Scoop: Cel­gene tar­gets a cure for myelo­ma/lym­phoma with $600M En­gMab buy­out

Cel­gene Ex­ec­u­tive Chair­man Bob Hug­in

Cel­gene has com­plet­ed a deal to ac­quire the Swiss biotech En­gMab for $600 mil­lion, adding a new BC­MA-tar­get­ing mul­ti­ple myelo­ma pro­gram to the pipeline, End­points News has learned. And it’s putting the new tech to work with its on­go­ing ef­forts on CAR-T and CD-3 an­ti­bod­ies with an eye on find­ing a cure for myelo­ma and lym­phoma.

A Cel­gene spokesper­son con­firmed the deal to me in a state­ment Fri­day morn­ing, say­ing that “we are ac­quir­ing En­gmab for $600 mil­lion.”

“B-cell mat­u­ra­tion anti­gen (BC­MA) is high­ly and se­lec­tive­ly ex­pressed on the sur­face of ma­lig­nant plas­ma cells in MM and tar­get of high val­ue for im­mune based ther­a­pies such as re-en­gi­neered au­tol­o­gous T-CAR-T and the re-di­rec­tion of CD4+ and CD8+ T lym­pho­cytes via an­ti-CD3 bi-spe­cif­ic an­ti­bod­ies,” he said. Cel­gene added:

Through this ac­qui­si­tion, Cel­gene is now unique­ly po­si­tioned to pur­sue BC­MA de­vel­op­ment op­por­tu­ni­ties us­ing both CAR-T and CD-3- redi­rect­ed killing plat­forms. Both ap­proach­es and as­sets pro­vide the op­por­tu­ni­ty for best in class as­sets.

We see both this and the Blue­bird BC­MA plat­form as high­ly com­ple­men­tary with the po­ten­tial to be cu­ra­tive.  In ad­di­tion to mono-ther­a­py in Myelo­ma pa­tients, both plat­forms pro­vide the op­por­tu­ni­ty for ra­tio­nal com­bi­na­tion ther­a­pies with CELMods and Check­point in­hibitors in or­der to fur­ther im­prove treat­ment ef­fi­ca­cy, as well as clin­i­cal de­vel­op­ment in oth­er BC­MA ex­press­ing B-cell ma­lig­nan­cies such as lym­phoma.

B-cell mat­u­ra­tion anti­gen, a tar­get com­mon­ly ex­pressed on mul­ti­ple myelo­ma cells, is a hot fo­cus at Cel­gene. The big biotech re­struc­tured its deal with blue­bird bio $blue last year to go af­ter BC­MA.

Jef­feries’ Bri­an Abra­hams high­light­ed signs of a pend­ing deal a cou­ple of weeks ago, not­ing that En­gMab has been work­ing on sev­er­al T cell-re­cruit­ing an­ti­bod­ies that ze­ro in on BC­MA.

Ac­cord­ing to En­gMab’s web site, the biotech has been la­bor­ing on T-cell bis­pe­cif­ic an­ti­bod­ies, which are de­signed to bring im­mune cells in­to con­tact with a tar­get on can­cer cells, a forcible head butt that should de­stroy the can­cer cell. And its in­ves­ti­ga­tors showed up at ASH late last year to talk up their work on mul­ti­ple myelo­ma.

Cel­gene is the leader in the mul­ti­ple myelo­ma mar­ket, dom­i­nat­ing the field with Revlim­id and Po­m­a­lyst while J&J and Bris­tol-My­ers Squibb have jumped in with Darza­lex and Em­plic­i­ti. And it has good rea­son to go af­ter BC­MA, a tar­get that is present at an es­ti­mat­ed 60% to 70% of all mul­ti­ple myelo­ma cas­es.

This is the lat­est in a long string of high-pro­file M&A and li­cens­ing deals for Cel­gene, which has been in­vest­ing heav­i­ly in its pipeline un­der ex­ec­u­tive chair­man Bob Hug­in. Hug­in will like­ly find him­self back in the spot­light to­day, as an­a­lysts won­der whether the com­pa­ny is pay­ing too much for its pro­grams. But Hug­in has al­ways said that there’s no re­al way to say if you’ve paid too much or too lit­tle. The drugs that work are al­ways ac­quired for a small price. The ones that don’t work are al­ways too ex­pen­sive.

Share­hold­ers seem to be lov­ing it to­day, bid­ding up Cel­gene’s shares by 2% in the ear­ly af­ter­noon.

Cel­gene is far from alone in the field. In a note out this morn­ing, Abra­hams cites the blue­bird pro­gram along with an ef­fort by the NCI, both in the clin­ic. “GSK has a BC­MA-tar­get­ed ADC (GSK2857916) and AMGN has a bis­pe­cif­ic (AMG420) al­so in ph.I tri­als,” the an­a­lyst adds. “JUNO and the Cal­i­for­nia In­sti­tute of Bio­med­ical Re­search al­so ap­par­ent­ly have (a) pre­clin­i­cal BC­MA pro­gram.”

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Anthony Fauci (AP Images)

NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

Mallinck­rodt, once the na­tion’s largest oxy­codone pro­duc­er, an­nounces ten­ta­tive $1.6B set­tle­ment

Three years after it first paid out fines for its role in the US opioid abuse epidemic, Mallinckrodt has announced an agreement-in-principle that will see the company pay out $1.6 billion and place its generics unit in bankruptcy.

The tentative deal would settle hundreds of lawsuits from states and local governments over Mallinckrodt’s role in the epidemic, while also helping address the company’s increasingly mountainous debt. Although Purdue Pharma has drawn the bulk of both public and legal acrimony for opioid sales, documents made public earlier this year showed that Mallinckrodt subsidiary SpecGx, along with the generic subsidiaries of Teva and Endo Pharmaceuticals, accounted for the vast majority of the 76 billion opioid pills distributed from 2006 to 2012. Mallinckrodt was at the top of that list.

No­var­tis' plans to wres­tle Eylea mar­ket share take a hit as Beovu is linked to safe­ty con­cerns

While Regeneron’s flagship eye therapy Eylea hurtles towards a patent cliff, the sales of its main rival — Novartis’ Beovu — could be tainted by safety concerns.

On Sunday night, Chicago-based American Society of Retina Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis (including 11 cases of occlusive retinal vasculitis) — a sight-threatening inflammatory eye condition that involves the retinal vessels — across 46,000 injections administered since Beovu’s launch in November 2019, Wall Street analysts reported.

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UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115M and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS-CoV-2, and to prevent new ones.