With help from J&J, up­start Proven­tion lands rights to two mid-stage IBD drugs and shoots for PhII

Af­ter set­ting up one biotech com­pa­ny with a drug plucked from the shelves of big phar­ma, the same team is do­ing it again.

Proven­tion Bio ex­ecs — who un­veiled a $28.4 mil­lion round just a few months ago that in­clud­ed a sig­nif­i­cant con­tri­bu­tion from J&J — are un­veil­ing a new deal with the phar­ma gi­ant to­day, bag­ging rights to a pair of mid-stage as­sets they plan to hus­tle in­to mid-stage stud­ies de­signed to il­lus­trate quick­ly whether they have some­thing that can be point­ed to a piv­otal study.

Ash­leigh Palmer

Proven­tion Bio is run by three key ex­ecs: CEO Ash­leigh Palmer, CMO Eleanor Ramos and sci­en­tif­ic co-founder Fran­cis­co Leon. Palmer and Leon had al­ready set up Ce­lim­mune, which is de­vot­ed to ad­vanc­ing a new drug for Celi­ac dis­ease, which they got from Am­gen. And Leon, a for­mer re­searcher at J&J, has di­rect ex­pe­ri­ence with the two drugs they’re pick­ing up from J&J for their new com­pa­ny.

The drugs are PRV-6527 (JNJ-40346527), an oral Colony Stim­u­lat­ing Fac­tor-1 Re­cep­tor (CSF-1R) small mol­e­cule in­hibitor for Crohn’s dis­ease, and PRV-300 (JNJ-42915925/CN­TO 3157), an an­ti-Toll-Like Re­cep­tor 3 (TLR3) mon­o­clon­al an­ti­body for ul­cer­a­tive col­i­tis. The CSF-1R drug has al­ready been in hu­man stud­ies, in­clud­ing a failed mid-stage study for rheuma­toid arthri­tis.

But Leon be­lieves there’s a “good chance of repo­si­tion­ing (PRV-6527) in IBD; there’s no oral drug for mod­er­ate and se­vere Crohn’s.” And he can count on what re­searchers learned from Ste­lara as well as hu­man and an­i­mal da­ta to pro­vide enough en­cour­age­ment to back up the move back to the clin­ic.

The mod­el that Proven­tion is fol­low­ing strikes a fa­mil­iar cord. A whole new wave of com­pa­nies is be­ing cre­at­ed from the dis­cards at Big Phar­ma. Vivek Ra­maswamy has turned it in­to an art form at Roivant, which has been rais­ing big mon­ey to back more of these deals, while Bio­haven was able to jump from ear­ly-stage re­search straight to late-stage by ex­e­cut­ing a deal with Bris­tol-My­ers Squibb — al­low­ing them to pull off a quick IPO.

In their ear­li­er re­lease on the fundrais­ing, which in­clud­ed $6 mil­lion from J&J, $19 mil­lion from high net worth in­di­vid­u­als and $3 mil­lion from the JDRF, the group men­tioned they were look­ing to an IPO next year to pro­vide con­tin­ued fund­ing. But when I talked to Palmer ahead of to­day’s an­nounce­ment, he said they’re fo­cus­ing on these two as­sets — plus an en­terovirus vac­cine they got in ear­ly — and will de­cide next steps on fi­nanc­ing af­ter they see some hard da­ta.

Proven­tion won’t be spend­ing a ton of mon­ey on salaries or of­fices. The three key ex­ecs are part of a 6-mem­ber vir­tu­al team, which won’t get much big­ger, says Palmer. Not on­ly is the team small, but they’re scat­tered around the coun­try, meet­ing in the vir­tu­al of­fice as they use con­trac­tors on man­u­fac­tur­ing and re­search.

“I’ve been de­vel­op­ing drugs for 20 years,” says Ramos. “The cost of drug de­vel­op­ment is sky­rock­et­ing.” But the Proven­tion team be­lieves they can pull off two small, blend­ed Phase I/II stud­ies that can tell them if they’re on the right track.

Then they can make their go/no go de­ci­sion.

Right now, the light is green.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Forget 1 billion. AstraZeneca is now promising to supply 2 billion doses of Oxford University’s Covid-19 vaccine around the world per year.

Three new partners are coming on board to help reach that goal, as well as a broader vision to ensure access for nations that have been largely left out of the bargaining table.

CEPI — the coalition that’s been doling out grants to support other vaccine projects — is providing $383 million to support manufacturing of 300 million doses, while Gavi the Vaccine Alliance will chip in $367 million and be in charge of the procurement and distribution, a spokesperson told Wall Street Journal. A separate licensing agreement directs the Serum Institute of India to produce 1 billion doses for low- and middle-income countries, with the first 400 million due before the end of the year.

Por­tion of Neil Wood­ford’s re­main­ing in­vest­ments, in­clud­ing Nanopore, sold off for $284 mil­lion

It’s been precisely one year and one day since Neil Woodford froze his once-vaunted fund, and while a global pandemic has recently shielded him from the torrent of headlines, the fallout continues.

Today, the California-based patent licensing firm Acacia Research acquired the fund’s shares for 19 healthcare and biotech companies for $284 million.  Those companies include shares for public and private companies and count some of Woodford’s most prominent bio-bets, such as Theravance Biopharma, Oxford Nanopore and Mereo Biopharma, according to Sky News, which first reported the sale. It won’t include shares for BenevelontAI, the machine learning biotech once valued at $2 billion.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.