BPC August 19 update

Phase 1/2 clinical data readouts remaining this quarter; Biotech week in review

Weekly watchlist

The latest week saw a marked decrease in the amount of biotech stock news flow, with companies wrapping up their earnings reports and looking forward to September where a significant number of clinical data readouts are expected. Following on from last week's list of Phase 3 catalysts left for the quarter, we turn our attention this week to notable Phase 1/2 events to watch.

First, let’s review the week that was with notable price-moving events.

REGULATORY:

Sesen Bio (NASDAQ: SESN) shares fell a further 53% for the week to close down at $1.00, adding to the previous Friday’s fall of 57%. The company announced last week that it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Initially the company noted concerns from the FDA regarding clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues. However, in an analyst call Monday, Sesen mentioned that a further 12-month confirmatory trial is also required with a BLA to be resubmitted in 2023 at the earliest.

CLINICAL UPDATES:

Travere Therapeutics, Inc. (NASDAQ: TVTX) announced positive topline interim data from its Phase 3 PROTECT Study of sparsentan, for the treatment of IgA nephropathy (IgAN). The trial met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p<0.0001). Patients will continue in a blinded manner to fully assess the treatment effect on eGFR slope over 110 weeks in the confirmatory endpoint analysis. Top-line data from the confirmatory endpoint analysis are expected in 2H 2023. Travere plans to submit an application for accelerated approval in 1H 2022. Shares closed the week up 31% to $20.19.

Fate Therapeutics, Inc. (NASDAQ: FATE) announced Thursday interim clinical data from its Phase 1 trials of FT516 and FT596 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma. Of the 11 patients treated in the FT516 trial, eight patients (73%) achieved an objective response, including six patients (55%) who achieved a complete response. Five patients (45%) maintained their response without further therapeutic intervention. In the FT596 trial, 10 of 14 patients (71%) in the monotherapy and combo arms achieved an objective response, including seven patients (50%) that achieved a complete response. Shares closed Friday down 22% to $67.01.

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Upcoming Phase 1/2 catalysts remaining 3Q 2021 (excludes ESMO list coming next week):

Drug Price Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
AFP (ADP-A2AFP)
Hepatocellular carcinoma

$5.40
+0.11  +2%
Phase 1 Phase 1 data displayed one complete response and a disease control rate of 64% with stable disease for ≥16 weeks in two patients. Phase 1 top-line data has an acceptable safety profile. Dose escalation is complete September 5, 2021.
$842.9 million

ALT – Altimmune Inc.
ALT-801
Non-alcoholic steatohepatitis (NASH) - Healthy Overweight and Obese Volunteers

$15.24
-1.16  -7%
Phase 1 Phase 1 6-week MAD released June 16, 2021. Weight loss of 5.4% achieved at 6 weeks of treatment with 1.8 mg once weekly dose. 12-week data due September 2021. Phase 2 obesity and NASH trials expected to initiate in Q1 2022.
$605.1 million

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

$33.50
+2.26  +7%
Phase 2a Phase 2a completion of dosing announced August 11, 2021 full data due early Fall 2021. Phase 3 trial to be initiated 1Q 2022.
$271.4 million

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

$3.22
+0.19  +6%
Phase 1 Phase 1 top-line data due end of 3Q 2021. Phase 2b trial to be initiated 4Q 2021.
$224.2 million

BLU – BELLUS Health Inc.
BLU-5937 (SOOTHE)
Chronic cough

$6.03
+0.24  +4%
Phase 2b Phase 2b initiation announced December 8, 2020. Administrative interim analysis released September 13, 2021- at least one dose of BLU-5937 met the predefined probability threshold for a clinically meaningful reduction in placebo-adjusted 24-hour cough frequency; Limited taste-related adverse events were observed, consistent with previous BLU-5937 trials. No serious adverse events were reported. Top-line results expected 4Q 2021.
$472.4 million

CRDF – Cardiff Oncology Inc.
Onvansertib, FOLFIRI and AVASTIN (bevacizumab)
KRAS-Mutated Colorectal Cancer

$6.86
+0.13  +2%
Phase 1/2 Phase 1b/2 data displayed 42% of patients achieved an initial partial response (PR) as of the data cutoff date, 37% have achieved a confirmed PR. Treatment is shown to be well-tolerated with only 10% of reported treatment-emergent adverse events. - September 8 2021.
$271.3 million

EDIT – Editas Medicine Inc.
AGN-151587 (EDIT-101) - BRILLIANCE
Leber Congenital Amaurosis type 10 (LCA10).

$63.20
+2.20  +4%
Phase 1/2 Phase 1/2 initial data due to be presented at the International Symposium on Retinal Degeneration planned for September 29, 2021.
$4.3 billion

ENTA – Enanta Pharmaceuticals Inc.
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)

$58.43
+0.33  +1%
Phase 2b Phase 2b interim analysis due 3Q 2021.
$1.2 billion

EVLO – Evelo Biosciences Inc.
EDP1815
Mild to moderate psoriasis

$8.34
+1.03  +14%
Phase 2b Phase 2b data due 3Q 2021.
$445.3 million

FBRX – Forte Biosciences Inc.
FB-401
Atopic Dermatitis

$3.60
+0.18  +5%
Phase 2 Phase 2 failed to meet primary endpoint September 02, 2021.
$50.7 million

LPCN – Lipocine Inc.
LPCN 1144 (LiFT)
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

$1.16
+0.02  +2%
Phase 2 Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. 36-week data released August 25, 2021.
$102.4 million

TBPH – Theravance Biopharma Inc.
Izencitinib
Ulcerative Colitis

$7.11
+0.25  +4%
Phase 2b Phase 2b data did not meet primary endpoint - August 23, 2021.
$522.4 million

XENE – Xenon Pharmaceuticals Inc.
XEN1101 (X-TOLE)
Adult Focal Epilepsy

$17.86
+0.86  +5%
Phase 2 Phase 2b completion of enrollment announced July 7, 2021. Top-line data due late-September to mid-October 2021.
$734.5 million