BPC July 17 update

Selection of notable COVID-19 vaccine trials; Biotech week in Review

Weekly watchlist

Last week we previewed a selection of key Phase 3 clinical trial readouts for small and mid-cap companies slated for release this quarter. We had intended to preview this week Phase 2 catalysts for the quarter but will put that off until next week. Instead, given the increased interest in COVID vaccines we take a look at notable companies either undergoing or planning vaccine trials. Note, the list focuses on vaccines and not therapies. We are limited by a cap of 15 drug entries in our weekly lists.

First, review the week that was with notable healthcare news.

COVID-19 VACCINE:

AstraZeneca plc (NYSE:AZN) shares closed Friday up 6% to $61.10. Data from its Phase 1 COVID-19 vaccine trial being developed with Oxford University, are due to be published in The Lancet medical journal on Monday.

Moderna, Inc. (NASDAQ:MRNA) shares closed the week up 51% to $94.85 following the publication in The New England Journal of Medicine of interim data from a Phase 1 trial of its COVID-19 vaccine, mRNA-1273. The company noted that "these Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study." The Phase 3 trial is expected to begin on July 27.

Altimmune, Inc. (Nasdaq: ALT) shares closed up 28% to $28.66. The company announced pre-clinical data from its intranasal COVID-19 vaccine candidate, AdCOVID. A Phase 1 safety and immunogenicity trial is slated to commence in 4Q 2020.

OTHER CLINICAL:

NextCure, Inc. (Nasdaq: NXTC) shares slid to close Monday down 54% to $8.15 on news it does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of its NC318 monotherapy Phase 1/2 trial. The company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts.

Celsion Corporation (NASDAQ:CLSN) announced that the independent Data Monitoring Committee (DMC) has recommended to stop the Phase 3 OPTIMA trial of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), due to futility. Shares fell Monday 64% to $1.29.

REGULATORY:

Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) announced that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for VP-102, for the treatment of molluscum contagiosum. The FDA is seeking additional information regarding certain aspects of the CMC (Chemistry, Manufacturing, and Controls) process for the drug/device combination, as well as Human Factors validation. The company informed investors late last month that these deficiencies had precluded discussion of labeling and post-marketing requirements.

-

COVID-19 vaccine trials (selection):

Drug Price Stage Catalyst Market Cap

ALT – Altimmune Inc.
AdCOVID
COVID-19 vaccine

$15.56
-0.08  -1%
Phase 1 Phase 1 data due June 2021.
$597.5 million

AZN – AstraZeneca PLC
AZD1222
COVID-19 vaccine

$57.89
-0.42  -1%
Phase 3 Phase 3 data exhibited 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial noted 76% efficacy rate - March 24, 2021.
$152 billion

DVAX – Dynavax Technologies Corporation
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine

$8.95
-0.31  -3%
Phase 2/3 Phase 2/3 interim analysis due mid-2021.
$1.1 billion

GSK – GlaxoSmithKline PLC
Adjuvanted COVID-19 vaccine
COVID-19 vaccine

$39.08
-0.70  -2%
Phase 3 Phase 3 trial initiation announced May 27, 2021 with data due around 4Q 2021.
$98.3 billion

IMV – IMV Inc.
DPX-COVID-19
COVID-19 vaccine

$2.32
0.00  0%
Phase 1/2 Phase 1/2 trial planned.
$157.3 million

INO – Inovio Pharmaceuticals Inc.
INO-4800
COVID-19 vaccine

$8.70
+0.06  +1%
Phase 2 Phase 2 data released May 10, 2021 - generally safe and well-tolerated. Phase 3 trial to commence 2Q 2021.
$1.8 billion

JNJ – Johnson & Johnson
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE)
COVID-19 vaccine (single dose)

$163.62
-0.22  -0%
Approved Phase 3 data released January 29, 2021. Efficacy rate 66% in overall population, 72% effective in U.S. and 57% in South Africa. EUA Approval by FDA announced February 27, 2021.
$430.9 billion

MRK – Merck & Company Inc. (new)
V590 (IAVI)
COVID-19 vaccine

$76.19
-0.56  -1%
Phase 1 Phase 1 trial discontinued due to inferior immune responses - January 25, 2021.
$192.9 billion

MRNA – Moderna Inc.
mRNA-1273
COVID-19 vaccine

$221.36
+13.12  +6%
Approved FDA approval (EUA) announced December 18, 2020. Initiation of rolling BLA filing announced June 1, 2021.
$88.9 billion

NVAX – Novavax Inc.
NVX-CoV2373
COVID-19 vaccine

$194.37
+13.38  +7%
Phase 3 Phase 3 U.S. trial data released June 14, 2021. 90.4% efficacy overall, 100% protection against moderate and severe disease.
$14.4 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

$39.61
+0.19  +0%
BLA Filing FDA EUA approval announced December 11, 2020. Rolling BLA filing has been submitted - May 7, 2021.
$221.7 billion

REGN – Regeneron Pharmaceuticals Inc.
REGEN-COV2
COVID-19 (Anti-viral antibody)

$534.02
-0.25  -0%
Phase 3 EUA approval announced November 21, 2020.
$56.9 billion

SNY – Sanofi
MRT5500
COVID-19 vaccine

$52.30
-0.32  -1%
Phase 1/2 Phase 1/2 interim data due 3Q 2021.
$130.8 billion

VXRT – Vaxart Inc.
VXA-CoV2-1
COVID-19 Vaccine

$7.89
-0.01  -0%
Phase 1 Phase 2 trial to commence mid-2021.
$964.7 million