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:


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%.


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

Breast cancer

Phase 3 Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death).

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

Phase 3 Phase 3 completion of enrollment noted June 20, 2017. Futility analysis due September or early October, 2017. Noted early August that outcome is due in 1-2 months. Top-line data due 1Q 2018.

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 - ORR 89%. Pivotal trial to be initiated by the end of 2017.

Opdivo + Yervoy
Malignant pleural mesothelioma (MPM)

Phase 2 Phase 2 late breaker at ASCO June 5, 2017. Control rate 44%. ORR 19%.


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

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

Phase 2 Phase 2 enrollment completed - announced May 31, 2017. Data updates at ASCO June 5, 2017.

Soft tissue sarcomas

Phase 2 Phase 2 data at ASCO 2017 with further interim analysis at ESMO September 2017. PFS 2.6 months, Disease Control Rate 61%.

Follicular non-Hodgkin Lymphoma - cancer

Phase 2 Phase 2 data at ASCO 2017 (June 2, 2017). Also due at ASH 2017.

Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)

Phase 1/2 Phase 1/2 initial data released at ASCO June 4, 2017.

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 at ASCO June 5, 2017. Updated data at ESMO Saturday, 9 September 2017 showed ORR 56% in melanoma patients.

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

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

r/r B cell non-Hodgkin lymphoma - cancer

Phase 1/2 Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017 - ORR 86%.

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

Phase 2 Announced 76% ORR at ASCO - June 3, 2017. Primary analysis by the end of 2017 with NDA filing late 2017 or early 2018.

Breast cancer - HER2-positive MBC and ER+/HER2-low MBC

Phase 2 Phase 2 open label trial to be initiated 4Q 2017.

Solid tumors - cancer

Phase 1/2 Phase 1/2 initial data released at ASCO June 5, 2017. Poster at ESMO September 9, 2017.

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.

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

Phase 3 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. Primary endpoint was met March 2, 2017. Data released June 5, 2017 - HR 0.81. Disease-free-survival +0.9% over Herceptin.

Solid tumors - cancer

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

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

Phase 2 Phase 2 trial initiation announced July 11, 2017 with three-month preliminary data 1H 2018.

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.

Solid tumors

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

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

Phase 3 Phase 3 data due 2H 2018 with interim analysis possibly due 4Q 2017.

Recurrent glioblastoma (rGBM) cancer

Phase 3 Phase 3 completion of enrollment announced January 6, 2017. Interim analysis due late September 2017. Top-line data due 1Q 2018.