Pfiz­er's in­vest­ment fund is mak­ing waves in VC — in­clud­ing a $25M bet on IBD play­er Vedan­ta Bio­sciences

Pfiz­er has a gut feel­ing about Vedan­ta Bio­sciences.

On Tues­day, the Cam­bridge, Mass­a­chu­setts-based mi­cro­bio­me up­start be­came the fourth biotech to re­ceive an in­vest­ment from the Pfiz­er Break­through Growth Ini­tia­tive (PG­BI), bag­ging $25 mil­lion to send its in­flam­ma­to­ry bow­el dis­ease can­di­date to Phase II.

Since its launch in June, the PG­BI has in­vest­ed $120 mil­lion in small- to medi­um-sized biotechs span­ning sev­er­al key fo­cus ar­eas: in­ter­nal med­i­cine, in­flam­ma­tion and im­munol­o­gy, on­col­o­gy, rare dis­ease, vac­cines and hos­pi­tal. So far, Ho­mol­o­gy Med­i­cines has the largest stake, with $60 mil­lion to ad­vance its phenylke­tonuria (PKU) pro­gram.

In­spired by the abil­i­ty of fe­cal trans­plants to re­boot the bal­ance of healthy mi­crobes in the gut, Vedan­ta is work­ing on tai­lored pack­ages of bac­te­r­i­al strains de­signed to spur spe­cif­ic ther­a­peu­tic re­spons­es. The com­pa­ny says Pfiz­er’s in­vest­ment will fund a Phase II tri­al for its live bio­ther­a­peu­tic to treat IBD — dubbed VE202 — which is ex­pect­ed to launch this year.

VE202 is pro­duced from pure, clon­al bac­te­r­i­al cell banks, by­pass­ing the need for di­rect sourc­ing of fe­cal donor ma­te­r­i­al. Topline Phase I da­ta showed VE202 was gen­er­al­ly safe and well-tol­er­at­ed, and “demon­strat­ed durable and dose-de­pen­dent col­o­niza­tion,” Vedan­ta said.

“We be­lieve Vedan­ta’s ap­proach to mod­u­lat­ing the mi­cro­bio­me may hold promise for peo­ple liv­ing with IBD, and we are ex­cit­ed for its po­ten­tial as this im­por­tant study moves for­ward,” Michael Vin­cent, se­nior VP and CSO of Pfiz­er’s in­flam­ma­tion and im­munol­o­gy re­search unit, said in a state­ment.

Vin­cent is join­ing Vedan­ta’s sci­en­tif­ic ad­vi­so­ry board, and Pfiz­er holds rights to first ne­go­ti­a­tion on VE202. Mer­ck and Ab­b­Vie vet Jef­frey Sil­ber is lead­ing Vedan­ta’s ef­forts as CMO af­ter join­ing the com­pa­ny back in Sep­tem­ber.

Ho­mol­o­gy and Vedan­ta aren’t the on­ly two Mass­a­chu­setts-based biotechs to ben­e­fit from the PG­BI. Cam­bridge-head­quar­tered Tril­li­um Ther­a­peu­tics al­so snagged a $25 mil­lion in­vest­ment for its CD47 pro­gram. ES­SA Phar­ma, lo­cat­ed in Van­cou­ver, British Co­lum­bia, re­ceived a $10 mil­lion in­vest­ment for its work in the prostate can­cer space.

“Now, more than ever, our pa­tients need us, work­ing to­geth­er, to turn great sci­en­tif­ic ideas in­to in­no­v­a­tive new med­i­cines,” Pfiz­er said in a state­ment in June.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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