An Alzheimer’s darkhorse fails its first big trial, but offers hope for a long-overlooked hypothesis

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

October 26, 2021 04:00 PM EDTUpdated 04:18 PM

R&D

An Alzheimer's darkhorse fails its first big trial, but offers hope for a long-overlooked hypothesis

Jason Mast

Editor

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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December 7, 2021 07:00 AM ESTUpdated 03:54 PM

People

Special

Special report: Meet 20 extraordinary women who are supercharging biopharma R&D

Endpoints Staff

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Optimizing Oral Drug Delivery using Zydis® Orally Disintegrating Tablet Technology to Address Patient Challenges

Catalent

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
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A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

December 6, 2021 09:52 AM EST

Deals

Bioregnum

The 2022 wave coming? Top analyst says Big Pharma will have more than $1T available to satisfy its growing appetite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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ENDPOINTS CAREERS

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

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December 7, 2021 11:00 AM EST

R&D

Merck pumps the brakes on two more PhIII trials for its lead anti-HIV drug

Zachary Brennan

Senior Editor

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Bolt Bio CEO Randy Schatzman

December 6, 2021 10:59 AM EST

R&D

Bolt Bio goes bust as investors boo single response in early test against HER2-expressing tumors

Kyle Blankenship

Managing Editor

Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech said Monday.

BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.

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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)

December 6, 2021 10:50 AM ESTUpdated 11:13 AM

R&D

Biohaven shakes up leadership team as it feels the heat from migraine competitors

Josh Sullivan

Associate Editor

As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.

Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.

Chen Schor, Adicet CEO

December 6, 2021 07:04 AM ESTUpdated 11:32 AM

R&D

Cell/Gene Tx

Adicet unveils early responses for off-the-shelf drug leveraging rare T cells. Will durability hold up?

Kyle Blankenship

Managing Editor

On the hunt for the next generation of “off-the-shelf” cell therapies, biotech players like Adicet Bio have looked to leverage some of the less-obvious members of the immune system as potent cancer fighters. In Adicet’s case, scarce gamma delta T cells are on the menu, and an early cut of data is showing some promise.

Adicet’s AD-001, an off-the-shelf cell therapy developed by engineering a CD20-targeting chimeric antigen receptor (CAR) onto a donor’s gamma delta T cells, posted two complete responses across four patients in an early Phase I study testing the drug in patients with heavily pretreated B cell non-Hodgkin’s lymphoma, the biotech said Monday.

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ENDPOINTS CAREERS

Executive Director - Data Analysis - Science & Technology

Alexandria Real Estate Equities

Pasadena, CA

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December 7, 2021 01:28 PM ESTUpdated 01:39 PM

Pharma

Marketing

MarketingRx Matchup: How AbbVie and Biohaven ads rank in head-to-head migraine challenge

Beth Snyder Bulik

Senior Editor

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

December 7, 2021 01:14 PM EST

Pharma

Marketing

Q&A: Organon chief communications officer Wendy Lund talks about the Merck spinoff, women’s health and why it matters

Beth Snyder Bulik

Senior Editor

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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