Medicxi’s David Grainger and Francesco De Rubertis pump €200M into six companies and what they say is a first-of-its kind fund

Francesco De Rubertis

September 22, 2020 07:12 AM EDTUpdated 01:48 PM

Medicxi's David Grainger and Francesco De Rubertis pump €200M into six companies and what they say is a first-of-its kind fund

Jason Mast

Associate Editor

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Michel Vounatsos, Biogen CEO (via YouTube)

October 21, 2020 08:11 AM EDTUpdated 10:22 AM

R&D

UPDATED: Biogen spotlights a pair of painful pipeline setbacks as aducanumab showdown looms at the FDA

John Carroll

Editor & Founder

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chapter in the decentralized clinical trial approach

Alison Holland

Head of Decentralized and Remote trials

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Bo Cumbo, AavantiBio CEO (file photo)

October 22, 2020 07:07 AM EDT

Venture

Startups

Cell/Gene Tx

Bo Cumbo jumps from the top commercial post at Sarepta to the helm of a gene therapy startup with some influential backers, big plans and $107M

John Carroll

Editor & Founder

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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ENDPOINTS CAREERS

Clinical Operations Lead

Vigeo Therapeutics

Cambridge, MA

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CEO Marc Gleeson (Azura)

October 22, 2020 08:05 AM EDT

Venture

Azura Ophthalmics gets a $20M boost for its R&D work on eye diseases

Nicole DeFeudis

Associate Editor

Three years after closing a $16 million Series B, the same group of investors are back to give Azura Ophthalmics a $20 million boost.

That brings the Tel Aviv-Yafo, Israel-based biotech’s total fundraise to $38 million, and should pave the way for a registration study of its lead candidate in Meibomian gland dysfunction (MGD) and related eye diseases, CEO Marc Gleeson told Endpoints News.

The topical candidate, dubbed AZR-MD-001, is designed to address abnormal hyperkeratinization, or the build-up and shedding of proteins at the opening of or within the Meibomian gland. When Meibomian glands become dysfunctional, rapid evaporation of the tear film can occur, leading to dry eye disease.

Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

October 22, 2020 09:09 AM EDT

Deals

Coronavirus

Exclusive: Eyeing big Covid-19 testing expansion, Ginkgo rolls out 50M rapid antigen diagnostics

Jason Mast

Associate Editor

In what they hope will be a key part of an extensive effort to boost Covid-19 testing in the US, Ginkgo Bioworks is acquiring and distributing 50 million rapid antigen tests that can potentially be used for virus surveillance in schools and communities and for quick, on the ground diagnoses.

The tests, developed by SD Biosensor, are in line with proposals from the Rockefeller Foundation and Harvard epidemiologists, among others, to blanket the country with fast, low-cost tests. Although not yet authorized in the US, they are a key part of testing efforts from the Bill and Melinda Gates Foundation, who announced plans last month to distribute 120 million of them in low and middle income countries. Roche has commercialized the diagnostic in Europe.

October 22, 2020 07:04 AM EDTUpdated 09:12 AM

Coronavirus

Covid-19 roundup: Azar openly planning Hahn ouster — report; Vulnerable populations likely to get vaccines by January

Max Gelman

Associate Editor

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

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Jean-Pierre Sommadossi, Atea president and CEO (file photo)

October 22, 2020 06:40 AM EDT

Deals

Coronavirus

Roche wades deeper into Covid-19 fight, inking antiviral pact with $350M cash following Regeneron deal

Amber Tong

Editor

Roche is making its first bet on an antiviral against Covid-19 in style, shelling out $350 million in cash to grab ex-US rights.

The drug comes from Atea Pharmaceuticals, the 7-year-old biotech created by Pharmasset co-founder Jean-Pierre Sommadossi, which essentially rebranded itself as a Covid-19 fighter in May when it closed a whopping $215 million venture round. Over a dozen investors bought in, including marquee names like Bain Capital and RA Capital.

ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Peter Kolchinsky and Raj Shah (file photo)

October 22, 2020 06:32 AM EDT

Venture

Peter Kolchinsky and Raj Shah's RA Capital has $461M more to play with, after 'rapid' investment in the last 15 months

Max Gelman

Associate Editor

Just over 15 months after launching its first venture fund, RA Capital Management is ready for more. And this time the firm is bringing an even bigger load of cash to the table.

Announcing the close of its Nexus II fund on Wednesday, RA said it raised $461 million for investments in private companies across the biotech industry. The first venture fund, which raised $300 million, has churned through roughly 80% of its capital already, a pace that managing partner Raj Shah called unusually quick.

Stephen Hahn, FDA commissioner (AP Images)

October 20, 2020 10:21 AM EDTUpdated 10:48 AM

Regulatory

Coronavirus

As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines

John Carroll

Editor & Founder

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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