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.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Peter Thiel (Riccardo Savi/Sipa via AP Images)

Tech bil­lion­aire Pe­ter Thiel backs a lead­ing psy­che­del­ic drug de­vel­op­er

Right on the heels of investing in antibody drug developer AbCellera, Facebook billionaire Peter Thiel has jumped into a syndicate putting up $125 million for a company with a portfolio of psychedelic drugs in the clinic for mental health.

The C round — which includes a $32 million conversion of notes to equity — will fuel the development programs at ATAI Life Sciences, a Berlin-based biotech that has assembled a portfolio of companies with psychedelic and non-psychedilc approaches to depression, anxiety and addiction.

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