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Friday, May 31, 2019

Genocea gains ahead of GEN-009 data at ASCO

Thinly traded nano cap Genocea Biosciences (NASDAQ:GNCA) is up 3% premarket on increased volume (~30K shares) on the heels of its announcement that the Journal of Clinical Oncology has selected its presentation of Phase 1/2a results on investigational neoantigen vaccine GEN-009 as a top 10 featured abstract at ASCO in Chicago. The data will be presented tomorrow.
Management will host a conference call on Monday, June 3, at 8:30 am ET to discuss the data.
#ASCO19

Kite, Humanigen Collaborate on Yescarta Combo for Large B-Cell Lymphoma

Kite, a Gilead Company (Nasdaq: GILD), and Humanigen, Inc. (HGEN) announced today the formation of a clinical collaboration to conduct a Phase 1/2 study of lenzilumab, an investigational anti-GM-CSF monoclonal antibody, with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The objective of this study is to determine the effect of lenzilumab on the safety of Yescarta. Kite will act as the sponsor of this study and will be responsible for its conduct.

Turning Point Therapeutics Updates Lung Cancer Data

  • In TKI-naïve ROS1+ Patients, Overall Response Rate by Blinded Review is 82 Percent, and 83 Percent at Likely Recommended Phase 2 Dose of 160 mg QD or Above; Median Duration of Response across all Dose Levels Not Yet Reached
  • Since Prior Update, Overall Response Rate by Blinded Review Increased in ROS1+ Patients Pretreated with one Prior TKI to 39 percent and to 55 Percent at Doses of 160 mg QD or Above
  • All Five ROS1+ Crizotinib-Pretreated Patients with G2032R Solvent Front Mutation had Tumor Regressions, and Overall Response Rate by Blinded Review is 40 Percent
  • Phase 2 Portion of TRIDENT-1 Registrational Study on Track for Initiation in 2H 2019
  • Company Files 10-Q and Provides Financial Update

Merck has final data from late-stage study of Keytruda in head-neck cancer

Merck (NYSE:MRKannounces the final analysis of the Phase 3 KEYNOTE-048 clinical trial evaluating KEYTRUDA (pembrolizumab), combined with chemo, for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The data are being presented today at ASCO in Chicago.
The combo failed to demonstrate a statistically significant improvement in progression-free survival (PFS) compared to the standard-of-care EXTREME regimen [Eli Lilly’s ERBITUX (cetuximab) + chemo] in patients with PD-L1 expression with Combined Positive Score (CPS) of at least 20 (high expression of PD-L1), although it did extend overall survival (OS) by 3.7 months (14.7 months versus 11.0 months) with 40% less risk of death (hazard ratio = 0.60) in this group.
The was no difference in PFS in the total population between KEYTRUDA monotherapy and the EXTREME regimen.
The company’s U.S. marketing application seeking approval to use KEYTRUDA alone and with chemo to treat HNSCC in a first-line setting is currently under FDA review with an action date of June 10.
#ASCO19

Iovance up on updated data

Iovance Biotherapeutics (NASDAQ:IOVA) is up 2% premarket on light volume on the heels of updated data on tumor-infiltrating lymphocyte (TIL) candidates LN-145 in cervical cancer (innovaTIL-04 study) and lifileucel in melanoma (innovaTIL-01 study). The results will be presented at ASCO in Chicago.
At a median follow-up of 7.4 months, the complete response rate was 11% (n=3/27) in advanced cervical cancer patients receiving LN-145 (average of 2.4 prior lines of therapy). The objective response rate (ORR) was 44% (n=12/27). Median duration of response had not been reached.
At a median follow-up of 8.8 months, the median duration of response had not been reached in advanced melanoma patients treated with lifileucel. The ORR in Cohort 2 (average of 3.3 prior lines of treatment) was 38% (n=25/66) with a disease control rate (responders + stable cancer) of 80% (n=53/66).
#ASCO19

Twist Bioscience started at Outperform by Evercore ISI

https://www.benzinga.com/stock/TWST/ratings

Minerva Neurosciences started at Buy by Wainwright

Target $22.