Sanofi teams up with Mer­ck to pair Keytru­da with a next-gen IL-2 can­di­date from the Syn­thorx buy­out

Near­ly a year af­ter snap­ping up a next-gen im­muno-on­col­o­gy can­di­date in its $2.5 bil­lion Syn­thorx buy­out, Sanofi is join­ing forces with Mer­ck to pair the drug with block­buster Keytru­da.

The phar­mas are plan­ning a Phase II tri­al of Sanofi’s non-al­pha IL-2 can­di­date THOR-707 in com­bi­na­tion or se­quenced ad­min­is­tra­tion with Keytru­da for var­i­ous can­cers. While the com­pa­nies are keep­ing mum about the fi­nan­cial terms and tar­gets, they said the tri­als will be Sanofi-spon­sored.

THOR-707 is cur­rent­ly in a Phase I open-la­bel dose es­ca­la­tion and ex­pan­sion tri­al as­sess­ing safe­ty and tol­er­a­bil­i­ty. Re­searchers are look­ing to nail down a rec­om­mend­ed dose for Phase II, both for the drug alone and in com­bi­na­tion with an­ti-PD-1 and an­ti-EGFR an­ti­bod­ies.

Syn­thorx de­vel­oped THOR-707 un­der the guid­ance of then-CEO Lau­ra Shawver as an al­ter­na­tive to Pro­leukin, which is known for its bad tox pro­file, in­clud­ing vas­cu­lar leak syn­drome. Ac­cord­ing to its 2018 S-1 fil­ing, the drug uti­lizes syn­thet­ic ge­net­ic al­pha­bets and is de­signed to “kill tu­mor cells by in­creas­ing CD8+ T and NK cells with­out caus­ing VLS (vas­cu­lar leak syn­drome) that has been ob­served with aldesleukin.” The biotech added that when com­bined with check­point in­hibitors, the drug could have “greater an­ti-tu­mor ef­fects” than PD-1 in­hibitors alone.

A year af­ter land­ing a $131 mil­lion pub­lic de­but, Syn­thorx was bought by Sanofi for $68 a share. The deal, CEO Paul Hud­son said at the time, “is aligned with our goal to build our on­col­o­gy fran­chise with po­ten­tial­ly prac­tice-chang­ing med­i­cines and nov­el com­bi­na­tions.”

In ad­di­tion to the Keytru­da com­bo, Sanofi is al­so study­ing THOR-707 in com­bi­na­tion with oth­er an­ti-PD-1 an­ti­bod­ies such as Lib­tayo, and with an­ti-EGFR and an­ti-CD38 an­ti­bod­ies. In pre­clin­i­cal stud­ies, the drug was shown to trig­ger the ex­pan­sion of CD8+ T cells both alone and with an an­ti-PD-1 mAb, ac­cord­ing to Sanofi.

“We be­lieve that THOR-707 has the po­ten­tial to be­come a foun­da­tion of the next gen­er­a­tion of im­muno-on­col­o­gy ther­a­pies,” Pe­ter Adam­son, Sanofi’s glob­al head of on­col­o­gy de­vel­op­ment and pe­di­atric in­no­va­tion, said in a state­ment. “This col­lab­o­ra­tion with MSD will en­able us to ex­plore whether THOR-707 can in­crease and ex­pand the ef­fec­tive­ness of Keytru­da and im­prove the out­comes for pa­tients with can­cer.”

The phar­ma ex­pects to read out full Phase I re­sults and an­nounce rec­om­mend­ed Phase II dose by 2021.

Nek­tar’s sec­ond-gen IL-2 can­di­date was grant­ed break­through des­ig­na­tion in com­bi­na­tion with Op­di­vo in Au­gust 2019. But con­tro­ver­sial ex­pla­na­tions for wan­ing re­sponse rates posed a set­back. And at this year’s vir­tu­al ES­MO, Alk­er­mes read out re­sults from a Phase I/II tri­al of their ALKS-4230, which is al­so be­ing test­ed in com­bi­na­tion with Keytru­da. The biotech said re­sults showed “en­cour­ag­ing sin­gle-agent ac­tiv­i­ty of ALKS-4230 in melanoma and durable re­spons­es in mul­ti­ple tu­mor types in com­bi­na­tion with pem­brolizum­ab.”

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.