Eight years af­ter Eli Lil­ly dumped it, an up­start biotech has nabbed teplizum­ab and filed a $56M IPO to back a PhI­II come­back

Eight years ago, a drug called teplizum­ab went down in flames af­ter it failed in a piv­otal di­a­betes study un­der­tak­en by Eli Lil­ly. But yes­ter­day a lit­tle start­up called Proven­tion Bio in-li­censed it from Macro­Gen­ics, the orig­i­nal de­vel­op­er, whipped around and to­day used it as their lead drug for a $56 mil­lion IPO fil­ing.

Teplizum­ab wasn’t com­plete­ly dead back in 2010 when Lil­ly dumped the whole thing. But it came aw­ful­ly close to that.

Jef­frey Blue­stone

Jef­frey Blue­stone, a high-pro­file sci­en­tist at UCSF who had worked long and hard on the drug, nev­er lost faith over 30 years of la­bor­ing on it. He con­tin­ued to pur­sue hu­man stud­ies for the drug, watch­ing large groups of di­a­bet­ics re­spond fa­vor­ably to the drug, but weary­ing at times at the task of try­ing to get some re­al mon­ey to back a come­back ef­fort. We ex­changed sev­er­al mes­sages about this drug a cou­ple of years ago as Blue­stone — now run­ning the Park­er In­sti­tute — pushed ahead.

The drug has shown val­ue in pre­serv­ing be­ta cells in the pan­creas, re­duc­ing the need for in­sulin among Type 1 pa­tients. And that’s where it will be test­ed in Phase III, with the study planned to launch next year.

“I am very ex­cit­ed about the “re­vival” of Teplizum­ab,” Blue­stone tells me in an email. “My col­leagues and I have al­ways felt that the drug could be im­pact­ful for re­cent on­set pa­tients with Type 1 Di­a­betes and more­over oth­er au­toim­mune dis­eases. The suc­cess in mul­ti­ple Phase II tri­als con­duct­ed by the aca­d­e­m­ic com­mu­ni­ty gives me great hope for the po­ten­tial for this drug to have an im­pact in a sig­nif­i­cant per­cent­age of these pa­tients. On­ward and up­ward.”

Ash­leigh Palmer

Proven­tion has been work­ing off of a $28 mil­lion A round it nabbed a year ago. That’s not much. And the plans call for on­ly a slice of it to be used to set up the Phase III. Proven­tion al­so has PRV-6527 (the CSF-1R in­hibitor JNJ-40346527, ob­tained from J&J) for Crohn’s dis­ease, and the ul­cer­a­tive col­i­tis can­di­date JNJ-42915925 (PRV-300), an an­ti-TLR3 an­ti­body.

The S-1 spells out all its li­cens­ing deals, in­clud­ing the $42.5 mil­lion it will owe Macro­Gen­ics based up­on “the achieve­ment of cer­tain de­vel­op­men­tal and ap­proval mile­stones for the first in­di­ca­tion, and an ad­di­tion­al $22.5 mil­lion up­on the achieve­ment of cer­tain reg­u­la­to­ry ap­provals for a sec­ond in­di­ca­tion. In ad­di­tion, we are ob­lig­at­ed to make con­tin­gent mile­stone pay­ments to Macro­Gen­ics to­tal­ing $225 mil­lion…” for sales mile­stones.

J&J al­so has a buy-back pro­vi­sion on PRV-6527, giv­ing them the right to claw it back for $50 mil­lion af­ter the next study.

The de­vel­op­ment of teplizum­ab will now lie pri­mar­i­ly in the hands of Ash­leigh Palmer, the CEO at Proven­tion who owns 12.2% of the com­pa­ny, and Fran­cis­co Leon, a J&J vet who once ran ear­ly-stage de­vel­op­ment work for J&J in im­munol­o­gy who al­so owns 12.2% of the com­pa­ny. Macro­Gen­ics now owns 10% of the com­pa­ny and J&J In­no­va­tion is a backer with 11.2%. MDB owns 10.8%.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.

CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,400+ biopharma pros reading Endpoints daily — and it's free.