MYOV To Report SPIRIT 1 Data, EVLO Joins COVID-19 Drug Race, NVTA Loosens Purse Strings

(RTTNews) - Today's Daily Dose brings you news about inclusion of Evelo's EDP1815 in COVID-19 trial; analyst upgrade of Five Prime; Gilead's plan to test inhaled version of experimental antiviral medicine Remdesivir; Hepion's efficacy of NASH drug candidate in mouse models of renal fibrosis; Invitae's acquisition of ArcherDX for about $1.4 billion and expanded approval of Karyopharm's Xpovio.

Read on…

1. Evelo Joins COVID-19 Drug Race

Evelo Biosciences Inc.'s (EVLO) drug candidate EDP1815 has been selected for inclusion in the TACTIC-E clinical trial, sponsored by Cambridge University Hospitals NHS Foundation Trust.

TACTIC-E is a phase II/III randomized trial designed to evaluate experimental therapies with the potential to prevent and treat complications of COVID-19 in patients at Addenbrooke's Hospital and other leading UK clinical centers.

The interim data from the TACTIC-E trial is expected in the fourth quarter of this year.

If the trial yields positive results, Evelo plans to engage in discussions with global regulatory agencies to determine if the data support registration.

EVLO closed Monday's trading at $4.41, up 18.07%.

2. Five Prime Gets Analyst Upgrade

Shares of Five Prime Therapeutics Inc. (FPRX) soared over 45 percent on Monday after Wedbush analyst Robert Driscoll upgraded the stock to "Outperform" from "Neutral" and raised the price target to $9 from $5.

Five Prime is a clinical-stage biotechnology company developing immune modulators and precision therapies for solid tumor cancers.

The Company's lead drug candidate is Bemarituzumab, under a phase II trial in gastric and gastroesophageal junction cancer, dubbed FIGHT. The top-line data from this trial is expected by the end of this year or early 2021.

Also in the pipeline are FPA150, under a phase 1a/1b clinical trial in patients with advanced solid tumors, FPT155, under a phase Ia/Ib study in patients with advanced solid tumors and a couple of partnered compounds with Bristol Myers Squibb and Seattle Genetics.

The preliminary safety results from the phase Ia study of FPT155 in patients with advanced solid tumors are anticipated by the end of this year.

FPRX closed Monday's trading at $6.39, up 45.39%. In after-hours, the stock gained another 2.50% and was at $6.55.

3. Gilead To Test Inhaled Form of Remdesivir For COVID-19 Patients

Gilead Sciences Inc. (GILD) is all set to start phase I trials of an inhaled version of its experimental antiviral medicine Remdesivir in healthy volunteers this week and hopes to begin studies in patients with COVID-19 in August.

Remdesivir is currently given to patients intravenously through daily infusions in the hospital. It secured FDA's emergency use authorization for the treatment of patients with COVID-19 last month.

According to Gilead, an inhaled formulation of Remdesivir would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of the disease. That could have significant implications in helping to stem the tide of the pandemic, the Company noted.

GILD closed Monday's trading at $75.67, down 2.32%.

4. Hepion's CRV431 Proves Efficacy In Mouse Model Of Kidney Fibrosis

Hepion Pharmaceuticals Inc.'s (HEPA) NASH drug candidate CRV431 has demonstrated antifibrotic activity in a mouse model of renal fibrosis.

The study, which was conducted by SMC Laboratories in Tokyo, Japan, found that in mice that underwent left ureter surgical ligation when orally administered CRV431, kidney fibrosis was 42% lower compared to vehicle-treated mice.

"CRV431 has exerted antifibrotic activity in a number of in vitro and in vivo studies conducted by independent research laboratories in the United States, United Kingdom, France, and Japan," stated Daren Ure, Hepion's Chief Scientific Officer.

Early this year, the Company announced that CRV431 prevented experimentally induced liver fibrosis to a greater extent in an expanded study with human precision-cut liver slices.

HEPA closed Monday's trading at $2.50, up 2.04%. In after-hours, the stock was up 37% to $3.43.

5. Invitae Loosens Purse Strings

Invitae (NVTA) is all set to acquire ArcherDX in a transaction valued at approximately $1.4 billion.

ArcherDX has developed and commercialized over 325 unique products with the goal to optimize therapy and enable cancer monitoring across sample types. The Company is partnered with AstraZeneca, BMS, and Bayer, to cost-effectively accelerate drug development. ArcherDX is also currently developing in-vitro diagnostic (IVD) products, including STRATAFIDE DX, for therapy optimization.

The combination of the two companies will bring germline and somatic testing, liquid biopsy and tissue genomic profiling onto a single platform to offer patients a full suite of cancer testing for risk, therapy optimization, and personalized cancer monitoring, Invitae noted.

The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in several months.

NVTA closed Monday's trading at $27.05, up 44.58%.

6. FDA Says 'Yes' To Expanded Indication of Karyopharm's Xpovio

The FDA, on Monday, granted accelerated approval to Karyopharm Therapeutics Inc.'s (KPTI) XPOVIO for the expanded indication of relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Xpovio, which is given in combination with steroid medicine called Dexamethasone, received accelerated FDA approval in July 2019 for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, i.e., for Penta-refractory multiple myeloma.

The drug recorded annual sales of $30.5 million last year and quarterly sales of $16.1 million in the first quarter of 2020.

KPTI closed Monday's trading at $18.99, down 0.05%.

7. Will Myovant Be Able to Lift Investors' Spirits?

Myovant Sciences (MYOV) is scheduled to discuss top-line results from its phase III study of once-daily Relugolix combination therapy in women with pain associated with endometriosis, dubbed SPIRIT I, on Tuesday, before the market open.

The SPIRIT 1 study is a replicate of the SPIRIT 2 trial, the results of which were announced in April of this year. SPIRIT 2 met its co-primary efficacy endpoints with a 75.2% response rate for dysmenorrhea (menstrual pain) and a 66.0% response rate for non-menstrual pelvic pain while achieving six key secondary endpoints and demonstrating minimal bone mineral density loss.

In other news, the Company announced that its New Drug Application for once-daily, oral Relugolix for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the FDA - with a decision expected on December 20, 2020.

MYOV closed Monday's trading at $17.41, up 4.44%.

8. Stocks That Moved On No News

Kitov Pharma Ltd (KTOV) closed Monday's trading at $0.76, up 34.80%.

NantKwest Inc. (NK) closed Monday's trading at $11.13, up 25.90%.

Athersys Inc. (ATHX) closed Monday's trading at $25.38, up 2.47%.

Crinetics Pharmaceuticals Inc. (CRNX) closed Monday's trading at $19.26, down 17.09%.

Protara Therapeutics Inc. (TARA) closed Monday's trading at $31.63, down 9.63%.