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.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

UP­DAT­ED: Eli Lil­ly toss­es a mar­quee pain drug and hits the gas on Alzheimer’s — as Bio­gen’s suf­fer­ing opens mar­ket to ri­vals

The furious chorus of critics that brought sales of Biogen’s ultra controversial Alzheimer’s drug aducanumab (sold as Aduhelm) to a near halt is opening up some big opportunities for a major league rival that has long sought the lead role in this largely untapped megamarket.

In its Q3 update today, Eli Lilly — noted for its dogged persistence in attempting for years to get solanezumab across the FDA finish line — said that it has begun a rolling submission of its rival Alzheimer’s drug donanemab in search of an accelerated approval. Anne White, senior VP of Lilly’s neuroscience unit, acknowledged during the investor call the challenges Biogen has faced with uptake and noted Lilly may face similar hurdles.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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