Jeff Bluestone just raised $265M to develop curative cell therapies. We asked him how

Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

August 4, 2021 07:00 AM EDT

Jeff Bluestone just raised $265M to develop curative cell therapies. We asked him how

John Carroll

Editor & Founder

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

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The Factors Driving a Rapid Evolution of Gene & Cell Therapy and CAR-T Clinical Research in APAC

Kasey Kime

Director of Regulatory Affairs at Novotech

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region.

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

September 24, 2022 06:00 AM EDT

Weekly

The Endpoints 11; bluebird's $3M gene therapy; Biogen tout new neuro data; Harsh reviews for cancer drugs; and more

Amber Tong

Senior Editor

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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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September 22, 2022 07:01 AM EDTUpdated September 23, 04:21 AM

Special

The Endpoints 11: The top private biotechs in pursuit of new drugs. Pushing the envelope with powerful new technologies

John Carroll

Editor & Founder

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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ENDPOINTS CAREERS

Head of Site Finance mRNA - Cell & Gene

Lonza

Geleen, Netherland

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September 23, 2022 12:30 PM EDT

Pharma

Manufacturing

EMA warns of shortages of two Boehringer heart drugs due to a spike in demand

Tyler Patchen

News Reporter

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

Jim Wells (UCSF)

September 23, 2022 08:37 AM EDT

Discovery

Antibodies once acted only as protein blockers. Now, scientists are finding new ways to make them protein destroyers

Lei Lei Wu

News Reporter

The first lab-made antibody medicine was approved in 1986 — it bound to an antigen known as CD3 on T cells and was meant to prevent kidney transplant rejection. While antibody technology improved, most antibodies were made as blocking agents, neutering clamps that attacked cells and proteins.

But then scientists got creative with their engineering. They made antibody-drug conjugates, or ADCs for short, which attached toxins or drugs to the antibodies, enabling them to kill cells. Then they made CAR-T therapies, which attached a patient’s T cell to the targeting fragment of an antibody, to destroy cancer cells.

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Wendy Lund, WPP chief client officer for health and wellness

September 22, 2022 10:36 AM EDTUpdated 12:10 PM

People

Pharma

Marketing

WPP taps Organon chief communications officer Wendy Lund for new health and wellness client role

Beth Snyder Bulik

Senior Editor

Wendy Lund is going home – to WPP, that is. Lund is leaving the Merck women’s health spinoff Organon where she is chief communications officer for a newly created role as WPP chief client officer for health and wellness. Before Organon, Lund led GCI Group, a WPP healthcare communications agency, as CEO for 11 years.

Lund joins WPP’s group of global client leaders who act as a single point of contact or entry for clients with WPP brands and businesses inside the holding company. and in this case, for the WPP health and wellness business.

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September 23, 2022 02:38 PM EDTUpdated 03:37 PM

R&D

AstraZeneca, Merck cull one Lynparza indication in heavily pretreated ovarian cancer patients

Paul Schloesser

Associate Editor

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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ENDPOINTS CAREERS

Head of Quality Systems

Lonza

Lexington, MA, USA

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September 23, 2022 02:29 PM EDTUpdated 04:16 PM

Manufacturing

Fujifilm continues CDMO expansion, breaking ground on $435M UK site

Tyler Patchen

News Reporter

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

September 23, 2022 01:48 PM EDT

Pharma

FDA+

Manufacturing

Another Cipla site lands a Form 483 over cleaning issues and QC controls

Tyler Patchen

News Reporter

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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