#BIO22: BIO chair Paul Hastings: ‘I think people should speak their truth’

Paul Hastings, BIO chair

June 9, 2022 12:31 PM EDTUpdated June 10, 12:15 AM

#BIO22: BIO chair Paul Hastings: 'I think people should speak their truth'

John Carroll

Editor & Founder

Paul Hastings doesn’t offer the usual biotech executive cliches. The ones endorsed by the media consultant crowd. And sometimes the Nkarta CEO doesn’t even wait for a question before jumping straight to his answers, his truth, as he likes to call it. And that was the way we started our conversation about his first year as chair of BIO, and how the next year is shaping up. Hastings will join our panel on managing a biotech during turbulent times, which will be available in a live setting in San Diego, or online. You can register for that — along with a lineup of virtual events — here. — John Carroll

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Lina Gugucheva, NewAmsterdam Pharma CBO

June 28, 2022 08:00 AM EDT

Deals

Pharma group bets up to $1B-plus on the PhIII resurrection of a once dead-and-buried LDL drug

John Carroll

Editor & Founder

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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June 28, 2022 07:17 AM EDT

Pharma

In Focus

How prepared is biopharma for the cyber doomsday?

Amber Tong

Senior Editor

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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June 27, 2022 07:00 AM EDT

R&D

Scoop: Boehringer quietly shutters a PhII for one of its top drugs — now under review

Kyle LaHucik

Associate Editor

John Carroll

Editor & Founder

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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ENDPOINTS CAREERS

Director of Quality Assurance

ImmunityBio

Dunkirk, NY, USA

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

June 28, 2022 07:00 AM EDT

People

Startups

Longtime biotech leader Pearl Huang takes the reins as CEO of Novartis-backed upstart

Tyler Patchen

News Reporter

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

June 28, 2022 07:47 AM EDT

R&D

Roivant chops sickle cell gene therapy, dermatology drugs to focus on 'higher value projects'

Amber Tong

Senior Editor

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

June 28, 2022 07:15 AM EDTUpdated 07:26 AM

R&D

Still in preclinical testing for ear gene therapies, Decibel touts small snapshot of chemo-induced hearing loss drug

Max Gelman

Senior Editor

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Deborah Dunsire, Lundbeck CEO

June 27, 2022 01:43 PM EDT

R&D

After a 5-year repeat PhIII sojourn, Lundbeck and Otsuka say they're finally ready to pursue OK to use Rexulti against Alzheimer's agitation

John Carroll

Editor & Founder

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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ENDPOINTS CAREERS

Product Sales Manager

ImmunityBio

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Chris Anzalone, Arrowhead CEO

June 27, 2022 11:12 AM EDT

R&D

Takeda, Arrowhead spotlight data from small trial showing RNAi works in a rare liver condition

Amber Tong

Senior Editor

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Ben Zimmer, Priovant CEO

June 28, 2022 06:18 AM EDT

Startups

Roivant unveils latest spinout as Pfizer entrusts JAK1/TYK2 to Priovant

Amber Tong

Senior Editor

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.