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.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Watch out, Roche: No­var­tis inks $1.5B deal to chase down promi­nent Parkin­son’s tar­get

Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

Glax­o­SmithK­line, Ox­ford un­veil new part­ner­ship pit­ting buzzy R&D ad­vances against neu­ro­log­i­cal dis­ease

When GlaxoSmithKline trumpeted its return to neuroscience with a $700 million upfront deal with Alector this summer, it touted its early investments in functional genomics as a key guidepost for that deal. Now, the drug giant has partnered up with Oxford to hopefully add jet fuel to its hunt for breakthroughs in the brain.

GSK and Oxford have kickstarted a five-year collaboration aimed at spurring R&D breakthroughs across a range of hard-to-treat diseases like Alzheimer’s and Parkinson’s through the use of genomic testing and machine learning, the partners said Wednesday.

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.