Incyte Announces Agreement to Acquire Medicxi-backed Villaris Therapeutics and Auremolimab (VM6), an Anti-IL-15Rβ Monoclonal Antibody

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Incyte (NASDAQ:INCY) today announced that the Company has entered into an agreement to acquire Villaris Therapeutics, an asset-centric biopharmaceutical company seeded by Medicxi and focused on the development of novel antibody therapeutics for vitiligo. Its lead asset, auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody (mAb), is expected to enter clinical development in 2023.

Discovery Starts with Jefferson Institute for Bioprocessing’s Brent Chamberlain

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Talent looking to join Greater Philadelphia’s cell and gene therapy hub can hear firsthand from those living and working here about the industry’s opportunities and the region’s quality of life. So far, 11 talent ambassadors have shared their stories as part of the Chamber of Commerce for Greater Philadelphia’s “Discovery Starts with Me” series.
For our latest “Discovery Starts with Me” story, we sat down with Brent Chamberlain, Associate Director of Cell and Gene Therapy at the Jefferson Institute of Bioprocessing (JIB). JIB is a full-service development and training organization specializing in biopharmaceuticals and biologics. JIB offers early-phase pre-clinical process development, product development, analytical, quality control, stability and release testing, world-class industry training, and strong credential programs through Thomas Jefferson University. JIB’s team of bioprocessing experts brings both industry knowledge and seasoned experience to all of its work.

Why Philly Ranks #2 Among Best Cell and Gene Therapy Hubs in the US

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There’s a handful of reasons why the Philadelphia region has been (perhaps unfortunately) dubbed Cellicon Valley in the last few years, and a new report from the Chamber of Commerce for Greater Philadelphia and economic consulting firm Econsult Solutions has ID’d them all.
In the report, which looked at 14 large cell and gene therapy hubs in the US, Philadelphia ranked as the runner up, just behind Boston, as the top spot for research and innovation in this space. Other metro areas such as New York and San Francisco scored the third and fourth spots on the list. The report shouts out early local work, including the first FDA-approved gene (Luxturna) and cell (Kymriah) therapies developed here at Spark Therapeutics and the University of Pennsylvania, respectively.
“The Philadelphia region is increasingly attracting new and expanding cell and gene therapy companies because it checks all the boxes, but it’s the region’s research infrastructure as defined by NIH-funded cell and gene therapy research and its large number of research institutions that give it the edge,” said Claire Marrazzo Greenwood, executive director and CEO of Council for Growth and SVP of economic competitiveness for the Chamber, in a statement.

Windtree Therapeutics Announces Positive Istaroxime Phase 2 Study in Early Cardiogenic Shock (SEISMiC) Published in the European Journal of Heart Failure

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Windtree Therapeutics Announces Positive Istaroxime Phase 2 Study in Early Cardiogenic Shock (SEISMiC) Published in the European Journal of Heart Failure WARRINGTON, Pa., Sept. 28, 2022 (GLOBE NEWSWIRE) — Windtree [….]

Idera Buys Rare Disease-Focused Aceragen in All-Stock Deal

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What caught Idera’s attention was Aceragen’s lead assets, including ACG-701, which is set to enter phase 2 trials later this year for acute pulmonary exacerbations associated with cystic fibrosis. Although sodium fusidate has been used in this indication for decades in the U.K. and Australia, it has yet to receive approval in the U.S.
ACG-701 is also undergoing a phase 2 trial as a potential treatment for a life-threatening infection called melioidosis, with an interim readout expected in the first quarter of next year.
The other cornerstone of Aceragen’s portfolio is ACG-801, a biologic enzyme replacement therapy that is due to enter clinical trials for Farber disease in the first quarter of 2023.  The drug was itself acquired from Enzyvant by Aceragen shortly after the company launched last year.

New Jersey Biotech Nets $50M+ BARDA Contract for Respiratory Candidate

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Ea­gle Phar­ma­ceu­ti­cals is keep­ing an eye on Enalare Ther­a­peu­tics’ lead res­pi­ra­to­ry can­di­date, and ap­par­ent­ly, so is the US gov­ern­ment.
The New Jer­sey-based biotech struck a deal with BAR­DA worth up to $50.3 mil­lion to de­vel­op the lead com­pound, dubbed ENA-001, the com­pa­ny an­nounced on Tues­day. The can­di­date is de­signed to sim­u­late breath­ing and is meant to be used in emer­gency cas­es when treat­ing drug over­dos­es or res­pi­ra­to­ry de­pres­sion post-surgery.
Ac­cord­ing to Enalare, the first phase of the con­tract will give it $6 mil­lion to com­plete any ac­tions through its Phase I tri­al. The over­all award, which will be based on sev­er­al mile­stones in R&D and pro­duc­tion, will give fund­ing for tox­i­col­o­gy, hu­man tri­als, man­u­fac­tur­ing and reg­u­la­to­ry fil­ings.

Comparative Study Ranks Philadelphia Region #2 Among 14 Cell and Gene Therapy Hubs

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In a newly released study comparing 14 U.S. cell and gene therapy hubs in five key categories, the Philadelphia region ranks #2 among U.S. locations. Commissioned by the Chamber of Commerce for Greater Philadelphia and researched by economic consulting firm Econsult Solutions, Inc. (ESI), the study compares cell and gene therapy hubs in research infrastructure, human capital, innovation output, commercial activity, and value proposition. The only region ranked higher overall than Philadelphia was Boston. New York and San Francisco were ranked #3 and #4, respectively.

Carisma’s CAR-M Steals Spotlight Among 42 Bidders to Reverse Merge With Sesen Bio

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Sesen Bio’s decade-plus jour­ney is over af­ter fail­ing to se­cure a blad­der can­cer drug ap­proval and carve its own path for IL-6 an­ti­bod­ies. The Cam­bridge, MA com­pa­ny’s spot on Nas­daq will serve as the new home for Caris­ma Ther­a­peu­tics, which is at­tempt­ing to ush­er in a new CAR cell ther­a­py in the world of macrophages and mono­cytes.
The two are ex­e­cut­ing an all-stock re­verse merg­er, with the fu­ture rest­ing sole­ly on Caris­ma’s line­up of ther­a­pies, in­clud­ing a Phase I as­set that had some lim­it­ed da­ta pre­sent­ed at AS­CO in June. The Philadel­phia start­up will be­gin trad­ing un­der the apt­ly sym­bol­ed tick­er $CARM in three to four months, the com­pa­nies said Wednes­day morn­ing.

Center for Breakthrough Medicines (CBM) and jCyte Announce Strategic Partnership to Manufacture jCyte’s Innovative Cell Therapy for Treatment of Retinal Degenerative Diseases

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The Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) dedicated to addressing the unique requirements associated with commercializing cell and gene therapies, and jCyte, a clinical-stage biotech company focused on preserving and restoring vision in patients with retinitis pigmentosa (RP) and other retinal degenerative diseases, today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte’s U.S. Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell. Under the terms of the agreement, CBM will provide Phase 3 clinical trial supplies and commercial drug product following Biologics License Application (BLA) approval of jCyte’s proprietary jCell platform technology. CBM will also provide all BLA-enabling Chemistry, Manufacturing and Controls (CMC) work to support the program through regulatory approval and commercialization.