ProKidney LP (ProKidney), a leading clinical-stage cellular
therapeutics company focused on the treatment of chronic kidney
disease (CKD) and the prevention of end-stage renal disease (ESRD)
requiring dialysis or transplant, today published data from a
patient study confirming the mechanistic action of its lead
candidate REACT™ with cell marker analysis.
“Renal Autologous Cell
Therapy to Stabilize Function in Diabetes-Related Chronic Kidney
Disease: Corroboration of Mechanistic Action with Cell Marker
Analysis” by Joseph Stavas et. al.
The paper, published in Kidney International
Reports, describes observed improvements in renal function and a
wide array of clinical parameters in patients with moderate to
advanced diabetic CKD treated with REACT™.
ProKidney’s decade-long research, performed in
multiple diseased animal models that were treated with the active
biological ingredient found in REACT™, demonstrated repair of
diseased kidneys and the improvement of kidney function. Extensive
structural, functional, and biochemical analyses, including
biopsies and dissection of the treated animal organs, highlighted
that REACT™ has the potential to promote the development of new
functional kidney structures, including glomeruli and tubules, as
well as reduce fibrosis and inflammation. In addition, proteomics,
genomic, and metabolomic analyses performed on the animal tissues
support the mechanism of repair, new kidney tissue formation, and
improvement in renal function promoted by the active biological
ingredients in REACT™. While similar extensive tissue analyses
cannot be performed on the kidneys of subjects in clinical trials,
analyses of blood and urine are consistent with the findings in the
animal studies.
“The translational analyses published in this
paper are major foundational discoveries in understanding REACT’s™
mechanism of action and what it could mean for CKD patients and
their caregivers. This publication is further evidence that REACT™
may successfully stabilize and improve kidney function in patients
with moderate to severe diabetic CKD,” said Dr. Tim Bertram, CEO
and Founder of ProKidney. “We are actively enrolling diabetic CKD
patients in the Phase 3 REACT™ program, which has been aligned with
regulatory authorities in the U.S. and Europe. We intend to bring
this first ever autologous cell therapy for CKD through regulatory
review and make it available to patients as expeditiously as
possible.”
REACT™ is an autologous cell therapy produced
from a patient’s own kidney cells that is comprised of a
proprietary mixture of progenitor cells that have been selected and
cultured so they can be placed back into the patient’s kidney to
restore the natural healing processes. REACT™ does not require
immunosuppression, which is required for allogeneic (from another
person) kidney or cellular transplants. ProKidney’s treatment
involves a minimally invasive procedure, starting with a standard
kidney biopsy, followed by in vitro amplification of selected renal
cells (SRCs), the active biological ingredient in REACT™, that are
able to harness the body's intrinsic ability to repair and restore
damaged kidney tissue. The injection procedure of REACT™ is done on
an outpatient basis with placement in the cortex of the patient’s
kidney. This procedure has been shown to be well-tolerated when
compared to kidney biopsy, a standard diagnostic procedure.
ProKidney’s RMCL-002 multi-center, randomized
Phase 2 trial enrolled 81 stage 3/4 CKD diabetic patients who
received two injections in the same kidney six months apart, is
ongoing and is evaluating safety, efficacy, and durability of
REACT™. A paper describing the 81 subject study was published in
March 2022 in the American Journal of Nephrology. Of the 81
subjects in RMCL-002, 22 subjects have consented to have further
phenotypic and proteomic, genomic, and metabolomic analyses of the
cells comprising their personalized REACT™ product. The results of
these analyses were published in The Kidney International Report
mentioned above.
All 22 subjects had moderate-to-advanced type 2
diabetic CKD. Annualized estimated glomerular filtration rate
(eGFR) slopes pre- and post-REACT™ injection were compared.
Fluorescent Activated Cell Sorting (FACS) analysis for renal
progenitor lineages in REACT™ and vascular endothelial growth
factor A (VEGF-A) analysis were performed. Annualized eGFR slope
was -4.63 ml/min per 1/73 m² pre-injection and this showed a
statistically meaningful improvement (P=0.015) post-injection.
Around 30% of patients achieved stabilization of kidney function
and seven had an eGFR slope of >0 ml/min per 1.73 m²
post-injection.
Selected renal cells were found to have cell
markers from ureteric bud, mesenchymal cap, and podocyte sources
and there was production of VEGF, a growth factor associated with
maintaining normal nephron function and repair. Improvements were
observed in a wide range of clinical parameters pre- and
post-injection, including serum creatinine, phosphorus, calcium,
and hemoglobin.
No SAEs were associated with the biopsies and
REACT™ injections. Other unrelated serious adverse events in this
study were common in this population due to the comorbidities of
advanced diabetic CKD and metabolic syndrome but were similar in
number and characteristics to other historical CKD trials.
The conclusions in the Kidney International
Report suggested that the selected renal cells in REACT™ may be
able to stabilize and improve kidney function, potentially halting
or reversing type-2 diabetic CKD progression or may initiate neo
kidney like tissue development to stabilize and improve kidney
function and halt type 2 D-CKD progression.
About The Phase 3 Clinical Program for
REACT™In October 2021, the FDA granted ProKidney’s REACT™
Regenerative Medicine Advanced Therapy (RMAT) designation, after
reviewing more than seven years of data collected from over 100
REACT™–treated patients with stages 3/4 diabetic CKD and
moderate-to-severe albuminuria and guided ProKidney on a
registrational clinical program and potency assay development. This
program is designed to generate efficacy and safety data in two
randomized, sham-controlled, blinded studies with a primary
composite endpoint under a Time-to-Event design. The trials in
total will include approximately 1,200 subjects globally, and a
clinical evidence package based on this design may provide the
necessary evidence of safety and effectiveness to support a
Biologics License Application (BLA) for commercialization of
REACT™.
The Phase 3 program will be conducted in
multiple centers in the United States, Europe, Latin America, and
Asia Pacific. Study subject demographics will be consistent with
previous trials involving REACT ™, including patients at
high-risk-of-end-stage kidney disease: Type 2 diabetic mellitus,
CKD stage 3/4, not on renal dialysis, eGFR 20-50 ml/min/1.73 m2,
and UACR ranging from 300-5000 mg/g. The robust safety profile of
REACT™ after two injections in the same kidney in clinical studies
thus far supports an effort to enhance efficacy potential by
injecting subjects in both kidneys in the Phase 3 program. This
broader injection pattern holds the potential to achieve greater
efficacy as the therapy will be delivered into the patients’ two
kidneys – 2x the kidney mass as compared to Phase 2.
Study subjects in the treatment arm will undergo
a kidney biopsy and then be injected in each kidney once with a
three-month interval in between injections. Study subjects
randomized to the standard of care arm of the study will receive
sham biopsies and injections. Following either the second REACT™ or
sham injections, subjects in the treatment or standard of care arms
will be followed clinically until they reach one of the three
components of the primary composite endpoint. Specifically, the
primary composite endpoint for this Phase 3 clinical program is the
time from the first injection to the earliest of:
- At least 40%
reduction in estimated glomerular filtration rate (eGFR), which is
a measure of how well the kidneys are working;
-
eGFR<15mL/min/1.73m² sustained for 30 days and/or chronic
dialysis, and/or renal transplant; or
- Death from renal or
cardiovascular causes.
In addition to the primary endpoint, a set of
key secondary endpoints will be included to evaluate trends in
proteinuria, quality of life, other kidney associated laboratory
parameters, and other metrics.
Eligible participants from the control standard
of care arms of both Phase 3 trials, will be offered the
opportunity to enroll into a new Phase 2 trial to allow them to be
injected with REACT™ after completing the Phase 3 trial or after
experiencing one of the qualifying events highlighted above. This
is expected to facilitate the recruitment of study subjects by
allowing them to access the potential benefits of REACT™, and at
the same time expand the clinical evidence for REACT™’s efficacy
and safety profile.
About ProKidneyProKidney, a
pioneer in the treatment of CKD through innovation in cellular
therapy, was founded in 2015 after a decade of research.
ProKidney’s lead product candidate, REACT™ (Renal Autologous Cell
Therapy), is a first-of-its-kind, patented, disease-modifying,
autologous cellular therapy with the potential not only to slow and
stabilize the progression of CKD, but in some cases drive
meaningful improvement in kidney function. REACT™ has received
Regenerative Medicine Advanced Therapy (RMAT) designation, as well
as FDA and EMA guidance, supporting the Phase 3 clinical program
that launched on schedule in January 2022. On January 18, 2022,
ProKidney announced that it would become a publicly traded company
via a business combination with Social Capital Suvretta Holdings
Corp. III (Nasdaq: DNAC). For more information, visit
www.prokidney.com.
Additional Information and Where to Find
ItIn connection with the proposed transaction between SCS
and ProKidney, SCS has filed a definitive proxy statement with the
U.S. Securities and Exchange Commission (the “SEC”). SHAREHOLDERS
OF SCS ARE ADVISED TO READ THE DEFINITIVE PROXY STATEMENT
(INCLUDING ANY AMENDMENTS AND SUPPLEMENTS THERETO) AND ALL OTHER
RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC IN
CONNECTION WITH THE PROPOSED TRANSACTION AS THEY BECOME AVAILABLE
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. THESE DOCUMENTS
ARE NOT INTENDED TO FORM THE BASIS OF ANY INVESTMENT DECISION OR
ANY OTHER DECISION IN RESPECT OF THE PROPOSED TRANSACTION. The
definitive proxy statement will be mailed to the shareholders of
SCS as of June 2, 2022, the record date established for voting on
the proposed transaction. Shareholders are also able to obtain
copies of the preliminary proxy statement, the definitive proxy
statement and other documents filed with the SEC that will be
incorporated by reference therein, without charge at the SEC’s
website at http://www.sec.gov.
The documents filed by SCS with the SEC also may
be obtained free of charge at SCS’s website at
https://socialcapitalsuvrettaholdings.com/dnac or upon written
request to 2850 W. Horizon Ridge Parkway, Suite 200, Henderson, NV
89052.
Participants in the
SolicitationSCS and ProKidney and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from SCS’s shareholders in
connection with the proposed transaction. A list of the names of
such directors and executive officers and information regarding
their interests in the proposed transaction between ProKidney and
SCS are contained in the definitive proxy statement. You may obtain
free copies of these documents as described in the preceding
paragraph.
No Offer or SolicitationThis
communication shall not constitute a solicitation of a proxy,
consent or authorization with respect to any securities or in
respect of the proposed transaction. This communication shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any sale of securities in any
states or jurisdictions in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offering of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended, or an exemption therefrom.
Forward-Looking StatementsThis
communication may contain certain forward-looking statements within
the meaning of the federal securities laws, including with respect
to the proposed transaction between ProKidney and SCS and the
timing of enrollment of ProKidney’s clinical trials, availability
of clinical data, obtainment of regulatory approvals and
manufacturing cost reductions. These forward-looking statements
generally are identified by the words “believe,” “project,”
“expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” and similar expressions.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
communication, including but not limited to: (i) the risk that the
proposed transaction may not be completed in a timely manner or at
all, which may adversely affect the price of SCS’s securities, (ii)
the risk that the proposed transaction may not be completed by
SCS’s business combination deadline and the potential failure to
obtain an extension of the business combination deadline if sought
by SCS, (iii) the failure to satisfy the conditions to the
consummation of the proposed transaction, including the adoption of
the definitive agreement related to the business combination
between SCS and ProKidney (the “Business Combination Agreement”) by
the shareholders of SCS and the satisfaction of the minimum cash
condition, (iv) the lack of a third-party valuation in determining
whether or not to pursue the proposed transaction, (v) the
inability to complete the private placement entered into in
connection with the transaction, (vi) the occurrence of any event,
change or other circumstance that could give rise to the
termination of the Business Combination Agreement, (vii) the effect
of the announcement or pendency of the transaction on ProKidney’s
business relationships, operating results, and business generally,
(viii) risks that the proposed transaction disrupts current plans
and operations of ProKidney and potential difficulties in ProKidney
employee retention as a result of the transaction, (ix) the outcome
of any legal proceedings that may be instituted against ProKidney
or against SCS related to the Business Combination Agreement or the
proposed transaction, (x) the ability to maintain the listing of
SCS’s securities on a national securities exchange, (xi) the price
of SCS’s securities may be volatile due to a variety of factors,
including changes in the competitive and highly regulated
industries in which SCS plans to operate or ProKidney operates,
variations in operating performance across competitors, changes in
laws and regulations affecting SCS’s or ProKidney’s business, and
changes in the combined capital structure, (xii) the ability to
implement business plans, forecasts, and other expectations,
including manufacturing cost reductions, after the completion of
the proposed transaction, and identify and realize additional
opportunities, (xiii) the risk of downturns and a changing
regulatory landscape in the highly competitive biotechnology
industry, and (xiv) uncertainties inherent in cell therapy research
and development, including the actual time it takes to initiate and
complete clinical studies and the timing and content of decisions
made by regulatory authorities. The foregoing list of factors is
not exhaustive. You should carefully consider the foregoing factors
and the other risks and uncertainties described in the “Risk
Factors” section of SCS’s definitive proxy statement on Schedule
14A (File No. 001-40560), including any amendments and supplemented
thereto, filed with the SEC on June 10, 2022, SCS’s annual report
on Form 10-K for the year ended December 31, 2021 filed with the
SEC on March 28, 2022, including those under “Risk Factors” therein
and other documents filed by SCS from time to time with the SEC.
These filings identify and address other important risks and
uncertainties that could cause actual events and results to differ
materially from those contained in the forward-looking statements.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and ProKidney and SCS assume no obligation and do not
intend to update or revise these forward-looking statements,
whether as a result of new information, future events, or
otherwise. Neither ProKidney nor SCS gives any assurance that
either ProKidney or SCS, or the combined company, will achieve its
expectations.
Contact:Investors:Lee RothBurns
McClellanlroth@burnsmc.com+1 (212) 300-8331
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