Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The Ger­man bil­lion­aires be­hind BioN­Tech have found a new vac­cine project to back.

Through their fam­i­ly of­fice Athos Ser­vice, twin broth­ers Thomas and An­dreas Strüng­mann are lead­ing a $25 mil­lion pri­vate place­ment in­to Switzer­land’s AC Im­mune — which con­cur­rent­ly an­nounced that it’s shelling out $58.7 mil­lion worth of stock to ac­quire Af­firis’ port­fo­lio of ther­a­pies tar­get­ing al­pha-synu­cle­in, in­clud­ing a vac­cine can­di­date, for Parkin­son’s dis­ease.

Build­ing on the oth­er a-syn drugs and di­ag­nos­tics al­ready in its pipeline, the deal means AC Im­mune can now cov­er the full spec­trum of treat­ment modal­i­ties against the pro­tein, CEO An­drea Pfeifer said.

On top of the as­sets, AC Im­mune is al­so get­ting $5 mil­lion in cash from Vi­en­na-based Af­firis.

Hav­ing op­ti­mized the for­mu­la­tion of Af­firis’ orig­i­nal drug, PD01, in­to a new can­di­date dubbed ACI-7104, the biotech plans to vault di­rect­ly in­to a Phase II study, where it will eval­u­ate an ini­tial dose-re­sponse while track­ing bio­mark­ers and pro­gres­sion of Parkin­son’s symp­toms.

The biotech had al­ready de­vel­oped two oth­er vac­cines against neu­rode­gen­er­a­tive dis­eases: the an­ti-tau ACI-35.030 and an­ti-amy­loid ACI-24, both to treat Alzheimer’s. It’s al­so been ac­tive in push­ing next-gen tau drugs for the brain-wast­ing ail­ment — long be­fore Bio­gen shook up the field with its Aduhelm win — al­though its Roche-part­nered lead pro­gram has seen its share of set­backs.

While the Parkin­son’s vac­cine is po­si­tioned for long-term man­age­ment, Pfeifer not­ed it may al­so play a role in pre­ven­tion of the dis­ease by stir­ring up an an­ti­body re­sponse against oligomer­ic a-syn.

At the same time, the com­pa­ny al­so boasts of an an­ti-a-syn an­ti­body, a small mol­e­cule ag­gre­ga­tion in­hibitor, and a first-in-class di­ag­nos­tic imag­ing agent for a com­pre­hen­sive pre­ci­sion med­i­cine ap­proach — both to Parkin­son’s and al­pha-synu­cle­inopathies.

“We have learned from Covid-19 that col­lab­o­ra­tion can ac­cel­er­ate the de­vel­op­ment of safe and ef­fi­ca­cious vac­cines that can be de­ployed broad­ly to de­liv­er high­ly ef­fec­tive pro­tec­tion for very large pop­u­la­tions,” Thomas Strüng­mann said in a state­ment. “We look for­ward to work­ing with the Com­pa­ny to po­ten­tial­ly trans­late what has been done for in­fec­tious dis­eases to neu­rode­gen­er­a­tive dis­eases like Parkin­son’s and Alzheimer’s.”

First Cap­i­tal Part­ner and MIG Fonds have joined Athos for the fi­nanc­ing. All three in­vestors were al­so the main share­hold­ers of Af­firis, AC Im­mune not­ed in a pre­sen­ta­tion.

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.

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.

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.

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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.

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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.

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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.

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Kim Smith, ViiV CEO, at GlaxoSmithKline's Investor Day

Bank­ing on in­te­grase in­hibitors as HIV cor­ner­stone, Vi­iV bags 3rd-gen­er­a­tion com­pound from Sh­iono­gi

As a 12% shareholder of ViiV Healthcare, Japan’s Shionogi has commanded a much lower profile than its fellow owners, GlaxoSmithKline and Pfizer. But behind the scenes, it’s played an outsized role in the development of ViiV’s HIV drugs, coming up with the two top programs — the integrase inhibitors dolutegravir and cabotegravir — currently in ViiV’s portfolio.

And it’s time for round three.