Mir Imran, Rani CEO

Rani nabs $69M Se­ries E for its stab at a ro­bot­ic pill to re­place in­jectable drugs

Rani Ther­a­peu­tics has tapped the ven­ture well again, this time rais­ing a sweet $69 mil­lion for its push to make in­jectable med­i­cines go down in a more de­light­ful way.

The San Jose, CA-based biotech is work­ing on a ro­bot­ic pill — dubbed the Ra­niP­ill — that’s de­signed to re­place in­jectable drugs like in­sulin. Rani says the Se­ries E round, which brings its to­tal raise to $211 mil­lion, will go straight in­to clin­i­cal de­vel­op­ment and man­u­fac­tur­ing for the can­di­date.

The idea of trans­form­ing in­jecta­bles in­to pills isn’t a new one. But a string of ef­forts to evade the en­zymes that break down an oral drug be­fore it can be ab­sorbed have large­ly hit a wall. Rani’s can­di­date has an en­teric coat­ing that pro­tects it from the acidic am­bi­ence of the stom­ach, then dis­solves as the pill moves in­to the in­tes­tine and pH lev­els rise. A chem­i­cal re­ac­tion in­flates a bal­loon, and the pres­sure push­es a dis­solv­able mi­cronee­dle in­to the in­testi­nal wall.

The in­jec­tion is pain-free, a Rani spokesper­son said. And be­cause the tech­nol­o­gy is ag­nos­tic to the pay­load, Rani be­lieves it could be used to de­liv­er pep­tides, pro­teins and an­ti­bod­ies.

So far the No­var­tis and Take­da-part­nered com­pa­ny has test­ed 9 mol­e­cules in pre­clin­i­cal stud­ies, and con­duct­ed clin­i­cal tri­als with adal­i­mum­ab, GLP-1 and oc­treotide — a mon­o­clon­al an­ti­body, meta­bol­ic drug and pep­tide, re­spec­tive­ly.

Back in Jan­u­ary, Rani said it got the re­sults it was look­ing for in an ear­ly-stage tri­al with oc­treotide. A to­tal of 58 vol­un­teers were en­rolled, 52 of whom got the Ra­niP­ill ver­sion, and 6 of whom got an in­tra­venous in­jec­tion with an iden­ti­cal dose. Rani CEO Mir Im­ran told End­points News at the time that the com­pa­ny proved its hy­poth­e­sis: The pa­tients didn’t feel a thing.

“And then the sec­ond end­point was bioavail­abil­i­ty, which turned out to be greater than 70%. Which is what ex­act­ly we had seen in our pre­clin­i­cal test­ing,” he said, adding that Rani would con­duct a head-to-head study to prove equiv­a­lence or non-in­fe­ri­or­i­ty to the in­jectable ver­sion.

Im­ran al­so said in Jan­u­ary that an IPO was a “dis­tinct pos­si­bil­i­ty” in about a year — which would be just about any time now. When asked on Fri­day if an IPO is in the near fu­ture, the com­pa­ny didn’t say yes. But they didn’t ex­act­ly say no, ei­ther.

“Right now we are fo­cused on ad­vanc­ing the clin­i­cal tri­als of our in­ter­nal pipeline of drugs, and our in-house man­u­fac­tur­ing of the Ra­niP­ill,” a spokesper­son said. “We do not com­ment on fu­ture fi­nanc­ing plans.”

Last year, a team of MIT and No­vo Nordisk sci­en­tists re­port­ed pos­i­tive an­i­mal re­sults from their own stab at a ro­bot­ic pill. Their can­di­date con­sists of a nee­dle in­side a cap­sule made of com­pressed freeze-dried in­sulin. Up­on con­tact with the wet in­ner lin­ing of the stom­ach, a sug­ar disk hold­ing the nee­dle in place dis­solves.

The pill de­liv­ered enough in­sulin to low­er an­i­mals’ blood sug­ar to lev­els sim­i­lar to in­jec­tions, ac­cord­ing to the re­searchers, who said they were still a few years away from the clin­ic.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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