Peter Luo. Adagene

WuXi-backed Ada­gene scores $69M round led by Gen­er­al At­lantic to push an­ti­bod­ies where Bris­tol-My­ers strug­gled

Back when Pe­ter Luo found­ed Ada­gene in 2012, much of Chi­na was still fo­cused on biosim­i­lars and con­tract ser­vices as the in­dus­try strug­gled to bring man­u­fac­tur­ing qual­i­ty up to glob­al stan­dards. But the Stan­ford-trained sci­en­tist and bat­tle-test­ed en­tre­pre­neur — to­geth­er with long­time friend and WuXi founder Ge Li — saw an op­por­tu­ni­ty to be­gin build­ing a plat­form play cen­tered around en­gi­neer­ing bet­ter an­ti­bod­ies.

Ge Li

Now Gen­er­al At­lantic has joined some top-tier Chi­nese in­vestors in­clud­ing WuXi Ven­tures, Eight Roads and Se­quoia for a $69 mil­lion Se­ries D, bring­ing the to­tal haul to $150 mil­lion just as Ada­gene be­gins to see some ear­ly clin­i­cal val­i­da­tion.

“We be­lieve Chi­na is a ris­ing, vi­brant hub for glob­al life sci­ences in­no­va­tion,” Lefei Sun, head of health­care for Chi­na at Gen­er­al At­lantic, said in a state­ment.

Ada­gene’s two lead as­sets both tar­get well known can­cer-dri­ving im­mune check­points: ADG106 ag­o­nizes CD137, or 4-1BB, and ADG116 blocks CT­LA-4.

Bris­tol-My­ers Squibb, which pi­o­neered the first and on­ly CT­LA-4 in­hibitor Yer­voy, al­so tried de­vel­op­ing a 4-1BB ag­o­nist an­ti­body dubbed ure­lum­ab, but hopes for a monother­a­py were dashed af­ter liv­er tox­i­c­i­ties emerged. And the use of Yer­voy it­self has been lim­it­ed due to safe­ty con­cerns.

Leifei Sun

By ze­ro­ing in on some “tricky epi­topes,” Luo said, they were able to find a su­pe­ri­or can­di­date that ac­ti­vates 4-1BB in a na­tive lig­and-like fash­ion. And part­ner­ing with WuXi, ar­guably the most pow­er­ful CRO in Chi­na, has saved lots of headaches in pro­duc­tion.

“There are all kinds of ways to make an­ti­bod­ies,” Luo ex­plained to End­points News. “But to do it con­sis­tent­ly and dis­cov­er some­thing un­usu­al […] you re­al­ly have to fig­ure out a nov­el li­brary of an­ti­bod­ies, such as our Dy­nam­ic Pre­ci­sion Li­brary, which will be able to hit and cov­er very ex­ten­sive epi­topes of that tar­get, and that al­low you to ask some fun­da­men­tal ques­tions about mech­a­nism of ac­tions if that an­ti­body en­gages on that unique epi­tope of a giv­en tar­get.”

The Dy­nam­ic Pre­ci­sion Li­brary, al­so called Neo­body in­ter­nal­ly, is on­ly one of three plat­forms up­hold­ing Ada­gene’s busi­ness. Short­ly af­ter it an­nounced a takeover by Bris­tol-My­ers, Cel­gene inked a deal with the biotech to dis­cov­er an­ti­bod­ies against tar­gets of their choice. And a Chi­nese part­ner, San­jin, has li­censed an­oth­er com­pound se­lect­ed from the li­brary.

Then there’s SAFEbody, which al­lows Ada­gene to mask the an­ti­body bind­ing sites such that they are on­ly ac­ti­vat­ed in tu­mor mi­croen­vi­ron­ments. It has at­tract­ed ADC Ther­a­peu­tics as the Swiss com­pa­ny searched for ways to lim­it sys­tem­at­ic ex­po­sure of their armed an­ti­bod­ies.

“In this case they can by­pass those on-tar­get, off-tu­mor tox­i­c­i­ty is­sues,” Luo said.

As he push­es for­ward for co­hort ex­pan­sions in glob­al tri­als of Ada­gene’s first as­sets, he’s al­so look­ing to de­but a third tech dubbed Power­body, de­signed to en­hance ef­fi­ca­cy.

Ada­gene has two head­quar­ters in Suzhou and San Fran­cis­co, with a heavy BD pres­ence in the US. Luo — who co-found­ed an­oth­er an­ti­body de­vel­op­er (Ab­max­is) that was ul­ti­mate­ly ac­quired by Mer­ck — is bank­ing on the sci­ence that’s hap­pen­ing in be­tween.

“So I think this is the most in­ter­est­ing part of the whole in­dus­try,” he said. “Doesn’t mat­ter how big a po­si­tion fi­nan­cial­ly in the in­dus­try. In terms of true in­no­va­tion it is still rare and it comes in a very un­ex­pect­ed way. There­fore, you can com­bine the glob­al tech­nol­o­gy in­no­va­tion with the scale of op­er­a­tion in Chi­na for the in­creased pro­duc­tiv­i­ty that al­lows you to hit the serendip­i­ty that we are look­ing for.”

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Tri­fec­ta of sick­le cell dis­ease ther­a­pies ex­tend life ex­pectan­cy, but are not cost-ef­fec­tive — ICER

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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