RBC Coronavirus Treatment and Vaccine Tracker - 08/25/20

RBC Coronavirus Treatment and Vaccine Tracker - 08/25/20 UpdateEQ U
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H RBC Health Care Equity Team Click here for contributing analysts' contact information
August 25, 2020
RBC Coronavirus Treatment and Vaccine Tracker - 08/25/20 Update Updates on COVID news, remdesivir, convalescent plasma, vaccine progress, and more We continue to update our tracker today to highlight ongoing themes, including case and mortality declines across the country, potential for reinfection, mental health, and updates from the constantly evolving vaccine landscape. We also highlight ongoing vaccine development and supply contracts, as well as incremental news on remdesivir and convalescent plasma.
Key themes we are watching in recent weeks:
• Declining case rates in U.S., with much lower mortality rates vs. earlier in the pandemic. Case rates, following a late-July peak, have continued to decline since throughout the U.S., and though they still remain above peak spring levels, mortality rates remain far lower. While increasing testing may contribute somewhat to the higher case rates during this "second wave," we believe what is being observed are rolling regional peaks in areas not as affected in the early spring, followed by a steady- state equilibrium of modest decline as some elements of potential herd immunity – which likely has a lower threshold given behavioral changes (mask wearing, distancing, isolation of sick individuals), heterogeneity of spread, and pre-existing immunity/protection – are likely reached. We believe many of the reasons we previously laid out on the decreasing death rates, such as improved pt management and treatments, appear to be playing out. Though this could become confounded by flu season, vaccination may also have some cross-protection vs. COVID-19.
• First confirmed COVID reinfection case: Yesterday, the first case of reinfection was reportedly confirmed in Hong Kong, with a 33yo man who was first infected with SARS-CoV-2 in March apparently affected again 4.5mo later. Reinfection has been reported anecdotally at least a few times throughout the summer, though this is the first known instance where reinfection was confirmed via RNA sequencing. Durability of immune response to COVID is an important question researchers continue to grapple with particularly as vaccine development continues to rapidly progress. We note the fact that this is the first formally confirmed case among nearly 25M COVID cases WW could perhaps be read encouragingly. Further, this man's second infection was nearly asymptomatic – perhaps suggesting some level of immune protection conferred by his first infection, also encouraging. On the flip side, one concern we continue to believe will be important will be any potential implications reinfection presents for a herd immunity threshold as the pandemic drags on, now nearing its 9th month.
• Mental health strain continues to be in focus: Recall we previously anticipated LT effects on mental health as the pandemic persists and had expected data on mental health strain to continue to emerge. Evidence in recent weeks continues to quantify the qualitatively apparent negative effects on mental health: Internet searches for anxiety have reportedly spiked over 10% from baseline during pandemic months and the CDC recently released an MMWR finding 26% of adult survey respondents have COVID-19-related trauma and stress disorders and 13% have started or increased substance use. We continue to believe lingering negative mental health consequences could have underappreciated longer-term impacts to society.
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Disseminated: Aug 25, 2020 14:04ET; Produced: Aug 25, 2020 14:04ET Priced as of prior trading day's market close, EST (unless otherwise noted).
All values in USD unless otherwise noted. For Required Conflicts Disclosures, see Page 10.
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New remdesivir data poses question for broad expansion of use; scientists plan to begin independently studying "catdesivir". Last Fri another RDV open-label RCT was published in JAMA from a global study conducted between March and April, importantly in moderate COVID-19 patients. Results from the 584 pts were mixed with a 5d course posting a stat sig result of uncertain clinical significance on the 7pt ordinal scale while a 10d course of RDV did not produce a stat sig response. No discernible effect or trend was observed on all-cause mortality at day 28, though this was an exploratory endpoint. We also note that the NIH has agreed with MD Anderson researchers to move forward with an independent investigation of GS-441524, which researchers have been highlighting for some time as a potentially more active compound against SARS-CoV-2 than RDV (thus far it has been known as a feline antiviral treatment for a different coronavirus).
EUA announcement for convalescent plasma stirs some controversy over the weekend, though unlikely to have significant impact on current COVID SoC. Recall we have written extensively about convalescent plasma (key write-ups here, here, and most recently here) and our latest view remains that data to date have been equivocal at best (most recent convalescent plasma study here). However, we also acknowledge the bar for an EUA is very low and we note this EUA was indicated for severe/immediately life-threatening COVID cases only. We continue to believe though likely relatively safe, significant variability from donor-mounted immune response, plasma collection methods, timing of collection and subsequent administration may obscure true treatment effects, necessitating scientifically rigorous trials such as the ongoing RECOVERY trial to provide useful insights into any incremental benefit potential from convalescent plasma. However, given the apparently widespread use of convalescent plasma across the U.S. already, we believe this EUA is unlikely to have substantial effects on the overall paradigm, and if anything could potentially lead to a shortage that makes future convalescent plasma studies more challenging. It could, however, also put more focus on ongoing antibody development efforts, given the mechanistic parallels.
Incremental updates: AZN today announced the ph.I initiation of its two antibody cocktail, AD7442, which may also read out as early as this year, and on favorable safety data, is anticipated to advance into late-stage ph.II and ph.III trials, likely putting this antibody cocktail further behind than most (see Exhibit 1). A small study comparing C5-targeting mAb eculizumab with C3-targeting drug candidate AMY-101 provided further incremental evidence to suggest a broader inhibitory profile offered by anti-C3 treatments vs. anti-C5 may be more beneficial, consistent with our growing understanding of late-stage inflammation characteristics. Research on BCG vaccines continues to progress with researchers suggesting off-target protective effects may be mediated by a non-specific boosting of innate immune mechanisms which could serve as the biologic rationale for recently reported high mortality rates in countries with longer cessation periods from BCG vaccination programs. Evidence for LMWH's role as co-receptors for SARS-CoV-2, potentially blocking infection by neutralizing binding, continues to build as we had previously suggested – heparin continues to remain on the FDA's drug shortage list presumably due to increased COVID use.
With ph.III’s underway from lead vaccine players for data in 4Q2020, companies in the second wave are initiating pivotals in September with an aim on 1H2021. As MRNA and PFE/BNTX continue to enroll their ph.III trial of 30,000 subjects (each around ~40% enrolled since initiation in July), both companies continue to expect data in October/November for potential EUA by YE2020 – the recently released ph.I data of PFE/BNTX’s BNT162b2 variant (selected for the ph.III trial) from the U.S. trial demonstrated a more favorable efficacy and safety profile than the b1 variant, especially in the elder population. We also continue to monitor the readout from AZN/ Oxford’s ph.II/III trial in ~10,000 HV in the UK, which could potentially serve as the basis for EUA
RBC Coronavirus Treatment and Vaccine Tracker - 08/25/20 Update
August 25, 2020 2
approval by FDA given the political push around the 2020 election – the U.S. ph.III trial in 30,000 subjects is expected to initiate in August. As part of the companies in the second wave, INO (covered by Renza), JNJ, and NVAX are expected to initiate their respective ph.III trials in various sizes (INO – 10,000; JNJ – 60,000; NVAX – 30,000) with data expected in 1H2021. Other clinical updates from vaccine players include CanSino initiated their ph.III trial in Russia (8/17), as well as NVAX initiated their ph.II trials in South Africa (8/17) and the U.S. (8/24). See our takeaways from our recent INO NDR here.
Europe continues to secure supply from vaccine companies. MRNA announced a supply agreement with the EMA on 8/24 for 80M doses. CVAC also announced its potential EU supply agreement of 225M doses (with potential for 80M additional doses) on 8/20 though their candidate is still in early-stage development – ph.I data and ph.II/III initiation are expected in 4Q2020. For now the EU has secured over 1B vaccine doses from multiple companies, with more supply agreements potentially on the horizon.
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Source: RBC Capital Markets research; Biomedtracker; Clinicaltrials.gov
Drug Company Stage Description Design Anticipated Readout NCT
COVID-19 treatments: small molecules
B (efficacy), randomized double
RDV alone
2H20 NCT04401579
randomized double blind, Fam +
HCQ vs HCQ alone
Nitazoxanide Romark Approved in
COVID-19 treatments: antibodies
REGN-COV2 REGN ph.III
controlled study
Sep-'20 NCT04452318
double-blinded, pbo-controlled
AZD7442 AZN ph.I Two antibody cocktail
(AZD8895 and AZD1061) 2H20 NCT04507256
JS016 Junshi ph.I Targets RBD 40 Chinese pts at high risk;
randomized, DB, pbo-controlled Late-'20/early-'21 NCT04441918
TY027 Tychan ph.I Targets spike protein 25 healthy volunteers; time
lagged, randomized, controlled 4Q20 NCT04429529
SCTA01 Sinocelltech ph.I -- 33 healthy subjects, randomized,
double blind SAD study 4Q20 NCT04483375
CT-P59 Celltrion ph.I Thought to neutralize
D614G variant -- Late-'20 N/A
600 HV; two dose levels; two
rounds of dosing 28d apart; two
age groups (18-54; 55+)
168 HV; three dose levels; two
rounds of dosing with 28d apart;
one age group (18-60)
age groups (18-54; 55-75)
1,045 HV; two dose levesl; two
dosing schedule (single or two
doses with 8wk apart); two age
groups (18-55; 65+)
dosing schedule (single or
69; 70+)
Fall-'20 NCT04400838
30,000 HV; one dose level -
100µg; two rounds of dosing
28d apart; one age group (18+)
Oct/Nov-'20 NCT04470427
protein delivered by LNP
30µg; two rounds of dosing 21d
apart; two age groups (18-55;
65-85)
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Subtype Drug Company Stage
Emtricitabine/tenofovir (Truvada) GILD ph.III --
EIDD-2801 Ridgeback Therapeutics ph.II Sept-'20
IMU-838 Immunic ph.II Aug-'20
Galidesivir BCRX ph.I Aug-'20
Danoprevir/ritonavir Ascletis Pharma ph.I --
Umifenovir (Arbidol) Pharmstandard N/A (China) --
Eculizumab (Soliris) ALXN Expanded access --
Tocilizumab (Actemra) Roche ph.III --
REGN-COV2 REGN ph.III Summer-'20
CD24Fc OncoImmune ph.III --
Lenzilumab HGEN ph.III-ready --
SNG-001 inhaled interferon SNG LN ph.II --
Leronlimab CYDY ph.II --
CMC4620-IE CalciMedica ph.II --
Camrelizumab+thymosin Investigator initiated N/A (China) --
Siltixumab (Sylvant) Investigator initiated N/A (China) --
Fingolimod (Gilenya) Investigator initiated N/A (China) --
Interferon Multiple Clinical Multiple
Fluoxetine University of Toledo ph.III --
Hydroxychloroquine/chloroquine Multiple ph.II/III --
Leronlimab CytoDyn ph.II/III --
Aviptadil NeuroRx ph.II --
Camrelizumab (Airuika) Investigator initiated N/A (China) --
Direct
Antiviral
Immune
Modulator
Other
August 25, 2020 5
Glecaprevir (Mayvret) ENTA/ABBV preclinical --
Boceprevir (Victrelis) MRK preclinical --
Imatinib (Gleevec) NOV preclinical --
AT-100 Airway Therapeutics preclinical --
BPI-002 BYSI preclinical --
Remestemcel-L (RYONCIL) MESO preclinical --
-- AlloVir preclinical --
August 25, 2020 6
Exhibit 4: Vaccines in development for COVID-19
Subtype Drug Company Stage Disclosed Clinical Timelines
BCG Vaccine MRK ph.II/III Initiated in the NL; planned in AU, UK, DE
-- Codagenix preclinical ph.I by Summer '20
Inactivated -- SVA ph.III
Brazil on 7/13/20
on the Lancet on 7/20/20 in China, approved for
military use on 6/28; ph.III in Russia initiated on
8/17/20; ph.I/II to start in Canada
AZD1222 AZN/Oxford ph.I/II
ph.III trial in U.S. expected in Aug-'20
Sputnik V Gamaleya Institute ph.I
Approved in Russia based on ph.I data; ph.III
expected in Aug-'20
JNJ-78436735 JNJ ph.I ph.I initiated in July-'20; ph.III expected in Sep-'20
-- MRK/Themis preclinical approaching a rapid entry to ph.I
-- MRK/IAVI preclinical --
TNX-1800 TNXP preclinical --
-- Zydus Cadila preclinical --
-- Sumagen preclinical --
-- GOVX preclinical --
-- Greffex preclinical --
-- ImmunityBio preclinical --
South Africa initiated on 8/18/20; ph.II in U.S.
initiated on 8/24/20; ph.III expected in Sep-'20
SCB-2019 Clover/GSK/DVAX ph.I
ph.II/III trial expected in late 2020
DPX-COVID-19 IMV preclinical
expected in fall-'20
ph.I expected to initiate in Sep-'20 with initial data in
Dec-'20; ph.II/III trial expected in Jan-'21
-- GNBT preclinical ph.I planned Jun-'20
-- ExpreS2ion preclinical ph.I/IIa expected by Mar-'21
-- Sanofi/TBIO preclinical FIH trial expected in 4Q'20
-- Vaxil Bio preclinical --
July/Aug-'20; ph.I data published on NEJM on
7/14/20; ph.III initiated in late-July '20
BNT162 PFE/BNTX ph.II/III
July '20
CVnCoV vaccine GSK/CureVac ph.I ph.I initiate in Germany and Belgian in June-'20
-- RNACure preclinical --
-- Stermina preclinical --
-- Sanofi preclinical --
-- ARCT preclinical --
in South Korea on 6/4/20; ph.II/III expected in Sept-
20'
-- Anges preclinical --
STI-6991 SRNE preclinical ph.I anticipated mid-'20
Live Attenuated
Other / Unknown
Viral Vector
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Exhibit 5: Additional detail for treatments in development for COVID-19
Source: RBC Capital Markets research; Clinicaltrials.gov
Remdesivir GILD ph.III 3Q20
EU
(stat sig) in hospital stay and numerical
mortality benefit; GILD SIMPLE Severe
suggests 10d and 5d course may have
similar efficacy, Moderate showed 65%
more likely to improve
Danoprevir/ritonavir Ascletis Pharma ph.I -- -- --
time to -PCR was 2d; CT scans improved
by 3d - unclear if driven by natural history.
Favipiravir (Avigan) Toyama Chemical N/A (China) Multiple Flu drug approved in Japan
Multiple (THDMS-COVID-19,
FAV-001, PIONEER,
FACCT, VIRCO,
COVERAGE, etc)
time (11d vs. 4d) and reduced ave. fever
duration (4.2d vs. 2.5d); In an n=240
(<12d sx onset) RCT vs arbidol, showed
higher 7d clinical recovery rate (71% vs
56%) with fever and cough reductions,
with no statistical difference in oxygen or
ventilation rate. Favipiravir raised AE rates
(14% vs 3%). Most recently failed in a
study (n=89) by Fujita Health University to
show an effect on fever reduction and viral
load.
Lopinavir/ritonavir
Multiple (DOLCI, CORIPREV-
LR, TREAT NOW,
16d) with notable TEAEs; subgroup
suggested signal of activity with earlier
treatment, UK RECOVERY Trial showed
no benefit
Baloxavir marboxil
Approved in China and
FDA approved
Eculizumab (Soliris) ALXN Expanded access -- Approved for PNH and
aHUS -- --
Sarilumab (Kevzara) REGN N/A -- Recently (2017) approved
anti-IL-6 RA drug --
Ph.III saw no clinical improvement
Baricitinib (Olumiant) LLY/INCY ph.III 2H20 Approved for RA BARI-COVID ph.III
registered 3/24/2020
signals
Plan to evaluate for
Polycythemia vera 1) China, 2) INCY/NVS in US --
Meplazumab -- ph.I/II -- -- --
clearance at days 7 (77% vs 27%,
p=0.019) and 14 (94% vs 54%, p=0.022).
Other positive endpoints included
profile was minimally reported.
02/2020 --
studies by early summer --
AmnioBoost Lattice Biologics ph.I --
severe COVID-19
Multiple (COVIDOSE,
CORON-ACT, TOCIVID-19,
COVITOZ-01, TOCIBRAS,
ARCHITECTS, TACOS,
MARIPOSA, TRONCHER,
TOSCA etc)
status improvement (ordinal scale) or
mortality
clinical progression to severe COVID with
their SNG001 interferon. Emerging
retrospective studies and mechanistic
guide towards early use.
Investigational drug for
Neutral/negative body of evidence led to
revocation of FDA EUA on 6/15. Totality of
growing data continues to suggest no
benefit.
Mortality HR of 0.65 in vented pts, 0.8 in
pts requiring O2 from UK RECOVERY trial
Convalescent plasma /
Mount Sinai; granted
<1% SAE 4h post-infusion and 15% 7d
mortality; pre-lim Mount Sinai report
suggests mortality benefit
August 25, 2020 8
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RBC Coronavirus Treatment and Vaccine Tracker - 08/25/20