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.”

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Eye­ing quick ap­proval, Ab­b­Vie of­fers a close-up on their pres­by­opia drug da­ta

AbbVie picked up some bonus points earlier this year as one of its pipeline adds from the $63 billion Allergan buyout hit its top-line marks. And now the researchers have produced the detailed data on the case they are making with regulators, with an eye on a major new market and a hoped-for approval before New Year’s.

AGN-190584 is aiming to be the first easy-on eyedrop for presbyopia, a common ailment for large numbers of people who find it harder and harder to read things like a watch or cell phone close up. Anyone who’s held a book out at arm’s length in order to read it will be very familiar with the condition, if not the exact diagnosis.

Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Rajiv Shukla, Constellation Alpha Holdings

Can­del gets busy IPO week mov­ing with down­sized raise as Ra­jiv Shuk­la's third SPAC goes pub­lic

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a week that’s expected to see several biotechs price their IPOs, Candel Therapeutics got things kicked off Tuesday with a muted opener.

The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.