Bernat Olle, Vedanta Biosciences CEO

Vedan­ta brings home a win for lead mi­cro­bio­me pro­gram, pass­ing a PhII test and clinch­ing BAR­DA in­vest­ment

Vedan­ta Bio­sciences wrapped up a Se­ries D about two months ago to ad­vance its mi­cro­bio­me re­search, but it’s not con­tent to rest on its lau­rels.

The Cam­bridge, MA-based biotech claimed a win in a Phase II study treat­ing Clostrid­ioides dif­fi­cile in­fec­tion, say­ing its lead pro­gram achieved a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in re­cur­rences af­ter eight weeks com­pared with place­bo. It’s a re­sult that os­ten­si­bly im­pressed the US gov­ern­ment as the study re­sults trig­gered a $23.8 mil­lion op­tion from BAR­DA.

“We were al­ready get­ting BAR­DA sup­port, but the ad­di­tion­al sup­port we’re get­ting now, the $23.8 mil­lion is more­so go­ing to­ward the Phase III study,” CEO Bernat Olle told End­points News in an in­ter­view.

Vedan­ta still has to sit down with the FDA to agree on a study de­sign, Olle added, but not­ed it will like­ly in­volve the same pa­tient pop­u­la­tion.

Olle and his team had been work­ing on the can­di­date known as VE303, an oral drug com­pris­ing eight dif­fer­ent bac­te­ria strains de­signed to pro­vide re­sis­tance to C. dif­fi­cile. The Phase II study en­rolled 79 pa­tients and ran­dom­ized them be­tween a low dose, high dose and place­bo group.

The high dose achieved the pri­ma­ry end­point. In the ac­tive arm, pa­tients saw a 13.8% C. dif­fi­cile re­cur­rence rate com­pared to 45.5% in the place­bo group, with re­searchers us­ing a com­bi­na­tion of mea­sure­ment tools to de­tect in­fec­tion. The re­sult proved a greater than 80% re­duc­tion in the odds of a re­cur­rence, good for a p-val­ue of p=0.0077.

Olle high­light­ed that the dif­fer­ent tools used in the pri­ma­ry are the norm for these kinds of stud­ies. Rather than on­ly use tox­in test­ing, Olle said Vedan­ta al­so looked at PCR test­ing in its end­point analy­sis. And when pa­tient sam­ples were un­avail­able for test­ing, Vedan­ta re­lied on a clin­i­cian’s di­ag­no­sis.

Re­searchers de­sired a broad­er de­f­i­n­i­tion of what con­sti­tutes a re­cur­rence be­cause tox­in test­ing is in­her­ent­ly in­ac­cu­rate, Olle said. The tests can miss be­tween 20% to 50% of pos­i­tive cas­es if pa­tient sam­ples are not im­me­di­ate­ly frozen in trans­fer.

“The sam­ple starts de­grad­ing right away,” Olle said. “Those are pa­tients that have C. dif­fi­cile, but … by the time you get the re­sult you on­ly cap­ture a por­tion of them.”

To ham­mer this point home, Vedan­ta al­so mea­sured the pro­por­tion of pa­tients re­main­ing re­cur­rence-free af­ter eight weeks us­ing on­ly the tox­in test­ing. An analy­sis look­ing at the dif­fer­ence be­tween the 86.2% of those in the high-dose co­hort who did not see a re­cur­rence, and the 54.5% of place­bo pa­tients, did not prove sta­tis­ti­cal­ly sig­nif­i­cant.

The re­sult is the “broad­est and most com­pre­hen­sive” de­f­i­n­i­tion of C. dif­fi­cile in­fec­tion re­cur­rence, Olle said.

Vedan­ta is con­tin­u­ing to build out a man­u­fac­tur­ing fa­cil­i­ty to pre­pare for Phase III and po­ten­tial com­mer­cial­iza­tion, re­main­ing on track to com­plete it by the end of 2021. Should the Phase III study val­i­date what re­searchers saw with Tues­day’s re­sults, Olle says it will hope­ful­ly be enough for an FDA ap­proval.

At that point, Vedan­ta could be pro­duc­ing about 1 mil­lion dos­es per year. With sup­port from BAR­DA, Olle ex­pects some gov­ern­ment in­vest­ment to build the na­tion­al se­cu­ri­ty stock­pile in case of an out­break.

Af­ter many in­vestors fled the mi­cro­bio­me space fol­low­ing a Seres Ther­a­peu­tics flop in 2016, cash has slow­ly start­ed com­ing back to the field. In May 2020, Re­bi­otix pre­sent­ed pos­i­tive da­ta from a place­bo-con­trolled study for its own C. dif­fi­cile trans­plant ther­a­py, and in Ju­ly, af­ter Seres found promis­ing re­sults with a new tack, Nestlé dropped $525 mil­lion to fund de­vel­op­ment for their lead mi­cro­bio­me treat­ment.

Pfiz­er al­so got in on the ac­tion, hav­ing in­vest­ed $25 mil­lion in Vedan­ta back in Jan­u­ary to help ad­vance its slate of IBD pro­grams. With the biotech now past a Se­ries D and hav­ing a pos­i­tive Phase II re­sult, ques­tions about an IPO will abound. Olle left the door open but didn’t give away many hints to his plans.

“At the stage that we are at, we’re open to all kinds of fi­nanc­ing,” Olle said.

Cor­rec­tion: This ar­ti­cle has been up­dat­ed to cor­rect in­for­ma­tion about the na­ture of test­ing for C. dif­fi­cile. A com­bi­na­tion ap­proach us­ing tox­in test­ing, PCR test­ing and clin­i­cian di­ag­no­sis is the norm. 

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.