Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

Mo­tion de­nied: Gilead still on the hook for $1.5B in dam­ages over CAR-T patent dis­pute with Bris­tol My­ers Squibb

Gilead’s bid to over­turn a ju­ry ver­dict that or­dered it to pay Bris­tol My­ers Squibb about $752 mil­lion for CAR-T patents owned by its sub­sidiary Juno Ther­a­peu­tics has end­ed in vain.

The rul­ing leaves Gilead vul­ner­a­ble to an even big­ger $1.5 bil­lion pay­ment that Bris­tol is now de­mand­ing — adding fu­el to the fiery crit­i­cism some an­a­lysts are al­ready heap­ing on its $11.9 bil­lion Kite buy­out.

In a 30-page doc­u­ment un­sealed on Mon­day, Judge James Otero of the dis­trict court in Los An­ge­les struck down sev­er­al dif­fer­ent ar­gu­ments for a new de­ci­sion. Here are Mor­gan Stan­ley an­a­lysts’ take­aways:

The court, in par­tic­u­lar, de­nied Kite’s con­tentions (1) that Juno’s patent is in­valid, (2) the dam­ages award was un­rea­son­able, and (3) that a new tri­al should take place. The court al­so de­nied Kite’s ar­gu­ment that its in­fringe­ment was not will­ful.

Gilead is like­ly to ap­peal to the fed­er­al cir­cuit, they not­ed, but the odds are not in their fa­vor as the same stan­dard for ev­i­dence will be ap­plied in that court. Ap­peals typ­i­cal­ly take 16 months.

Be­fore that, the low­er court is due to rule on Juno’s own post-tri­al mo­tion to dou­ble the dam­ages from $585 mil­lion to $1.5 bil­lion, and raise the run­ning roy­al­ty rate payable to Bris­tol My­ers from 27.6% to 33.1%.

The num­bers are as­tro­nom­i­cal on their own, but es­pe­cial­ly so con­sid­er­ing that Yescar­ta has on­ly earned $456 mil­lion in sales last year — which is al­ready a jump from $264 mil­lion in 2018. Gilead will have to pay roy­al­ties un­til Juno’s patents ex­pire in Au­gust 2024, which “makes Yescar­ta po­ten­tial­ly a neg­a­tive-mar­gin busi­ness.”

It is yet un­clear whether, or how much, the patent is­sues will af­fect the oth­er CAR-T prod­ucts in Kite’s pipeline. Un­der CEO Kristi Shaw, the group has scored pri­or­i­ty re­view for a sec­ond CAR-T dubbed KTE-X19.

At the crux of the dis­pute is the claim that Steve Rosen­berg of the Na­tion­al Can­cer In­sti­tute copied MSK in­ves­ti­ga­tor Michel Sade­lain’s CAR back­bone in cre­at­ing the CD19-tar­get­ing con­struct that he lat­er li­censed to Kite.

Dur­ing the pro­ceed­ings the in­ter­ac­tion be­tween Arie Bellde­grun, who co-found­ed Kite and has since moved on­to pi­o­neer­ing al­lo­gene­ic CAR-T ther­a­pies, and Memo­r­i­al Sloan Ket­ter­ing ex­ecs were thrust in­to the spot­light. The court again high­light­ed those episodes as part of the “suf­fi­cient ev­i­dence of will­ful­ness.”

Plain­tiff’s fact wit­ness Dr. Dash tes­ti­fied that Dr. Bellde­grun was so des­per­ate to pur­sue a li­cense to the ‘190 Patent that he ap­peared at her of­fice, de­spite not hav­ing a meet­ing. Dr. Jakobovitz sim­i­lar­ly tes­ti­fied that Dr. Bellde­grun met with Plain­tiffs in an at­tempt to li­cense the ‘190 Patent. Plain­tiffs fur­ther ar­gued that De­fen­dant’s fil­ing of the IPR against the ‘190 Patent demon­strat­ed the im­por­tance of the ‘190 Patent to De­fen­dant.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Multiple antibiotic resistant Pseudomonas aeruginosa bacterium

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

About four years ago, Ruben Tommasi, the gregarious scientific chief of antibiotics startup Entasis, walked into a meeting with his top chemist and top biologist to chew over another batch of unchanging results.

“It felt like we were running the same experiment over and over,” Tommasi told Endpoints News. “We had all sort of come to that point in time where we felt like we were banging our heads against the wall.”

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Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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