That $335M JV Bayer set up on CRISPR/Cas9? They’re letting the biotech partner carry on

October 21, 2019 02:13 PM EDT

That $335M JV Bayer set up on CRISPR/Cas9? They’re letting the biotech partner carry on

John Carroll

Editor & Founder

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Samarth Kulkarni

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.

Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

As Casebia’s programs have advanced beyond the discovery stage, we are evolving the operating model to leverage the manufacturing and clinical expertise of CRISPR Therapeutics to further accelerate these programs.

And Kemal Malik, Bayer board member for innovation, says Bayer remains excited about the prospect of what’s ahead.

CRISPR’s shares surged 7.5% Monday morning.

Under the original plan, the JV planned to hire 80 staffers and house them in the heart of the Cambridge hub, with support work at the biotech as well as Bayer’s R&D centers in Europe and San Francisco. But it’s CRISPR’s show now.

AUTHOR

John Carroll

Editor & Founder

john@endpointsnews.com @JohnCendpts

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Data Literacy: The Foundation for Modern Trial Execution

Kristin Mauri

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

January 25, 2021 06:45 AM ESTUpdated 07:07 AM

Coronavirus

Merck scraps Covid-19 vaccine programs after they fail to measure up on efficacy in another major setback in the global fight

John Carroll

Editor & Founder

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

January 25, 2021 04:54 PM ESTUpdated 4 hours ago

In Focus

After 3 deaths rock the field, gene therapy researchers contemplate AAV's future

Jason Mast

Editor

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

January 26, 2021 04:55 PM ESTUpdated 05:23 PM

R&D

Agios scores its second positive round of data for its lead pipeline drug — but that won't answer the stubborn questions that surround this program

John Carroll

Editor & Founder

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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January 26, 2021 10:58 AM ESTUpdated 06:09 PM

Manufacturing

Vir's CMO says he's surprised that a low dose of their hepatitis B drug appears promising in early slice of data — shares soar

Conner Mitchell

Associate Editor

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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January 26, 2021 10:30 AM ESTUpdated 11:18 AM

Coronavirus

Eli Lilly demonstrates that 2 antibodies beat 1 for guarding against severe Covid-19. But can that solve the first antibody’s problem amid slow uptake?

Jason Mast

Editor

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

January 26, 2021 07:35 AM ESTUpdated 07:48 AM

R&D

Coronavirus

Regeneron touts positive preliminary impact of its Covid antibody cocktail, preventing symptomatic infections in high-risk group

John Carroll

Editor & Founder

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Matt Gline (L) and Vivek Ramaswamy

January 25, 2021 09:30 AM ESTUpdated 01:19 PM

Bioregnum

Scoop: Vivek Ramaswamy is handing the CEO job to a top lieutenant at Roivant — but he’s not exactly leaving the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

January 25, 2021 08:00 AM EST

Regulatory

Albireo just advanced down to the 10-yard line at the FDA. And Ron Cooper’s team is getting prepped for the next big play

John Carroll

Editor & Founder

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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