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 It should be noted that data included in the abstracts are some months out of date, with the cut-off date for inclusion of data being February 12, 2019.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.


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.


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.


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 1 trial to be discontinued - noted December 17, 2019.
$262.7 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.
$133.2 billion

AMGN – Amgen Inc.
AMG 510 (ASCO)
Solid tumors

Phase 1 Phase 1 update at ASCO May 29, 2020.
$133.2 billion

AZN – Astrazeneca PLC
Lynparza (POLO)
Pancreatic cancer

Approved FDA Approval announced December 30, 2019.
$144.9 billion

BMY – Bristol-Myers Squibb Company
Liso-cel (JCAR017) - TRANSCEND CLL-004
Chronic Lymphocytic Leukemia (CLL)

Phase 1 Phase 1 updated data at ASH December 8, 2019. 45.5% CR; 81.5% ORR.
$137.5 billion

BPMC – Blueprint Medicines Corporation
Avapritinib BLU-285
PDGFRA exon 18 mutant Gastrointestinal stromal tumors (GIST)

Approved FDA Approval announced January 9, 2020.
$3.5 billion

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

Phase 2 Phase 2 trial continues to enrol as of May 6, 2020.
$50.9 million

CNST – Constellation Pharmaceuticals Inc.
CPI-0610 and ruxolitinib - Manifest (EHA)

Phase 2 Phase 2 update due at EHA June 12, 2020.
$1.6 billion

EPZM – Epizyme Inc.
Epithelioid Sarcoma

Approved FDA approval announced January 23, 2020.
$1.9 billion

IMV – IMV Inc.
DPX-Survivac and epacadostat (DeCidE1) (ASCO)
Ovarian cancer

Phase 2 Phase 2 updated data due at ASCO May 29, 2020.
$213.4 million

IOVA – Iovance Biotherapeutics Inc.
Cervical cancer

Phase 2 Phase 2 data released May 31, 2019 noted ORR 44%; CR 11%. Top-line data due 2020.
$5.2 billion

MEIP – MEI Pharma Inc.
Relapsed/refractory Follicular Lymphoma (FL) Non Hodgkin Lymphoma

Phase 2 Phase 2 enrolment to be completed summer of 2020.
$372.1 million

MGNX – MacroGenics Inc.
Metastatic breast cancer

PDUFA BLA filing announced December 19, 2019. PDUFA date estimate December 18, 2020. FDA will require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.
$1.2 billion

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

Approved FDA Approval announced February 26, 2020.
$461 million

SRRA – Sierra Oncology Inc.
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%.
$140.3 million