No­var­tis spin­out resTOR­bio re­verse merges with T cell biotech af­ter big PhI­II fail­ure

The end of their lead pro­gram will, it turns out, spell the end for No­var­tis spin­out resTOR­bio.

Shares for the once well-fund­ed an­ti-ag­ing biotech crum­bled af­ter its lead pro­gram failed a Phase III tri­al last year. The com­pa­ny said they would shift fo­cus to an ear­ly stage Parkin­son’s can­di­date, but that looked like a long shot at the time, and to­day, the com­pa­ny an­nounced they will re­verse merge with Adicet Bio.

Anil Sing­hal

The new biotech will cen­ter around Adicet’s off-the-shelf T cell plat­form. Found­ed by for­mer Kite Phar­ma CEO Aya Jakobovits and now led by Ab­b­Vie alum Anil Sing­hal, the com­pa­ny has so far raised over $130 mil­lion in an ef­fort to build a more po­tent and eas­i­er to man­u­fac­ture CAR-T ther­a­py, along with sev­er­al oth­er T cell-based treat­ments. It’s a crowd­ed field but Adicet has a big name part­ner in Re­gen­eron. The biotech gi­ant has spent the last few years try­ing to catch up fast on im­muno-on­col­o­gy, in­clud­ing by chip­ping in $25 mil­lion for Adicet’s Se­ries B last year.

Adicet’s ap­proach is based around gam­ma-delta T cells, ver­sa­tile im­mune cells that are be­lieved to play an im­por­tant role in rec­og­niz­ing can­cers and cer­tain hard-to-see anti­gens. They were over­looked in the first gen­er­a­tion of au­tol­o­gous CAR-T ther­a­pies be­cause they rep­re­sent on­ly a tiny per­cent­age of the T cells in the blood, but a long list of biotechs — in­clud­ing Juno Ther­a­peu­tics and sev­er­al com­pa­nies that, like Adicet, are built sole­ly around the cell type — are now try­ing to use them to de­vel­op more po­tent cell ther­a­pies.

The dis­ap­pear­ance of resTOR­bio is a loss not on­ly for No­var­tis and Puretech, who set up the com­pa­ny three years ago to ad­vance a pair of mid-stage com­pounds, but al­so for an en­tire cel­lu­lar path­way — called mTOR — that at var­i­ous times has seemed a promis­ing tar­get for a host of dis­eases re­lat­ed to ag­ing, in­clud­ing can­cer. resTOR­bio had been try­ing to de­vel­op a TORC1 in­hibitor, called RTB101, that would boost the pa­tient’s im­mune sys­tem and re­duce the rate of res­pi­ra­to­ry in­fec­tions in the el­der­ly.

They raised $85 mil­lion in an IPO off that idea in 2017 and shares soared the next year af­ter they cleared a Phase II tri­al in pa­tients with asth­ma. But in No­vem­ber a Phase III tri­al showed their drug ac­tu­al­ly per­formed worse than place­bo. In two days, their stock went from a lit­tle over $9 to bare­ly $1.

The stock was 32% — which trans­lat­ed to a 39 cent gain — per mar­ket. Adicet’s lead pro­gram, an off-the-shelf CAR-T tar­get­ing CD-20, is in the pre­clin­i­cal stage.

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.

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As­traZeneca trum­pets the good 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.”

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The Advance 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.

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.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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