Less than a year af­ter pulling in an im­pres­sive $62 mil­lion Se­ries C round, PMV Phar­ma is back at it again.

The Cran­bury, NJ-based biotech an­nounced Mon­day an ad­di­tion­al $70 mil­lion in Se­ries D fi­nanc­ing as it seeks to de­vel­op can­cer ther­a­pies tar­get­ing p53 mu­ta­tions. Ad­di­tion­al­ly, PMV al­so in­tro­duced long­time biotech en­tre­pre­neur Rich Hey­man as chair­man of the board of di­rec­tors.

David Mack

“This fi­nanc­ing pro­vides PMV Phar­ma with the re­sources to ex­pand our pipeline and to po­ten­tial­ly ad­vance mul­ti­ple p53 ther­a­pies in­to the clin­ic,” said PMV pres­i­dent and CEO David Mack in a state­ment.

The Se­ries D was fund­ed by Avoro Cap­i­tal, RA Cap­i­tal Man­age­ment and Welling­ton Man­age­ment Com­pa­ny, who joined ex­ist­ing in­vestors Or­biMed Ad­vi­sors, Nex­tech In­vest, Viking Glob­al In­vestors and Box­er Cap­i­tal.

PMV de­clined to com­ment be­yond Mon­day’s press re­lease, sug­gest­ing they may be prepar­ing for an IPO. Com­pa­nies that meet this pro­file typ­i­cal­ly have their S-1 fil­ings ready to go, putting them in a qui­et pe­ri­od be­fore their stock hits Wall Street.

Hey­man comes to PMV af­ter found­ing the biotechs Aragon and Ser­agon, each of which sold for more than $1 bil­lion in the span of 12 months back in 2013 and 2014. J&J bought Aragon, and while Roche and Genen­tech pur­chased Ser­agon, the duo qui­et­ly scrapped that biotech’s lead pro­gram from Phase II stud­ies in 2017.

“[Hey­man’s] wealth of ex­pe­ri­ence and proven track record of strate­gic busi­ness, sci­en­tif­ic and clin­i­cal ac­com­plish­ments will be in­valu­able as we con­tin­ue to progress our pipeline of p53 pro­grams to­wards the clin­ic,” Mack said.

Though PMV hasn’t an­nounced any of its pipeline pro­grams just yet, it’s fo­cused stud­ies on mu­tant p53 pro­teins — one of the biggest and most frus­trat­ing tar­gets in the field. The pro­tein is a tu­mor sup­pres­sor, and the wild, or nor­mal, p53 plays a piv­otal role in the body’s nat­ur­al de­fense mech­a­nism against can­cer.

P53 can in­duce a high­ly or­ga­nized pro­gram of cel­lu­lar death to pre­vent the pro­lif­er­a­tion of po­ten­tial­ly can­cer­ous cells, and mu­ta­tions, which can lose their tu­mor sup­press­ing func­tion, are found in al­most half of all can­cers. PMV hopes its can­di­dates can re­store the pro­tein in such in­stances, but the tar­get has proved elu­sive for oth­er biotechs in the past.

PMV likes their chances how­ev­er, giv­en that one of their co-founders, Arnold Levine, was one of the sci­en­tists cred­it­ed with the dis­cov­ery of the p53 pro­tein in 1979.

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.