Rick Modi, Affinia Therapeutics CEO (Affinia)
Nine months after Affinia Therapeutics raised $110 million in a Series B, the biotech has set its eyes on the Nasdaq.
The MA-based preclinical gene therapy biotech, which got $60 million in startup capital from New Enterprise Associates, F-Prime and Atlas in 2019, filed an S-1 with the SEC on Tuesday, announcing initial plans to go public and penciling in a $100 million raise. Affinia plans to list under the ticker $AFTX.
Affinia, founded back in 2019 by AveXis veterans Sean Nolan and Rick Modi and an Endpoints 11 winner last year, has been focused on trying to solve the limitations of AAV gene therapy, as highlighted by the safety scares and setbacks of the last two years.
Its three scientific co-founders include Luk Vandenberghe, who is an associate professor at Harvard Med and director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear Infirmary in Boston — and is credited as a co-inventor of the more commonly-used AAV9.
In terms of current financial stake in the company, NEA managing partner Ed Mathers — on Affinia’s board of directors — is the largest shareholder, owning over 11.8 million shares and equivalent to 20.5% of the company. Other big shareholders currently include Atlas Venture with just shy of 7.5 million shares, or 13% of Affinia; F-Prime with almost a 10% stake and 5.7 million shares; and Lonza Houston with 4.9 million shares and an 8.6% stake.
CEO Rick Modi has a 1.4% stake with over 800,000 shares, and Vandenberghe has 1.5 million shares, or a 2.7% stake.
While the biotech has already raked in over $200 million in deals and private financings, Affinia wants to use whatever money it raises in an IPO to push towards clinical trials, pipeline expansion and manufacturing — although no specific dollar amounts for those objectives were listed. The money should fund operations through 2024, it said. Its lead candidate, AFTX-001, is being developed for the treatment of metachromatic leukodystrophy, a rare genetic disorder that leads to fat buildup in the body. Its second candidate, AFTX-002, is in development to treat brain metastases secondary to HER2+ breast cancer.
Affinia expects to file INDs on the two candidates in 2023 — the first candidate in the first half of the year, and the other candidate in the second half of 2023.
But those aren’t the only things Affinia is working on: They also have a substantial deal with Vertex that Affinia signed in 2020. The S-1 gave further details on the deal, showing it could net Affinia up to $4.7 billion to engineer capsids for use in programs for Duchenne muscular dystrophy (DMD), myotonic dystrophy 1 (DM1) and cystic fibrosis (CF).
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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The FDA this week announced further changes to revamp its structure, this time with alterations to its Office of the Chief Scientist that were agreed to by HHS late last month.
The FDA’s OCS has decided to shift its technology transfer program from the Office of Regulatory Science and Innovation to the OCS Immediate Office to further enhance the effectiveness of the agency’s outside partnership programs.
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Jeff Albers and Kate Haviland (Brad Bahner Photography/PR Newswire)
After a busy 2021 brought Blueprint Medicines its fourth FDA approval, the company is kicking off the new year with plans to shake up its C-suite.
Jeff Albers, Blueprint’s CEO for the past eight years, will be stepping down April 4 and transitioning to the executive chairman position, the biotech announced Wednesday morning. He will be replaced by COO Kate Haviland, who moves into both the chief executive and president roles. Christina Rossi also nabs a promotion from chief commercial officer to COO.
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Catalent CEO John Chiminski (Catalent)
If there was one defining theme at Catalent in recent years, it was expansion, as the CDMO upped its operations all over the world, from Baltimore to Japan. It did so under longtime CEO John Chiminski, who has led the Somerset, NJ-based company for 12 years, topped by 2 years of the pandemic. This year will be the last in the C-suite for Chiminski, however, as the company announced plans for a passing of the torch this summer.
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As the CEO of RNA editing startup Korro Bio, Ram Aiyar often gets the same question.
‘I get always asked, you know, if you can fix DNA, why bother with RNA?’ he told Endpoints News. ‘And it’s like asking, which child do you prefer — your older one or your younger one?’
But investors are appreciating the difference. More than a year after closing its Series A just shy of the megaround mark, Korro Bio is back in the spotlight with $116 million in fresh cash and a lead candidate — targeting alpha-1 antitrypsin deficiency, or AATD.
Ray Tabibiazar, SalioGen CEO
Roughly 10 months ago, a fledgling biotech emerged from stealth with a modest Series A and a big promise looking to develop gene therapy 3.0. The promise inched closer to reality Wednesday as investors have now hopped on board thanks to a new, nine-figure round.
SalioGen Therapeutics closed its $115 million Series B, the company announced Wednesday morning, aiming to push forward its ‘gene coding’ platform and growing preclinical pipeline. The biotech, which focuses on activating dormant mammalian enzymes to edit genes in vivo, secured the new raise after fleshing out some of the technologies’ applications, CEO Ray Tabibiazar told Endpoints News.
For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.
Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.
Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
https://endpts.com/gene-therapy-player-affinia-aims-to-go-public-hoping-to-raise-big-money-in-effort-to-remake-aavs/
