Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A lit­tle un­der two years af­ter a com­pa­ny re­brand­ing, Im­mune Reg­u­la­tion is tak­ing an even big­ger step to­ward ad­vanc­ing its goals.

For­mer­ly known as Peptin­no­vate, the British biotech an­nounced a $53.4 mil­lion Se­ries B ear­ly Mon­day morn­ing, help­ing to fur­ther ad­vance two clin­i­cal pro­grams in rheuma­toid arthri­tis and asth­ma. Though those are the two ini­tial in­di­ca­tions the com­pa­ny is fo­cus­ing on, CEO Jonathan Rig­by told End­points News he hopes the can­di­dates can be ap­plied to a broad swath of au­toim­mune dis­or­ders.

“We’re not look­ing for the nee­dle in the haystack; we kind of have a haystack made out of nee­dles,” Rig­by said.

Mon­day’s round was led by Morn­ing­side Ven­tures and in­clud­ed fund­ing from Lon­don-based 24Hay­mar­ket. Rig­by ex­pects the cash to go to­ward fur­ther Phase II tri­als in RA and al­ler­gic dis­eases and help the com­pa­ny build out its US in­fra­struc­ture, giv­ing the com­pa­ny run­way through 2022.

The the­o­ry be­hind Im­mune Reg­u­la­tion’s sci­ence, Rig­by says, is that its prod­ucts can “re­set” the im­mune sys­tem by in­ter­fer­ing with the com­mu­ni­ca­tion be­tween den­drit­ic cells and T cells when ex­posed to anti­gens, ef­fec­tive­ly re­duc­ing in­flam­ma­to­ry re­spons­es with­out sup­press­ing the body’s nat­ur­al de­fens­es. By do­ing so, this can help pa­tients with­out ex­pos­ing them to the po­ten­tial in­fec­tions that can af­flict in­di­vid­u­als tak­ing im­muno­sup­pres­sive drugs.

Im­mune Reg­u­la­tion’s lead pro­gram, re­ferred to as ‘1805, is a bind­ing im­munoglob­u­lin pro­tein that has com­plet­ed a Phase IIa tri­al in RA for pa­tients who had pre­vi­ous­ly been un­re­spon­sive to oth­er med­i­cines. With da­ta show­ing that the in­jectable ‘1805 in­duced re­mis­sion out to 12 weeks, Rig­by is tak­ing aim at Ab­b­Vie’s Hu­mi­ra, as­sert­ing his prod­ucts are more con­ve­nient than TN­Fs that need con­stant main­te­nance.

“These drugs re­quire chron­ic dos­ing, so a pa­tient takes an in­jec­tion every cou­ple of weeks or every month,” Rig­by said, adding that the ef­fects of ‘1805 last for sev­er­al months.

‘1104, mean­while, is a pep­tide that seeks to in­crease the ex­pres­sion of A20, re­duc­ing the in­flam­ma­tion re­sponse in asth­ma. Prepa­ra­tions for Phase II tri­als have al­ready be­gun and Im­mune Reg­u­la­tion is ex­pect­ed to be­gin those at some point next year. The com­pa­ny is al­so look­ing at whether or not the pro­gram can be an ef­fec­tive ther­a­peu­tic for pa­tients hos­pi­tal­ized with Covid-19.

Try­ing to take a piece of Hu­mi­ra’s pie is a tall task for any biotech, let alone one that didn’t have any US em­ploy­ees be­fore Rig­by was ap­point­ed to steer the ship back in April. Ab­b­Vie’s block­buster, ap­proved in sev­er­al in­di­ca­tions such as arthri­tis, plaque pso­ri­a­sis and ul­cer­a­tive col­i­tis, has been one of the world’s best-sell­ing drugs for years and pulled in more than $19 bil­lion in glob­al sales last year.

But Rig­by is con­fi­dent that Im­mune Reg­u­la­tion has a fair chance to eat in­to, at the very least, some of that mar­ket share. Though he re­mained tight-lipped about which spe­cif­ic ar­eas he’d take his pro­grams, Rig­by said the im­me­di­ate next steps in­volve go­ing in­to rare au­toim­mune dis­eases. Clin­i­cal tri­als for ‘1805 and ‘1104 in that field are al­so ex­pect­ed to be­gin next year.

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.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

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.

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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.

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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.

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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.