EIGR Disappoints, EXEL's CELESTIAL Excels, JUNO In CELG's Crosshairs?

Pharma 011718

Today's Daily Dose brings you news about Juno's suitor; Eiger's failed LIBERTY trial; encouraging hepatocellular carcinoma trial data of Ipsen and Exelixis; MiMedx's progress in recalcitrant plantar fasciitis pain trial; positive FDA feedback related to the design of Athenex's breast cancer trial; MabVax's clinical trial catalysts to watch out for this quarter, and Merck's encouraging data from its KEYNOTE-189 trial.

Read on…

Athenex Inc. (ATNX) has received positive feedback from the FDA on the design of the currently ongoing phase III trial for Oraxol in the treatment of patients with metastatic breast cancer. The trial is investigating the superiority of Oraxol over intravenous Paclitaxel.

The Company has been informed that if the study meets the primary endpoint with an acceptable Benefit/Risk profile, it could be adequate as a single comparative trial to support registration of Oraxol for a metastatic breast cancer indication in the United States.

The study is designed to enroll 360 patients. The study has completed the first of two planned interim analyses, and the second interim analysis based on 180 evaluable patients is planned for the middle of 2018.

ATNX closed Tuesday's trading at $15.95, up 0.50%.

Eiger BioPharmaceuticals Inc. (EIGR) slumped more than 49% on Tuesday, following disappointing data from a phase II study of Ubenimex in pulmonary arterial hypertension, dubbed LIBERTY.

The LIBERTY study demonstrated no improvement overall or in key subgroups for both the primary efficacy endpoint of pulmonary vascular resistance (PVR) and the secondary endpoint of 6-minute walk distance (6MWD).

Ubenimex is also being explored as a potential treatment for lymphedema, and a phase II study in this indication, dubbed ULTRA, is ongoing. Data from this study are expected in the second half of 2018.

EIGR closed Tuesday's trading at $8.10, down 49.37%. In after-hours, the stock fell another 1.85% to $7.95.

Ipsen (IPSEY) and Exelixis Inc. (EXEL) announced that their pivotal phase III trial of Cabozantinib, demonstrated significant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma.

In the trial, dubbed CELESTIAL, the median overall survival was 10.2 months with Cabozantinib versus 8.0 months with placebo. The median progression-free survival more than doubled, at 5.2 months with Cabozantinib and 1.9 months with placebo.

Cabozantinib, under brand name Cabometyx, is approved for the treatment of patients with advanced renal cell carcinoma (RCC). The drug is not approved for the treatment of advanced hepatocellular carcinoma.

EXEL closed Tuesday's trading at $29.65, down 2.40%. In after-hours, the stock was up 2.53% to $30.40.

Shares of Juno Therapeutics Inc. (JUNO) soared nearly 43% in extended trading on Tuesday, following reports that the Company could be acquired by Celgene Corp. (CELG).

Juno's lead CAR-T therapy candidate is JCAR017, and it is under phase I/II testing in Diffuse large B-cell lymphoma, Chronic lymphocytic leukemia and acute lymphocytic leukemia.

Juno has a ten-year collaboration in place with Celgene that was inked in June 2015, to advance potentially groundbreaking immunotherapies for patients with cancer and autoimmune diseases.

Last month, the Company announced updated data from TRANSCEND study, a phase 1 trial evaluating JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, follicular lymphoma Grade 3B, and mantle cell lymphoma.

According to the updated data, at Dose level 2 (DL2 = 100 million cells), the 3-month overall response rate (ORR) was 74% and 3-month complete response (CR) rate was 68%. Of patients that have reached 6 months of follow-up, 50% were in complete response.

JUNO closed Tuesday's trading at $45.60, down 6.46%. In after-hours, the stock was up 42.92% at $65.10.

MabVax Therapeutics Holdings Inc. (MBVX) remains on track to report safety and response data from its phase I studies of MVT-1075 and MVT-5873 in the first quarter of 2018.

MVT-1075 is under phase I trial for the treatment of pancreatic, colon and lung cancer. MVT-5873 is under a phase 1 clinical study in combination with Gemcitabine and Nab-paclitaxel in first line therapy for the treatment of newly diagnosed patients with pancreatic cancer.

MBVX closed Tuesday's trading at $0.94, up 5.71%.

Merck & Co. Inc.'s (MRK) pivotal phase III trial of blockbuster cancer drug KEYTRUDA in combination with pemetrexed (Alimta) and cisplatin or carboplatin, dubbed KEYNOTE-189, has met its dual primary endpoints of overall survival and progression-free survival.

In the combination study, KEYTRUDA was evaluated as a first-line treatment of patients with metastatic non-squamous non-small cell lung cancer.

Keytruda is already approved for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, and gastric cancer.

The drug recorded sales of $1.4 billion in full year 2016, and $2.51 billion in the first nine months of 2017.

MRK closed Tuesday's trading at $62.07, up 5.81%.

MiMedx Group Inc. (MDXG) has randomized and enrolled the first patients in its pivotal phase III trial of AmnioFix Injectable in patients with recalcitrant plantar fasciitis pain.

The study is designed to enroll about 164 patients at 15 centers. Top-line results from this study are expected in the second half of 2019.

Plantar fasciitis is the most common cause of chronic heel pain in adults, making up 11-15% of the foot symptoms requiring professional care among adults, according to studies published in the Journal of Research in Medical Sciences.

MDXG closed Tuesday's trading at $13.94, up 0.58%.

Ophthotech Corp. (OPHT) has enrolled the first patient in its phase 2b clinical trial of Zimura in patients with autosomal recessive Stargardt disease (STGD1).

STGD1 is an inherited orphan retinal disease causing vision loss during childhood or adolescence. Currently there is no FDA or EMA approved treatment for patients with STGD1.

The Stargardt disease trial is designed to enroll approximately 120 patients, and the mean rate of change in the area of ellipsoid zone defect is set as the primary endpoint. Initial top-line data is expected to be available in 2020.

A phase 2a clinical trial of Zimura in combination with anti-vascular endothelial growth factor (VEGF) therapy for idiopathic polypoidal choroidal vasculopathy, an age-related retinal disease, has also been initiated. This study is designed to enroll about 20 patients, and initial top-line data is expected to be available during the second half of 2019.

OPHT closed Tuesday's trading at $2.98, up 4.56%.

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