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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.