→ Amar­na Ther­a­peu­tics  — de­vel­op­ing an SV40-based gene de­liv­ery vec­tor plat­form called SVac — has raised €10 mil­lion. The round was led by Swedish in­vest­ment com­pa­ny Flerie In­vest AB, along with con­tri­bu­tions from the Nether­lands En­ter­prise Agency and ex­ist­ing share­hold­er Pim Berg­er. The funds will be used to de­vel­op SVac and steer it in­to a first-in-man clin­i­cal study, ex­pect­ed to com­mence in the com­ing years.

→ Ed­i­tas Med­i­cine — who re­cent­ly wel­comed a new CEO, Cyn­thia Collins — and AskBio are part­ner­ing up in a strate­gic re­search col­lab­o­ra­tion to ex­plore in vi­vo de­liv­ery of genome edit­ing med­i­cines to treat neu­ro­log­i­cal dis­eases. The part­ner­ship will bring to­geth­er AskBio’s cap­sid de­vel­op­ment, clin­i­cal-stage AAV vec­tor de­liv­ery sys­tem with Ed­i­tas’ genome edit­ing tech­nolo­gies.

→ CRISPR Ther­a­peu­tics and KSQ Ther­a­peu­tics have inked a li­cense agree­ment in which CRISPR will gain ac­cess to KSQ’s in­tel­lec­tu­al prop­er­ty (IP) for edit­ing cer­tain gene tar­gets in its al­lo­gene­ic on­col­o­gy cell ther­a­py pro­grams, and KSQ will gain ac­cess to CRISPR’s IP for edit­ing gene tar­gets iden­ti­fied by KSQ as part of its cur­rent and fu­ture eTILTM (en­gi­neered tu­mor-in­fil­trat­ing lym­pho­cyte) cell pro­grams. Fi­nan­cial terms of the agree­ment have not been dis­closed.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.