PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Phar­ma, the lofty goal to un­leash a “tsuna­mi” of T cells per­son­al­ized for each pa­tient has hinged on the abil­i­ty to cor­rect­ly iden­ti­fy the neoanti­gens that form some­thing of a fin­ger­print for each tu­mor, and ex­tract the small group of T cells primed to at­tack the can­cer. It still has a long way to go test­ing a treat­ment in hu­mans, but the biotech says it has nailed that high­ly tech­ni­cal piece of the process.

Cristi­na Puig-Saus

It’s a key step in mak­ing im­muno-on­col­o­gy work for every­one be­cause sci­en­tists can now pin­point what ex­act­ly is dri­ving, say, pa­tient re­sponse to check­point in­hibitors, ac­cord­ing to the team be­hind the work — open­ing the door to elim­i­nat­ing sol­id tu­mors.

Work­ing with some im­mune cells cap­tured from a pa­tient who had a long-last­ing re­sponse to an­ti-PD-1 ther­a­py, re­searchers ran the sam­ple through their “ul­tra-sen­si­tive and high-through­put” iso­la­tion tech­nol­o­gy, dubbed im­PACT. Af­ter re­triev­ing the T cells that they be­lieve were re­spon­si­ble for the re­sponse, they en­gi­neered (with non-vi­ral gene edit­ing) oth­er T cells to ex­press those same re­cep­tors and demon­strat­ed the re­sult­ing T cells can kill the same per­son’s can­cer cells.

An­toni Ribas

With back­ing from the Park­er In­sti­tute for Can­cer Im­munother­a­py, Cristi­na Puig-Saus led the study at UCLA, where PACT co-founder An­toni Ribas di­rects the tu­mor im­munol­o­gy pro­gram at the Jon­s­son Com­pre­hen­sive Can­cer Cen­ter. Ribas is list­ed as a se­nior au­thor.

“We hope that a bet­ter un­der­stand­ing of the T cell re­spons­es that oc­cur af­ter im­mune check­point block­ade will guide the de­sign of per­son­al­ized adop­tive T cell ther­a­pies,” Puig-Saus said in a re­lease ac­com­pa­ny­ing their pre­sen­ta­tion at an AACR spe­cial con­fer­ence days ago.

Once PACT gets to clin­i­cal stud­ies — and it’s re­cruit­ing for a Phase I now — it would al­so have to show it can quick­ly ex­pand the pop­u­la­tion of those T cells and safe­ly re­in­fuse them in­to the pa­tients.

Alex Franzu­soff

“While it is ear­ly, the re­sults demon­strate the pos­si­bil­i­ty for PACT’s ap­proach to ig­nite a pa­tient’s im­mune re­sponse di­rect­ly against their unique tu­mor mu­ta­tion sig­na­ture, with­in a clin­i­cal­ly rel­e­vant time­frame, with po­ten­tial ap­plic­a­bil­i­ty to most can­cers and all eth­nic­i­ties across the globe,” CEO Alex Franzu­soff said in a state­ment.

The ap­proach puts a twist on CAR-T and next-gen TCR ther­a­pies, which rec­og­nize a fixed set of anti­gens shared among pa­tients. Can­cer vac­cines are of­ten too slow to catch up with tu­mor growth; tu­mor-in­fil­trat­ing lym­pho­cytes are hard to man­u­fac­ture in vast quan­ti­ties, the com­pa­ny wrote — prob­lems that oth­er star­tups such as Neon Ther­a­peu­tics and Io­vance are at­tempt­ing to ad­dress.

PACT, of course, will al­so face its own chal­lenges in ad­vanc­ing a tai­lor-made im­munother­a­py. From a pa­per quot­ed on its web­site:

Per­son­al­iz­ing the im­mune ef­fec­tors used and the can­cer anti­gens tar­get­ed will re­quire rec­on­cil­ing timescales of clin­i­cal need, on-de­mand man­u­fac­tur­ing, and reg­u­la­to­ry com­pli­ance.

With a star-stud­ded founder team — in­clud­ing Ribas, David Bal­ti­more, Jim Heath, Ter­ry Rosen and Juan Jaen — and a well-heeled syn­di­cate that’s poured in $126 mil­lion, PACT is ready to tack­le the chal­lenges head on.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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