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.

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COVID-19 vaccine trials (selection):

Drug Stage Catalyst Market Cap

ALT – Altimmune Inc.
Intranasal COVID-19 Vaccine
COVID-19 vaccine

Phase 1 Phase 1 trial to commence 4Q 2020.
$758.9 million

AZN – Astrazeneca PLC
AZD1222 (ChAdOx1 nCoV-19)
COVID-19 vaccine

Phase 3 Phase 1 data July 20, 2020 noted neutralising activity was seen in 91% of participants one month and in 100% of participants who received a second dose. Phase 3 data from non-U.S. trials due 3Q 2020. Phase 3 U.S. trial to start soon.
$149.2 billion

DVAX – Dynavax Technologies Corporation
SCB-2019 + adjuvant system (Clover)
COVID-19 vaccine

Phase 1 Phase 1 initiation announced June 19, 2020 with preliminary safety and immunogenicity data due September 2020.
$757.3 million

EBS – Emergent Biosolutions Inc.
Covid-19 vaccine
COVID-19 Vaccine

Phase 1 Phase 1 IND filing announced August 10, 2020.
$6.8 billion

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

Phase 1/2 Phase 1/2 trial to commence September 2020. Late-stage trial to commence late-2020.
$105.7 billion

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

Phase 1 Phase 1 trial to commence summer 2020. Data due fall of 2020.
$269.6 million

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

Phase 1 Phase 1 interim data released June 30, 2020. 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 but no data on how many patients produced antibodies. Phase 2/3 trial to commence July/August 2020.
$2.2 billion

JNJ – Johnson & Johnson
Ad26.COV2-S
COVID-19 vaccine

Phase 1/2 Phase 1/2 trial has been initiated, Initial Phase I data due second half of September, with a Phase 3 trial to start mid to end September.
$394.9 billion

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

Phase 1 Phase 1 trial to commence 2H 2020.
$209.5 billion

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

Phase 2/3 Phase 2 interim efficacy data due 3Q 2020. Phase 3 enrollment to be completed September 2020.
$27.4 billion

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

Phase 1/2 Phase 1 preliminary data released August 4, 2020. Well-tolerated and elicited robust antibody responses.
$7.3 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 2/3 Phase 2/3 trial initiation announced July 27, 2020. Data due October 2020. On track to seek regulatory review in October 2020.
$214.2 billion

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

Phase 2/3 Phase 2/3 initial virology and biomarker data due September 2020.
$65.6 billion

SNY – Sanofi
mRNA vaccine
COVID-19 vaccine

Phase 1b Phase 1 trial to commence by the end of 2020.
$130.6 billion

SVA – Sinovac Biotech Ltd.
COVID-19 vaccine
COVID-19 vaccine

Phase 2 Phase 1/2 preliminary data noted neutralizing antibody seroconversion rate above 90% - June 13, 2020. Phase 2 trial to be completed at the end of 2020.
$639.9 million