Brian Hubbard, Anji Pharmacetuticals CEO

Look­ing to rewrite the rules of drug li­cens­ing, start­up An­ji is on the hunt for 'dy­nam­ic eq­ui­ty' joint ven­tures

Li­cens­ing is one of the most com­mon ways big drug­mak­ers lever­age biotech in­no­va­tion to dri­ve gains across their pipelines — and the struc­ture of those deals is pret­ty well es­tab­lished. But one biotech with home bases in Chi­na and the US thinks it may have a bet­ter way.

On Tues­day, Cam­bridge-based biotech An­ji Phar­ma closed a $70 mil­lion Se­ries B with two late-stage mol­e­cules in the fold and a mis­sion to rewrite the rules of drug li­cens­ing through what it calls “dy­nam­ic eq­ui­ty” deals and a joint ven­ture-heavy game plan. The round was fund­ed in whole by Chi­nese hedge fund CR Cap­i­tal.

Let’s start with the busi­ness plan: Un­like tra­di­tion­al li­cens­ing deals, which usu­al­ly in­clude big up­front pay­ments and down­stream clin­i­cal and reg­u­la­to­ry mile­stone pay­ments, oth­er­wise known as “biobucks,” An­ji looks to build joint ven­tures around im­port­ed drugs and dy­nam­ic eq­ui­ty — or eq­ui­ty that vests at pre­spec­i­fied mile­stones — to the mol­e­cules’ li­censers.

That li­cens­ing and op­er­a­tions mod­el, what CEO Bri­an Hub­bard calls “hub-and-spoke,” lever­ages An­ji’s cen­tral ex­per­tise in drug de­vel­op­ment, reg­u­la­to­ry ap­provals and com­mer­cial­iza­tion to help guide found­ing teams, which stay en­gaged with their mol­e­cules rather than hand it over for de­vel­op­ment to a large phar­ma or oth­er arm’s-length part­ner.

Mean­while, An­ji’s ex­ist­ing brain trust would take the bur­den off star­tups to spend their time chas­ing fund­ing rounds, in­stead of fo­cus­ing sole­ly on push­ing their drug through clin­i­cal tri­als.

Here’s how Hub­bard ex­plained the com­pa­ny’s ra­tio­nale:

To be hon­est, when we start­ed this, we thought for sure biotech com­pa­nies with small pipelines or sin­gle as­sets would ben­e­fit … be­cause they wouldn’t have to go through all the rais­es, and they would par­tic­i­pate. What we found was that this mod­el was able to tap in­to every in­dus­try, whether that’s phar­ma or biotech or acad­e­mia — and re­al­ly it works for a sim­ple rea­son, which is shar­ing. We al­low the li­censer to par­tic­i­pate and main­tain this role. I think what they don’t want to do of­ten is go out and do a large raise to hire a CMO and a de­vel­op­ment per­son and a reg­u­la­to­ry per­son. They clear­ly want to be in­volved, they want to share the knowl­edge, they want to have suc­cess and have years do­ing it while cre­at­ing that val­ue.

Mean­while, An­ji hopes to up its chances of suc­cess by on­ly tar­get­ing mol­e­cules it thinks of­fer the clear­est path through the clin­ic. The biotech’s two lead pro­grams, a gut-se­lec­tive met­formin prod­uct for type 2 di­a­betes, dubbed ANJ900, and a drug for chron­ic id­io­path­ic con­sti­pa­tion, tagged as ANJ908, look very on-brand. But the biotech’s first on­col­o­gy drug, de­vel­oped un­der its An­ji On­co sub­sidiary, could present a chal­lenge.

The drug, an in-li­censed can­di­date from the Broad In­sti­tute, aims to in­hib­it the MCL1 path­way, which reg­u­lates cell death and was once thought un­drug­gable by re­searchers. An­ji likes the sci­ence be­hind the drug, but how ex­act­ly does an un­proven mol­e­cule in a nov­el tar­get class qual­i­fy as a high chance of suc­cess for ap­proval? In Hub­bard’s telling, An­ji has seen enough on the drug’s ear­ly pre­clin­i­cal find­ings to make it worth a shot and has the right clin­i­cal tri­al strat­e­gy and “great in­sight” to take it over the fin­ish line.

“We set a very high bar for our projects, which need to have ei­ther hu­man ge­net­ic val­i­da­tion or clin­i­cal val­i­da­tion,” Hub­bard said. “We are not in the game of get­ting in­to the clin­ic and fig­ur­ing out if it works. We want to take prod­ucts in­to the clin­ic that we know will work.”

Whether An­ji’s math is cor­rect is still very much up to ques­tion, but the team is show­ing it isn’t con­tent with on­ly go­ing af­ter high­ly val­i­dat­ed tar­gets and path­ways with mod­er­ate­ly bet­ter “me-too” drugs. It wants to take a few big swings as well.

Dan Mey­ers

An­oth­er big val­ue-add to An­ji’s mod­el is its heavy fo­cus on run­ning si­mul­ta­ne­ous clin­i­cal tri­als in Chi­na, a mar­ket where the team saw an op­por­tu­ni­ty to emerge as a lead­ing play­er while back­stop­ping its work in the US and Eu­rope. The name “An­ji,” af­ter all, refers to Chi­na’s An­ji Bridge in Shi­ji­azhuang, sig­ni­fy­ing the biotech’s bridg­ing of East and West.

It’s not on­ly a play to cut down costs but al­so tap in­to emerg­ing Chi­nese dis­ease in­di­ca­tions, CMO Dan Mey­ers said.

“Where we think a lot of com­pa­nies will talk about this, we’ve re­al­ly put our mon­ey where our mouth is and es­tab­lished on-the-ground clin­i­cal op­er­a­tions and a reg­u­la­to­ry team that are ac­tive­ly run­ning these stud­ies and are start­ing to see the syn­er­gy of the glob­al ap­proach.”

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.

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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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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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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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.

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.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

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.