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FDA hands MorphoSys and Incyte a quick OK on their potential blockbuster CAR-T alternative

August 3, 2020 07:22 AM EDT

FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Jason Mast

Associate Editor

Near­ly three years af­ter okay­ing the CAR-Ts Yescar­ta and Kym­ri­ah, the FDA has ap­proved a new CD19 ther­a­py.

Mor­phoSys’ Mon­ju­vi, or taf­a­sita­m­ab-cx­ix, was cleared Fri­day for use in re­frac­to­ry dif­fuse large B-cell lym­phoma (DBLCL). The ap­proval sets up both Mor­phoSys and their com­mer­cial part­ner In­cyte to com­pete with Gilead and No­var­tis in the ul­tra-com­pet­i­tive in­di­ca­tion, where sim­i­lar tri­al re­sults and far eas­i­er de­liv­ery could al­low them to cut a fair share of the mar­ket.

The first ap­proved in­di­ca­tion is in sec­ond-line DBLCL, for pa­tients in­el­i­gi­ble for au­tol­o­gous stem cell trans­plant. Mizuho’s Mara Gold­stein es­ti­mat­ed that mar­ket at around 6,000 US pa­tients and said the drug had “block­buster po­ten­tial,” but she not­ed those pa­tients have sev­er­al oth­er op­tions avail­able to them.

“The ini­tial mar­ket op­por­tu­ni­ty as a sec­ond-line treat­ment … is mean­ing­ful,” she wrote in a note to in­vestors, “though we are some­what cau­tious on the ramp of the drug giv­en the com­pet­i­tive land­scape for this in­di­ca­tion that in­cludes sev­en drug reg­i­mens as well as treat­ment with CAR-T ther­a­py.”

SVB Leerink’s Ge­of­frey Porges called the ap­proval a “best case sce­nario,” not­ing it had been un­clear whether the drug would be ap­proved for sec­ond-line or third-line ther­a­py. He es­ti­mat­ed a po­ten­tial pa­tient pop­u­la­tion around 12,000.

Both an­a­lysts sin­gled out Mon­ju­vi’s du­ra­tion in par­tic­u­lar. The 21.7 months it showed at the top line read­out is more than twice the 6 months to a year Roche’s an­ti­body-drug Po­livy, ap­proved last year, has shown.

“We be­lieve the CAR-T like ef­fi­ca­cy demon­strat­ed by tafa, as well as its fa­vor­able safe­ty pro­file should en­able broad adop­tion in the 2L set­ting,” Porges wrote in a note to in­vestors,  “and ex­pect the prod­uct to be pre­ferred over Roche’s CD79 ADC Po­livy.”

Si­mon Mo­roney

For­mer Mor­phoSys CEO Si­mon Mo­roney po­si­tioned Mon­ju­vi as an op­tion for pa­tients who can’t han­dle the in­tense bod­i­ly stress of high-dose chemother­a­py or stem cell trans­plant, or of CAR-T. In ad­di­tion to the cost­ly and lengthy process of ex­tract­ing, treat­ing and re-im­plant­i­ng T cells, CAR-T ther­a­pies al­so re­quire pa­tients to un­der­go “con­di­tion­ing” reg­i­mens of in­ten­sive chemother­a­py to clear out the bone mar­row and es­sen­tial­ly give a pock­et for the new cells to take hold.

By con­trast, Mon­ju­vi is an an­ti-CD19 an­ti­body that is giv­en in­tra­venous­ly and re­quires no con­di­tion­ing.

“Our pa­tients tend to be old­er — me­di­an age in the tri­al is 72,” Mo­roney told Med­C­i­ty News last June, re­fer­ring to par­tic­i­pants in their piv­otal Phase II study. “They have co­mor­bidi­ties and are not el­i­gi­ble for CAR-T.”

The FDA de­ci­sion is an ac­cel­er­at­ed ap­proval based on re­sults from that Phase II study. Topline re­sults re­leased last year showed a 55% over­all re­sponse rate and a 37% com­plete re­sponse rate. The lat­est da­ta, re­leased in May, showed a 59% re­sponse rate, a 39% com­plete re­sponse rate, and a me­di­an du­ra­tion of re­sponse that had risen to 34.6 months — near­ly 3 years. The com­plete re­sponse rates were in line with the ear­ly CAR-T tri­als, and the FDA grant­ed the drug pri­or­i­ty re­view.

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Jean-Paul Kress

Both Mor­phoSys and In­cyte have staked a lot on Mon­ju­vi. Mor­phoSys raised $208 mil­lion in an IPO in 2018, fun­nel­ing much of that cash in­to build­ing out a US com­mer­cial op­er­a­tion in an­tic­i­pa­tion of their lead drug’s ap­proval. They tapped the US com­mer­cial lead for Mer­ck KGaA’s Baven­cio, David Trexler, to lead that ef­fort. And af­ter Mo­roney’s re­tire­ment, Jean-Paul Kress stepped in to lead a new stage for the com­pa­ny.

In­cyte, mean­while, spent $900 mil­lion ear­li­er this year to join with In­cyte on the com­mer­cial launch, hop­ing the CAR-T al­ter­na­tive could pour some oil in­to a sput­ter­ing R&D en­gine. Mizuho’s Gold­stein said the drug would help di­ver­si­fy In­cyte’s rev­enue base, but its over­all im­pact may be mut­ed.

“Mon­ju­vi may not have enough im­pact in the near term to al­ter the fun­da­men­tal pic­ture for the com­pa­ny,” she said of In­cyte.

Gold­stein al­so called the drug “val­i­da­tion” for Xen­cor’s plat­form. The Cal­i­for­nia biotech orig­i­nal­ly de­vel­oped the an­ti­body. The ap­proval trig­gered a $25 mil­lion mile­stone for them.

August 3, 2020 06:50 AM EDTUpdated 07:34 AM

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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August 3, 2020 07:32 AM EDT

Im­mu­nic’s lead MS drug hits pri­ma­ry and key sec­ondary end­points in PhII, but ques­tions re­main

Max Gelman

Associate Editor

Just a week after its lead program began enrolling patients in a study to treat Covid-19, Immunic Therapeutics is making more waves.

This time, the biotech is providing a glimpse at topline data from a Phase II trial studying the efficacy of vidofludimus calcium, or IMU-838, in relapsing-remitting multiple sclerosis patients. Taken orally, the candidate met its primary endpoint in reducing the cumulative number of combined unique active MRI lesions after 24 weeks for a 45 mg dose compared to a placebo, as well as a key secondary endpoint in such reductions for the 30 mg dose.

August 3, 2020 08:35 AM EDT

Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H’s Covid-19 ‘Shark Tank’ com­pe­ti­tion

Nicole DeFeudis

Associate Editor

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

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The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.

August 3, 2020 08:11 AM EDTUpdated 08:42 AM

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH

Jason Mast

Associate Editor

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

Frank Zhang (AP Images)

August 3, 2020 07:22 AM EDT

CAR-T fil­ing in sight, Frank Zhang grabs full con­trol of J&J-part­nered Leg­end Biotech, steps down from Gen­Script

Two months after Yuan Xu steered Legend Biotech to a $424 million public debut on the Nasdaq, founder and chairman Frank Zhang is grabbing the reins as CEO.

In conjunction with the move, Zhang is also stepping down from the helm of GenScript — a position he’s held for 18 years. GenScript, a Hong Kong-listed CRO, hatched Legend as a subsidiary in 2015 before spinning it out, and remains a majority shareholder.

July 29, 2020 06:37 AM EDT

Roche de­clares a PhI­II fail­ure for Covid-19 as the IL-6 re­pur­pos­ing the­o­ry bites the dust

John Carroll

Editor & Founder

Another big IL-6 drug has failed to move the needle for Covid-19 patients, leaving that particular field of repurposed drug R&D on the ropes for the pandemic.

This morning it was Roche’s turn to outline a Phase III failure for Actemra, adding compelling data that have now all but extinguished the theory that an IL-6 drug could significantly help the most severely afflicted patients. That comes just weeks after Regeneron and Sanofi hit the red light on their trial for Kevzara after getting back-to-back readouts that made Roche’s trial a long shot at best.

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Elizabeth Nabel speaks at a news conference, Oct. 7, 2019 (Elise Amendola/AP Images)

July 31, 2020 07:29 AM EDTUpdated 08:19 AM

Brigham and Wom­en’s pres­i­dent Eliz­a­beth Nabel fol­lows Mon­cef Slaoui off Mod­er­na’s board

Amid recent scrutiny on how Moderna’s top executives have been cashing out their increasingly valuable shares, the biotech is parting ways with a board member who’s also heading a hospital where its Covid-19 vaccine is being tested.

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Elizabeth Nabel — the president of Brigham and Women’s Hospital — has followed in Moncef Slaoui’s footsteps in resigning from Moderna’s board of directors. She took the role in 2015, two years before the Operation Warp Speed leader did; and as with Slaoui and MIT professor Robert Langer, her term was due to expire in 2021.

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Tony Coles, Cerevel Therapeutics CEO

July 30, 2020 07:00 AM EDTUpdated 07:46 AM

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Jason Mast

Associate Editor

Max Gelman

Associate Editor

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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Ludwig Hantson, Alexion CEO

July 30, 2020 09:35 AM EDTUpdated 03:06 PM

UP­DAT­ED: The lead drug in Alex­ion’s $930M buy­out deal last fall just flopped — adding in­jury to an­a­lysts’ M&A in­sults

John Carroll

Editor & Founder

When Alexion $ALXN put down $930 million in cash last fall to buy Achillion, the biotech’s top execs were particularly proud of 2 clinical-stage assets, with a spotlight on the lead drug danicopan (ACH-4471) in Phase II. That drug, along with a companion therapy in Phase I, fit right in their R&D wheelhouse, noted CEO Ludwig Hantson.

But now the lead drug, redubbed ALXN2040, is being washed out and repositioned after failing 2 Phase II trials for C3 Glomerulopathy.

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