Merck revs up dealmaking engine ahead of #JPM22, inking collaborations with AI protein design player Absci

In the year-plus since Roger Perlmutter left his post leading Merck’s R&D efforts, the Big Pharma’s new leadership has continued to pursue an aggressive dealmaking strategy. On Friday, Merck enlisted a new partner as the spree shows no signs of slowing down.

Merck signed a pair of collaborations with Absci aiming to bolster its AI research capabilities, the companies announced Friday. The first is a relatively modest deal on Merck’s end — there are no details about the upfront or milestone payments but the duo said it could lead to more.

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Their Staying Power Lies in their Patient-Centricity

Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.

Exscientia CEO Andrew Hopkins and Sanofi CEO Paul Hudson

Drug R&D has for years had an abysmal track record of success, with the vast majority of drug candidates never making it to market. The promise of AI to shorten the discovery time for new drugs and up their chances of success has more big drugmakers buying in — and Sanofi is the latest.

Sanofi will pay $100 million upfront with a potential $5.2 billion in downstream milestones for access to up to 15 small molecule drugs from Exscientia, a red-hot UK deep learning company at the forefront of the so-called ‘AI-discovered’ drug R&D movement, the partners said Friday.

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A district court in Texas will likely tie up the FDA’s FOIA office for months, as the court ruled late Thursday that the agency must release all documents related to its review of Pfizer-BioNTech’s Covid-19 vaccine.

The order from district judge Mark Pittman, handed down late Thursday, notes that while the Court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA, there also ‘may not be’ a more important issue at the FDA right now than the pandemic, the Pfizer vaccine, getting every American vaccinated, and making sure to the American public that the process was not rushed.

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Scott Clarke, Ambagon Therapeutics CEO

The saying goes necessity is the mother of invention — and few areas of drug development are in greater need than oncology. A new startup is now repurposing promising technology to tackle the hardest-to-drug proteins, and a suite of big-name backers are buying in.

Ambagon Therapeutics launched Friday with an $85 million A round and a world-class group of researcher-founders building what are known as ‘molecular glues’ to crack the code on a class of elusive cellular proteins, the biotech said.

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Cytokinetics stumbled a bit with its closely watched lead heart drug over the last year or so, losing two pharma partners after missing a key secondary endpoint in a Phase III study. But things are looking up in 2022, as Royalty Pharma is reaching a little deeper into its wallet to bolster that program and another heart candidate.

Royalty Pharma has agreed to lend up to $300 million to support the potential commercialization of Cytokinetics’ lead candidate, omecamtiv mecarbil, and development of its other heart program, aficamten. The cash will come in five tranches, including an initial tranche of $50 million upon closing and four others upon certain regulatory and clinical milestones. Each tranche has an interest-free and payment-free period of six calendar quarters, followed by 34 calendar quarters of installment re-payments totaling 1.9 times the amount drawn.

Regeneron has held high hopes for evinacumab, a rare cholesterol disorder drug that earned a first-in-class nod from the FDA early last year, as a centerpiece of its cardiometabolic franchise. Now, the company is tapping an ultra-rare specialist to take evinacumab to the next level abroad.

Regeneron will receive $30 million in upfront cash and a potential $63 million in downstream milestones from Ultragenyx for ex-US licensing rights to Evkeeza (evinacumab), an ANGPTL3 blocker with an FDA approval to treat a rare cholesterol disorder alongside LDL-C lowering therapy and diet, the companies said Friday.

New year, same Fujifilm Diosynth.

The CDMO giant hit the ground running at full speed this year, announcing it will expand its BioProcess Innovation Center in Research Triangle Park, NC. The move will double its existing laboratory footprint in the Tar Heel State, and add another 145 skilled jobs to the site by 2024. Another 89,000 square feet will be added, which will allow for a more robust commercial process.

Aligos Therapeutics took a beating Thursday after reporting it is stopping development on its lead program for chronic hepatitis B.

The biotech’s shares $ALGS closed down 57% and fell into penny stock territory Thursday, following a morning press release saying Aligos’ ALG-010133 program did not prove efficacious at the dose tested in a Phase I study. Additionally, the company concluded that higher doses were also unlikely to be effective, and ultimately decided to axe the candidate altogether.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

AstraZeneca — or, more specifically, its rare disease subsidiary Alexion — is serious about getting into ATTR amyloidosis.

Just weeks after licensing a late-stage antisense candidate from Ionis, AstraZeneca has struck another deal to pick up a Phase Ib antibody hitting the same target, this time from Swiss biotech Neurimmune.

The upfront from Alexion comes in at $30 million, with the potential to add up to $730 million in milestones. Alexion is hoping the program would tackle transthyretin amyloid cardiomyopathy, or ATTR-CM, which is characterized by cardiac buildup of toxic amyloid fibrils.
https://endpts.com/merck-revs-up-dealmaking-engine-ahead-of-jpm22-inking-collaborations-with-ai-protein-design-player-absci