Stephen Elledge (Emmanuel Ording, Harvard)

Stephen Elledge's Harvard lab again proves fruitful with the launch of high-throughput antibody startup

After working with esteemed Harvard professor Stephen Elledge to launch TCR-focused TScan Therapeutics three years ago, the Longwood Fund approached the scientist last spring about spinning out more of his work.

Together, they launched a Cambridge, MA-based startup in December called ImmuneID, which uses Elledge’s platform to identify and target the antibody interactions that drive immune diseases, like severe allergies. And on Wednesday morning, the company unveiled a $50 million Series A round, bringing its total raise to over $70 million.

Christoph Westphal

“ImmuneID’s unique and powerful immunological target identification platform unlocks the complexity of human immune responses to guide the development of precision immunology therapeutics in areas where there remains significant unmet patient need,” Longwood’s Christoph Westphal said in a statement.

The round was led by Alta Partners, with a hand from Alexandria Venture Investments, Redwood Capital Investments, Section 32, Tekla Capital Management, Arch Venture Partners, the Longwood Fund, Pitango Health Tech, In-Q-Tel, Xfund and others.

While Elledge set out with TScan to screen antigen-TCR matches in a faster, more systematic way, ImmuneID is looking at antibody targets. The platform is based on tech developed along with Johns Hopkins’ Ben Larman and Harvard’s Tomasz Kula, and uses next-gen sequencing, robotic automation and AI to “interrogate and ultimately drug” the immune system. It requires small volumes of fluids (like plasma or saliva), that can be fresh or frozen, providing the company flexibility to survey broad patient populations. And every time the team runs the platform, they collect a huge amount of data on hundreds of thousands of antibody interactions.

David Donabedian

“So you can imagine what you find are antibodies against viruses if that’s what you’re interested in; you find IgE antibodies against allergens that could cause anaphylaxis, you find autoantibodies that might be markers of autoimmune disease, cancer, etc.,” said Lea Hachigian, who was CEO before David Donabedian took the helm in April.

The company plans on developing its own, in-house pipeline of next-gen precision therapies, though Donabedian says the team will “remain open to other business development opportunities as they arise.” He declined to comment on a timeline for reaching the clinic.

“Though we can’t provide more detail at this time, we have engaged in promising conversations with potential biotech and pharma partners,” he said via email.

While Hachigian told Endpoints News in February that allergies will be the team’s main focus to start, Donabedian says the company is also continuing its work on other areas of focus, including autoimmune diseases, cancer and infectious diseases.

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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