BPC April 20 update

ASCO abstract titles released; BioPharmX (BPMX) data now due early May

Price and Volume Movers

The annual American Society of Clinical Oncology (ASCO) meeting is just around the corner, to be held from June 2-6, 2017. The meeting is regarded as the leading oncology meeting of the year and given that oncology stands to the forefront in terms of drug development, ASCO is seen by many as the central medical meeting for 2017.

Given the importance of the meeting, investors not only look forward to the actual oral and poster presentations, but they also obtain a glimpse of what will be presented when the abstracts are released. Wednesday May, 15 (5pm EST) is the time and date to note for release. Visit abstracts.asco.org to obtain the abstracts.

The abstract titles were released yesterday and relevant companies have been quick to inform the investment community of their upcoming presentations, some of which are noted below in the Pipeline Updates section. It is by no means a complete list and more titles will be added.

Given the number of abstract titles we have just included the Tesaro news in today's newsletter:

TESARO Inc (NASDAQ:TSRO) shares dropped 6% to close down at $139.01 following its release of its pricing plans for its recently approved PARP inhibitor Zejula (niraparib). The company announced Wednesday that the Wholesale Acquisition Cost (WAC) for its recently approved ZEJULA would be $9,833 for a one-month supply of the 200mg dose. Patients will however initially receive a 300mg dose that will cost $14,750 a month and will be down-dosed to the 200mg and 100mg ($4917) doses if the patient receives an adverse reaction. In its Phase 3 NOVA trial of 367 patients treated with ZEJULA, adverse reactions led to dose reduction in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%). The permanent discontinuation rate due to adverse reactions was 15%. The net result of the down-dosage will be an average price of around $10,350 according to estimates by Leerink analyst, Seamus Fernandez, who also lowered his price target from $186 to $158.


Major price movers:

ADVANCERS: 

Immune Pharmaceuticals Inc (NASDAQ:IMNP): $3.65; +50%.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $16.37; +19%.

ImmunoGen, Inc. (NASDAQ:IMGN): $4.19; +17%.

Titan Pharmaceuticals, Inc. (NASDAQ:TTNP): $3.00; +9%.

Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI): $6.97; +8%.


DECLINERS:

Argos Therapeutics Inc (NASDAQ:ARGS): $0.478; -20%.

Aldeyra Therapeutics Inc (NASDAQ:ALDX): $4.35; -16%.

KemPharm Inc (NASDAQ:KMPH): $4.10; -11%.

Apricus Biosciences Inc (NASDAQ:APRI): $1.39; -10%.

Innocoll Holdings PLC (NASDAQ:INNL): $2.05; -6%.


Pipeline updates below (including ASCO titles): 

Pipeline Database Updates

Drug Stage Catalyst

AZN
Lynparza
Breast cancer

Phase 3 Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017. Abstract LBA4.

AVEO
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

Phase 3 Phase 3 enrollment to be completed June 2017. Futility analysis due mid-2017. Top-line data due 1Q 2018 (Poster session at ASCO June 4, 2017). Abstract TPS4600.

BLUE
bb2121
Relapsed/refractory multiple myeloma

Phase 1 Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017. Abstract 3010

BMY
Opdivo + Yervoy
Malignant pleural mesothelioma (MPM)

Phase 2 Phase 2 late breaker at ASCO June 5, 2017. Abstract LBA8507.

BPMX
BPX-01
Acne

Phase 2b Phase 2b data released May 3, 2017 - primary endpoint met, secondary missed.

GLYC
GMI-1271
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer

Phase 2 Phase 2 enrollment of first arm completed - March 7, 2017. Completion of enrollment in second arm due mid-2017. Data updates due at ASCO June 5, 2017. Abstract 2520 and 2560.

IMDZ
CMB305
Soft tissue sarcomas

Phase 2 Phase 2 data at ASCO 2017 (June 2, 2017). Abstract 11006.

IMDZ
G100
Follicular non-Hodgkin Lymphoma - cancer

Phase 2 Phase 2 data at ASCO 2017 (June 5, 2017). Abstract 7537.

FPRX
Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)

Phase 1/2 Phase 2 dose expansion phase initiated May 2016. Completion of enrollment announced April 10, 2017. Data due at ASCO June 4, 2017. Abstract 11078.

INCY
Epacadostat with Keytruda - ECHO-202/KEYNOTE-037
NSCLC, RCC, Triple-Negative Breast, Ovarian, Urothelial Carcinoma, Solid Tumors

Phase 1/2 Phase 1/2 various presentations (5) at ASCO June 3-5, 2017. Abstracts 9014, 4515, 4503, 3012, 6010.

INCY
Epacadostat with Opdivo (nivolumab) - (ECHO-204)
Solid tumors

Phase 1/2 Phase 1/2 trial enrolling. Oral presentation at ASCO June 5, 2017. Abstract 3003.

JUNO
JCAR017
r/r B cell non-Hodgkin lymphoma - cancer

Phase 1/2 Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017. Abstract 7513.

LOXO
Larotrectinib (LOXO-101) - NAVIGATE
Solid tumors that harbor a TRK fusion.

Phase 2 Announced February 21, 2017 that trial enrollment has been completed with Phase 2 data due 2H 2017. NDA filing late 2017 or early 2018. Late breaker ASCO June 3, 2017. Abstract LBA2501.

MRUS
MCLA-128
Breast cancer

Phase 1/2 Phase 1/2 interim data due at ASCO June 5, 2017. Abstract 2522.

NKTR
NKTR-214
Solid tumors - cancer

Phase 1/2 Phase 1/2 initial data due at ASCO investor event June 3, 2017. Abstract 2545 (June 5 poster).

SNDX
Entinostat plus Keytruda - ENCORE 601
Recurrent non-small cell lung cancer (NSCLC)

Phase 1/2 Phase 2 trial to advance to second stage of trial - noted May 16, 2017. Poster presentation at ASCO June 3, 2017.

PBYI
Roche (RHHBY) - Perjeta + Herceptin (APHINITY)
Adjuvant HER2+ breast cancer

Phase 3 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. The data will likely have a significant impact on the share price of Puma (e.g. positive data would likely have a negative impact on Puma and vice versa). Primary endpoint was met March 2, 2017. Late breaker at ASCO - June 5, 2017. Abstract LBA500.

EPZM
Tazemetostat
Solid tumors - cancer

Phase 2 Phase 2 interim data due at ASCO 2017 - June 4, 2017. Abstract 11057.

CLSD
Suprachoroidal CLS-TA - TYBEE
Diabetic Macula Edema (DME)

Phase 2 Phase 2 trial to be initiated mid-2017.

CLSD
Suprachoroidal CLS-TA - HULK
Diabetic macular edema (DME)

Phase 1/2 Phase 1/2 enrollment completion announced April 20, 2017. Preliminary data due 2H 2017.

AGEN
AGEN2034
Solid tumors

Phase 1/2 Phase 1/2 initiation announced April 20, 2017.

CRMD
Neutrolin - LOCK-IT 100
Hemodialysis patients with central venous catheters

Phase 3 Phase 3 enrollment to be completed 2Q 2018. Data due end of 2018 with interim analysis possibly due 4Q 2017.

VBLT
VB-111
Recurrent glioblastoma (rGBM) cancer

Phase 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis due 3Q 2017. Full data due early 2018. Poster presentation at ASCO June 5, 2017. Abstract 2055.