BPC October 22 update

Upcoming COVID-19 vaccine catalysts; Biotech week in Review

Weekly watchlist

The next couple months will see the first key data readouts from Phase 3 COVID-19 vaccine trials. These feature among other key COVID vaccine catalysts in this week’s list below.

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

COVID-19:

Gilead Sciences, Inc. (NASDAQ:GILD) announced Thursday that the FDA has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, making it the first FDA-approved treatment in the U.S. for COVID-19. Previously, the FDA had issued an Emergency Use Authorization (EUA) which meant that while Gilead was not given permission to market the product, hospital doctors were be able to obtain and use it in a stated dosage regimen for patients with COVID-19.

Moderna, Inc., (Nasdaq: MRNA) announced that it has completed enrolment of 30,000 participants for its Phase 3 trial of mRNA-1273, its vaccine candidate against COVID-19. Interim data are expected in November.

CLINICAL DATA:

CRISPR Therapeutics (NASDAQ:CRSP) closed Wednesday down 14% to $92.22 following the release of initial data from its Phase 1 trial evaluating the safety and efficacy of CTX110 in relapsed or refractory non-Hodgkin lymphoma. Complete responses (CRs) were achieved in 4 out of 11 patients across four dose levels with 2/4 CRs at the third-highest dose. However, the single patient to receive the highest dose died 52 days after receiving treatment.

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) shares closed Friday down 86% to $5.20 following news its Phase 3 trial of M-001, its universal flu vaccine candidate, failed to meet both the primary and secondary efficacy endpoints.

REGULATORY

Zosano Pharma Corporation (NASDAQ:ZSAN) shares closed Wednesday down 28% to $0.44 on news it received a complete response letter (CRL) from the FDA for its New Drug Application (NDA) for Qtrypta. The FDA has recommended that the company conduct a repeat bioequivalence study before resubmitting its NDA.

BUYOUT RELATED

Endo International plc (NASDAQ:ENDP) announced it will acquire all of the outstanding shares of BioSpecifics Technologies Corp. (NASDAQ:BSTC) for $88.50 in cash per share, or an estimated enterprise value of approximately $540m. BioSpecifics shares closed Monday up 45% to $88.69, while Endo shares closed up 13% to $5.64.

Cleveland BioLabs, Inc., (NASDAQ:CBLI) announced a reverse merger with Cytocom. Cleveland shareholders will own approximately 39% of the newly merged company. Cleveland shares closed the week up 14% to $2.60.

Upcoming COVID-19 vaccine catalysts:

Drug Stage Catalyst Market Cap

ALT – Altimmune Inc.
AdCOVID
COVID-19 vaccine

Phase 1 Phase 1 trial to commence December 2020 with data due 1Q 2021.
$404.5 million

ARCT – Arcturus Therapeutics Holdings Inc.
LUNAR-COV19
COVID-19 vaccine

Phase 1 Phase 1 initial data released November 9, 2020. Additional results due at a later date.
$2.2 billion

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

Phase 3 Phase 3 initial data met primary endpoint. 70% efficacy (90% and 60% across two dosing regimens).
$138.9 billion

CVAC – CureVac N.V.
CVnCoV
COVID-19

Phase 2 Phase 2a trial initiation announced September 29, 2020 with first data due 4Q 2020. Phase 2b/3 trial to be initiated also during 4Q 2020.
$18.7 billion

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

Phase 1/2 Phase 1/2 trial initiation announced September 4, 2020 with initial data due December 2020. Phase 3 trial to be initiated December 2020.
$92.3 billion

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

Phase 1/2 Phase 1/2 trial to commence before the end of 2020 with initial data due 1Q 2021.
$260.3 million

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

Phase 2 Phase 2 part of Phase 2/3 trial has been initiated - November 16, 2020. Phase 3 part remains on partial clinical hold.
$2.1 billion

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

Phase 3 Phase 3 trial initiation announced September 23, 2020. Emergency use authorization expected early 2021. Second Phase 3 trial initiation announced November 15, 2020.
$380.9 billion

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

Phase 3 Phase 3 data released November 30, 2020 with94.1% efficacy rate. EUA filed. FDA Advisory Committee meeting scheduled for December 17, 2020.
$60.4 billion

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

Phase 2/3 Phase 3 U.K. interim data due 1Q 2021. Completion of enrollment announced November 30, 2020. Phase 3 U.S. trial to commence December 2020 or early 2021.
$8.9 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 3 Phase 3 final efficacy analysis noted vaccine was 95% effective in preventing COVID-19. EUA filing announced November 20, 2020. Advisory Committee meeting December 10, 2020.
$212.9 billion

TBIO – Translate Bio Inc.
mRNA vaccine
COVID-19 vaccine

Phase 1/2 Phase 1/2 trial to commence 1Q 2021.
$1.7 billion

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

Phase 1 Phase 1 commencement of dosing announced October 13, 2020. Company noted first data due in a "few weeks".
$873.6 million