Agenus on go to start study of cell therapy in COVID-19

The FDA has cleared Agenus (NASDAQ:AGEN) unit, AgenTus Therapeutics’ IND application for an allogeneic iNKT therapy, as a potential therapy for treatment of patients with COVID-19.

A clinical trial is expected to commence shortly.

https://seekingalpha.com/news/3579526-agenus-on-go-to-start-study-of-cell-therapy-in-covidminus-19

FDA accepts Y-mAbs naxitamab application for neuroblastoma

Under Priority Review status, the FDA accepts for review Y-mAbs Therapeutics’ (NASDAQ:YMAB) marketing application for Danyelza (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma, a cancer that develops from immature nerve cells.

The agency’s action date is November 30.

Naxitamab is a humanized monoclonal antibody called 3F8 that targets a protein called GD2 that is expressed on tumors of neuroectodermal origin like neuroblastoma.

https://seekingalpha.com/news/3579532-fda-accepts-y-mabs-naxitamab-application-for-neuroblastoma

SmileDirectClub expands presence in Hong Kong

SmileDirectClub (NASDAQ:SDC) has expanded its SmileShop partnership with Watsons, Asia’s largest health and beauty products retailer, with its first locations in Mong Kok and Kwun Tong in Hong Kong.
https://seekingalpha.com/news/3579542-smiledirectclub-expands-presence-in-hong-kong

AgeX Therapeutics +12% on ESI 053 deal for COVID-19

AgeX Therapeutics (NYSEMKT:AGE) inks a non-binding letter of intent with ImStem Biotechnology to obtain from AgeX, a non-exclusive license to use its embryonic stem cell line ESI 053 to derive ImStem’s investigational MSC product IMS001 for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) due to other causes.

Financial terms and other provisions of agreement are yet to be finalized.

https://seekingalpha.com/news/3579547-agex-therapeuticsplus-12-on-esi-053-deal-for-covidminus-19

Planet Fitness sees about 60% of its customers return in early stages

Planet Fitness (NYSE:PLNT) says it has reopened about 800 stores across 30 states and one province in Canada. The company anticipates that an additional 200 stores may be able to open by mid-June.

As expected, Planet Fitness is taking extreme measures to sanitize high-touch areas and promote distancing.

So far, usage indexing is at about 60% for open PLNT locations compared to the same level last year.

SEC Form 8-K

https://seekingalpha.com/news/3579553-planet-fitness-sees-60-of-customers-return-in-early-stages

Nicox launches first late-stage NCX 470 trial in Glaucoma

Nicox SA (OTCPK:NICXF) has initiated the first Phase 3 clinical trial, named Mont Blanc, evaluating NCX 470 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, by enrolling the first 12 patients.

The Mont Blanc trial will evaluate the efficacy and safety of NCX 470 ophthalmic solution, 0.065% and 0.1% compared to latanoprost ophthalmic solution, 0.005%.

The primary efficacy is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3.

Adaptive dose selection in Mont Blanc will allow the start of the second Phase 3 trial, Denali.

https://seekingalpha.com/news/3579559-nicox-launches-first-late-stage-ncx-470-trial-in-glaucoma

Sanofi’s Sarclisa reduced risk in late-stage multiple myeloma study

Sanofi (SNY) announces more positive results from a Phase 3 clinical trial, IKEMA, evaluating Sarclisa (isatuximab), added to Amgen’s Kyprolis (carfilzomib) and dexamethasone, in patients with relapsed multiple myeloma (MM).

The addition of Sarclisa reduced the risk of cancer progression or death by 47% (hazard ratio = 0.53) compared to carfilzomib and dexamethasone alone. It showed a consistent treatment benefit across a range of subgroups.

The company announced positive topline data from the study on May 12.

Interim data will be virtually presented at the European Hematology Association Congress on June 14.

The company expects to file global marketing applications later this year.

The CD38-directed cytolytic antibody is currently approved in the U.S. and Europe for relapsed/refractory MM when combined with Bristol Myers Squibb’s Pomalyst (pomalidomide) and dexamethasone.

https://seekingalpha.com/news/3579558-sanofis-sarclisa-reduced-risk-in-late-stage-multiple-myeloma-study