BPC July 24 update

TCRR early stage oncology data due Monday; Drug pipelines of new IPOs ANNX INZY ITOS NRIX

Price and Volume Movers

TCR2 Therapeutics Inc. (Nasdaq: TCRR) announced that it will be releasing initial data from the Phase 1 portion of its Phase 1/2 clinical trial of TC-210 for patients with mesothelin-expressing solid tumors on July 27, 2020 (premarket).

Genocea Biosciences, Inc. (NASDAQ:GNCA) shares closed up 24% to $4.48. The company will be releasing oncology data from their Phase 1/2 trial of GEN-009 on July 30.

Gilead Company (NASDAQ:GILD) announced that the FDA approved Tecartus (brexucabtagene autoleucel, formerly KTE-X19), a CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Solid Biosciences Inc. (Nasdaq: SLDB) announced after hours that its Phase 1/2 IGNITE DMD clinical trial of SGT-001, in patients with Duchenne muscular dystrophy, remains on clinical hold. The company submitted a response to the FDA in June related to manufacturing process improvements. However, the FDA responded by maintaining the clinical hold and has requested further manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Capricor Therapeutics, Inc. (CAPR): $7.72; +29%.

Oncternal Therapeutics, Inc. (ONCT): $2.90; +23%.

Miragen Therapeutics (MGEN): $1.24; +13%.

Qualigen Therapeutics, Inc. (QLGN): $5.55; +11%.

Aldeyra Therapeutics, Inc. (ALDX): $6.98; +10%.

DECLINERS:

Arbutus Biopharma Corporation (ABUS): $4.96; -20%.

Stoke Therapeutics, Inc. (STOK): $25.25; -14%.

Fusion Pharmaceuticals Inc. (FUSN): $13.20; -13%.

Dynavax Technologies Corporation (DVAX): $8.88; -12%.

Aravive, Inc. (ARAV): $7.91; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ANNX – Annexon Inc.
ANX005
Guillain-Barré Syndrome

Phase 2/3 Phase 2/3 trial to be initiated early 2021 with data due 1H 2023.
$1 billion

ANNX – Annexon Inc.
ANX005
Warm autoimmune hemolytic anemia (WAIHA)

Phase 2 Phase 2 trial to be initiated with data due 2H 2021.
$1 billion

ANNX – Annexon Inc.
ANX005
Huntington’s disease

Phase 2a Phase 2a trial to be initiated with data due 1H 2021.
$1 billion

ANNX – Annexon Inc.
ANX005
Amyotrophic lateral sclerosis (ALS)

Phase 2 Phase 2 trial be be initiated with data due 2H 2021.
$1 billion

ANNX – Annexon Inc.
ANX007
Geographic atrophy

Phase 2 Phase 2 trial to be initiated in 2021.
$1 billion

AZN – Astrazeneca PLC
Breztri - (ETHOS)
Chronic obstructive pulmonary disease (COPD)

Approved FDA approval announced July 24, 2020.
$149.2 billion

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer

Approved FDA approval announced July 24, 2020.
$86.3 billion

INZY – Inozyme Pharma Inc.
INZ-701
ENPP1 deficiency

Phase 1/2 Phase 1/2 trial planned.
$608.9 million

ITOS – iTeos Therapeutics Inc.
EOS-850
Solid tumors

Phase 1/2 Phase 1/2 initial expansion data due 1H 2021.
$1 billion

ITOS – iTeos Therapeutics Inc.
EOS-448
Solid tumors

Phase 1/2 Phase 1/2a data due 1H 2021.
$1 billion

ITOS – iTeos Therapeutics Inc.
EOS-850 in combination with pembrolizumab
PD-1-Resistant Melanoma

Phase 1 Phase 1 trial planned for 3Q 2020.
$1 billion

ITOS – iTeos Therapeutics Inc.
EOS-850 in combination with pembrolizumab
Castrate-R Prostate Cancer

Phase 1 Phase 1 trial planned for 3Q 2020.
$1 billion

NRIX – Nurix Therapeutics Inc.
NX-2127
Non-Hodgkin lymphoma /chronic lymphocytic leukemia

Phase 1 Phase 1 trial planned.
$657.8 million

SLDB – Solid Biosciences Inc.
SGT-001
Duchenne Muscular Dystrophy

Phase 1/2 Phase 1/2 trial remains on clinical hold - noted July 24, 2020.
$111.1 million

TCRR – TCR2 Therapeutics Inc.
TC-210
Mesothelin-positive solid tumors

Phase 1/2 Phase 1 interim update 2H 2020.
$549.4 million