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 Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

Paul Grayson, Tentarix CEO (Versant)

Phar­ma vet­er­ans re­group with $50M and a plan to dis­cov­er new mul­ti-specifics

While a horde of drugmakers develops bispecific antibodies to more directly target tumor cells — there were about 100 programs in or nearing clinical trials back in May — a new company is emerging to go one step further.

On Thursday, Tentarix Biotherapeutics unveiled a $50 million Series A round to support its next-gen multi-specifics platform. While the field has largely focused on bispecifics, which engage two targets, Tentarix believes its multifunctional programs have the potential to be even more specific, since more conditions must be met for potent activity to occur.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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