Out to chal­lenge Gilead­'s dai­ly pills, Vi­iv scores three-year da­ta on month­ly com­bo; Rigel bags $33M from Asia li­cens­ing deal

→ On the heels of an NDA sub­mis­sion, Vi­iv has post­ed longterm da­ta sup­port­ing its the­o­ry that an­oth­er one of its long-act­ing two-drug com­bos could work just as well as the dai­ly triplets of­fered by its big ri­val Gilead. In a Phase IIb tri­al, re­searchers found that at the three-year mark, 90% pa­tients re­ceiv­ing the in­jectable reg­i­men of cabote­gravir and rilpivirine every eight weeks re­mained vi­ral­ly sup­pressed; 83% of those on the four-week reg­i­men did. It echoes a set of Phase III re­sults the GSK sub­sidiary un­veiled in Au­gust, which Vi­iv says points to the com­bo’s po­ten­tial in “chang­ing HIV treat­ment from 365 dos­ing days per year, to just 12.”

→ Progress in Janssen’s Phase II tri­al of ni­ra­parib monother­a­py has trig­gered an $18 mil­lion mile­stone pay­ment to Tesaro $TSRO, which is mount­ing a leap from Phase Ib to Phase III for a com­bo prostate can­cer ther­a­py fea­tur­ing the drug. Janssen first took over de­vel­op­ment of ni­ra­parib in 2016 af­ter hand­ing over $35 mil­lion up­front.

→ Now that Rigel Phar­ma $RIGL is ful­ly on track with the US com­mer­cial­iza­tion of Tavalisse (fos­ta­ma­tinib), it is ready to tap in­to the Asian mar­kets through a li­cens­ing deal with Japan’s Kis­sei Phar­ma. Pay­ing $33 mil­lion in cash and $147 mil­lion in biobucks, Kis­sei can now de­vel­op and mar­ket the drug — cur­rent­ly in­di­cat­ed for dan­ger­ous­ly low platelet counts, or throm­bo­cy­tope­nia — in Japan, Chi­na, Tai­wan and South Ko­rea.

ViewRay $VRAY is team­ing up with can­cer ser­vice provider Gen­e­sis­Care to in­stall its MRI-guid­ed ra­di­a­tion ther­a­py in Gen­e­sis­Care’s UK care cen­ters. The MRId­i­an lin­ear ac­cel­er­a­tors, the part­ners say, will sup­port pre­ci­sion med­i­cine by in­form­ing on­col­o­gists “what’s re­al­ly hap­pen­ing in­side the body dur­ing treat­ment.”

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Once a gem, now just a rock, Take­da punts PhI­II IBD drug as ri­vals mus­cle ahead

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.

Sier­ra On­col­o­gy brings on for­mer Aim­mune CEO to the helm; Flag­ship woos ex-No­var­tis ex­ec Fab­rice Chouraqui

Momelotinib-focused Sierra Oncology, which launched a Phase III trial in November for myelofibrosis patients, has made Stephen Dilly its president and CEO, effective June 1. Dilly was previously the CEO at Aimmune from 2014 until what was billed as his retirement in 2018, but now he’s back at the helm of another company and is also a member of Sierra’s board of directors. Additionally, the seasoned vet has held posts at Genentech, Chiron and GSK.