BPC September 13 update

aTyr Pharma LIFE +67% Phase 1b/2a data; Leap LPTX +21% Mixed ESMO abstract data

Price and Volume Movers

aTyr Pharma, Inc. (NASDAQ: LIFE) released results from its Phase 1b/2a trial of ATYR1923 to treat pulmonary sarcoidosis, a major form of interstitial lung disease (ILD). The trial met the primary endpoints and was well-tolerated at all dose levels. Shares closed up 67% at $9.15.

Leap Therapeutics (NASDAQ: LPTX) released initial data from the DisTinGuish Phase 2a study of DKN-01 plus tislelizumab to treat gastric or gastroesophageal junction cancer (G/GEJ). The abstract noted that the overall response rate (ORR) was 68.2%, however, four Grade 5 adverse events [patient deaths] occurred. Further results will be presented at the ESMO 2021 Congress on September 16, 2021. Shares closed up 21% at $1.77.

Regenxbio, Inc. (NASDAQ: RGNX) entered into a $1.8 billion partnership with AbbVie (NYSE: ABBV) to develop and commercialize RGX-314, a gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other chronic retinal diseases. Under the collaboration, Regenxbio will be responsible for the completion of the ongoing trials of RGX-314. AbbVie will lead the clinical development and commercialization of RGX-314 globally. Shares closed up 31% at $43.40.

Adaptimmune Therapeutics PLC (NASDAQ: ADAP) announced that the clinical responses from its Phase 1 trial across five solid tumor indications had an overall response rate of 36%. Results showed a complete response in ovarian cancer and confirmed partial responses in ovarian, head and neck, esophagogastric junction, bladder, and synovial sarcoma cancers. Most patients experienced antitumor activity with a disease control rate of 86%. Adaptimmune Shares closed down 7% at $5.85.

Valneva SE (NASDAQ: VALN) announced that they received a termination notice from the United Kingdom Government in relation to a supply agreement for its COVID-19 vaccine candidate, VLA2001. Valneva’s vaccine uses CpG 1018, an adjuvant developed by Dynavax Technologies Corporation (NASDAQ: DVAX). Valneva stated that they intend to continue clinical development of VLA2001 and the Phase 3 trial for VLA2001, Cov-Compare, remains ongoing. Valneva shares closed down 40% at $18.65. Dynavax shares closed down 16% at $14.74.

Matinas BioPharma Holdings, Inc. (NYSE: MTNB) reported top-line data in the ongoing Phase 2 EnACT trial of MAT2203 for the treatment of cryptococcal meningitis. Overall survival was >95% for the 40 patients in Cohort 2. Enrollment in Cohort 3 of EnACT has commenced and is expected to complete by the end of 2021. Shares closed up 27% at $1.05.



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

ADAP – Adaptimmune Therapeutics plc
ADP-A2M4CD8 (SURPASS)
Solid tumors

$5.40
+0.11  +2%
Phase 1 Phase 1 data released September 13, 2021 - 4% of patients received CR, 28% received PR, 44% received SD, 12% received PD, 3% not evaluable. Additional data due at ESMO September 16-21, 2021.
$842.9 million

BGNE – BeiGene Ltd.
Tislelizumab (RATIONALE 302)
Esophageal Squamous Cell Carcinoma (ESCC)

$403.14
+17.90  +5%
PDUFA PDUFA date July 12, 2022. Phase 3 top-line data met primary endpoint of overall survival - January 27, 2021. Poster at ASCO June 4, 2021 noted median OS of 8.6 months compared to 6.3 months in the chemotherapy arm.
$37.5 billion

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

CYTK – Cytokinetics Incorporated
Aficamten - Redwood-HCM
Hypertrophic cardiomyopathy (HCM)

$33.89
+0.40  +1%
Phase 2 Phase 2 full trial data resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular (LV) outflow tract pressure gradient and the average post-Valsalva. The observed reductions in LVOT-G were dose dependent. Patients treated with aficamten in both Cohort 1 and Cohort 2 also experienced statistically significant reductions in NT-proBNP, noted September 12, 2021. Phase 3 trial to commence in 2021.
$2.8 billion

DMAC – DiaMedica Therapeutics Inc.
DM199 (ReMEDy2)
Acute ischaemic stroke

$4.18
+0.13  +3%
Phase 2/3 Phase 2/3 trial initiated September 13, 2021.
$78.3 million

IBRX – ImmunityBio Inc.
IL-15 Superagonist N-803 (QUILT 3.032)
BCG-Unresponsive Bladder Cancer Carcinoma

$10.18
+0.44  +5%
Phase 2/3 Phase 2/3 trial data showed a complete response rate of 72% with a median duration of 19.9 months, and 85% remaining Cystectomy-free, noted September 13, 2021.
$4 billion

LIFE – aTyr Pharma Inc.
ATYR1923
Pulmonary sarcoidosis

$10.31
+0.05  +0%
Phase 1/2 Phase 1b/2a trial met primary endpoint September 13, 2021.
$174.4 million

MTNB – Matinas Biopharma Holdings Inc.
Oral amphotericin b (MAT2203) - (EnACT)
Cryptococcal meningitis

$1.10
-0.06  -5%
Phase 1/2 Phase 1/2 DSMB evaluation of safety and efficacy data released September 13, 2021 and exceeded prespecified primary endpoint. Enrollment in Cohort 3 has commenced and is expected to be completed by end of 2021.
$236.2 million

MYMD – MyMD Pharmaceuticals Inc.
MYMD-1
Aging

$7.49
+0.70  +10%
Phase 2 Phase 2 trial to initiate dosing early 4Q 2021. Interim data is expected in 1Q 2022.
$279.9 million

SRNE – Sorrento Therapeutics Inc.
ABIVERTINIB (STI-5656)
Non-small cell lung cancer (NSCLC)

$8.25
+0.17  +2%
Phase 3 Phase 3 trial has been completed and is pending final review. Phase 3 top-line data due 4Q 2021.
$2.5 billion

TGTX – TG Therapeutics Inc.
Ublituximab (TG-1101) + UKONIQ (umbralisib) + VENCLEXTA (venetoclax) - (ULTRA-V)
Chronic Lymphocytic Leukemia

$31.28
+0.65  +2%
Phase 1/2 Phase 1/2 data to be presented at iwCLL September 19, 2021. Phase 2 trial enrollment has been completed with data due in 2022.
$4.5 billion

TGTX – TG Therapeutics Inc.
TG-1701
Non Hodgkin Lymphoma / Chronic Lymphocytic Leukemia

$31.28
+0.65  +2%
Phase 1 Phase 1 updated data to be presented at iwCLL September 19, 2021.
$4.5 billion

VTGN – VistaGen Therapeutics Inc.
PH94B (PALISADE-2)
Social Anxiety Disorder (SAD)

$2.98
+0.06  +2%
Phase 3 Phase 3 PALISADE-2 [second P3 trial] initiated September 13, 2021. Top-line data due 2H 2022.
$574.9 million

ZNTL – Zentalis Pharmaceuticals Inc.
ZN-c3-003 with gemcitabine (chemotherapy)
Osteosarcoma

$70.28
-2.56  -4%
Phase 1/2 Phase 1/2 trial first patient dosed September 13, 2021. Phase 1/2 results expected 2H 2022.
$3.2 billion