Bruised by a pun­ish­ing Op­di­vo fail­ure, Bris­tol-My­ers looks to shake up the busi­ness, ac­cel­er­ate R&D

Gio­van­ni Caforio, Bris­tol-My­ers Squibb CEO

Fresh off one of the biggest clin­i­cal tri­al set­backs of the year, Bris­tol-My­ers Squibb $BMY is plan­ning to re­group and ac­cel­er­ate on the R&D side as part of a broad re­or­ga­ni­za­tion, shift­ing more mon­ey in­to re­search af­ter hunt­ing out sav­ings in the rest of the busi­ness.

The de­tails are sparse, but the com­pa­ny says in its new­ly re­leased Q3 up­date that it plans to cre­ate a “com­pet­i­tive and more ag­ile R&D or­ga­ni­za­tion that can ac­cel­er­ate the pipeline, stream­lined op­er­a­tions and re­aligned man­u­fac­tur­ing ca­pa­bil­i­ties that broad­en bi­o­log­ics ca­pa­bil­i­ties to re­flect cur­rent and fu­ture port­fo­lio. The new op­er­at­ing mod­el will en­able the com­pa­ny to de­liv­er the strate­gic, fi­nan­cial and op­er­a­tional flex­i­bil­i­ty nec­es­sary to in­vest in the high­est pri­or­i­ties across the com­pa­ny.”

The ex­ec­u­tive crew stayed fo­cused on broad gen­er­al­i­ties in the call with an­a­lysts Thurs­day morn­ing. CEO Gio­van­ni Caforio em­pha­sized that the com­pa­ny will “con­tin­u­ing to al­lo­cate re­sources dri­ven by op­por­tu­ni­ties we see in the port­fo­lio.” Over the next three to five years, he ex­pects that the op­por­tu­ni­ties for rev­enue growth with stay fo­cused pri­mar­i­ly on Op­di­vo, Yer­voy and Eliquis.

“At same time,” he adds, “we’re ad­vanc­ing the ear­ly pipeline,” ready to back pro­grams that emerge as high po­ten­tial per­form­ers. Bris­tol plans to in­crease R&D spend­ing next year, fo­cus­ing even more on its core ar­eas, while squeez­ing op­er­at­ing ex­pens­es, in­fra­struc­ture and man­u­fac­tur­ing costs wher­ev­er pos­si­ble.

The R&D spot­light now shifts to Check­mate-227, test­ing a com­bi­na­tion of Op­di­vo and Yer­voy. Im­muno-on­col­o­gy chief Fouad Namouni says that the com­pa­ny has learned from the Check­mate-026 set­back, dou­bling the num­ber of pa­tients it’s re­cruit­ing for ‘227 in or­der to avoid a re­peat of what Bris­tol views was a poor se­lec­tion of pa­tients test­ed in ‘026.

Bris­tol-My­ers suf­fered a damn­ing Phase III fail­ure with their flag­ship drug, the check­point in­hibitor Op­di­vo. Eas­i­ly the dom­i­nant check­point on the mar­ket, Op­di­vo flunked a late-stage tri­al that tried and failed to demon­strate an ad­van­tage for a broad pop­u­la­tion of non-small cell lung can­cer pa­tients as a front­line ther­a­py. Even more damn­ing, the sub­pop­u­la­tion break­down in the study — re­viewed at ES­MO — looked bad for Op­di­vo.

Mer­ck, which had had to ac­cept a run­ner-up po­si­tion in the mar­ket, was able to quick­ly leapfrog Bris­tol-My­ers by demon­strat­ing Keytru­da was ef­fec­tive among high PD-L1 ex­pressers, and the FDA swift­ly fol­lowed up with a pi­o­neer­ing front­line ap­proval in that key group.

What re­mains to be seen is how Bris­tol-My­ers plans to make its R&D group “more ag­ile.” The com­pa­ny has been pour­ing mon­ey in­to its im­muno-on­col­o­gy work, hir­ing new staffers and adding a cam­pus in Cal­i­for­nia.

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.

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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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

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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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.

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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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.

Ali Tehrani, Zymeworks CEO

Zymeworks squares up with Her­ceptin af­ter HER2 bis­pe­cif­ic aces mid-stage test in esophageal can­cer

Roche’s Herceptin has long stood as standard of care across multiple advanced cancers, but a suite of next-gen players are looking to beat the aging giant at its own game. In HER2-expressing esophageal cancer, BeiGene partner Zymeworks thinks its bispecific antibody could have the juice to get it done.

Zymeworks’ bispecific antibody zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy, the Vancouver-based biotech said Thursday.