Former Akcea president makes the leap to CEO seat at Avidity Biosciences; Astellas invests $12.5M into two incubators

October 1, 2019 10:52 AM EDTUpdated 12:11 PM

Former Akcea president makes the leap to CEO seat at Avidity Biosciences; Astellas invests $12.5M into two incubators

Endpoints Staff

→ After it was announced last week, in a surprise twist, that Akcea president Sarah Boyce along with her two top exec colleagues, CEO Paula Soteropoulos and COO Jeffrey Goldberg were hitting the exit at the Ionis spinoff, Boyce has found a new home. Boyce has been tapped to the helm of Avidity Biosciences — a company pioneering antibody-oligonucleotide conjugates (AOCs) — as their new CEO, president and board member. Boyce will draw from experience from her previous stints at Ionis, Forest Laboratories, Alexion Pharmaceuticals, Novartis Oncology and Roche.

→ ElevateBio — the cell and gene therapy umbrella company run by former Alexion chief David Hallal — on Tuesday unveiled the launch of HighPassBio, which is focused on developing T-cell immunotherapies. The startup’s lead experimental product, developed by researchers at Fred Hutchinson Cancer Research Center, is engineered to treat and potentially prevent relapse of leukemia following hematopoietic stem cell transplant. The therapy is currently in early-stage development.

→ A little after Astellas secured approval for Roxadust, which was co-developed with FibroGen, in Japan for patients with chronic kidney disease, the Tokyo-based company is now investing $12.5 million into two innovation incubators operated by LabCentral — a US-based laboratory facility for biotech startups focused on cell and gene therapies.

The investment will make Astellas “the only pharmaceutical/biotechnology company among five Founding Sponsors of a new incubator, which will feature a core lab space where companies can easily conduct process development studies and a non-GMP pilot plant, being developed by LabCentral” in Cambridge. The new incubator is expected to be operational in 2021.

In addition, Astellas will invest at least $450,000 over three years to become a Gold Sponsor of LabCentral’s existing incubator located in Cambridge.

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Endpoints Staff

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June 3, 2020 08:57 AM EDT

R&D

Is a powerhouse Merck team preparing to leap past Roche — and leave Gilead and Bristol Myers behind — in the race to TIGIT domination?

John Carroll

Editor & Founder

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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June 2, 2020 06:00 AM EDTUpdated 07:18 AM

Venture

Pfizer’s Doug Giordano has $500M — and some advice — to offer a certain breed of 'breakthrough' biotech

John Carroll

Editor & Founder

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Platform and the Evolution Toward Off-The-Shelf Immuno-Oncology Approaches

Peter Kufer

Vice President & Innovator of BiTE® Technology, Amgen

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Process Development Scientist, Compound Management

Recursion Pharmaceuticals

Salt Lake City, UT

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June 3, 2020 07:39 AM EDT

Coronavirus

Covid-19 roundup: BARDA supports Operation Warp Speed with big $628M contract to service America's vaccine production needs

Natalie Grover

Reporter

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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June 3, 2020 07:34 AM EDT

R&D

Regulatory

FDA delays decision on Novartis’ potential blockbuster MS drug, wiping away priority review

Jason Mast

Associate Editor

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Adam Keeney (NodThera)

June 3, 2020 07:36 AM EDTUpdated 08:32 AM

Venture

As NLRP3 players head for first clinical face-off, Novo, Sanofi fuel trans-Atlantic contender with $55M

Amber Tong

Editor

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

Ken Frazier, AP Images

June 2, 2020 11:17 AM EDTUpdated 6 hours ago

People

R&D

In Focus

Why Merck waited, and what they now bring to the Covid-19 fight

Jason Mast

Associate Editor

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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ENDPOINTS CAREERS

Senior Drug Discovery Scientist

New York, NY

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Mark Genovese (Stanford via Twitter)

June 2, 2020 10:31 AM EDTUpdated 10:45 AM

People

Gilead woos filgotinib clinical investigator from Stanford to lead the charge on NASH, inflammatory diseases

Amber Tong

Editor

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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June 2, 2020 10:19 AM EDT

Protocols

Novartis chips in $10M for IPO-bound partner Pliant; Tenax shares soar on heart drug data

Endpoints Staff

→ Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.