AwesomeCapital

Tuesday, November 5, 2019

Aerie Pharma’s Rhopressa successful in mid-stage study in Japan

Aerie Pharmaceuticals (AERI -1.3%) announces positive results from a Japan-based Phase 2 clinical trial evaluating netarsudil ophthalmic solution 0.02%, branded as Rhopressa in the U.S., for lowering intraocular pressure (IOP) in Japanese patients with open-angle glaucoma or ocular hypertension.

The primary endpoint of mean IOP on day 29 versus placebo was met.

Phase 3 studies are next up.

https://seekingalpha.com/news/3514536-aerie-pharmas-rhopressa-successful-mid-stage-study-japan

Allogene teams up with Notch to develop next-gen CAR T therapies

Allogene Therapeutics (ALLO -3.1%) will collaborate with privately held Notch Therapeutics to develop AlloCAR T therapies using induced pluripotent stem cells (iPSC) to create gene-edited T cells instead of using mature donor T cells. The approach, leveraging Notch’s Engineered Thymic Niche platform, enables the creation of the gene-edited variety on an industrial scale, potentially expanding patient access.

Initial applications are non-Hodgkin lymphoma, leukemia and multiple myeloma.

Under the terms of the agreement, Notch will receive $10M upfront, up to $7.25M in research milestones, up to $4M per target in preclinical milestones, up to $283M per target in clinical, regulatory and commercial milestones and tiered mid-to-high-single-digit royalties on net sales. Notch will be responsible for preclinical research while Allogene will be responsible for clinical development and exclusive global commercialization.

Allogene has also acquired a 25% stake in Notch and will assume one board seat.

https://seekingalpha.com/news/3514551-allogene-teams-notch-develop-next-gen-car-t-therapies

InMode up 11% after Q3 beat

Recent IPO InMode (INMD +10.7%) is up on more than 50% higher volume on the heels of better-than-expected Q3 results. Highlights:

Revenue up 57% to $40M driven by expanded direct saleforce.

Net income up 87% to $16.2M, EPS up 62% to $0.42.

Previously: InMode EPS beats by $0.11, beats on revenue (Nov. 5)

https://seekingalpha.com/news/3514476-inmode-11-percent-q3-beat

NextCure up 61% as lockup ends, ahead of key data readout

Thinly traded NextCure (NXTC +60.7%) is up on almost an 8x surge in volume, albeit on turnover of only 722K shares, on the expiration of the lockup period today.

A key looming event is updated results from a Phase 1 clinical trial evaluating lead candidate NC318, a Siglec-15 (S15)-targeting monoclonal antibody, in patients with solid tumors. The data will be presented at the SITC Annual Meeting in Maryland on Saturday, November 9, followed by a webcast of an event chaired by its Chief Medical Officer to discuss the results.

Update: Results from the just-published abstract showed one complete response (41 weeks to date), one partial response (14 weeks to date) and a disease control rate (DCR) of 71% (n=5/7) in patients with non-small cell lung cancer (NSCLC) who received NC318 alone. Response data from 11 additional patients will be presented on Saturday.

The expression of S15 and PD-L1 are mutually exclusive in NSCLC and certain other cancers, supporting the rationale of S15-targeting therapy in patients who do not respond adequately to PD-1 inhibitors.

Single-agent anti-tumor activity was observed in 71% (n=5/7) of PD-L1-refractory patients.

The most common treatment related adverse events were diarrhea (1-life-threatening, 2-moderate), itchy skin (1-serious, 1-moderate), rash (mild, moderate), joint pain (mild), elevated amylase (mild – serious) and elevated lipase (serious, life-threatening).

https://seekingalpha.com/news/3514496-nextcure-61-percent-lockup-ends-ahead-key-data-readout