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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,700+ biopharma pros reading Endpoints daily — and it's free.