Cel­gene inks first deals since Bris­tol-My­ers an­nounced $74B buy­out — bets $80M on im­munome­tab­o­lism

Cel­gene may be busy wrap­ping up the biggest deal in its ex­is­tence — the pro­posed $74 bil­lion sale to Bris­tol-My­ers Squibb — but it’s still snap­ping up op­tions to nascent im­muno-on­col­o­gy drugs while it can.

The lat­est tie-up in­volves Kyn Ther­a­peu­tics, a Boston start­up backed by At­las Ven­ture and Or­biMed to go af­ter metabo­lites that keep the im­mune sys­tem from at­tack­ing can­cer. For $80 mil­lion up­front and an undis­closed eq­ui­ty in­vest­ment, Cel­gene ob­tains ex­clu­sive op­tions to two of these im­munome­tab­o­lism ther­a­pies — which they will make a de­ci­sion about once Kyn is done with the Phase Ib.

Robert Her­sh­berg

Both pro­grams have some­thing to do with TDO and IDO, the lat­ter be­ing a path­way Bris­tol-My­ers has gam­bled $800 mil­lion on — on­ly to hasti­ly halt two Phase II­Is in the wake of a rout in the field. But in­stead of di­rect­ly and on­ly in­hibit­ing IDO, Kyn has de­vel­oped drugs to de­grade kynure­nine or an­tag­o­nize the aryl hy­dro­car­bon re­cep­tor to pre­vent their bind­ing, which would re­sult in broad sup­pres­sion of the im­mune sys­tem.

The col­lab­o­ra­tion sig­nals Cel­gene’s “con­tin­ued com­mit­ment to work with part­ners,” said Robert Her­sh­berg, head of busi­ness de­vel­op­ment and glob­al al­liances.

And not just with Kyn, ei­ther. Cam­bridge, MA-based Ob­sid­i­an Ther­a­peu­tics says it’s al­so scored a col­lab­o­ra­tion with Cel­gene fea­tur­ing an ex­clu­sive op­tion to in-li­cense its desta­bi­liz­ing do­main tech­nol­o­gy, which it calls an “op­er­at­ing sys­tem” for liv­ing med­i­cines like CAR-T. It adds that the pact fo­cus­es on DD-reg­u­lat­ed IL12 and CD40L, but is keep­ing qui­et about the fi­nan­cials.

Here’s CEO Michael Gilman on the ex­pe­ri­ence:

Once one of the in­dus­try’s most ac­tive deal­mak­ers, Cel­gene has a rep for of­fer­ing a sup­port­ive role for its small­er part­ners and pay­ing top dol­lar for its best prospects.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.