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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol-My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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