Bernat Olle, Vedanta Biosciences CEO (Vedanta)

Building off Pfizer investment, microbiome-focused Vedanta expands new fundraise to launch 2 studies

A little more than six months after winning an endorsement from Pfizer for its IBD microbiome program, Vedanta Biosciences is ready to step on the gas.

Vedanta wrapped up a $68 million Series D raise Wednesday morning, which included the $25 million equity investment Pfizer plunked down back in January. With the biotech content with its early-stage results and manufacturing capabilities, Vedanta is getting ready to potentially launch multiple mid- to late-stage studies and needed the extra cash, CEO Bernat Olle tells Endpoints News.

“With the last financing, we already started to delve into our first patient studies, including our lead program into Clostridioides difficile infection, which is in Phase II,” Olle said. “Now that we’re looking at the end of that study, in anticipation of the results we’re starting to prepare for the late-stage study.”

The Phase II study is expected to read out data by the end of September, and Vedanta plans to have its Phase III manufacturing facility up and running at the end of 2021. Should everything proceed according to plan, the Phase III trial will begin in mid-2022.

On top of this lead candidate, known as VE303, Vedanta is anticipating advancing a second program for IBD with Wednesday’s funds. That’s Pfizer’s focus, and the biotech expects to launch the Phase II study for the candidate, known as VE202, in the second half of this year.

Vedanta is aiming to shake up the field of microbiome treatments, which thus far has typically seen companies develop therapeutics based on fecal transplants to restore balance of healthy microbes in the gut. The Cambridge, MA-based biotech is taking a different approach, however, utilizing clonal cell banks to make their experimental drugs rather than rely on donor samples.

It’s a method Olle says is similar to how the biotech industry evolved over the years from making drugs based on plasma donations to focusing more on monoclonal antibodies. The old approach became a particular thorn in biotech’s side several decades ago, Olle said, when the rise of HIV and hepatitis C — which could be passed through transfusions — made the treatments highly risky.

Looking out at the rest of the microbiome field, Olle thinks similar issues are popping up again. Vedanta hopes to eliminate the variability seen among donor samples and developing therapies that are all the same.

With their cell banks, Vedanta can “create a cell line, store it in a freezer and essentially have unlimited supply in the future,” Olle said. “We can go back to the freezer stock and start the fermentation process where every capsule has the exact same composition every time, in contrast to those based on transplants.”

Investors largely fled the microbiome treatment space after a key late-stage flop in 2016 from Seres Therapeutics sent VCs running. But cash has slowly started to trickle back in as new successes emerge. In May 2020, Rebiotix presented positive data from a placebo-controlled study for its own C. diff transplant therapy, and earlier this month, after Seres found promising results with a new tack, Nestlé dropped $525 million to fund development for their lead microbiome treatment.

The round also marks another win this week for PureTech, which founded Vedanta in 2010. On Monday, the PureTech-backed entity Gelesis, developing a weight management capsule that makes patients feel fuller, shuffled to Nasdaq through a SPAC merger.

Wednesday’s financing was led by affiliates of Magnetar Capital. Other participants included new and earlier investors such as Verition Fund Management, Fosun Health Capital, co-founder PureTech Health, Rock Springs Capital, Skyviews Life Science, JSR Corporation, SymBiosis LLC, Shumway Capital and Health for Life Capital, among others.

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UPDATED: Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multibillion-dollar buyout of an mRNA pioneer after falling behind in the race for a Covid-19 jab — report

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clinical trials lined up for Zentalis drugs, China's Zentera sets its sights on more dealmaking and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What happens when you give a mouse a human self-antigen? Investors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UPDATED: Watch out GlaxoSmithKline: AstraZeneca's once-failed lupus drug is now approved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mRNA vaccines are created equal. Does it matter?; Neuro is back; Private M&A affair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's oncology head Rick Pazdur defends the accelerated approval pathway, claiming it is 'under attack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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