Jeff Aron­in's Emalex rais­es $35M Se­ries C; British pro­tein degra­da­tion biotech emerges from stealth

Jeff Aronin has a new raise in place for one of his port­fo­lio com­pa­nies.

Emalex Bio­sciences is bank­ing a $35 mil­lion C round for its work on a drug for Tourette syn­drome and stut­ter­ing. The biotech will use the mon­ey to ad­vance its clin­i­cal work, with 3 Phase II stud­ies un­der­way for ecopi­pam (EBS-101).

Aronin is per­haps best known for Marathon, a con­tro­ver­sial play that took a cheap, gener­ic steroid through the FDA and priced it at $89,000 a year af­ter an ap­proval. He dis­band­ed the com­pa­ny and sold the steroid to PTC.

Aronin’s um­brel­la com­pa­ny, Paragon Bio­sciences, led the round, with Fi­deli­ty Man­age­ment & Re­search Com­pa­ny LLC and Val­or Eq­ui­ty Part­ners join­ing in. — John Car­roll

British biotech emerges from stealth to fo­cus on pro­tein degra­da­tion

A new pro­tein degra­da­tion biotech emerged from stealth in Eng­land on Tues­day.

Dunad Ther­a­peu­tics is look­ing to de­vel­op small mol­e­cule treat­ments that they hope will pro­vide more di­rect mod­i­fi­ca­tion of pro­tein degra­da­tion, the biotech an­nounced. Ini­tial fi­nanc­ing has come from Ep­i­darex Cap­i­tal to push the goal of build­ing their plat­form, en­hanc­ing pro­teomics and bioin­for­mat­ics in­fra­struc­ture and ex­pand­ing the pro­pri­etary li­brary of co­va­lent de­graders.

“To date, there has not been a broad­ly ap­plic­a­ble, plug-and-play, mono­va­lent ap­proach to pro­tein degra­da­tion, and we be­lieve Dunad’s unique plat­form pro­vides the po­ten­tial to de­liv­er next-gen­er­a­tion de­grad­er ther­a­peu­tics with ad­van­tages over tra­di­tion­al drugs,” act­ing CEO Patrick Gun­ning said in a state­ment.

Dunad was orig­i­nal­ly found­ed in 2020 and is based in Cam­bridge, UK. — Max Gel­man

Evelo finds a part­ner for its atopic der­mati­tis can­di­date

Lit­tle Evelo Bio­sciences has part­nered with a big glob­al in­vestor to de­vel­op and com­mer­cial­ize its atopic der­mati­tis can­di­date in the Mid­dle East, Turkey and Africa.

The Cam­bridge, MA-based biotech un­veiled a col­lab­o­ra­tion with Ab­dul Latif Jameel on Tues­day morn­ing, though the com­pa­nies are keep­ing the fi­nan­cial terms of the deal un­der wraps for now.

Up­on read­ing out the first cut of da­ta from a small study in atopic der­mati­tis back in De­cem­ber, Evelo chair­man David Ep­stein told End­points News the drug, dubbed EDP1815 starts to work at two weeks. “That’s re­al­ly fast,” he said.

Phase Ib da­ta sug­gest the can­di­date is safe, ac­cord­ing to Evelo. In ad­di­tion, the can­di­date is in a Phase II tri­al for pso­ri­a­sis, and two tri­als for Covid-19.

“I have had the priv­i­lege to work with Akram Bouchena­ki, CEO of Ab­dul Latif Jameel Health, for more than 20 years. He has deep ex­pe­ri­ence build­ing and de­vel­op­ing suc­cess­ful busi­ness­es in this re­gion, dat­ing back to his tenure with Gilead,” Evelo CEO  Sim­ba Gill said in a state­ment. — Nicole De­Feud­is 

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.