BPC October 06 update

Biotech stocks to watch at ESMO - abstracts out October 9

Weekly watchlist

The main oncology event in Europe, ESMO, will be held In two weeks.  We highlight a number of presentations to watch leading up to and during the conference.

Abstracts will be published online via the ESMO website at 00:05 CEST on Tuesday, 9 October 2018. All late-breaking abstracts will be made public at the start of the official Congress session during which they are presented.

First, let’s review the week that was with a selection of and clinical and regulatory events.

Roche (OTCQX: RHHBY) noted on Thursday that the FDA has approved Hemlibra for patients with haemophilia A without factor VIII inhibitors.

Akcea Therapeutics, Inc. (NASDAQ: AKCA) and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced Friday that the FDA has approved Tegsedi (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. 

Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) announced Tuesday the FDA has approved Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). The company also received approval that same day for Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Omeros Corporation (NASDAQ: OMER) announced Monday data from its Phase 2 clinical trial of OMS721 for the treatment of renal diseases. A marginal difference compared with placebo was shown, resulting in shares closing the week down 43% to $13.97. Shares closed the week 

"For the nine evaluable patients, median reductions in proteinuria following the initial 12-week course of treatment were 18.4 percent and 18.0 percent for the OMS721 and placebo groups, respectively."

In an extension part of the trial, just under half of pooled patients on OMS721/placebo received a further six weeks of treatment at investigator discretion. The patients showed a median proteinuria reduction of 55.7%.

Presentation to watch at ESMO - October 19-23, 2018.

Drug Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
MAGE-A10
Non-Small Cell Lung Cancer (NSCLC)

Phase 1 Phase 1 data at ESMO noted no current response.
$539.6 million

AZN – Astrazeneca PLC
Lynparza - SOLO 1
First-line ovarian cancer following platinum-based chemotherapy

PDUFA priority review PDUFA date under priority review 1Q 2019.
$99.2 billion

BLRX – BioLineRx Ltd.
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer

Phase 2 Triple combo arm initiation announced December 11, 2018 with data due 2H 2019.
$70.9 million

CLVS – Clovis Oncology Inc.
Rucaparib - TRITON2
Castrate-resistant prostate cancer (mCRPC)

Phase 2 Phase 2 initial data presented at ESMO - 44% ORR.
$1.1 billion

CTMX – CytomX Therapeutics Inc.
CX 072
Solid tumors

Phase 1/2 Phase 1/2 initial data released at ESMO 2018. 8% ORR. Further updates due 2019.
$664.8 million

DCPH – Deciphera Pharmaceuticals Inc.
DCC-2618
Gastrointestinal Stromal Tumors (GIST)

Phase 1 Phase 1 update at ESMO October 2018. ORR 21%, PFS 40 weeks - 2nd/3rd line.
$987.1 million

MRK – Merck & Company Inc. (new)
Keytruda KN-048
Head and Neck Cancer

Phase 3 Phase 3 data presented at ESMO October 2018. HR 0.61, no difference in PFS.
$198.9 billion

MRTX – Mirati Therapeutics Inc.
Sitravatinib plus nivolumab
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 biomarker analysis presented at SITC November 2018.
$1.3 billion

NCNA – NuCana plc
NUC-3373
Solid tumors

Phase 1 Phase 1 additional data due 2019.
$533 million

NCNA – NuCana plc
NUC-1031 (Acelarin)
Front-Line Treatment of Advanced Biliary Tract Cancer

Phase 3 Phase 3 trial to be initiated by YE 2018.
$533 million

RHHBY – Roche Holding Ltd ADR (Sponsored)
Tecentriq plus nab-paclitaxe - IMpassion 130
First-line triple negative breast cancer (TNBC)

Phase 3 Phase 3 data released July 1, 2018. PFS endpoint met. PFS =7.2 vs. 5.5 months. HR 0.80.
$212.5 billion

RXDX – Ignyta Inc.
STARTRK-2 entrectinib
Solid tumors - cancer

Phase 2 Pooled Analysis of STARTRK-2, STARTRK-1 and ALKA-372-001 - ESMO October 21, 2018; 11:24 CEST.
$