BPC February 06 update

Cellectis (CLLS) receives green light for CAR-T trials; Kitov (KTOV) tumbles following fraud accusations

Price and Volume Movers

Cellectis (Nasdaq: CLLS) announced that it has received an Investigational New Drug (IND) approval from the FDA to conduct Phase 1 clinical trials for UCART123 in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) making it the first off-the-shelf gene-edited CAR T-cell product candidate that the FDA has approved for clinical trials. Cellectis intends to initiate Phase 1 trials in 1H 2017. Shares are currently up 5% to $21.00 in the after-hours session.

Nano-cap Galena Biopharma, Inc. (NASDAQ:GALE) saw its shares initially spike up over 100% before settling down to close up 18% to $1.41. The company announced that the Data Safety Monitoring Board (DSMB) recommended that its Phase 2b trial of NeuVax plus trastuzumab continue as planned.  Completion of enrollment is expected in 2Q 2017, with interim efficacy analysis due near the end of 2017.  

Shares of Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) dropped 11% to $2.55 in normal trading hours due to an apparent report in Israel that the company’s CEO was detained and questioned under suspicion of fraud. Traders reacted by sending shares down a further 34% in the after-hours session. The company has yet to confirm the report.

Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) shares are currently trading down 10% to $3.00 in the after-hours trading session. The company announced the resignation of Charles Rowland as CEO and an executive member of the Board, effective immediately.

Other major movers:

ADVANCERS:

Pulmatrix Inc (NASDAQ:PULM): $4.98; +29%.

Concordia International Corp (NASDAQ:CXRX): $2.97; +17%.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $5.09; +17%.

Threshold Pharmaceuticals, Inc. (NASDAQ:THLD: $0.579; +11%.

Threshold Pharmaceuticals, Inc. (NASDAQ:THLD): $1.15; +11%.

DECLINERS:

Moleculin Biotech Inc (NASDAQ:MBRX): $2.00; -11%.

Invivo Therapeutics Holdings Corp (NASDAQ:NVIV): $4.40; -7%. 

Cerulean Pharma Inc (NASDAQ:CERU): $1.21; -7%.

Evoke Pharma Inc (NASDAQ:EVOK): $2.50; -7%.

Supernus Pharmaceuticals Inc (NASDAQ:SUPN): $25.00; -7%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

ADXS
Axalimogene filolisbac - AIM2CERV Trial
High-risk, locally advanced cervical cancer

Phase 3 Announced Phase 3 first patient dosed - February 6, 2017. Enrollment continues as of August 2017. Data due 2020 or 2021.

AVXS
AVXS-101 STR1VE
Spinal muscular atrophy (SMA) Type 1

Phase 3 Phase 3 trial has been initiated - noted November 9, 2017.

GALE
NeuVax in combination with Herceptin
Breast cancer - 1+/2+

Phase 2b Phase 2b completion of enrollment announced September 28, 2017 - with interim efficacy analysis due 1Q 2018.

ZYNE
ZYN002 - STAR 1
Adult Epilepsy Patients with Refractory Focal Seizures

Phase 2 Phase 2 data released August 7, 2017 - endpoints not met.

ZYNE
ZYN002
Fragile X syndrome

Phase 2 Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label. Phase 3 trial to commence 1H 2018.

ZYNE
ZYN002 - STOP
Osteoarthritis

Phase 2 Phase 2 data released August 14, 2017 - primary endpoint not met. However, company still intends to initiate Phase 3 trial pending discussions with FDA.