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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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Spar­ingVi­sion rais­es $52M to kick off long jour­ney for a next-gen gene ther­a­py that goes much, much broad­er than Lux­tur­na

Until Spark Therapeutics’ pioneering gene therapy, Luxturna, came along, patients with retinitis pigmentosa had few treatment options. Even after it was approved, though, the majority were left with the exact same options.

Because it’s targeting mutations in a specific gene known as RPE65, Luxturna can only address 2 to 3% of the entire RP population, Stephane Boissel told Endpoints News.

Boissel is the newly-minted CEO of SparingVision, a French biotech co-founded by José-Alain Sahel and Thierry Léveillard at the Institut de la Vision. They have their sight set on a new kind of AAV construct — a next-generation gene therapy if you will — that can treat all patients of RP independent of genetic mutations.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Sean McClain, AbSci

UP­DAT­ED: Months af­ter strik­ing a deal with Sanofi, Ab­Sci nails its largest fundraise yet to sup­port its pro­tein print­ing tech

Months after nailing down a $10.4 million Series D and a partnership with French pharma giant Sanofi, AbSci is pulling in its largest fundraise yet — $65 million to advance what it calls its protein printing tech.

The Vancouver, WA-based biotech is working on a more efficient way to manufacture proteins — from full-length antibodies to insulin — using E. coli. The company says it’s on a quest to make protein production “as simple as DNA synthesis,” allowing for swift production of difficult-to-produce biotherapeutics. It’s tagging the Series E for expansion of its production capacity, which includes a new 60,000-square-foot facility in Vancouver.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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MD An­der­son es­tab­lish­es new $50M+ biotech fund to choose the next promis­ing can­cer ther­a­pies

Researchers at MD Anderson have a new partner to help them get early-stage programs into the clinic.

In conjunction with The Focus Fund, MD Anderson is launching the Cancer Focus Fund to advance investigational cancer therapies from late preclinical development through Phase I and Phase Ib/II clinical trials. The fund will start off with more than $50 million of initial capital.

“Without appropriate support, we know that some therapies with great potential may be delayed, may not be developed properly in the clinical setting or may never make it into clinical studies,” MD Anderson senior VP Ferran Prat said in a statement. “Through investment from the Cancer Focus Fund and the support of MD Anderson, we hope to advance worthwhile new treatments past the traditional hurdles in the drug development process.”