Medicxi bankrolls the launch of a pair of biotech twins focused on orexins for narcolepsy and more

February 4, 2019 06:47 AM EST

John Carroll

Medicxi bankrolls the launch of a pair of biotech twins focused on orexins for narcolepsy and more

The venture investors at Medicxi are funding a pair of biotech spinouts from UK-based Sosei Heptares, which has been fine tuning its expertise in G protein-coupled receptors for a number of years now.

Francesco De Rubertis

Medicxi is offering €40 million to kickstart two new companies — the twins Orexia and Inexia, which will target Orexin OX1 and OX2 for neurological diseases. The Heptares subsidiary will put its researchers to work on the two projects, identifying narcolepsy as one key disease on the menu.

Orexins are well known targets in the biotech world. These neuropeptides are involved in the regulation of sleep, wakefulness and appetite.

Malcolm Weir

Medicxi partner Francesco De Rubertis will sit on the board to watch over the firm’s investment. Both of these groups have deep roots in the UK, with Sosei looking to build up the Heptares operation under Malcolm Weir.

The VC’s cash should be enough to get through proof-of-concept studies, fitting neatly in Medicxi’s asset-centric focus, which often focuses the money on early-stage research programs stripped of as much overhead as they can.

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December 12, 2019 09:18 AM ESTUpdated 09:47 AM

John Carroll

R&D

On the heels of promising MCL data, Kite hustles its 2nd CAR-T to the FDA as the next big race in the field draws to the finish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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Paul Hudson, Getty Images

December 9, 2019 05:27 PM ESTUpdated December 10, 08:48 AM

John Carroll

R&D

UPDATED: Sanofi CEO Hudson lays out new R&D focus — chopping diabetes, cardio and slashing $2B-plus costs in surgical dissection

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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December 12, 2019 08:57 AM EST

Jason Mast

R&D

Correvio is putting itself up on the auction block after FDA review panel points to another rejection

For 13 years, the Canadian biotech Correvio tried to get the FDA to accept a heart drug since abandoned by Merck and Astellas. Yesterday, the agency’s outside experts voted 11-2 against approval, all but assuring another rejection for the atrial fibrillation compound vernakalant.

And today Correvio announced that Correvio may soon be no more. The company said it is looking to sell itself as its stock plummets into penny-stock territory $CORV and its potential moneymaker sputters once more.

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Psilocybin mushrooms (via The Denver Post)

December 12, 2019 07:22 AM ESTUpdated 08:39 AM

Natalie Grover

R&D

In a key step for psychedelic research, magic mushroom compound clears first clinical safety hurdle

Exasperated with the often-ineffective existing slate of antidepressants, COMPASS Pathways set up shop in London 2016 — and made a beeline for psilocybin, the psychoactive ingredient in magic mushrooms.

On Wednesday, the startup said its man-made version of the chemical — which is illegal across geographies in its natural fungi form — had been well-tolerated in an early-stage, placebo-controlled trial in 89 healthy volunteers.

December 12, 2019 07:08 AM EST

Amber Tong

China

IPOs

Alphamab Oncology rounds out HKEX's second biotech IPO year with $230M raise and high local interest

Alphamab Oncology has inspired a surge of local interest in what will likely be the Hong Kong Stock Exchange’s last biotech run of the year, pricing its IPO on the high end of the range and raising over $230 million (HK$1.83 billion).

After rejigging the offering structure and making up to 50% available for enthusiastic local investors, the biotech sold 179.4 million shares at $1.31 (HK$10.2) and saw its stock rise to $1.77 ($13.8) on the first day of trading.

December 12, 2019 07:02 AM ESTUpdated 07:15 AM

John Carroll

R&D

For sale: Long-acting PhIII GLP-1 diabetes drug that’s way behind rivals, now spurned by Sanofi

Almost exactly 4 years ago Sanofi came to the bargaining table with South Korea’s Hanmi bearing $434 million dollars in cash and offering about $4 billion in milestones to in-license their once-weekly GLP-1 injectable. The pact was intended to revive their ailing diabetes division. Instead, it turned into a very expensive grave to mark the end of Sanofi’s R&D ambitions in the field.

Sanofi CEO Paul Hudson used efpeglenatide’s demise — while committing to paying hundreds of millions of more dollars to push it through 5 late-stage studies — as a marker of the company’s determination to stay focused on first and best-in-class drugs.

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December 11, 2019 10:23 AM ESTUpdated 5 hours ago

John Carroll

R&D

What does $6.9B buy these days in oncology R&D? AstraZeneca has a landmark answer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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December 12, 2019 06:00 AM ESTUpdated 09:19 AM

Jason Mast

Startups

Parkinson's transplants emerge as stem cell pioneer Jeanne Loring joins R&D race

Jeanne Loring hadn’t studied Parkinson’s in 22 years when she got an email from a local neurologist.

The neurologist, Melissa Houser, didn’t know Loring had ever published on the disease. She was just looking for a stem cell researcher who might hear her out.

“I think I was just picked out of a hat,” Loring told Endpoints News.

At a meeting in Loring’s Scripps Research office, Houser and a Parkinson’s nurse practitioner, Sherrie Gould, asked her why there was so much research done in stem cell transplants for other neurodegenerative diseases but not Parkinson’s. They wanted to know if she would work on one.

Paul Hudson, Sanofi

December 10, 2019 10:46 AM ESTUpdated 11:00 AM

John Carroll

R&D

Paul Hudson promises a bright new future at Sanofi, kicking loose me-too drugs and focusing on landmark advances. But can he deliver?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class. The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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