Krish Krishnan, Krystal Biotech CEO

Der­ma­tol­ogy biotech Krys­tal set­tles law­suit from for­mer part­ner as it pre­pares first FDA pitch

Krys­tal Biotech’s le­gal trou­bles with a small part­ner are over.

The Pitts­burgh com­pa­ny set­tled its trade se­crets dis­pute with Pe­ripha­Gen on Tues­day, agree­ing to pay $25 mil­lion with­in 10 days of a fi­nal agree­ment and up to four ad­di­tion­al pay­ments of $12.5 mil­lion each de­pend­ing on cer­tain prod­uct mile­stones. Krys­tal ad­mit­ted no wrong­do­ing as part of the set­tle­ment.

Ad­di­tion­al­ly, all claims against Krys­tal ex­ecs Kr­ish Kr­ish­nan and Suma Kr­ish­nan were dis­missed, as well as coun­ter­claims made against Pe­ripha­Gen and its ex­ecs, James Wechuck and David Krisky.

The dis­pute cen­tered around cer­tain patents and trade se­crets for a gene ther­a­py vec­tor uti­liz­ing the Her­pes sim­plex virus 1 as the “back­bone” of the treat­ment. In the orig­i­nal suit, filed by Pe­ripha­Gen in May 2020, the biotech al­leged Krys­tal had de­vel­oped a top­i­cal gene ther­a­py for der­ma­to­log­i­cal dis­eases us­ing Pe­ripha­Gen’s patent­ed re­search.

Ac­cord­ing to the suit, Krys­tal and Pe­ripha­Gen en­tered in­to five ma­te­r­i­al trade agree­ments be­tween 2016 and 2017, in which Pe­ripha­Gen gave the Kr­ish­nans — a hus­band-and-wife team who launched Krys­tal out of their house in 2015 — ac­cess to pre­clin­i­cal re­search and lab­o­ra­to­ry space.

Un­known to Pe­ripha­Gen, Krys­tal soon im­prop­er­ly used this in­for­ma­tion to file its own patents and de­vel­op its own ther­a­pies, breach­ing the five con­tracts, the suit al­leged. A patent filed by Krys­tal al­leged­ly con­tained some of the same tox­i­col­o­gy re­ports and pre­clin­i­cal da­ta Pe­ripha­Gen had shared.

Krys­tal’s ac­tions led to an IPO of rough­ly $45 mil­lion in 2017 and a mar­ket cap that’s ex­ceed­ed $1 bil­lion, gains that al­leged­ly should have gone to Pe­ripha­Gen.

Krys­tal de­nied the al­le­ga­tions in June 2020 and filed a mo­tion to dis­miss, as well as coun­ter­claims against Pe­ripha­Gen and its two ex­ecs. Krys­tal al­leged Pe­ripha­Gen was in bad shape fi­nan­cial­ly and was try­ing to re­coup its loss­es through the suit. A judge al­lowed the case to pro­ceed in De­cem­ber 2020, per Krys­tal’s most re­cent 10-K.

With the set­tle­ment, Krys­tal will pay the $25 mil­lion in ex­change for “all of Pe­ripha­Gen’s bi­o­log­i­cal ma­te­ri­als and skin as­sets,” the biotech said Tues­day. Each of the ad­di­tion­al pay­ments will come af­ter Krys­tal’s first FDA ap­proval and sales reach $100 mil­lion, $200 mil­lion and $300 mil­lion.

Re­search in­to HSV1 as a po­ten­tial gene ther­a­py vec­tor dates back decades, with the the­o­ry that mod­i­fy­ing the virus’ abil­i­ty to repli­cate can re­sult in ther­a­peu­tic us­es. Krys­tal is ex­pect­ed to file its first BLA in the first half of this year for one of the prod­ucts us­ing such tech­nol­o­gy, aim­ing to treat dy­s­troph­ic epi­der­mol­y­sis bul­losa, a skin blis­ter­ing con­di­tion caused by the lack of col­la­gen in the skin.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

George Church (courtesy EnPlusOne BioSciences)

George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

RNA medicine has been at the forefront for the past few years, with the first RNA silencing therapy approved in 2018, and mRNA Covid vaccines following after. But flying under the radar has been the process of actually making RNA for these treatments.

That’s what Daniel Wiegand and Jonathan Rittichier have been working on in George Church’s lab for the past six years.

Friday morning, they unveiled EnPlusOne Biosciences, a biotech built on their RNA synthesis platform. Wiegand will serve as the Watertown, MA-based biotech’s CEO, and Rittichier will be CSO. And no different from his other startups, Church will be acting as scientific advisor. Its fourth co-founder, Dan Ahlstedt, joined through a Harvard Business School program, and will be COO.

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