Today’s Daily Dose brings you news about IMV’s ovarian cancer trial results, reports of Iovance considering a possible sale, Nemaura’s head -to-head study with a major Glucose Monitoring System, and disappointing trial results of Vanda and Supernus.
IMV Inc. (IMV) reported updated results from DeCidE1, an ongoing phase II study of its lead candidate, DPX-Survivac, in patients with advanced recurrent ovarian cancer.
According to the updated results, 79% of evaluable patients achieved disease control, 53% experienced a decrease in the size of the tumor while 37% achieved durable clinical benefit lasting more than 6 months.
Armed with the promising data, the Company plans to request the FDA for a Type B meeting to finalize the design of a pivotal phase IIb study that could support the accelerated approval pathway.
A phase II study of DPX-Survivac in combination with Merck’s Keytruda in recurrent/refractory diffuse large B-cell lymphoma and a basket study across five solid tumor indications are underway. Updated data from both studies are expected in the first half of 2020.
IMV closed Tuesday’s trading at $2.87, down 39.96%.
Shares of Iovance Biotherapeutics Inc. (IOVA) soared nearly 40% to touch a new high of $34.46 in intraday trading on Tuesday after Bloomberg reported that the Company is exploring a possible sale.
Iovance is focused on developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes, or TILs in short.
The lead asset is Lifileucel for the treatment of patients with metastatic melanoma, under a pivotal study. Iovance intends to submit a biologics license application Lifileucel to FDA subsequent to consultation with the agency in 2020.
Also in the pipeline is LN-145 for metastatic cervical cancer, under a pivotal study.
IOVA closed Tuesday’s trading at $31.46, up 27.42%.
Nemaura Medical Inc (NMRD), a medical technology company developing sugarBEAT, a non-invasive Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, which soared more than 77% on Tuesday, was one of the top gainers of the day.
The Company announced that it is planning to initiate a user study comparing sugarBEAT directly against a highly successful major incumbent CGM sensor with the goal of positioning sugarBEAT as a non-invasive, daily/flexible, cost-effective alternative to traditional, expensive invasive CGM.
SugarBEAT received CE Mark approval in Europe last May and was launched in August of 2019. The device is currently being evaluated by the FDA.
NMRD closed Tuesday’s trading at $5.80, up 77.37%.
Shares of Supernus Pharmaceuticals Inc. (SUPN) dropped over 17 percent in after-hours on Tuesday, following the Company’s decision to halt all development activities on SPN-810 in Impulsive Aggression (IA) in patients with ADHD.
The decision to throw in the towel on SPN-810 in Impulsive Aggression was based on the disappointing phase III trial results. In the phase III trial, patients receiving SPN-810 36 mg showed a median percent reduction of 51.3% in the average weekly frequency of impulsive aggression episodes from a baseline that was not statistically significant compared to placebo.
The Company has an important regulatory catalyst to watch out for this year. A New Drug Application for SPN-812 for the treatment of ADHD is under priority review by the FDA, with a decision date set for November 8, 2020.
SUPN closed Tuesday’s trading at $22.94, down 4.22%. In after-hours, the stock fell 17.31% to $18.97.
Vanda Pharmaceuticals Inc.’s (VNDA) phase III clinical trial of Tradipitant for the treatment of pruritus in atopic dermatitis in adults has failed to achieve its primary endpoint.
In the study, dubbed EPIONE, there was no reduction of pruritus across the overall study population. However, the antipruritic effect of Tradipitant was robust in the mild atopic dermatitis study population, noted the Company.
Mild atopic dermatitis represents over 60% of the total atopic dermatitis population in the U.S.
Commenting on the study results, Sonja Stander, professor of Dermatology and Neurodermatology at the Department of Dermatology, and head of the Interdisciplinary Center for Chronic Pruritus (KCP) of the University Hospital Münster, Germany, said, ” The majority of atopic dermatitis patients across all age groups from children to seniors suffer from a form of atopic dermatitis characterized by mild lesions. Yet these patients might still have severe pruritus and suffer from impacts to quality of life, as well as sleep. With a beneficial safety profile and assuming this significant improvement in itch in the mild-type atopic dermatitis is confirmed in a future study, this therapy would be of interest to all these mild-type atopic dermatitis patients.”
VNDA closed Tuesday’s trading at $11.47, down 2.42%. In after-hours, the stock fell 7.59% to $10.60.
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