Dermira’s lebrikizumab Fast Track’d for atopic dermatitis; shares up 12%

Dermira (DERM +12.3%) is up on modestly higher volume in reaction to Fast Track status in the U.S. for IL-13 inhibitor lebrikizumab for the treatment of atopic dermatitis.

Two Phase 3 studies, ADvocate 1 and ADvocate 2, are in process.

Fast Track provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

https://seekingalpha.com/news/3525169-dermiras-lebrikizumab-fast-trackd-for-atopic-dermatitis-shares-up-12

Intra-Cellular up 10% ahead of presentation of lumateperone data

Intra-Cellular Therapies (ITCI +10%) perks up on modestly higher volume ahead of a presentation of lumateperone data tomorrow at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, FL.

Results from a Phase 3 study in bipolar depression, pooled data in schizophrenia and results from a 12-month safety study will be presented at 5:30 pm ET.

The FDA’s action date for the company’s application seeking approval of lumateperone for schizophrenia is Friday, December 27.

https://seekingalpha.com/news/3525176-intra-cellular-up-10-ahead-of-presentation-of-lumateperone-data

Bluebird bio up 3% on updated CAR T candidate bb21217 data

Bluebird bio (BLUE +3%) and collaboration partner Bristol-Myers Squibb (BMY +0.5%) (via its acquisition of Celgene) announce updated results from a two-part open-label Phase 1 clinical trial, CRB-402, evaluating BCMA-targeted CAR T candidate bb21217 in heavily pretreated patients with relapsed/refractory multiple myeloma (MM), a population with a poor prognosis. The data were presented at ASH in Orlando.

The dose-escalation portion (three dose levels) is finished. The dose-expansion phase is in process. Final enrollment should be 74 subjects.

12 patients in the 150 x 10⁶ CAR+ T cells arm (the lowest dose) were evaluable. Mean follow-up was 17.6 months. 83% (n=10/12) showed clinical response, including four complete responders and six with very good partial responses. Median duration of response was 11.1 months.

As of the data cutoff, follow-up was still early in the other dose arms (300 x 10⁶ CAR+ T cells and 450 x 10⁶ CAR+ T cells) but no confirmed responders have progressed. The response rate in the 300 group was 43% (n=6/14), none complete, and 57% (n=4/7) in the 450 group with one complete responder. Median follow-up periods were 4.0 months and 3.3 months, respectively.

On the safety front, the most frequent serious/life-threatening adverse events in 38 treated patients were neutropenia (82%), leukopenia (55%), thrombocytopenia (55%), anemia (50%), lymphopenia (34%), hypophosphatemia (21%), hyponatremia (13%) and febrile neutropenia (11%). Seven patients experienced serious/life-threatening infections.

66% (n=25/38) developed bb21217-related cytokine release syndrome (CRS), most mild or moderate. There was one case of serious CRS and one death (in the 450 arm after 15 days of follow-up). 24% (n=9/38) developed neurotoxicity, two serious and one life-threatening (encephalopathy).

The estimated completion date is January 2025.

#ASH19

https://seekingalpha.com/news/3525157-bluebird-bio-up-3-on-updated-car-t-candidate-bb21217-data

Amgen Phase 3 KYPROLIS-DARZALEX data is ASH19 late breaker

Amgen (NASDAQ:AMGN) today announced additional results from the primary analysis of the Phase 3 CANDOR study evaluating KYPROLIS^® (carfilzomib) in combination with dexamethasone and DARZALEX^® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma. The data will be presented in a late-breaking abstract session at the 61^st American Society of Hematology (ASH) Annual Meeting & Exposition.

At a median follow up of 17 months, the study met its primary endpoint of progression-free survival (PFS), resulting in a 37% reduction in the risk of disease progression or death in patients receiving KdD (HR=0.63; 95% CI: 0.464, 0.854; p=0.0014). Median PFS was not reached for the KdD arm versus 15.8 months for the Kd arm.

“This primary analysis of the CANDOR study adds to the body of evidence supporting the combination of KYPROLIS and DARZALEX, two powerful targeted agents for multiple myeloma,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “KYPROLIS has demonstrated deep and sustained responses in treating patients with multiple myeloma that have relapsed. The CANDOR study now offers additional insight into the effectiveness of this combination as a potential new treatment option for relapsed myeloma patients.”

In addition to meeting the primary endpoint, the KdD combination demonstrated efficacy in key secondary endpoints, including overall response rate (ORR), minimal residual disease (MRD) negative-complete response at 12 months and overall survival (OS). The ORR was 84.3% versus 74.7% (p=0.0040), and the rate of complete response or better was 28.5% versus 10.4% for the KdD and Kd arms, respectively. The analysis found the MRD-negative complete response rate at 12 months was 12.5% for KdD versus 1.3% for Kd (p<0.0001), a nearly 10-times higher response rate versus Kd-treated patients. The median OS was not reached in either group (HR=0.75; 95% CI: 0.49, 1.13; p=0.08).

https://www.biospace.com/article/releases/amgen-data-from-phase-3-candor-study-combining-kyprolis-carfilzomib-and-darzalex-daratumumab-to-be-presented-during-late-breaking-session-at-american-society-of-hematology-annual-meeting/

Cantel Medical Q1 revenues up 14%

Cantel Medical (CMD) Q1 results: Revenues: $257.2M (+14.0%).

Net Income: $5.8M (-69.8%); EPS: $0.14 (-69.6%); non-GAAP Net Income: $27.2M (+5.0%); non-GAAP EPS: $0.65 (+4.8%); CF Ops: $8.9M (-72.4%).

Previously: Cantel Medical EPS beats by $0.06, beats on revenue (Dec. 10)

https://seekingalpha.com/news/3525055-cantel-medical-q1-revenues-up-14

Sanofi’s sutimlimab successful in late-stage cold agglutinin disease study

A Phase 3 clinical trial, CARDINAL, evaluating Sanofi’s (NASDAQ:SNY) sutimlimab (BIVV009) in patients with primary cold agglutinin disease (CAD) met the primary and secondary endpoints. The results were presented at ASH in Orlando.

The primary efficacy endpoint was the response rate as measured by a composite of an increase in hemoglobin from baseline or reaching a certain hemoglobin level at week 26 and the absence of transfusions from week 5 to 26.

54% (n=13/24) of subjects met the composite criteria and 63% (n=15/24) achieved hemoglobin levels of at least 12 g/dL (normal range for men and women: 13.5 – 17.5 g/dL and 12.0 – 15.5 g/dL, respectively). 83% (n=20/24) achieved clinically significant improvements in hemoglobin levels.

On the safety front, 29% (n=7/24) of patients experienced at least one serious adverse event, none considered related to the study drug.

Sutimlimab is a humanized monoclonal antibody that binds to (inhibits) a complement-specific serine protease enzyme called C1s that plays a key role in the mechanism of hemolysis in CAD, a rare autoimmune disorder in which the body’s immune system destroys red blood cells.

The company plans to file marketing applications in the near future. The indication has Breakthrough Therapy status in the U.S.

#ASH19

https://seekingalpha.com/news/3525094-sanofis-sutimlimab-successful-in-late-stage-cold-agglutinin-disease-study

Amneal to acquire majority stake in AvKARE

Amneal Pharmaceuticals (NYSE:AMRX) and AvKARE Inc. have entered into a definitive agreement under which Amneal will acquire a 65.1% majority interest in AvKARE and its related affiliate doing business as R&S Northeast for an implied enterprise value of $340M.

Amneal will acquire its majority interest through an unrestricted subsidiary, which will finance the purchase with a new $180M senior secured term loan facility, ~$75M cash and an ~$44M Seller Note, with the balance value contributed through the selling shareholders’ rollover interest in the newly formed subsidiary.

The transaction is expected to be completed in early 2020.

https://seekingalpha.com/news/3525100-amneal-to-acquire-majority-stake-in-avkare