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.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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