PD-L1 check­point play­er Mer­ck KGaA dives in­to next-gen work with F-star col­lab­o­ra­tion

John Hau­rum

CHICA­GO — Not all the biotech news on can­cer drugs this past week­end is di­rect­ly re­lat­ed to the big AS­CO con­fab in Chica­go. Cam­bridge, UK-based F-star para­chut­ed in news of its lat­est tie-up, this one a buy-in from Mer­ck KGaA, which picked up rights to a lead bis­pe­cif­ic check­point drug.

Mer­ck KGaA and its Big Phar­ma part­ner Pfiz­er re­cent­ly hit the mar­ket with one of the first 5 check­points, the PD-L1 drug Baven­cio (avelum­ab). Now it’s look­ing past that ini­tial mar­ket en­try in­to the next-gen ther­a­pies mak­ing their way in­to the clin­ic. And it picked up an op­tion on a pre­clin­i­cal LAG-3, PD-L1 bis­pe­cif­ic at F-star called FS118. In ad­di­tion, Mer­ck KGaA gets an op­tion on 4 oth­er pre­clin­i­cal ther­a­pies — all un­spec­i­fied i/o drugs.

F-Star set up its fourth as­set ve­hi­cle in struc­tur­ing the deal, dubbed F-star Delta. Mer­ck KGaA will pay €115 mil­lion in the first cou­ple of years, a sum bro­ken up for an un­spec­i­fied up­front, R&D pay­ments as well as a pair of ear­ly mile­stones for the first two years. Then Ger­man Mer­ck will have the op­por­tu­ni­ty to de­cide if it wants to ex­er­cise its buy­out op­tion, bit­ing off a sec­ond stage that brings the to­tal to a po­ten­tial $1 bil­lion-plus, says F-star CEO John Hau­rum.

Hau­rum tells me the hy­poth­e­sis that his team is pur­su­ing is that “there will be ben­e­fits in the bis­pe­cif­ic that go be­yond the straight com­bi­na­tion” of two drugs di­rect­ed at each check­point tar­get. LAG-3 is one of a group of check­point tar­gets that has at­tract­ed wide­spread in­ter­est among the bio­phar­ma com­pa­nies go­ing deep­er in­to the field.

Hau­rum notes that there’s lot of work to be done yet, but the bis­pe­cif­ic has the po­ten­tial to de­liv­er more drug in­to the tu­mor tis­sue, of­fer­ing a bet­ter safe­ty pro­file. There could al­so be ad­van­tages in bridg­ing be­tween T cells and the tar­get­ed tu­mor anti­gen.

F-star has three oth­er as­set sub­sidiaries it’s work­ing on, in­clud­ing Gam­ma part­nered with the Bay Area biotech De­nali. Be­ta is an­oth­er i/o deal with Ab­b­Vie while Bris­tol-My­ers Squibb kicked loose its HER-2 pro­gram Al­pha a few weeks ago. The one-time part­ners kept the spe­cif­ic rea­sons for the breakup un­der wraps, but Hau­rum not­ed that the HER-2 field is a crowd­ed one.

F-star has 85 staffers these days, a sig­nif­i­cant work­force in these cir­cles. And Hau­rum says they’re al­so work­ing on pro­pri­etary ther­a­pies as they con­tin­ue to ramp up new part­ner­ships.

Mer­ck KGaA re­cent­ly sold off its biosim­i­lars port­fo­lio, look­ing to fol­low up on its suc­cess in on­col­o­gy.

“Our col­lab­o­ra­tion with Fstar will help us to rapid­ly en­hance our pipeline and grow our port­fo­lio of bis­pe­cif­ic im­munother­a­pies,” not­ed Mer­ck KGaA R&D chief Lu­ciano Ros­set­ti in a pre­pared state­ment.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

Christos Kyratsous (via LinkedIn)

He built a MERS treat­ment in 6 months and then the best Ebo­la drug. Now Chris­tos Kyrat­sous turns his sights on Covid-19

TARRYTOWN, NY — In 2015, as the Ebola epidemic raged through swaths of West Africa, Kristen Pascal’s roommates sat her down on their couch and staged an intervention.

“Are you sure this is what you want to be doing with your life?” she recalls them asking her.

Pascal, a research associate for Regeneron, had been coming home at 2 am and leaving at 6 am. At one point, she didn’t see her roommate for a week. For months, that was life in Christos Kyratsous’ lab as the pair led a company-wide race to develop the first drug that could effectively treat Ebola before the outbreak ended. For Pascal, that was worth it.

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Left to right, top to bottom: Carl Gordon, Adam Stone, Peter Moglia, David Schenkein, Robert Nelsen, Carol Gallagher; Srinivas Akkaraju, Ray Debbane, Jim Flynn, Peter Kolchinsky, Thilo Schroeder, Brad Bolzon

The top 100 bio­phar­ma ven­ture in­vestors at the mega­bil­lions deal ta­ble

The VC crowd took a step back last year, but nevertheless maintained a furious pace of new investments in therapeutic tech platforms and biotech startups. And the top 100 players completely dominated the megabillions game.

Just looking at the number of deals done by each of the top 100, OrbiMed came in at the top, with 20, followed by Alexandria (18), Perceptive (16) and the ubiquitous RA Capital at 16. It’s impossible to say exactly how much they invested in total — those numbers are only rarely provided — but it is clear from the numbers assembled by Chris Dokomajilar at DealForma who’s most likely to be found sitting at the table during the go-go days of biotech investing.

Dokomajilar tracked $14.06 billion in biotech venture investing last year, a dip from the frenzied pace of $16.02 billion in 2018 and more than $10 billion higher than he recorded for 2010, as the economy was recovering from a profound economic crisis.

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Rahul Ballal, Imara

As sick­le cell pa­tients find new op­tions, NEA-found­ed Imara pitch­es mid-stage al­ter­na­tive for $86M IPO

November 2019 proved to be a fruitful month for patients with blood disorders known as hemoglobinopathies. Within days, the FDA ushered two drugs for sickle cell disease and another for beta thalassemia to the market — livening up a barren field.

Imara, a relatively young plower, is riding on that enthusiasm as it shoots for an $86.25 million IPO.

Imara emerged from New Enterprise Associates’ orphan drug accelerator Cydan in 2016 as a single-product company. $77.3 million in private financing later IMR-687 remains the sole asset in its pipeline; the difference is the drug is now in Phase II for sickle cell disease, with topline data slated for later this year and two other mid-stage beta thalassemia studies lined up.

RA joins glob­al syn­di­cate to back a $98M round for CAN­bridge

A Beijing-based rare disease and oncology player has raised $98 million to help fund the expansion of its pipeline as well as a commercial portfolio.

CANbridge put out word Tuesday that the global private equity player General Atlantic joined forces with Chinese CRO Wuxi AppTec to lead the Series D, with both ready to chip in an extra $10 million each under the right conditions. The syndicate includes RA Capital Management, Hudson Bay Capital Management, YuanMing Prudence Fund and Tigermed.

Carol Robinson, Professor Dame Carol Robinson Research Group

UP­DAT­ED: Drug dis­cov­ery in HD: Ox­ford spin­of­f's mass spec­trom­e­try ap­proach scores fresh fund­ing

The technology used to detect explosives at airports — mass spectrometry — is being piloted as an engine for drug discovery.

Mass spectrometry is a tool designed to measure with profound accuracy the mass of a single molecule. Typically, mass spectrometers can be used to identify unknown compounds, to quantify known compounds, and to determine the structure and chemical properties of molecules.

UP­DAT­ED: Chi­na ap­proves flu drug be­ing tout­ed as a po­ten­tial coro­n­avirus treat­ment amid a rush of clin­i­cal stud­ies

One of the three drugs that China’s Ministry of Science and Technology has tapped as potential COVID-19 treatments to watch has notched its first Chinese OK — for the flu.

While there’s no proof yet that fapilavir, or favipiravir, is the cure that patients and physicians are yearning for, it stands out for a unique constellation of qualities. It’s been commercially available in Japan for several years (unlike Gilead’s experimental remdesivir) yet it’s new to China (unlike the malaria drug chloroquine phosphate). Perhaps more importantly, a domestic biotech — Zhejiang Hisun Pharma — owns the rights to manufacture and market the drug, preempting any concerns about patents.

FDA goes on high alert as coro­n­avirus rais­es threat to drug man­u­fac­tur­ing and clin­i­cal tri­als grind to a halt

The FDA isn’t quite sure just what the coronavirus outbreak in China will mean for the US pharma industry, but it has the potential to trigger a host of troublesome issues around the supply chain the country is directly plugged into.

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Warren Buffett, AP Images

War­ren Buf­fett gets a dou­ble take as the in­vest­ment pow­er­house set­tles on its first biotech in­vest­ment

Coke. American-Express. Apple. And Biogen?

Warren Buffet’s Berkshire Hathaway, which made itself into a symbol of rock-solid investment strategy, has revealed a stake in the big biotech as it takes on one of the biggest gambles in the industry.

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