Blake Wise, Novome Biotechnologies CEO

Genen­tech-part­nered Novome lands $43.5M to push gas­troin­testi­nal drug through mid-stage study

A biotech with con­nec­tions to Roche’s Genen­tech has now land­ed its newest cash in­fu­sion.

Mi­cro­bio­me out­fit Novome Biotech­nolo­gies said Tues­day that it has now se­cured $43.5 mil­lion in new fi­nanc­ing via a Se­ries B round. The funds, ac­cord­ing to the com­pa­ny, will be used to ad­vance its lead can­di­date through an on­go­ing Phase IIa — and ad­vance oth­er can­di­dates for a po­ten­tial in­di­ca­tion in in­flam­ma­to­ry bow­el dis­ease.

The com­pa­ny’s drug can­di­dates, all pre­clin­i­cal ex­cept its lead drug, fall in one of two cat­e­gories: ei­ther 100% owned by Novome, or part of a Genen­tech col­lab­o­ra­tion an­nounced late last year. CEO Blake Wise — a Genen­tech vet and for­mer CEO of Achao­gen — joined the com­pa­ny back in ear­ly 2020, the same time Novome se­cured $33 mil­lion in a Se­ries A.

The $605 mil­lion deal with Genen­tech got things mov­ing on Genen­tech’s ef­fort to pur­sue tar­gets in the hu­man in­tes­tine, with the Roche sub­sidiary hav­ing had an in­ter­est in that space and ob­serv­ing Novome’s tech­nol­o­gy for some time, Wise tells End­points News.

That deal gave Novome ear­ly-stage dis­cov­ery and de­vel­op­ment re­spon­si­bil­i­ties for IBD un­til the IND-en­abling stage, at which point Genen­tech would take on fur­ther clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion.

Wise fur­ther added that the round will last the com­pa­ny, cur­rent­ly at a head­count of around 40, some­where around 2-3 years. As for ex­pan­sion plans, the CEO said they don’t ex­pect to hire a lot more peo­ple as a re­sult of the fund­ing.

The com­pa­ny’s cur­rent clin­i­cal pro­gram is an en­gi­neered strain of bac­te­ria called NOV-001 — be­ing test­ed to treat a dis­ease called en­teric hy­per­ox­aluria, a side ef­fect of in­flam­ma­to­ry bow­el dis­ease and gas­tric by­pass that ends up in­creas­ing lev­els of ox­alate in the body. Ox­alate can com­bine with cal­ci­um to form cal­ci­um-ox­alate kid­ney stones, the most com­mon kind of kid­ney stone.

“We’re main­ly look­ing here at the abil­i­ty to re­duce the ox­alate in pa­tients with dis­ease,” the CEO added.

The Phase IIa study this strain is be­ing test­ed in is ex­pect­ed to read out ear­ly next year. A Phase I study read out last year showed that the strain could col­o­nize the hu­man gut and be con­trolled.

How the com­pa­ny op­er­ates, says Wise, is that its strains are en­gi­neered to be graft­ed in­to the gut and feed off a sug­ar. A pa­tient would then take the sug­ar every day, and the mi­crobes would grow in the gut based on how much of that sug­ar was tak­en. And those strains can al­so be used as a de­liv­ery mech­a­nism for ther­a­peu­tic pro­teins — by en­gi­neer­ing the pro­teins in­to the bac­te­r­i­al strains, so the gut bac­te­ria ex­press­es the pro­teins di­rect­ly. Wise said that this mech­a­nism would by­pass the need to de­liv­er these pro­teins sys­tem­i­cal­ly.

On top of hy­per­ox­aluria, the com­pa­ny has more un­der­way in pre-clin­i­cal and dis­cov­ery re­search in ir­ri­ta­ble bow­el syn­drome and im­muno-on­col­o­gy. Wise tells End­points that there are oth­er in­di­ca­tions that the biotech is look­ing at be­yond IBD — in­clud­ing po­ten­tial­ly di­a­betes, obe­si­ty and more.

The round, led by Ten­cent, in­clud­ed a slate of new in­vestors — Uni­ver­si­ty of Min­neso­ta, Na­vian In­vest­ments, Col­or­con Ven­tures and Touch­down Ven­tures. Pre­vi­ous in­vestors such as DCVC Bio, 5AM Ven­tures, Al­ta Part­ners and Alexan­dria Ven­ture In­vest­ments al­so pitched in.

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.

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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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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User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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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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Look­ing to push CAR-T in sol­id tu­mors, Bay Area biotech goes pub­lic in SPAC flip — with slight name change

SPACs might be slowly creeping back.

Monday evening, Estrella Biopharma said it was going public via a SPAC deal with TradeUP Acquisition Corp. The deal is set to close in the first half of 2023, and if all goes as planned, the public version of Estrella — dubbed Estrella Immunopharma — will be worth around $398.5 million.

The Bay Area biotech will also get around $45.4 million in cash, and TradeUp stockholders will get around 15% stock in the public biotech.