AGEN, AGE To Battle Coronavirus, BCLI Awaits ALS Trial Data, FDA Delays Decision On NVS’ Drug

Today’s Daily Dose brings you news about Agenus’ foray into COVID-19 drug development space; AMERI Holdings’ progress in glioblastoma multiforme drug development; BrainStorm Cell’s anticipated milestone related to its amyotrophic lateral sclerosis drug candidate; Citius Pharma’s path forward for antibiotic lock solution; Novartis’ revised FDA decision date and stock offerings of EvoFem and OraSure.

Read on…

1. Agenus Forays Into COVID-19 Drug Development Space

Agenus Inc.’s (AGEN) subsidiary AgenTus Therapeutics has received FDA clearance to initiate a clinical trial of its allogeneic iNKT therapy AgenT-797 for the treatment of patients with COVID-19. The trial is expected to commence shortly.

In preclinical studies, iNKTs have demonstrated their potential to eliminate the virus, dampen harmful inflammation, and promote protection from reinfection, and these are all particularly important features to overcome COVID-19, the Company added.

Agenus is also exploring multiple options for its AgenTus Therapeutics subsidiary – say, spinning out AgenTus and issuing a portion of its holdings in AgenTus to Agenus shareholders in the form of a stock dividend. A decision is expected to be made by the end of this year.

AGEN closed Tuesday’s trading at $4.07, down 4.01%.

2. AgeX All Set To Battle Coronavirus

AgeX Therapeutics Inc. (AGE) and privately-held ImStem Biotechnology have signed a non-binding letter of intent regarding investigational mesenchymal stem cell candidate IMS001 for COVID-19 as well as acute respiratory distress syndrome (ARDS) due to other causes.

As per the proposed agreement, ImStem will obtain from AgeX a non-exclusive license to use AgeX’s embryonic stem cell line ESI 053 to derive ImStem’s investigational MSC product IMS001. The two companies are in talks to finalize financial terms and other provisions of a license agreement.

AGE closed Tuesday’s trading at $1.04, down 2.80%.

3. AMERI Awaits Final Approval To Test CBD In Glioblastoma Multiforme

AMERI Holdings Inc.’s (AMRH) proposed amalgamation partner Jay Pharma Inc. is awaiting final approval this summer from the Israel Ministry of Health to conduct a phase I/II clinical trial investigating its proprietary cannabidiol formulation for the treatment of glioblastoma multiforme.

According to Jay Pharma, the study is expected to enroll 40 patients with recurrent or progressive glioblastoma multiforme tumors who are currently undergoing chemotherapy treatments. Half the patients are expected to be treated with Jay Pharma’s orally administered synthetic cannabidiol derived from citrus, and half will be treated with cannabidiol in combination with clomiphene, an estrogen binding site inhibitor.

AMRH closed Tuesday’s trading at $2.87, up 114.18%.

4. BrainStorm’ ALS Trial Data Expected In Q4

BrainStorm Cell Therapeutics Inc. (BCLI) continues to expect that top-line data from its phase III pivotal trial investigating NurOwn in amyotrophic lateral sclerosis will be announced by the fourth quarter of this year.

Merit Cudkowicz, the Julieanne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital said, “Despite the challenges presented by COVID-19, patient dosing remains on track with all participants having received at least 2 treatments of NurOwn.
Moving forward, only 20 patients are still to be dosed for the third and final time, and these final treatments remain on schedule.”

BCLI closed Tuesday’s trading at $7.90, up 3.00%.

5. Citius To Move Ahead With Compatibility Studies For Mino-Lok Therapy

Citius Pharmaceuticals Inc. (CTXR) has received positive feedback from the FDA on its proposed catheter compatibility studies for the Company’s Mino-Lok therapy.

Mino-Lok is an antibiotic lock solution used to treat patients with central line-associated bloodstream infections (CLABSIs), which is currently under a phase III trial. This pivotal trial had reached the halfway point for enrollment in February of this year and the next milestone is the result of an interim efficacy analysis, which is expected to occur in the second half of this year.

The catheter compatibility studies will be conducted in parallel with the completion of the ongoing phase III clinical study, according to the Company.

The successful completion of the studies would allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies will meet European and world standards.

CTXR closed Tuesday’s trading at $0.90, up 1.25%.

6. Evofem Announces Stock Offering

Evofem Biosciences Inc. (EVFM), which secured its first FDA approval to market Phexxi, a vaginal gel contraceptive, last week, has announced a proposed offering of common stock. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of shares of its common stock offered in the offering.

Phexxi, the first commercial product of the Company, is expected to be launched in early September. The only other investigational product is EVO100, being developed for the prevention of chlamydia and gonorrhea, which successfully completed a phase IIb study last December. A phase III trial of EVO100 is expected to be initiated by the end of this year.

EVFM closed Tuesday’s trading at $4.66, down 7.91%. In after-hours, the stock fell another 8.80% and was at $4.25.

7. FDA Delays Decision On Ofatumumab

The FDA decision on Novartis’ (NVS) supplemental Biologics License Application for Ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis in adults has been extended by three months to September 2020.

Ofatumumab, a fully human anti-CD20 monoclonal antibody (mAb), is marketed under the brand name Arzerra and is currently approved for the treatment of chronic lymphocytic leukemia.

The drug is marketed worldwide by Novartis under a license agreement between Genmab (GMAB) and Novartis Pharma AG.

NVS closed Tuesday’s trading at $86.46, down 0.25%.

8. OraSure Prices Stock Offering

OraSure Technologies Inc. (OSUR) has offered to sell 8 million shares of its common stock in a public offering at a price of $11.00 each. The net proceeds from the offering are expected to be approximately $82.48 million.

In addition, OraSure has granted the underwriters a 30-day option to purchase up to an additional 1.2 million shares of its common stock. The offering is expected to close on June 5, 2020.

The Company intends to use the net proceeds from this offering to expand its manufacturing capacity for both existing and in-development products for use in testing for COVID-19 and to fund potential acquisitions, among others.

Late last month, OraSure agreed to acquire privately owned UrSure Inc. , which is developing and commercializing products that measure adherence to HIV medications including pre-exposure prophylaxis or PrEP, the daily medication to prevent HIV.

OSUR closed Tuesday’s trading at $12.11, down 14.24%.

9. Stocks That Moved On No News

Mereo BioPharma Group plc (MREO) closed Tuesday’s trading at $1.90, up 49.61%.

Artelo Biosciences Inc. (ARTL) closed Tuesday’s trading at $1.63, up 35.83%.

ORIC Pharmaceuticals Inc. (ORIC) closed Tuesday’s trading at $35.09, up 15.81%.

IDEAYA Biosciences Inc. (IDYA) closed Tuesday’s trading at $8.99, down 12.12%.

PhaseBio Pharmaceuticals, Inc. (PHAS) closed Tuesday’s trading at $5.30, down 10.47%.

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