Chi­na back­ers help bankroll a $100M mega-round as an in­flu­en­tial an­ti­body en­gi­neer read­ies tri­als

Dave Chiswell

Kymab turned to some mar­quee names in the UK and the US for the mon­ey need­ed to es­tab­lish the com­pa­ny as a high-pro­file play­er in the world of an­ti­body cus­tomiza­tion over the past 6 years. But now the game plan for the next three years will be un­der­writ­ten by an ex­pand­ed syn­di­cate that in­cludes two new play­ers based in Chi­na, ex­tend­ing its net­work of back­ers in­to a glob­al loop.

The biotech has un­veiled a whop­ping $100 mil­lion round led by ORI Health­care Fund — found­ed by Si­mone (Hong Fang) Song, the for­mer chief of Gold­man Sachs’ Health­care Fund in Chi­na —  and the man­u­fac­tur­er Shen­zhen He­palink Phar­ma­ceu­ti­cal Com­pa­ny.

To hear vet­er­an biotech ex­ec and Kymab CEO Dave Chiswell tell it, this was all part of a care­ful­ly con­struct­ed ef­fort to es­tab­lish new ties in what is fast be­com­ing a key glob­al hub in the bio­phar­ma world.

The Cam­bridge, UK-based biotech has been steadi­ly build­ing its syn­di­cate since the Well­come Trust kicked things off with the $30 mil­lion Se­ries A round for the Sanger In­sti­tute spin­out back in 2010. The Bill & Melin­da Gates Foun­da­tion stepped in with Neil Wood­ford’s two funds and Ma­lin Corp. in 2015 with a $90 mil­lion Se­ries B. This lat­est fund­ing brings their to­tal to a re­mark­able $220 mil­lion.

The goal at this stage: “Build a prop­er pipeline,” says Chiswell, who co-found­ed Cam­bridge An­ti­body Tech­nol­o­gy, an an­chor play­er to the UK biotech in­dus­try which was ac­quired by As­traZeneca. Chiswell had been ex­ec­u­tive chair­man at Kymab be­fore he added the CEO ti­tle in ear­ly 2015.

The com­pa­ny is built on the work of Al­lan Bradley, one of the world’s lead­ing genome en­gi­neers who did some pi­o­neer­ing work at Sanger on a new mouse mod­el — which de­buted as the Ky­mouse — that could be used to gen­er­ate new and bet­ter hu­man an­ti­bod­ies. Bradley had been a Howard Hugh­es Med­ical In­ves­ti­ga­tor and Bay­lor pro­fes­sor be­fore tak­ing the lead role at Sanger. He’s now the chief tech­ni­cal of­fi­cer at Kymab, where im­muno-on­col­o­gy, hema­tol­ogy and in­flam­ma­to­ry con­di­tions are big fo­cus­es.

Kymab’s lead pro­gram now is fo­cused on OX40L, a T-cell ac­ti­va­tor in­volved in in­flam­ma­to­ry dis­eases. It is ex­pect­ed to be in the clin­ic in ear­ly 2017, says the CEO, who’s plan­ning to have 5 in­de­pen­dent prod­ucts in the clin­ic by 2019. Kymab in­ves­ti­ga­tors will be pre­sent­ing pre­clin­i­cal da­ta at ASH on graft-vs-host dis­ease, which Chiswell thinks very high­ly of.

Kymab now has a sub­stan­tial staff of 120, which should con­tin­ue to grow, though on­ly slow­ly. And with enough cash in re­serves to get in­to 2019, Chiswell con­cedes that the next fund­ing step for the biotech may well be an IPO — though on­ly time will tell.

“It’s very ear­ly,” he notes, “but we may look like a pub­lic com­pa­ny in 2019, or 2020.” Get­ting there re­quired an ex­pan­sion of a syn­di­cate with deep roots around the world.

“Kymab al­ways saw that Chi­na was a big op­por­tu­ni­ty,” Chiswell tells me, “but we didn’t know how best to re­al­ize it.” So they took some time, work­ing with con­sul­tants and do­ing their home­work on the coun­try and its biotech in­ter­ests and in­vestors. “It’s been quite a long courtship with Chi­na.”

Their rep­u­ta­tion in the an­ti­body field has helped, along with a col­lab­o­ra­tion with MD An­der­son in Hous­ton.

“Speed and qual­i­ty helps,” says the CEO. “In the end, it’s your choice of an­ti­bod­ies. We think we have the best way of mak­ing the best an­ti­bod­ies.” And with­in a year they can have new an­ti­bod­ies test­ed in mice and in man­u­fac­tur­ing.

Now, they have the mon­ey to es­tab­lish proof-of-con­cept da­ta on their own in­ter­nal pipeline.

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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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.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

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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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Daphne Zohar (PureTech)

PureTech bags $200M from sale of Karuna shares — still siz­zling from promis­ing schiz­o­phre­nia da­ta

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

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