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.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

Endpoints Premium

Premium subscription required

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

Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Licensing is one of the most common ways big drugmakers leverage biotech innovation to drive gains across their pipelines — and the structure of those deals is pretty well established. But one biotech with home bases in China and the US thinks it may have a better way.

On Tuesday, Cambridge-based biotech Anji Pharma closed a $70 million Series B with two late-stage molecules in the fold and a mission to rewrite the rules of drug licensing through what it calls “dynamic equity” deals and a joint venture-heavy game plan. The round was funded in whole by Chinese hedge fund CR Capital.

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 118,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.