Mark Smith, Finch Therapeutics CEO

Take­da breaks off five-year pact with mi­cro­bio­me part­ner, hand­ing back two pre­clin­i­cal drugs

When Take­da first part­nered up with Finch Ther­a­peu­tics in 2017, the Japan­ese phar­ma put on the map what was still a very ear­ly-stage mi­cro­bio­me play­er aim­ing to cap­i­tal­ize on the idea that you could reap the ben­e­fits of fe­cal trans­plants with an oral pill — and its pre­clin­i­cal pro­gram for in­flam­ma­to­ry bow­el dis­ease.

Over the next few years, Take­da re­jigged the al­liance a few times, get­ting its hands on a sec­ond drug, tak­ing more re­spon­si­bil­i­ty for de­vel­op­ment and man­u­fac­tur­ing, and lat­er tap­ping Finch to con­duct more fea­si­bil­i­ty work.

But Take­da is now walk­ing away from it all.

Finch said its phar­ma part­ner has de­cid­ed to ter­mi­nate their col­lab­o­ra­tion, ef­fec­tive this No­vem­ber. As a re­sult, the biotech will re­gain glob­al rights to FIN-524 (pre­vi­ous­ly TAK-524, for ul­cer­a­tive col­i­tis) and FIN-525 (for Crohn’s dis­ease).

Both pro­grams, which con­tain spe­cif­ic bac­te­ria strains Finch deemed cru­cial in treat­ing dis­ease, re­main pre­clin­i­cal, al­though Finch had orig­i­nal­ly hoped that FIN-524 would reach the clin­ic with­in two and a half to three years.

“We are grate­ful for Take­da’s sub­stan­tial in­vest­ment in the FIN-524 and FIN-525 pro­grams and want to thank our ded­i­cat­ed col­leagues at Take­da who have worked along­side us to de­vel­op these in­no­v­a­tive prod­uct can­di­dates,” CEO Mark Smith said in a state­ment.

He added that Finch will ex­plore new col­lab­o­ra­tion op­por­tu­ni­ties for these as­sets.

In­ter­nal­ly, Finch has been fo­cus­ing its ef­forts on CP101, its “com­plete con­sor­tia” mi­cro­bio­me cap­sule for re­cur­rent C. dif­fi­cile in­fec­tions. De­spite a brief clin­i­cal hold due to man­u­fac­tur­ing con­cerns, the biotech is knee-deep in a crit­i­cal Phase III tri­al that may pave the way to­ward its first ap­proval.

Like many biotechs hun­ker­ing down for the biotech down­turn, Finch took to lay­offs ear­li­er this year to con­serve cash. Its stock is lan­guish­ing at $2.64, down about 75% from the be­gin­ning of the year.

On top of the $10 mil­lion cash Take­da hand­ed over in 2017, Finch has re­ceived $4 mil­lion in mile­stone pay­ments and more than $30 mil­lion in R&D re­im­burse­ment dur­ing the col­lab­o­ra­tion.

Now that the deal is wind­ing down, Take­da is al­so giv­ing Finch all the da­ta and in­tel­lec­tu­al prop­er­ty gen­er­at­ed, in­clud­ing “full rights to a large li­brary of char­ac­ter­ized bac­te­r­i­al iso­lates, da­ta from mul­ti­ple ex vi­vo and in vi­vo stud­ies, a suite of phar­ma­co­ki­net­ic and phar­ma­co­dy­nam­ic as­says, and a sig­nif­i­cant body of chem­istry, man­u­fac­tur­ing, and con­trols (CMC) da­ta gen­er­at­ed dur­ing the in­ves­ti­ga­tion­al new drug (IND)-en­abling phase of de­vel­op­ment.”

“We are cur­rent­ly con­duct­ing a re­view of our port­fo­lio and as­sess­ing the fi­nan­cial and strate­gic im­pact of the dis­con­tin­u­a­tion of our col­lab­o­ra­tion with Take­da,” Smith said.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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#JPM23: What's re­al­ly dri­ving the cost of health­care and drugs in 2023?

Executive Editor Drew Armstrong spoke with PhRMA CEO Steve Ubl, EmsanaRx CEO Greg Baker and ICER President Steve Pearson about how the debate over drug costs has changed (or not) in the last decade, the shifting payer landscape and why there seems to be so little movement on drug rebates. This transcript has been edited for brevity and clarity.

Drew Armstrong:

So first of all, thank you to everybody for being here and for our panel for being here. Incredibly excited to have this discussion on the cost of healthcare and drugs and what’s driving that. We’re here with Steve Ubl, the head of PhRMA. Thank you so much. Steve Pearson from ICER, and Greg Baker from EmsanaRx. I want to start this conversation with a little bit of a personal reminiscence. So about almost 10 years exactly. I was a reporter back in my previous job and I was covering drug pricing and Gilead had just launched their hepatitis C drug and I was having a conversation with another Steve over at Express Scripts and he made some comments essentially about how they intended to launch a price war over hepatitis C therapies.

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Pa­tient death spurs tri­al halt for Ma­gen­ta Ther­a­peu­tics

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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