
economies reopen and begin to recover from COVID-19," said Florian
Krammer, PhD, Professor of Microbiology at the Icahn School of
Medicine. "With the launch of Kantaro, we look forward to bringing
a kit based on our highly specific and sensitive test to every
corner of the globe." The serological assay developed by Dr.
Krammer and colleauges for the screening and identification of
human SARS-CoV-2 seroconverters was described in a paper published
in Nature Medicine on May 12, 2020.
"We believe that this technology has the potential for providing
insight into immunity, and we're working intensely to develop a
quantitative version," said Carlos Cordon-Cardo, MD, PhD, Irene
Heinz Given and John LaPorte Given Professor and Chair of
Pathology, Molecular and Cell-Based Medicine at Mount Sinai. "We
expect that future findings will be critical to vaccine development
and the development of advanced therapeutics." Due to the large
number of COVID-19 patients who have been treated at Mount Sinai,
with over 5,000 patients returning home to date, the Mount Sinai
technology has been utilized across a large and highly diverse
population.
"This technology reflects our commitment to everyone affected by
SARS-CoV-2 and to developing tools for effectively combatting this
disease," said Erik Lium, PhD, Executive Vice President and Chief
Commercial Innovation Officer at Mount Sinai. "We believe that the
rapid development, scaleup and distribution of these kits, based on
the highly accurate Mount Sinai assay, can be a cornerstone in the
global battle against COVID-19."
"Diagnostics are a national strategic priority and we are now
witnessing unprecedented cooperation between academic medicine and
private industry to innovate," said James McCullough, Chief
Executive Officer of Renalytix AI. "Working together there is no
doubt we can rapidly and safely advance the science to begin
winning the war on COVID."
Related party transaction
Kantaro has been formed as a joint venture between Mount Sinai
and RenalytixAI's wholly-owned subsidiary, Renalytix AI, Inc., in
order to develop and scale production and distribution of COVID-19
antibody test kits.
Kantaro's founding board members include Erik Lium, PhD,
Executive Vice President and Chief Commercial Innovation Officer at
Mount Sinai, Niyum Gandhi, Executive Vice President and Chief
Population Health Officer at Mount Sinai, and James McCullough, CEO
of Renalytix AI. Dr. Lium will serve as Chairman.
Mount Sinai has granted a non-exclusive licence to Kantaro to
use certain of its intellectual property in connection with the
test kits in return for equity interests in Kantaro and a customary
sales royalty. Renalytix AI, Inc. will provide key strategic,
regulatory, reimbursement and commercial advice to Kantaro in
return for equity interests in Kantaro. Mount Sinai will initially
hold 75% of the equity interests in Kantaro with Renalytix AI, Inc.
initially holding the remaining 25% of the equity interests. Mount
Sinai has the ability to appoint up to three board managers to
Kantaro with Renalytix appointing one. The joint venture agreements
contain customary provisions, including standard indemnities in the
event of third party claims against the parties arising out of
negligence or actions unrelated to the joint venture to the extent
the losses are not covered by insurance. Both Renalytix, AI Inc.
and Mount Sinai will advance initial start-up funding to Kantaro in
the form of interest bearing loans. The total quantum of the loans
is not of a significant nature.
The entry by Renalytix AI, Inc. into the joint venture together
with the associated agreements and obligations contained within
them is deemed to be a related party transaction pursuant to AIM
Rule 13 as Mount Sinai is a substantial shareholder in the Company.
The directors of the Company, excluding Erik Lium and Barbara
Murphy, who are not considered to be independent for this purpose
on account of their connection with Mount Sinai, having consulted
with the Company's nominated adviser, Stifel, consider the terms of
the joint venture to be fair and reasonable insofar as the
Company's shareholders are concerned.
The person responsible for arranging the release of this
announcement on behalf of the Company is
James McCullough, CEO.
For further information, please contact:
Renalytix AI plc www.renalytixai.com
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser & Broker) Tel: 020 7710 7600
Alex Price / Nicholas Moore
N+1 Singer (Joint Broker) Tel: 020 7496 3000
Aubrey Powell / George Tzimas (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / 07584 391
303
About Kantaro BioSciences
Kantaro Biosciences ("Kantaro"), a Mount Sinai Health System
venture, is dedicated to ensuring that diagnostic tests for
critical health challenges are accessible. The company provides
academically rigorous, validated and results-driven diagnostics to
advance the wellbeing of people, communities and society. Kantaro
specializes in the rapid scaleup of groundbreaking diagnostic
innovations and the creation of partnerships to bring these crucial
technologies to market. The company is majority owned and
controlled by Mount Sinai. For more information, visit
www.kantarobio.com .
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest
academic medical system, encompassing eight hospitals, a leading
medical school, and a vast network of ambulatory practices
throughout the greater New York region. Mount Sinai is a national
and international source of unrivaled education, translational
research and discovery, and collaborative clinical leadership
ensuring that we deliver the highest quality care-from prevention
to treatment of the most serious and complex human diseases. The
Health System includes more than 7,200 physicians and features a
robust and continually expanding network of multispecialty
services, including more than 400 ambulatory practice locations
throughout the five boroughs of New York City, Westchester, and
Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News
& World Report's "Honor Roll" of the Top 20 Best Hospitals in
the country and the Icahn School of Medicine as one of the Top 20
Best Medical Schools in country. Mount Sinai Health System
hospitals are consistently ranked regionally by specialty and our
physicians are in the
top 1% of all physicians nationally by U.S. News & World
Report.
For more information, visit https://www.mountsinai.org or find
Mount Sinai on Facebook, Twitter and YouTube.
About Renalytix AI
Renalytix AI is a developer of artificial intelligence-enabled
clinical in vitro diagnostic solutions for kidney disease, one of
the most common and costly chronic medical conditions globally.
RenalytixAI's products are being designed to make significant
improvements in kidney disease diagnosis, transplant management,
clinical care, patient stratification for drug clinical trials, and
drug target discovery. For more information, visit
renalytixai.com
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END
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