A veteran oncology startup crew is making a very serious bet that they’ve found the key to unlocking the promise of oncolytic viruses

Clodagh O’Shea (Salk)

January 5, 2021 06:00 AM ESTUpdated 07:03 AM

A veteran oncology startup crew is making a very serious bet that they’ve found the key to unlocking the promise of oncolytic viruses

John Carroll

Editor & Founder

Five years ago, when Amgen ushered the oncolytic virus T-Vec over the finish line at the FDA, 2 things seemed completely clear in short order.

One was that an important new avenue in cancer therapy had been opened up, finding a clean shot at solid tumors while recruiting an immune system attack to “mop up” cancer cell survivors. The other was that any of a number of upstart rivals following that path could do a lot better.

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March 3, 2021 08:33 AM EST

Deals

The 2021 top 100 biopharma investors: As the pandemic hit and IPOs boomed, VCs swung into action like never before

John Carroll

Editor & Founder

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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March 1, 2021 05:22 PM ESTUpdated March 2, 06:22 AM

Pharma

Regulatory

UPDATED: Merck pulls Keytruda in SCLC after accelerated nod. Is the FDA getting tough on drugmakers that don't hit their marks?

Kyle Blankenship

Managing Editor

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

March 3, 2021 10:52 AM EST

Financing

Sofinnova Partners stays focused on late-stage deals with a new, $540M crossover fund

John Carroll

Editor & Founder

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Hal Barron, Endpoints UKBIO19

March 3, 2021 10:48 AM EST

R&D

Coronavirus

GSK, Vir's hopes for a Covid-19 antibody fall flat in NIH 'master protocol' with no benefit in hospitalized patients

Kyle Blankenship

Managing Editor

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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March 2, 2021 07:03 AM ESTUpdated 3 hours ago

Publisher's note

Introducing Endpoints FDA+, our new premium weekly regulatory news report led by Zachary Brennan

Arsalan Arif

Publisher & Founder

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

March 3, 2021 10:23 AM EST

R&D

As BrainStorm continues to tout ‘clear signal’ on ALS drug, the FDA offers a rare public slapdown on the data

John Carroll

Editor & Founder

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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March 3, 2021 08:10 AM ESTUpdated 09:15 AM

R&D

Eli Lilly claims success in a new JAK indication: hair loss

Jason Mast

Editor

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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CEO David Campbell (Janux)

March 3, 2021 08:00 AM EST

Financing

Fresh off $1B+ Merck deal, Janux locks down first private fundraise for its T cell engagers

Max Gelman

Associate Editor

Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers.

As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively.

Rachel Haurwitz, Caribou CEO (Kimberly White/Getty Images for TechCrunch)

March 3, 2021 08:00 AM ESTUpdated 09:16 AM

Financing

A Jennifer Doudna-launched upstart nabs $115M for off-the-shelf CAR-Ts

Nicole DeFeudis

Associate Editor

There is no shortage of biotechs pursuing off-the-shelf CAR-Ts, a so-called Holy Grail in oncology R&D. Now, less than a month after teaming up with AbbVie, a California player launched by CRISPR pioneer Jennifer Doudna has returned to the venture well, scooping up a big crossover round to help it along.

Caribou Biosciences took the wraps off a $115 million Series C on Wednesday morning, bringing their total raise to around $157 million, CEO Rachel Haurwitz said.

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