Sanofi steps up with its data on a new MS drug, shining a spotlight on PhIII hopes after fending off a short attack

Paul Hudson, Sanofi CEO (Getty Images)

April 23, 2020 01:00 AM EDTUpdated April 24, 06:47 AM

Sanofi steps up with its data on a new MS drug, shining a spotlight on PhIII hopes after fending off a short attack

John Carroll

Editor & Founder

Sanofi CEO Paul Hudson was drawn early on in his new job to a multiple sclerosis drug in the pipeline, talking it up ahead of the mid-stage data and later reserving a prominent place in the late-stage pipeline on the top-line readout. Sanofi has started to map out an ambitious Phase III effort aimed at taking it over the commercial line — even as they face delays inflicted by Covid-19.

On Thursday morning, researchers spelled out the data for the Phase IIb that give them confidence that SAR442168 has the potential to play a disruptive role in the MS market — where some tough competitors are roiling the field even as physicians and patients continue to press for more choices.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

August 3, 2020 01:40 PM EDTUpdated August 4, 03:38 AM

R&D

Coronavirus

When will it end? Goldman economist gives late-stage vaccines a good shot at targeting 'large shares' of the US by mid-2021 — but the downside is daunting

John Carroll

Editor & Founder

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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August 3, 2020 10:53 AM EDT

R&D

Regulatory

J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about?

John Carroll

Editor & Founder

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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August 4, 2020 04:20 PM EDTUpdated 1 hour ago

Coronavirus

UPDATED: Novavax heralds the latest positive snapshot of early-stage Covid-19 vaccine — so why did its stock briefly crater?

John Carroll

Editor & Founder

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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August 5, 2020 08:00 AM EDT

Venture

Startups

Versant debuts Ridgeline's startup #4, armed with $30M and alternative TCR cell therapies for solid tumors

Amber Tong

Editor

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

August 5, 2020 07:36 AM EDTUpdated 08:18 AM

Coronavirus

Covid-19 roundup: BARDA quietly pulls plug on IL-6 drugs; BioNTech and Fosun begin mRNA trial

Max Gelman

Associate Editor

Nicole DeFeudis

Associate Editor

IL-6 inhibitors showed some early promise in potentially treating Covid-19 patients, but recent trial flops have dashed hopes. Now it appears BARDA has officially pulled the plug.

The HHS office’s website has quietly updated to reflect that it is “no longer supporting product development” for Covid-19 in both Actemra (tocilizumab) and Kevzara (sarilumab), dealing a blow to the Roche and Regeneron/Sanofi drugs. This all but assures that IL-6 drugs repurposed to treat Covid-19 are essentially dead in the water.

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August 5, 2020 07:22 AM EDT

Venture

Cell/Gene Tx

CF Foundation, Longwood team on new incubator for companies with cutting-edge CF treatments

Jason Mast

Associate Editor

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

Kiersten Stead, John Hamer (DCVC Bio)

August 5, 2020 06:00 AM EDT

Venture

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life science spear

Amber Tong

Editor

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.

ENDPOINTS CAREERS

Director of Clinical Operations

Recursion Pharmaceuticals

Salt Lake City, UT

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August 4, 2020 10:26 AM EDT

R&D

Novartis says Kymriah reaches primary endpoint in new PhII, although numbers still to come

Max Gelman

Associate Editor

The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.

Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.

August 4, 2020 09:34 AM EDT

R&D

AbbVie shrugs off $134M cash deals, quitting a neuro R&D pact with Voyager Therapeutics on vectorized antibody treatments

Nicole DeFeudis

Associate Editor

It’s the end of the road for Voyager Therapeutics’ collaboration with AbbVie on tau and alpha-synuclein vectorized antibody development.

In two deals spanning the last two years, AbbVie dropped more than $134 million upfront for Voyager’s preclinical R&D of vectorized antibody treatments for diseases like Alzheimer’s and Parkinson’s. But Voyager says AbbVie is walking away now, without offering an explanation for why.