Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vet­ted by the Biden team to lead the FDA as com­mis­sion­er, Lu­ciana Bo­rio is now com­pil­ing quite the ré­sumé.

Bo­rio has now been named a ven­ture part­ner at Bob Nelsen’s ARCH Ven­ture Part­ners, and Nelsen told End­points News, “She will be in­volved in projects across the port­fo­lio, in­clud­ing on­go­ing projects in man­u­fac­tur­ing, clin­i­cal tri­als, gene ther­a­py and gene edit­ing, cell ther­a­py, and de­liv­ery. We are ex­plor­ing mul­ti­ple projects in in­fec­tious dis­ease, and next gen­er­a­tion man­u­fac­tur­ing.”

Bo­rio an­nounced her new role via tweet on Fri­day. The role will al­low her to show­case her FDA and Na­tion­al Se­cu­ri­ty Coun­cil-re­lat­ed ex­per­tise to ad­vance in­no­va­tion, sci­ence, and pub­lic health, Pfiz­er board mem­ber and for­mer FDA com­mis­sion­er Scott Got­tlieb, said.

Bob Nelsen

Nelsen and Bo­rio have worked close­ly in the past. He pre­vi­ous­ly told End­points News that he spent last spring in his Seat­tle home, talk­ing on the phone with Bo­rio about her work run­ning pan­dem­ic pre­pared­ness on the NSC, and fum­ing with her about the dire state of Amer­i­can man­u­fac­tur­ing. Those talks helped lead to the launch of Nelsen’s $800 mil­lion bi­o­log­ics man­u­fac­tur­ing start­up Re­silience.

Bo­rio, who pre­vi­ous­ly served as the FDA’s act­ing chief sci­en­tist and as VP at that non­prof­it in­vest­ment firm In-Q-Tel, serves as a se­nior fel­low for glob­al health at the Coun­cil on For­eign Re­la­tions for about the last year. Bo­rio did not re­spond to a re­quest for com­ment on whether she would keep that role at the CFR. She al­so serves as a mem­ber of CEPI’s sci­en­tif­ic ad­vi­so­ry com­mit­tee, where she pro­vides Covid-re­lat­ed guid­ance and work on the pub­lic-pri­vate part­ner­ship’s $3.5 bil­lion plan to re­duce the threat of fu­ture pan­demics and epi­demics.

And she played a hand in Pres­i­dent Biden’s race to nom­i­nate an FDA com­mis­sion­er, ac­cord­ing to one for­mer agency of­fi­cial.

Dur­ing the saga around the first ac­cel­er­at­ed ap­proval for Sarep­ta Ther­a­peu­tics’ DMD drug eteplirsen, Bo­rio — then FDA’s act­ing chief sci­en­tist — wrote to then-FDA com­mis­sion­er Robert Califf with fears that cur­rent act­ing com­mis­sion­er Janet Wood­cock “chilled sci­en­tif­ic de­bate with­in (the FDA Cen­ter for Drug Eval­u­a­tion and Re­view) and re­duced the lev­el of par­tic­i­pa­tion by the re­view team dur­ing the fi­nal stages of the de­ci­sion-mak­ing process.”

A for­mer se­nior FDA of­fi­cial said it was this dis­pute that led Wood­cock to push Bo­rio out of the FDA en­tire­ly, af­ter Bo­rio cir­cu­lat­ed an in­ter­nal memo con­cern­ing Wood­cock’s role with Sarep­ta. This for­mer of­fi­cial al­so said he thinks Bo­rio, who was vet­ted but ul­ti­mate­ly not nom­i­nat­ed to lead FDA, might have a hand in ic­ing Wood­cock’s fail­ure to land a nom­i­na­tion, too.

Ar­ti­cle up­dat­ed with com­ment from Bob Nelsen.

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.

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.

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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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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