Material Update from Portfolio Company
08/12/2022 17:57
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20221208:nRSH1336Ja&default-theme=true
RNS Number : 1336J RTW Venture Fund Limited 08 December 2022
LEI: 549300Q7EXQQH6KF7Z84
8 December 2022
RTW Venture Fund Limited
Material Update from Portfolio Company
Prometheus Biosciences releases positive data updates, materially NAV
accretive
RTW Venture Fund Limited (the "Company" or "RTW Venture Fund"), a London Stock
Exchange-listed investment fund focused on identifying transformative assets
with high growth potential across the life sciences sector, is pleased to note
positive data updates on two clinical trials of Prometheus Biosciences, Inc.
(NASDAQ: RXDX) ("Prometheus"), the third largest holding in RTW Venture Fund's
portfolio, representing c. 7.5% of NAV and which the Company expects will
translate into a materially accretive NAV performance for the Company.
Prometheus is a clinical-stage biotechnology company pioneering a precision
medicine approach for the discovery, development, and commercialization of
novel therapeutic and companion diagnostic products for the treatment of
immune-mediated diseases. PRA023, the lead program, is a monoclonal antibody
that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A)
and has the potential to substantially improve outcomes for moderate-to-severe
inflammatory bowel disease (IBD) patients predisposed to increased TL1A
expression. Prometheus is developing PRA023 for the treatment of
immune-mediated diseases including ulcerative colitis (UC), Crohn's Disease
(CD), and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
On the 7(th) of December, Prometheus shared two positive data readouts from
its Phase 2 study in UC and Phase 2a study in CD of PRA023 demonstrating
strong efficacy and favourable safety results in both studies, positioning
PRA023 as potentially best- and first-in-class therapeutic for IBD.
As of last published 31 October 2022 NAV, the Company's holding in Prometheus
represented c. 7.5% of NAV. Given the positive news on clinical trials
progress, Prometheus' share price traded up +165.7% on 07 December 2022, which
the Company expects will translate into a materially accretive NAV performance
for the Company.
The Company together with other funds managed by RTW Investments, LP (the
"Investment Manager") participated in a $130 million financing round in
Prometheus in November 2020 and then supported Prometheus' IPO in March 2021.
Stephanie Sirota, Chief Business Officer of the Investment Manager and
Director of the Company, commented:
"We are delighted with Prometheus' successful Phase 2 clinical trial results
and look forward to supporting the company in its efforts to bring novel
therapeutics for patients with inflammatory bowel disease.
Prometheus brings to life RTW Venture Fund's investment strategy. As a
specialist investor focused on disruptive innovations in biotech and medical
technologies, we can uncover compelling opportunities derived from our
research-led internal idea generation process. As a long-term, full life cycle
investor, supporting companies ranging from newco formation to mid-stage
venture to pre-IPO and public markets, we can support and capture the true
value of pioneering companies like Prometheus."
Prometheus announcement is contained below.
For Further Information
RTW Investments, LP
+44 (0) 77 1741 7711
Woody Stileman, Managing Director
Buchanan
+44 (0)20 7466 5107
Charles Ryland
Henry Wilson
George Beale
About RTW Venture Fund Limited:
RTW Venture Fund Limited (LSE: RTW & RTWG) is an investment fund focused
on identifying transformative assets with high growth potential across the
life sciences sector. Driven by a long-term approach to support innovative
businesses, RTW Venture Fund invests in companies developing next-generation
therapies and technologies that can significantly improve patients' lives.
RTW Venture Fund Limited is managed by RTW Investments, LP, a leading
healthcare-focused entrepreneurial investment firm with deep scientific
expertise and a strong track record of supporting companies developing
life-changing therapies.
Visit the RTW website at www.rtwfunds.com (http://www.rtwfunds.com/) for more
information.
***********
The information in this announcement may include forward-looking statements,
which are based on the current expectations and projections about future
events, and in certain cases can be identified by the use of terms such as
"may", "will", "should", "expect", "anticipate", "project", "estimate",
"intend", "continue", "target", "believe" (or the negatives thereon) or other
variations thereon or comparable terminology. These forward-looking
statements, as well as those included in any related materials, are subject to
risks, uncertainties and assumptions about the Company and/or its underlying
investments, including, among other things, the development of the applicable
entity's business, trends in its operating industry, expected use of financing
proceeds and future capital expenditures and acquisitions. In light of these
risks, uncertainties and assumptions, the events in the forward-looking
statements may not occur.
The information contained in this announcement is given at the date of its
publication (unless otherwise marked). No reliance may be placed for any
purpose whatsoever on the information or opinions contained in this
announcement or on its completeness, accuracy or fairness.
The foregoing disclosure is made in connection with a material movement in the
share price of a material position in the Company's portfolio on 7 December
2022. There were no other material portfolio position movements on 7 December
2022 that warrant further disclosure herein.
***********
Prometheus Biosciences Announces Positive Results for PRA023 in Both ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a Studies Enabling Pathway to Both First-in-Class and Best-in-Class Anti-TL1A mAb
December 7, 2022
- ARTEMIS-UC trial met primary endpoint with 26.5% of patients on PRA023
achieving clinical remission compared to 1.5% of patients on placebo at Week
12 (p<0.0001) -
- ARTEMIS-UC Cohort 1 met all ranked secondary endpoints -
- APOLLO-CD trial showed 26.0% endoscopic response and 49.1% clinical
remission rates (p=0.002 and p<0.001, respectively, compared to
prespecified historical placebo rates) -
- PRA023 demonstrated favorable safety and tolerability results across both
studies with no safety signal identified -
- ARTEMIS-UC Cohort 1 interim analysis suggests a trend towards increased
PRA023 response in CDx+ patients over all comers -
- PRA023 showed a significant impact on multiple markers of inflammation and
fibrosis in APOLLO-CD -
- Prometheus intends to advance PRA023 into Phase 3 studies for UC and CD in
2023 -
- Conference call and webcast to discuss results today at 8:30 am ET -
SAN DIEGO, Dec. 07, 2022 (GLOBE NEWSWIRE) -- Prometheus Biosciences, Inc.
(https://www.globenewswire.com/Tracker?data=KgxHCplViYHBPplztjutz3FRFRGJMpp019hsDlX6KD6KdaFBjY0sHbcc3xMg2Pgr0Na21YBOPbkMz1HmuGYtQRZcjZY1Btm3Dr34n2Ibn3-e8poD5bxm1THd6fFmECUq)
(Nasdaq: RXDX), a clinical-stage biotechnology company pioneering a
precision medicine approach for the discovery, development, and
commercialization of novel therapeutic and companion diagnostic products for
the treatment of immune-mediated diseases, today reported results from its
ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023 demonstrating
strong efficacy and favorable safety results in both studies. Based on the
totality of the data in these two studies, Prometheus intends to advance
PRA023 into Phase 3 studies for ulcerative colitis (UC) and Crohn's disease
(CD) in 2023.
Topline Results from the ARTEMIS-UC Phase 2 Study
Prometheus' Phase 2 ARTEMIS-UC clinical trial was a 12-week, double-blind,
placebo-controlled, randomized study to evaluate the efficacy and safety of
PRA023 in patients with moderate-to-severely active UC who have failed
conventional or advanced therapy. PRA023 met the primary and all ranked
secondary endpoints including clinical, endoscopic, histologic, and
patient-reported outcome measures in the initial cohort (Cohort 1) of the
trial. 68/68 (100%) of PRA023-treated patients completed the Cohort 1 study,
compared to 60/67 (89.6%) in the placebo group. The topline results for the
key endpoints were as follows:
· 26.5% of patients on PRA023 reached the primary endpoint of
clinical remission (per modified Mayo Score), compared to 1.5% on placebo, for
a placebo-adjusted clinical remission rate of 25.0% on the primary endpoint
(p<0.0001)
· 36.8% of patients on PRA023 reached the secondary endpoint of
endoscopic improvement (Mayo endoscopy subscore of ≤ 1), compared to 6.0% on
placebo, for a placebo-adjusted endoscopic improvement rate of 30.8% on the
secondary endpoint (p<0.0001)
· All secondary endpoints met with statistical significance
PRA023 was well tolerated in Cohort 1, with no treatment-emergent serious
adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe
AEs, opportunistic infections or infusion reactions reported in the PRA023
treatment group. The only AE that occurred in more than two patients and at a
higher frequency in the PRA023 group compared to placebo was COVID-19 (5/68
7.4% and 3/67 4.5% , respectively).
Based upon confidence in its precision approach and speed to market, the
company conducted an interim companion diagnostic (CDx) analysis of Cohort 1
to evaluate the effectiveness of the CDx candidate in ARTEMIS-UC. Although
from limited patient numbers, data from the subset of patients who tested
positive on the CDx in Cohort 1 (N=32) demonstrated a placebo-adjusted
clinical remission rate of 37.5%, compared with the placebo-adjusted remission
rate of 25.0% for all-comers. The expansion cohort (Cohort 2), which is
statistically powered to further assess the treatment effect of PRA023 in CDx+
patients will continue to enroll, and the company expects results in the
second quarter of 2023.
Results from the APOLLO-CD Phase 2a Study
Prometheus' Phase 2a APOLLO-CD clinical trial was a 12-week open-label study
that enrolled 55 patients with moderate-to-severely active CD with
endoscopically active disease who had failed conventional or biologic therapy.
The study enrolled a highly refractory patient population with 70.9% of
patients previously treated with at least one biologic therapy and 52.7%
treated with two or more biologic therapies. The results on the key endpoints
were as follows:
· 26.0% of patients on PRA023 achieved endoscopic response (p=0.002
compared to 12% prespecified historical placebo rate)
· 49.1% of patients on PRA023 achieved clinical remission
(p<0.001 compared to 16% prespecified historical placebo rate)
PRA023 was well tolerated in the APOLLO-CD study. There were no
treatment-emergent serious adverse events (SAE), adverse events (AE) leading
to discontinuation, or severe AEs assessed as related to PRA023 by the
investigator. There were no opportunistic infections or infusion reactions
reported. AEs that occurred in more than two patients included COVID-19,
urinary tract infection, CD, anemia, nasopharyngitis and fatigue.
The predictive power of the company's prespecified genetic markers was
validated using an alternative Crohn's-specific CDx algorithm which showed
45.0% (9/20) endoscopic response relative to all-comers of 26% (13/50). While
the original algorithm provided limited benefit on some of the endpoints, the
alternative algorithm demonstrated enhanced performance across both clinical
and endoscopic outcomes. The company plans to advance this alternative
algorithm in registrational studies for CD.
In addition, a compelling reduction in markers of inflammation and fibrosis
was observed between pre-treatment and post-treatment with PRA023, as measured
by circulating cytokine levels, immunohistochemistry and gene expression in
disease tissue.
"We are beyond enthusiastic with these study results and what they could mean
for patients suffering from IBD. The performance of PRA023 in both UC and
Crohn's patients has surpassed our expectations," said Mark McKenna, Chairman
and CEO of Prometheus Biosciences. "We believe PRA023 and our precision
medicine approach has the potential to change the paradigm of IBD treatment
and we look forward to discussions with regulatory agencies as we prepare to
advance into Phase 3 studies in Ulcerative Colitis and Crohn's Disease."
"PRA023 has clearly demonstrated clinical proof-of-concept in CD and
remarkable efficacy for the treatment of UC," added Allison Luo, MD, Chief
Medical Officer. "We are grateful to all of our investigators and patients for
their participation and look forward to further evaluating PRA023 in Phase 3
studies with the goal of bringing this promising candidate to the market."
Next Steps
As a result of these positive data, Prometheus plans to advance PRA023 into
pivotal development in 2023, following discussions with regulators. The full
data sets from these studies will be presented at a future medical meeting.
Webcasting Information
Prometheus management will hold a call today, December 7, at 8:30 am ET to
discuss both ARTEMIS-UC and APOLLO-CD Phase 2 results. Registration for the
event as well as a live and archived webcast of the webcast and call will be
available in the Events & Webcasts
(https://www.globenewswire.com/Tracker?data=LLdnGFp1mcAzTE2h51cNBu1Wbk1XspcNavLZE97YgsUDHLzPLltW9IMguOIT9vPxecYn0ZxisgRXCDn2U8-1kOInO4J5HApLoHDX_DumtkSK5tEXXDRVlyQI2p2u3ZAOWbV0NFO4cfg6I87YFvuUGA==)
page of the Prometheus Biosciences website.
About PRA023: Pipeline in a Product Candidate
PRA023 is an IgG1 humanized monoclonal antibody that has been shown to block
tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble
and membrane-associated human TL1A with high affinity and specificity and has
the potential to substantially improve outcomes for moderate-to-severe IBD
patients predisposed to increased TL1A expression. Prometheus is developing
PRA023 for the treatment of immune-mediated diseases including UC, CD, and
systemic sclerosis-associated interstitial lung disease (SSc-ILD).
About Prometheus Biosciences
Prometheus Biosciences, Inc. is a clinical-stage biotechnology company
pioneering a precision medicine approach for the discovery, development, and
commercialization of novel therapeutic and companion diagnostic products for
the treatment of immune-mediated diseases. The Company's precision medicine
platform, Prometheus360™, combines proprietary machine learning-based
analytical approaches with one of the world's largest gastrointestinal
bioinformatics databases to identify novel therapeutic targets and develop
therapeutic candidates to engage those targets.
Forward Looking Statements
Prometheus cautions readers that statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. These statements are based on the Company's current beliefs and
expectations. Such forward-looking statements include, but are not limited to
statements regarding: the potential of PRA023 to improve IBD treatment and to
be both a first-in-class and best-in-class anti-TL1A mAb; the timing of
results from Cohort 2 of the ARTEMIS-UC trial; plans to advance PRA023 into
Phase 3 studies in UC and CD, including the timing thereof, as well as plans
to use an alternative CDx algorithm for CD. The inclusion of forward-looking
statements should not be regarded as a representation by Prometheus that any
of its plans will be achieved. Actual results may differ from those set forth
in this press release due to the risks and uncertainties inherent in our
business, including, without limitation: topline results Prometheus reports
are based on preliminary analysis of key efficacy and safety data, and such
data may change following a more comprehensive review of the data related to
the clinical trial and such topline data may not accurately reflect the
complete results of a clinical trial; Prometheus' approach to the discovery
and development of precision medicines based on Prometheus360 is unproven;
interim results of a clinical trial such as with Cohort 1 CDx analysis do not
predict final results and the clinical outcomes may materially change as
patient enrollment in Cohort 2 continues, following more comprehensive reviews
of the data, as follow-up on the outcome of any particular patient continues
and as more patient data become available, including from from Cohort 2;
potential delays in the commencement, enrollment and completion of clinical
trials and preclinical studies; the results of clinical trials are not
necessarily predictive of future results; Prometheus' dependence on third
parties in connection with product manufacturing, research and preclinical and
clinical testing; Prometheus' ability to develop companion diagnostics for its
therapeutic product candidates; unexpected adverse side effects or inadequate
efficacy of its product candidates that may limit their development,
regulatory approval and/or commercialization, or may result in recalls or
product liability claims; planned future trials of PRA023 may not support
regulatory registration; regulatory developments in the United States and
foreign countries; Prometheus' ability to maintain undisrupted business
operations due to the COVID-19 pandemic, including delaying or otherwise
disrupting its preclinical studies, clinical trials, manufacturing and supply
chain; and other risks described in the Company's prior press releases and
filings with the Securities and Exchange Commission (SEC), including under
the heading "Risk Factors" in Prometheus' most recent quarterly report on Form
10-Q and any subsequent filings with the SEC. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date hereof, and Prometheus undertakes no obligation to update such statements
to reflect events that occur or circumstances that exist after the date
hereof. All forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
Contacts:
Noel Kurdi
VP Investor Relations and Communications
(646) 241-4400
nkurdi@prometheusbiosciences.com
Media contact:
Juniper Point
Amy Conrad
(858) 914-1962
media@prometheusbiosciences.com
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END UPDUPGAAPUPPGMR