BPC May 17 update

Biotech week in review; stocks to watch leading up to and during ASCO 2019

Weekly watchlist

Abstracts were released Wednesday for ASCO, the main oncology event of the year. It should be noted that data included in the abstracts are some months out of date, with the cut-off date for inclusion of data being February 12, 2019. Detailed and updated data will be delivered at the conference itself from May 31, so a number stocks will still be closely watched leading up to and during the conference. A selection of such stocks are noted below.

First, let’s review the week that was.

ASCO ABSTRACTS:

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares closed Thursday up 36% to $15.28. The company noted an overall response rate (ORR) of 44% from its Phase 2 trial of LN-145 in patients with recurrent cervical cancer, which included one complete response and nine partial responses.

Mirati Therapeutics, Inc. (NASDAQ: MRTX) shares closed Thursday up 11% to $70.57, in reaction to data released in an ASCO abstract by Amgen (NASDAQ: AMGN) and its Phase 1 KRAS G12C inhibitor trial of AMG 510. The data showed two out of nine patients exhibited a partial response. Further data will be presented at the actual conference on June 3. Mirati is developing its own KRAS G12C inhibitor, MRTX849, with data due later this year.

MacroGenics, Inc. (NASDAQ: MGNX) was another impressive mover, seeing a 2-day gain of 15% to $18.71 on the back of its abstract from its Phase 3 Sophia trial of margetuximab and chemotherapy compared to trastuzumab with chemotherapy, in patients with HER2-positive metastatic breast cancer.

OTHER NEWS:

Adverum Biotechnologies, Inc. (Nasdaq: ADVM) shares closed the week up 37% to $9.05. The company announced Thursday that the FDA lifted the clinical hold on ADVM-022 for the second cohort in its Phase 1 trial for wet age-related macular degeneration (wet AMD). Adverum will begin dosing the second cohort at a dose three times lower than the dose used in the first cohort.

MeiraGTx Holdings plc (NASDAQ:MGTX) shares closed the week up 28% to $23.48 following news that its Phase 1/2 dose escalation trial of AAV-RPE65, for the treatment of RPE65-deficiency, a condition that causes blindness, achieved the primary endpoint of safety and tolerability.

INSYS Therapeutics, Inc. (NASDAQ: INSY) shares slumped to close the week down 71% to $1.06 on news of bankruptcy concerns following the report of first quarter earnings. The company noted increasing losses due to significant declines in the transmucosal immediate-release fentanyl (TIRF) market and significant legal expenses resulting from the investigation by the U.S. Department of Justice.

ImmunoGen, Inc., (Nasdaq: IMGN) shares closed Wednesday down 32% to $2.14 following news the FDA has requested the company conduct a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with ovarian cancer. Its previous FORWARD I trial did not meet the primary endpoint.

Myovant Sciences (NYSE: MYOV) announced that its first Phase 3 trial of relugolix for the treatment of uterine fibroids met its primary efficacy endpoint, with 73.4% of women receiving once daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo (p < 0.0001). Shares, however, closed the week down down 28% to $12.48 with investors concerned how it would compete with the larger Abbvie and its drug Elagolix.

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Biotech stocks to watch leading up to ASCO 2019:

Drug Stage Catalyst Market Cap

ADRO – Aduro Biotech Inc.
ADU-S100 and Spartalizumab
Solid tumors or lymphomas

Phase 1b Phase 1b presentation at ASCO June 2, 2019 noted 1 CR and 2/8 PRs among TNBC patients. 2/25 PRs among melanoma patients.
$110.6 million

AMGN – Amgen Inc.
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)

Phase 1 Phase 1 data ASCO June 2, 2019. Overall response rate 70% (7/10) in high dose, 13/42 response across all cohorts.
$122.4 billion

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 data at ASCO June 3, 2019. 50% ORR in lung cancer patients. 90% SD.
$122.4 billion

AZN – Astrazeneca PLC
Lynparza (POLO)
Pancreatic cancer

Phase 3 Phase 3 data at ASCO noted median PFS 7.4 months vs 3.8 months for placebo. HR 0.53.
$116.3 billion

BPMC – Blueprint Medicines Corporation
Avapritinib BLU-285
PDGFRα driven Gastrointestinal stromal tumors (GIST)

PDUFA PDUFA date under priority review February 14, 2020.
$4.1 billion

CELG – Celgene Corporation
Liso-cel (JCAR017) - TRANSCEND CLL-004
Chronic Lymphocytic Leukemia (CLL)

Phase 1 Phase 1 updated data at ASCO June 4, 2019 noted best overall response rate was 82% (18/22), with 46% (10/22) of patients achieving complete remission.
$67.1 billion

CLDX – Celldex Therapeutics Inc.
CDX-3379
Recurrent/metastatic head and neck squamous cell cancer

Phase 2 Phase 2 data ASCO June 1, 2019 noted 2/19 CRs + one PR.
$32.9 million

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib
Myelofibrosis

Phase 2 Phase 2 additional data due 4Q 2019.
$205 million

EPZM – Epizyme Inc.
Tazemetostat
Epithelioid Sarcoma

PDUFA priority review PDUFA date priority review January 23, 2020.
$1.2 billion

INCY – Incyte Corporation
DPX-Survivac and epacadostat (DeCidE1)
Ovarian cancer

Phase 1/2 Phase 2 top-line data due 2H 2019.
$17.9 billion

IOVA – Iovance Biotherapeutics Inc.
LN-145
Cervical cancer

Phase 2 Phase 2 update due at ASCO June 1, 2019, 8am. Data released May 31, 2019 noted ORR 44%; CR 11%. BLA filing due 2H 2020.
$2.6 billion

MEIP – MEI Pharma Inc.
ME-401
Relapsed/refractory Follicular Lymphoma/Chronic Lymphocytic Leukemia (CLL)

Phase 1b Phase 1b presentation at ASCO June 3, 2019. 80% ORR.
$109.8 million

MGNX – MacroGenics Inc.
Margetuximab SOPHIA study
Metastatic breast cancer

Phase 3 Second interim overall survival analysis and BLA filing due 4Q 2019.
$736.8 million

PBYI – Puma Biotechnology Inc
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer

NDA Filing NDA filing announced July 1, 2019.
$364.9 million

SRRA – Sierra Oncology Inc.
SRA737
Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)

Phase 1/2 Phase 1/2 preliminary data ASCO June 1, 2019 noted stable disease rate of 32%.
$31.8 million