Boehringer backs $33M can­cer vac­cine play at Switzer­land's AMAL Ther­a­peu­tics

A can­cer vac­cine de­vel­op­er spun out of the Uni­ver­si­ty of Gene­va has gar­nered €29 mil­lion ($32.7 mil­lion) to fu­el its dri­ve in­to the clin­ic.

AMAL Ther­a­peu­tics man­aged to con­vince all the in­vestors who col­lec­tive­ly gave €8 mil­lion last Sep­tem­ber to step up their com­mit­ment in this sec­ond clos­ing of the Se­ries B, fea­tur­ing co-lead­ers Boehringer In­gel­heim Ven­ture Fund, Bio­Med Part­ners and Helsinn In­vest­ment Fund in ad­di­tion to VI Part­ners, Schroder Ad­veq and High-Tech Grün­der­fonds.

Madi­ha Der­ouazi

With a plat­form tech called KISI­MA de­signed to pack a cell-pen­e­trat­ing pep­tide for anti­gen de­liv­ery, an ad­ju­vant­i­ng TLR- pep­tide ag­o­nist and a mul­ti-anti­genic car­go in­to one sin­gle vac­cine, the biotech says it is open­ing up a new class of can­cer vac­cines that can stoke an im­mune re­sponse in a broad­er spec­trum of pa­tients than the pre­vi­ous gen­er­a­tion could.

“KISI­MA al­lows prim­ing of both helper and killer cells for var­i­ous anti­gens and for var­i­ous HLA re­stric­tions, CEO Madi­ha Der­ouazi wrote in an email. She went on to ex­plain: “One mech­a­nism of im­mune es­cape by tu­mour cells is down reg­u­la­tion of anti­gen ex­pres­sion or of HLA pre­sen­ta­tion, hav­ing both mul­ti-anti­genic and tar­get­ing var­i­ous HLA would al­low to cir­cum­vent this im­mune es­cape mech­a­nisms.”

The first test will be in stage IV metasta­t­ic col­orec­tal can­cer, as Der­ouazi and her team of 15 steer the lead prod­uct can­di­date ATP128 to­ward clin­i­cal proof-of-con­cept across the US and Eu­rope, ex­pect­ed to be­gin in sum­mer 2019.

A sea­soned re­searcher in the field, Der­ouazi first de­vised the cell-pen­e­trat­ing pep­tide-based vac­cine at the Lab­o­ra­to­ry of Tu­mour Im­munol­o­gy at the Uni­ver­si­ty of Gene­va.

AMAL al­so says that its can­cer vac­cine — like many of its coun­ter­parts — makes good com­bi­na­tions with oth­er im­mune mod­u­la­tion agents, which is why it’s test­ing ATP128 with an an­ti-PD1 in its first-in-hu­man stud­ies. It will now have to prove that its ap­proach can find a place in the wave of next-gen can­cer vac­cines be­ing pro­gressed, in­clud­ing mR­NA ef­forts at Mod­er­na and BioN­Tech as well as the per­son­al­ized route ad­vanced by Neon and Grit­stone.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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