BPC May 08 update

Final week of biotech earnings; Selection of companies presenting at ASCO; Biotech week in Review

Weekly watchlist

Widely regarded as the major oncology conference of the year, ASCO 2020 will be held this year in a virtual format due to COVID-19. Abstract titles have been released for the meeting, scheduled to commence on May 29. Most abstracts will be released on May 13 at 5pm ET, with late-breaking abstracts set to be made available on May 28.

We note a selection of anticipated presentations, while also noting below key companies set to report during the last full week of first quarter earnings. First, let’s review the week that was with key price-moving events.

Moderna, Inc. (NASDAQ:MRNA) provided noted that it intends to initiate a Phase 3 trial of its COVID-19 vaccine, mRNA-1273, early this summer, compared with previous guidance of a start during this fall. A Phase 2 trial is scheduled to commence imminently. Shares closed the week up 24% to $59.25.

MacroGenics, Inc. (NASDAQ: MGNX) shares closed the week up 204% to $20.34 following an update in its first quarter earnings call of data to be presented at ASCO from its Phase 1 trial of MGD013 in solid tumor patients. The company noted that in a cohort of patients with advanced HER2-positive tumors treated with a combination of MGD013 and margetuximab, confirmed and unconfirmed objective responses over in excess of 40% were observed.

Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) shares closed the week up 53% to $2.02 following news that La Jolla Pharmaceutical Company (NASDAQ: LJPC) has proposed to acquire Tetraphase for $22m in cash plus an additional $12.5m potentially payable under Contingent Value Rights (CVRs).

Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) announced it will be acquired by Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) for $18 per share in cash. Shares closed the week up 154% to $17.90.

Stemline Therapeutics Inc., (NASDAQ:STML) announced it will also be acquired, by Menarini Group, a privately held Italian pharmaceutical company, for up to $677m. Stemline shareholders will be offered a total potential consideration of $12.50 per share, consisting of an upfront payment of $11.50 in cash and one non-tradeable CVR of an additional $1.00 in cash per share. Shares closed the week up 156% to $12.18.

TG Therapeutics, Inc. (NASDAQ: TGTX) shares closed the week up 67% $18.82 following its announcement that its Phase 3 UNITY-CLL trial evaluating the combination of umbralisib plus ublituximab compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL), met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) (p<.0001).

Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced that it met primary endpoints in its Phase 3 INNO2VATE trial, evaluating the efficacy and safety of vadadustat, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Shares closed the week up 50% to $11.98.

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Selection of companies reporting 1Q earnings. Further companies listed on the BioPharmCatalyst Earnings Calendar for premium members:

Mo: AMAG AMRX ASRT AVDL CPRX EGRX HALO ICPT MYL PTLA RTRX XENT

Tu: BNTX

Th: ACHV ARGX

Drug Stage Catalyst Market Cap

ALLO – Allogene Therapeutics Inc.
ALLO-501 - ALPHA
Non-Hodgkin lymphoma (NHL)

Phase 1 Phase 1 initial data at ASCO May 29, 2020. Overall Response Rate (ORR) of 63% and CR Rate of 37%.
$6 billion

AMGN – Amgen Inc.
AMG 510
Solid tumors

Phase 1 Phase 1 update at ASCO May 29, 2020. Objective response rate (ORR) was 12% (3/25) in 960 mg once-daily target dose cohort.
$135.1 billion

ARVN – Arvinas Inc.
ARV-110
Castration-resistant prostate cancer (CRPC)

Phase 1 Phase 1 data at ASCO 2020 - two ongoing confirmed PSA responses.
$1.3 billion

AVEO – AVEO Pharmaceuticals Inc.
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

Phase 3 NDA filing announced March 31, 2020. Overall survival data noted a hazard ratio of 0.97 - May 29, 2020.
$131.2 million

AZN – Astrazeneca PLC
Tagrisso (ADAURA) (ASCO)
Non-small Cell Lung Carcinoma

Phase 3 Phase 3 presentation at ASCO May 31, 2020. Data released May 28, 2020 noted a reduction in the risk of disease recurrence or death by 83%.
$143.3 billion

CRVS – Corvus Pharmaceuticals Inc.
CPI-444
Solid tumors - cancer

Phase 1b Phase 1b/2 initial data from the RCC cohort at ASCO May 29, 2020. AdenoSig positive group -ORR of 17%. AdenoSig negative group - no partial responses.
$96.4 million

CTMX – CytomX Therapeutics Inc.
PROCLAIM-CX-2029
Solid tumors / diffuse large B-cell lymphoma (DLBCL)

Phase 1/2 Phase 1 presentation at ASCO May 29, 2020. 3/17 partial reponses.
$406.9 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer

Phase 1/2 Phase 1b/2 initial data at ASCO May 29, 2020 noted Overall Response Rate of 47%. Data from platinum-sensitive triplet cohort due fall of 2020.
$816.2 million

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

Phase 2 Phase 2 new cohort 2 interim data presented at ASCO May 29, 2020. 36.4% Overall Response Rate (ORR) maintained
$4.1 billion

MGNX – MacroGenics Inc.
MGD013
Solid tumors

Phase 1 Phase 1 data presented at ASCO May 29, 2020.
$945.4 million

MRK – Merck & Company Inc. (new)
Keytruda KN-177
Colorectal cancer (CRC)

Phase 3 Phase 3 PFS endpoint met.
$203.7 billion

MRSN – Mersana Therapeutics Inc.
XMT-1536
Ovarian Cancer, Non Small Cell Lung Cancer

Phase 1 Phase 1 interim dose expansion data May 27, 2020 noted 35% objective response rate, including 10% complete response rate.
$1.3 billion

PFE – Pfizer Inc.
Bavencio (Avelumab) - JAVELIN Bladder 100
Bladder cancer

sNDA Filing sBLA filing announced April 9, 2020.
$212.1 billion

RHHBY – Roche Holding Ltd ADR (Sponsored)
Tiragolumab and atezolizumab - CITYSCAPE
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 data presented at ASCO May 29, 2020.
$296.8 billion

TRIL – Trillium Therapeutics Inc.
TTI-622
Refractory lymphoma or multiple myeloma

Phase 1b Phase 1a/b update at May 29, 2020. 2/19 objective responses.
$565.7 million