Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

As new C. diff treat­ments prep for mar­ket, spe­cial­ists di­vid­ed on 'poop in a pil­l' or small mol­e­cule, study finds

What do physicians think about the emerging market for recurrent C. diff? That depends on who you talk to, especially which specialists you talk to.

Fecal microbiota transplants, or FMT, are favored by gastroenterologists familiar with them, while infectious disease doctors prefer traditional small molecule therapies, according to a recent future market evaluation by Spherix Global Insights. While current FMT involves transplanting healthy stool into a C. diff patient through a colonoscopy, FMT encapsulated microbiome pills that are swallowed – referred to by doctors as “poop in a pill” in Spherix’s interviews – are likely on the way to market.

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