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.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.