An­oth­er can­cer vac­cine play out of Gene­va shoots for 'hard end­point' in PhII head and neck can­cer test

Af­ter qui­et­ly plow­ing the arid can­cer vac­cine field for a decade, a low pro­file Swiss biotech is throw­ing it­self in the ring as a play­er to watch in the fre­net­ic race to ex­tend the ben­e­fits of im­munother­a­pies to sol­id tu­mors.

Bernard Mach

Co-found­ed by biotech vet Bernard Mach — who was in­volved in the cre­ation of Bio­gen and Novim­mune — and his son Nico­las, Max­i­VAX is laser-fo­cused on de­vel­op­ing a two-part can­cer vac­cine that ac­ti­vates the im­mune sys­tem to at­tack can­cer. And it has been award­ed a €2.785 mil­lion ($3.07 mil­lion) grant from the Eu­ro­pean Com­mis­sion — on top of CHF 5 mil­lion ($5.01 mil­lion) from a Se­ries B2 round — to push through a Phase II study in head and neck can­cer in Switzer­land and kick off a US study for an undis­closed rare tu­mor.

Much has been made of can­cer vac­cines’ po­ten­tial to com­ple­ment im­mune check­point in­hibitors, which can be in­cred­i­bly ef­fec­tive in sub­sets of pa­tients, some­times as few as 20%. But the first gen­er­a­tion of can­cer vac­cines, large­ly made of pep­tides de­rived from can­cer cells, has failed to in­duce the im­mune ef­fects need­ed to make a dif­fer­ence on their own.

Dim­itrios Goundis

A key is­sue, Max­i­VAX CEO Dim­itrios Goundis said, is that pep­tides car­ry mu­ta­tions that vary from pa­tient to pa­tient. Their so­lu­tion: Iso­late the whole tu­mor cells, con­tain­ing the com­plete anti­genic reper­toire for the im­mune cells to pro­file and tar­get, in­ac­ti­vate them, then im­plant them sub­cu­ta­neous­ly next to an ad­ju­vant meant to sus­tain the im­mune re­sponse.

“So our ther­a­py ba­si­cal­ly is a vac­cine, which is pa­tient spe­cif­ic, and an im­mune boost­ing agent (GM-CSF) which is de­liv­ered by en­cap­su­lat­ed ge­net­i­cal­ly mod­i­fied cells, which al­low con­tin­ued de­liv­ery of GM-CSF over sev­er­al days at the site of vac­ci­na­tion,” he told End­points News. “And with that we ad­dress we think all the weak­ness­es that we’ve iden­ti­fied over the course of the last 20, 30 years when peo­ple start to look at vac­cines against can­cers in a more sys­tem­at­ic way.”

Nico­las Mach

GM-CSF, or gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor, is a nat­u­ral­ly oc­cur­ring im­mune mod­u­la­tor that has a rel­a­tive­ly short half life, nor­mal­ly dis­ap­pear­ing with­in a cou­ple hours in the blood­stream. To keep it flow­ing, Max­i­VAX is in­sert­ing a gene in­to hun­dreds of thou­sands of cells to pro­duce a steady sup­ply of GM-CSF such as im­mune cells that can stay en­er­gized as they get fa­mil­iar­ized with ir­ra­di­at­ed tu­mor cells.

The im­prove­ment should be clear cut, he said. While check­points have ex­tend­ed me­di­an sur­vival in ad­vanced and re­frac­to­ry head and neck can­cer from three to six months, that still means half of the pa­tients don’t live that long. For the on­go­ing Phase II, for which they are re­cruit­ing around 40 pa­tients across six sites, Max­i­VAX will be mon­i­tor­ing the num­ber of pa­tients who pass the 6-month sur­vival thresh­old as the main ef­fi­ca­cy mea­sure.

“It’s a hard end­point,” he said. “So we’re not on­ly look­ing at whether or not the tu­mor is re­duced in size or dis­ap­pears, but al­so what is the ef­fect of that in pro­long­ing the life of the pa­tients.”

He ex­pects the fi­nal re­sults from the open-la­bel tri­al to be in around 2021. Be­fore that, Max­i­VAX’s small team of 10 will al­so ini­ti­ate a Phase II for which they have al­ready ob­tained an IND in the US.

The new funds from pri­vate in­vestors — Max­i­VAX has man­aged to stay away from ven­ture cap­i­tal­ists in rais­ing over $15 mil­lion so far — will al­so go to­ward build­ing out man­u­fac­tur­ing.

Right now the biotech re­lies on the Gene­va Hos­pi­tal, where Nico­las Mach is head of on­col­o­gy, to iso­late the tu­mor cells and to gen­er­ate and fill the cap­sules with GM-CSF pro­duc­ing cells. Its of­fices are lo­cat­ed in the neigh­bor­hood, which al­so hous­es AMAL Ther­a­peu­tics, an­oth­er next-gen can­cer vac­cine play­er re­cent­ly bought out by Boehringer In­gel­heim.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Neu­vo­gen un­cloaks with broad plan of at­tack for whole-cell can­cer vac­cines, clin­i­cal hopes with­in the year

After about four stealthy years in the development phase, San Diego-based Neuvogen is emerging with a new approach to whole-cell cancer vaccines and nine solid tumor programs bound for the clinic.

Whole-cell tumor vaccines are developed by taking cancer cells from patients and modifying them to make them immunogenic.

“What’s different from what we do, is most people use one cell line. We use six,” CEO Todd Binder said. From there, the company builds out six modifications to eliminate problematic immunosuppressive factors, and add what the executive called three “stimulatory factors” to generate a prime and overcome peripheral tolerance.