The Daily Biotech Pulse: Iovance To Delay Regulatory Filing For Cancer Therapy, Departures At Passage Bio, Positive Readout For Silence Therapeutics

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs May 18)

• Alexion Pharmaceuticals, Inc. ALXN
• AbbVie Inc. ABBV
• BioCryst Pharmaceuticals, Inc. BCRX
• Catalyst Pharmaceuticals, Inc. CPRX
• Elanco Animal Health Incorporated ELAN
• HOOKIPA Pharma Inc. HOOK
• Maravai LifeSciences Holdings, Inc. MRVI
• Protagonist Therapeutics, Inc. PTGX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 18)

• Corvus Pharmaceuticals, Inc. CRVS
• Evofem Biosciences, Inc. EVFM (announced public offering of common stock and warrants)
• Fusion Pharmaceuticals Inc. FUSN
• Pharvaris N.V. PHVS
• Talaris Therapeutics, Inc. TALS

Stocks In Focus

Iovance to Delay BLA Filing For Cell Therapy In Melanoma Following FDA Feedback

Iovance Biotherapeutics, Inc. IOVA announced the receipt of regulatory feedback from the FDA regarding its potency assays for lifileucel, a tumor-infiltrating lymphocyte therapy being evaluated for solid tumors.

Following the feedback, the company said it will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet with the FDA in the second half of 2021. The company's biologics license application submission for lifileucel is now expected to occur during the first half of 2022, as opposed to the earlier timeline of 2021.

The stock slipped 6.79% to $25.14 in after-hours trading.

Roche Launches Control For Insulin Pump to Facilitate Self-management By Diabetes Patients

Roche Holding AG RHHBY announced the launch of the mySugr Pump Control, a new module within the mySugr app.
The mySugr Pump Control is designed to enable people with diabetes to control an insulin pump directly via a smartphone: import its data, view its status, and remotely deliver a standard bolus.

The mySugr Pump Control is an important building block within Roche's strategy of integrated Personalised Diabetes Management bringing true relief to people with diabetes by supporting their self-management of insulin pump therapy.

Idera Not to Pursue Tilsotolimod-Yervoy Combo Study In Advanced Melanoma, Announces Departure of Chief Medical Officer

Idera Pharmaceuticals, Inc. IDRA said it will not continue the ILLUMINATE-301 study of tilsotolimod in combination with Bristol-Myers Squibb Company's BMY Yervoy versus Yervoy alone in patients with anti-PD-1 refractory advanced melanoma, to its overall survival primary endpoint.

The company reported in March that the trial did not meet its primary endpoint of objective response rate.

Idera also said Elizabeth Tarka, its chief medical officer since July 2019, will be leaving on May 28. Tarka will continue working with Idera on a consulting basis, it added.

The stock slipped 3.77% to $1.02 in after-hours trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates

Immunocore Commences Phase 1 Study of Immunotherapy Candidate For Hepatitis B Virus Infection

Immunocore Holdings Plc IMCR announced dosing of the first patient in the first-in-human clinical trial of IMC-I109V, a new class of bispecific protein immunotherapy that is being developed for the treatment of patients with chronic hepatitis B infection.

IMC-I109V is the first candidate in development using Immunocore's immune‐mobilising monoclonal T cell receptors against virus platform to enter clinical trials.

Galapagos Starts Phase 4 Study of Filgotinib In Rheumatoid Arthritis Patients In Europe

Galapagos NV GLPG announced that the first patient has been enrolled in the FILOSOPHY Phase 4 European real-world outcomes study. The goal of the FILOSOPHY study is to advance understanding of the effectiveness and safety of filgotinib as it is used with patients with rheumatoid arthritis in clinical practice.

The study, with target enrollment of 1500 patients across Europe, will evaluate the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active RA while receiving filgotinib in a real-world setting for up to two years.

Passage Bio Announces Departure of CMO; CFO To Leave By May-end

Passage Bio, Inc. PASG revealed in a filing with the SEC, Richard Morris, its chief financial officer, will leave the company, effective May 30, to pursue other opportunities.

Additionally, the company's chief medical officer Gary Romano left the company, effective Monday. Dr. Eliseo Salinas, who assumed the role of chief R&D Officer as of March 22, will assume the role of interim CMO, the filing revealed.

The stock was down 7.52% at $14.75 in premarket trading, Tuesday.

BioXcel's Regulatory Application For Schizophrenia Drug Accepted For Review

BioXcel Therapeutics, Inc. BTAI said the FDA has accepted for filing the new drug application for BXCL501, its investigational, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.

The FDA has assigned a PDUFA target action date of January 5, 2022.

Reata to Request Pre-NDA Meeting For Friedreich's Ataxia Drug Based On FDA Recommendation

Reata Pharmaceuticals, Inc. RETA announced that it received a communication from the Division of Neurology Products 1 of the FDA, stating that, after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich's ataxia.

Based on the division's suggestion, the company said it plans to withdraw the current request for a Type C meeting and submit a request for a pre-NDA meeting as soon as practicable.

Silence Therapeutics' SLN124 Aces Early-stage Study In Iron-loading Anemia Conditions

Silence Therapeutics plc SLN nnounced positive topline data from the GEMINI phase 1 study of its wholly owned product candidate, SLN124, in healthy volunteers.

SLN124, an siRNA which targets TMPRSS6, is in development for the treatment of iron-loading anemia conditions, thalassemia and myelodysplastic syndromeA.

Initial data from the study showed all doses of SLN124 were generally well-tolerated with no serious or severe treatment emergent adverse events. Additionally, up to an approximate four-fold increase in average hepcidin and 50% reduction in plasma iron levels were also observed after a single dose of SLN124, the company said.