Adelene Perkins, Infinity CEO

Could a fourth lead drug fi­nal­ly bring In­fin­i­ty an ap­proval?

Maybe fourth time’s the charm?

In­fin­i­ty Phar­ma­ceu­ti­cals, the thrice-failed on­col­o­gy biotech, an­nounced up­dat­ed da­ta Tues­day from its new lead drug in a pair of can­cers, show­ing that blad­der can­cer pa­tients who took its mol­e­cule in com­bi­na­tion with Bris­tol My­ers Squibb’s Op­di­vo lived near­ly twice as long as pa­tients who took Op­di­vo alone. And the biotech showed the mol­e­cule ap­peared to of­fer a mod­est ben­e­fit for pa­tients with triple-neg­a­tive breast can­cer.

“In our view, these da­ta are over­all pos­i­tive and con­tin­ue to sup­port eganelis­ib po­ten­tial,” Tru­ist’s Robyn Kar­nauskas wrote in a note to in­vestors, us­ing the chem­i­cal name of the drug.

And yet In­fin­i­ty’s stock $IN­FI slid on the news, drop­ping 31% Tues­day from $2.22 to $1.53, al­though it has since bounced back up.

The prob­lem is one In­fin­i­ty has faced be­fore: Whether or not the drug is ef­fec­tive, it may not have a mar­ket. The biotech’s pre­vi­ous lead P13K drug, du­velis­ib, was aban­doned af­ter show­ing a 46% re­sponse rate in non-Hodgkin lym­phoma — good, but not good enough to com­pete in a field where oth­er op­tions are avail­able. (They dumped the drug to Ve­rastem, who got it ap­proved but gen­er­at­ed lit­tle sales). It was the third In­fin­i­ty drug to go down, af­ter clin­i­cal fail­ures for oth­er mol­e­cules in 2009 and 2012 shook what had once been one of the biggest biotechs in tar­get­ed on­col­o­gy.

Sim­i­lar­ly, in­vestors had been hop­ing to see a greater ben­e­fit in triple-neg­a­tive breast can­cer, an in­di­ca­tion that’s no­to­ri­ous­ly tough to treat. In­fin­i­ty showed its drug, when com­bined with Roche’s PD-1 block­er Tecen­triq and chemother­a­py, halt­ed dis­ease for 7.5 months, or just 0.2 months — six days — more than Roche showed Tecen­triq and chemother­a­py can alone.

Those da­ta al­so came out the same day Mer­ck an­nounced Keytru­da im­proved pro­gres­sion-free sur­vival in triple-neg­a­tive breast can­cer, adding an­oth­er op­tion In­fin­i­ty would have to com­pete against.

The da­ta for blad­der can­cer were far stronger, but in­vestors had been hop­ing the com­pa­ny would lay out a clear­er path to ap­proval. In­stead, In­fin­i­ty CEO Ade­lene Perkins promised an up­date to­ward the end of the year and an­a­lysts now ex­pect the tri­al could take longer than an­tic­i­pat­ed. With the FDA tak­ing a tougher stance on PD-1 ap­provals, the com­pa­ny will like­ly have to prove its com­bi­na­tion can im­prove sur­vival in a large study, push­ing ap­proval back to­ward 2025.

In the mean­time, com­peti­tors are en­ter­ing the mar­ket. In­fin­i­ty has stud­ied its drug in pa­tients who have al­ready gone through one line of treat­ment but have yet to re­ceive a check­point in­hibitor. But B. Ri­ley Se­cu­ri­ties’ Kalpit Pa­tel not­ed that PD-1s are in­creas­ing­ly be­ing used in new­ly di­ag­nosed blad­der can­cer pa­tients, in­clud­ing in com­bi­na­tion with Seagen’s new an­ti­body-drug con­ju­gate Pad­cev.

“We ac­knowl­edge a lim­it­ed op­por­tu­ni­ty,” Pa­tel said, es­ti­mat­ing 4,200 pa­tients per year would be el­i­gi­ble for In­fin­i­ty’s drug if it suc­ceeds.

Nev­er­the­less, few an­a­lysts soured on In­fin­i­ty al­to­geth­er, par­tic­u­lar­ly with shares sell­ing at so­da bot­tle prices. Eganelis­ib, a P13K-gam­ma in­hibitor, is in­tend­ed to re­pro­gram the im­mune cells that clus­ter around the tu­mor, short-cir­cuit­ing one of sol­id tu­mors’ key meth­ods for avoid­ing T cells and oth­er tu­mor-killing arms of the im­mune sys­tem.

Ac­cord­ing­ly, the com­pa­ny hoped it would both im­prove re­spons­es in pa­tients who al­ready ex­press PD-L1 and are like­ly to ben­e­fit from check­point ther­a­py, and those who don’t ex­press PD-L1 and are less like­ly to ben­e­fit. In the­o­ry, the mol­e­cule could con­vert some of these tu­mors to PD-L1 pos­i­tive.

An­a­lysts ex­pect In­fin­i­ty to push for an ap­proval in PD-L1-neg­a­tive pa­tients for blad­der can­cer. And some ar­gued that the triple-neg­a­tive breast can­cer da­ta were skewed be­cause In­fin­i­ty had a greater num­ber of neg­a­tive pa­tients than those in Roche’s orig­i­nal tri­al. Bro­ken down by PD-L1 pos­i­tive and neg­a­tive, they not­ed, In­fin­i­ty’s drug ac­tu­al­ly im­proved PFS by 2 months for neg­a­tive pa­tients and near­ly 4 months for pos­i­tive pa­tients.

That kind of spec­u­la­tive analy­sis, though, is far from the kind of ev­i­dence it will take to get ap­proval.

“While en­cour­ag­ing,” Pa­tel wrote, “we cur­rent­ly ex­clude TNBC as a po­ten­tial in­di­ca­tion as we wait for da­ta from ad­di­tion­al num­ber of pa­tients as well as longer-term re­sponse dura­bil­i­ty/PFS re­sults.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.