BPC September 02 update

Forte Biosciences FBRX Phase 2 trial for atopic dermatitis failed to meet endpoints -86% AH; Scopus BioPharma SCPS launching Duet Therapeutics +21%

Price and Volume Movers

Forte Biosciences, Inc. (NASDAQ: FBRX) released topline data from its Phase 2 trial of FB-401 for the treatment of atopic dermatitis. The data which were released ahead of its scheduled date of September 7, failed to meet its primary endpoint. Forte will not continue to advance FB-401 and will provide an update on the future plans for the company over the next several months. Shares are trading down 86% in afterhours at $4.00.

Scopus BioPharma Inc. (NASDAQ: SCPS) announced the launch of Duet Therapeutics, a subsidiary of Scopus following its acquisition of Olimmune in June 2021. The Duet Platform comprises three technologies, one of which is in a Phase 1 clinical trial, as monotherapy for B-cell non-Hodgkin lymphoma. In 2022, Duet is targeting to file two Investigational New Drug applications (IND) for DUET-02 in two separate indications: genitourinary and head & neck cancers. Shares closed up 21% at $6.05.

Assembly Biosciences (NASDAQ: ASMB) announced after hours yesterday that they will discontinue clinical development of ABI-H2158 as a treatment for hepatitis B virus (HBV). After the observation of symptoms consistent with drug-induced hepatotoxicity, Assembly voluntarily chose to discontinue development of 2158 and the Phase 2 study. Shares closed down 16% at $3.27.

Tiziana Life Sciences (NASDAQ: TLSA) announced an exclusive license agreement to evaluate foralumab and allogeneic CAR T candidates for cancer treatment with Precision BioSciences. Precision will be responsible for the development, commercialization, and costs for use of foralumab. Tiziana will receive an upfront payment, certain milestone payments, and royalties. Shares closed up 21% at $2.

Advancers

CompanyPriceChange
CRVS
Corvus Pharmaceuticals Inc.
$5.32+3.06  +135.40%
IPHA
Innate Pharma S.A.
$8.10+2.35  +40.87%
CYDY
Cytodyn Inc
$2.01+0.37  +22.56%
SURF
Surface Oncology Inc.
$7.10+1.09  +18.14%
ATNM
Actinium Pharmaceuticals Inc. (Delaware)
$7.83+1.15  +17.22%
EVLO
Evelo Biosciences Inc.
$8.34+1.03  +14.09%
MGTA
Magenta Therapeutics Inc.
$7.79+0.92  +13.39%
CNTB
Connect Biopharma Holdings Limited
$23.06+2.51  +12.21%
TRVN
Trevena Inc.
$1.36+0.14  +11.48%
FULC
Fulcrum Therapeutics Inc.
$30.83+3.14  +11.34%

Decliners

CompanyPriceChange
PTGX
Protagonist Therapeutics Inc.
$17.53-28.6  -62.00%
TCRR
TCR2 Therapeutics Inc.
$9.99-5.73  -36.45%
ELYM
Eliem Therapeutics Inc
$18.77-5.27  -21.92%
JANX
Janux Therapeutics Inc.
$27.39-6.96  -20.26%
ICVX
Icosavax Inc.
$33.06-6.4  -16.22%
IPSC
Century Therapeutics Inc.
$24.76-4.49  -15.35%
GRTS
Gritstone bio Inc.
$11.50-2.04  -15.07%
VERV
Verve Therapeutics Inc.
$59.88-9.99  -14.30%
INAB
IN8bio Inc.
$7.00-1.09  -13.47%
TNYA
Tenaya Therapeutics Inc.
$20.85-3.2  -13.31%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
Tempol
COVID-19

$1.10
0.00  0%
Phase 2/3 Phase 2/3 trial initiated dosing September 2, 2021.
$163.8 million

AZN – AstraZeneca PLC
Durvalumab, Monalizumab, and Oleclumab (COAST)
Non-small cell lung cancer (NSCLC)

$55.56
-1.04  -2%
Phase 2 Phase 2 trial met primary endpoint of confirmed ORR of 30% for durvalumab plus oleclumab, for durvalumab plus monalizumab 36%, for durvalumab alone 18%. The 10-month PFS rate was 64.8% for the durvalumab plus oleclumab combination and 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone, September 17, 2021.
$172.1 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson (COMFORT)
Psoriasis

$1.74
0.00  0%
Phase 3 Phase 3 top-line data due 1Q 2022. Enrollment completed September 2, 2021.
$33.2 million

CAPR – Capricor Therapeutics Inc.
CAP-1002
Duchenne Muscular Dystrophy (DMD)

$5.03
+0.30  +6%
Phase 2 Phase 2 final data to be presented at World Muscle Society Virtual Congress (WMS) on September 24, 2021. Phase 3 trial to be initiated 2H 2021.
$115.8 million

CRBU – Caribou Biosciences Inc.
CB-010 (ANTLER)
B-Cell Non-Hodgkin Lymphoma

$24.57
-3.10  -11%
Phase 1 Phase 1 trial ongoing. Initial data due 2022.
$1.5 billion

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

MEIP – MEI Pharma Inc.
Zandelisib (ME-401) - TIDAL
Relapsed/refractory Follicular Lymphoma (FL) Non Hodgkin Lymphoma

$2.69
-0.11  -4%
Phase 2 Phase 2 top-line data due 4Q 2021.
$303.1 million

MEIP – MEI Pharma Inc.
ME-344
Solid tumors

$2.69
-0.11  -4%
Phase 2 Phase 2 pilot study in relapsed colorectal cancer to be initiated 1H 2022.
$303.1 million

MEIP – MEI Pharma Inc.
Voruciclib
B-Cell Malignancies

$2.69
-0.11  -4%
Phase 1 Phase 1 updated data from the monotherapy portion due 2021.
$303.1 million

PFE – Pfizer Inc.
RENOIR (RSVpreF)
Respiratory syncytial virus (RSV) vaccine

$43.89
-0.58  -1%
Phase 3 Phase 3 trial to be initiated in September 2021 with potential conclusion in 1Q 2022.
$246.1 billion

PSTV – PLUS THERAPEUTICS Inc.
Rhenium-186 NanoLiposome ( 186 RNL) - (ReSPECT)
Glioblastoma

$1.97
+0.09  +5%
Phase 2/3 Phase 2/3 study to be initiated mid-2022. Phase 1 data presented August 21, 2021. Treatment was well tolerated, with no dose-limiting toxicity or serious adverse events observed.
$23.8 million

SRNE – Sorrento Therapeutics Inc.
COVI-MSC (MSC-COV-202BR)
COVID-19 / Acute Respiratory Distress Syndrome

$8.25
+0.17  +2%
Phase 2 Phase 2 trial initiated enrollment September 3, 2021. Phase 2 US and long haul studies to begin enrollment in 2021.
$2.5 billion

TCRR – TCR2 Therapeutics Inc.
Gavo-cel (TC-210)
Mesothelin-positive solid tumors

$9.99
-5.73  -36%
Phase 1/2 Phase 1/2 data showed 1 Grade 3 and 1 Grade 5 [patient death] reported. 6 patients achieved partial response (PR), and 1 complete response (CR). Overall response rate (ORR) of 31%. By independent review assessment, the ORR was 25% with a DCR Rate of 81%. The median overall survival for patients with mesothelioma is 11.2 months, whereas the median progression free survival (PFS) is 5.9 months, September 17, 2021.
$381.6 million