Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A can­cer-fight­ing con­cept from the in­ven­tor of the first can­cer vac­cine is near­ing prime time, and its biotech de­vel­op­er has re­ceived a sig­nif­i­cant new in­fu­sion of cash to get it there.

Bolt Bio­ther­a­peu­tics an­nounced a $93.5 mil­lion Se­ries C round led by Sofinno­va In­vest­ments and joined by more than 9 oth­ers, in­clud­ing Pfiz­er Ven­tures and RA Cap­i­tal Man­age­ment. That mon­ey will go to­ward push­ing the San Fran­cis­co biotech’s plat­form of in­nate im­mune-boost­ing war­heads through its first tri­al on metasta­t­ic sol­id tu­mors and in­to sev­er­al more.

Randy Schatz­man

It’s “a fair­ly el­e­gant but sim­ple mol­e­cule,” CEO Randy Schatz­man told End­points News. “It’s ba­si­cal­ly an off-the-shelf ther­a­peu­tic that physi­cians can call on to treat their pa­tients with­out all the per­son­al­iza­tion and man­u­fac­tur­ing dif­fi­cul­ties that many of the I/O ap­proach­es have to­day.”

The ex­per­i­men­tal drug is what Bolt calls an im­mune-stim­u­lat­ing an­ti­body con­ju­gate. It’s based on a con­cept from Stan­ford im­mu­nol­o­gist Edgar En­gle­man, who in­vent­ed the first can­cer vac­cine in Provenge, a treat­ment for prostate can­cer. That vac­cine in­volves a mul­ti-step process where in­nate im­mune cells called den­drit­ic cells are ex­tract­ed, ex­posed to a pro­tein from the pa­tients’ own tu­mors (as you would ex­pose the im­mune sys­tem to a vi­ral or bac­te­r­i­al pro­tein in a tra­di­tion­al vac­cine) and then re­in­fused.

Bolt’s plat­form is de­signed to di­rect­ly ac­ti­vate den­drit­ic cells around tu­mors with­out the need for re­moval, treat­ment and re-in­fu­sion. The ther­a­py is an an­ti­body drug con­ju­gate sim­i­lar to those pro­duced by Seat­tle Ge­net­ics, ADC Ther­a­peu­tics, and Im­munomedics, each of which con­tain an an­ti­body to guide the ther­a­py like a war­head to the tu­mor. The dif­fer­ence is that in­stead of strap­ping a chem­i­cal to the an­ti­body that will kill cells in the area, Bolt’s drug has an ag­o­nist that will bind to re­cep­tors on the den­drit­ic cells and ac­ti­vate them to at­tack the tu­mor.

Edgar En­gle­man

If it works, the drug would turn the en­vi­ron­ment around the tu­mor from an im­muno-sup­pres­sive to one that could not on­ly kill the tu­mors once but pre­vent re­cur­rence. Their first can­di­date us­es a Her­ceptin biosim­i­lar to tar­get HER2, but in the­o­ry, Schatz­man said, it should work with an an­ti­body tar­get­ed at any onco­gene and Bolt is ex­plor­ing those op­tions, both in­ter­nal­ly and with part­ner­ships.

In Feb­ru­ary, five years af­ter the com­pa­ny’s foun­da­tion, they launched their first tri­al, putting the drug — known as BDC-1001 — in­to a Phase I/II tri­al for metasta­t­ic tu­mors that are HER2+, in­clud­ing gas­tric and breast can­cer. That tri­al will test the drug both as a sin­gle-agent ther­a­py and in com­bi­na­tion with Mer­ck’s Keytru­da. The idea is that ac­ti­vat­ing the im­mune sys­tem in two dif­fer­ent ways might make for a more ef­fec­tive treat­ment.

De­spite some ear­ly con­cerns, Schatz­man says, the com­pa­ny has not seen any de­lays in that tri­al from Covid-19.

Af­ter the first da­ta emerge from the Phase I/II tri­al, the com­pa­ny will move in­to tri­als specif­i­cal­ly for gas­tric and breast can­cer, look­ing to see if it can not on­ly clear can­cers ini­tial­ly but al­so, by keep­ing the im­mune sys­tem on guard, ward off re­cur­rence, an event that can come quick­ly for pa­tients with these late-stage tu­mors.

”We’re go­ing to see some quick an­swers in go­ing past what is the cur­rent stan­dard of care,” Schatz­man said. “I’d like to think it will take a long time to know where the end of this is, be­cause in that sense, we’ll have been very ef­fec­tive at treat­ing these pa­tients.”

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

Contract research organizations are a fairly mysterious bunch. They’re typically considered the skilled laborers behind big drug development — the stage crews who run the trials behind some of the most (and least) successful data reveals in biopharma history.

But all that is changing.

This year, a couple of huge, out-of-the-blue M&A deals sounded the alarm on just how much money is flying around in this corner of the industry.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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