Len Schleifer, Regeneron CEO (Andrew Harnik/AP Images)

Surg­ing US de­mand trig­gers new $2.9B pur­chase of Re­gen­eron's Covid-19 an­ti­bod­ies

Re­gen­eron has re­ceived a new $2.9 bil­lion or­der for its Covid-19 an­ti­body cock­tail as de­mand for mon­o­clon­al an­ti­bod­ies surges in the US amid a spike in cas­es.

The US gov­ern­ment is pur­chas­ing 1.4 mil­lion ad­di­tion­al dos­es of RE­GEN-COV, a com­bi­na­tion of casiriv­imab and imde­vimab, at a price of $2,100 for each 1,200mg dose — bring­ing the to­tal pur­chase to near­ly 3 mil­lion dos­es.

This marks the third sup­ply deal Re­gen­eron has scored in the US.

Un­der emer­gency use au­tho­riza­tions by the FDA, RE­GEN-COV is be­ing used to treat in­fect­ed pa­tients to low­er their risk of hos­pi­tal­iza­tion or death, and for post-ex­po­sure pro­phy­lax­is for close con­tacts of in­fect­ed in­di­vid­u­als.

“More than a year and a half in­to this pan­dem­ic, too many peo­ple are still be­ing hos­pi­tal­ized and dy­ing due to COVID-19,” Re­gen­eron CEO Len Schleifer said in a state­ment. “While vac­ci­na­tion re­mains the first line of de­fense to de­crease the bur­den of COVID-19, RE­GEN-COV is a key tool that re­duces the risk of hos­pi­tal­iza­tion or death by 70% in high-risk in­di­vid­u­als when giv­en ear­ly in the course of the in­fec­tion.”

Uti­liza­tion of the treat­ment start­ed off slow. In Ju­ly — al­most eight months af­ter RE­GEN-COV was first grant­ed an EUA — sites around the coun­try were col­lec­tive­ly or­der­ing about 25,000 dos­es per week. And that was dur­ing a time that ship­ments of Eli Lil­ly’s an­ti­bod­ies were halt­ed na­tion­wide, mean­ing RE­GEN-COV and Glax­o­SmithK­line/Vir’s sotro­vimab were the on­ly op­tions avail­able.

But by late Au­gust, that num­ber for Re­gen­eron shot up to 125,000, and states where in­fec­tions were sky­rock­et­ing, such as Flori­da or Texas, set up new in­fu­sion cen­ters to ad­min­is­ter the drugs.

Ac­cord­ing to of­fi­cial da­ta, 179 mil­lion peo­ple are ful­ly vac­ci­nat­ed in the US, trans­lat­ing to a 54.5% vac­ci­na­tion rate, al­though the ac­tu­al rate varies de­pend­ing on lo­ca­tion. Chil­dren or ado­les­cents un­der the age of 12 re­main in­el­i­gi­ble for any shots.

Re­gen­eron ex­pects to be­gin send­ing its new RE­GEN-COV dos­es to the US gov­ern­ment stock­pile al­most im­me­di­ate­ly, and have the vast ma­jor­i­ty de­liv­ered in Q4. Roche, its man­u­fac­tur­ing part­ner pri­mar­i­ly re­spon­si­ble for ex-US dis­tri­b­u­tion, will pro­duce around one third of the dos­es in this agree­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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.

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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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.

Stéphane Bancel, Moderna CEO (Nancy Lane/The Boston Herald via AP Images, Pool)

At­tempt­ing to ride boost­er ad­comm coat­tails, Mod­er­na says its Covid-19 shot is bet­ter than Pfiz­er/BioN­Tech

As the FDA prepares to convene an adcomm to discuss Pfizer/BioNTech’s Covid-19 vaccine boosters later this week, the other major mRNA player is sticking its thumb out and trying to hitch a ride on the corporate media blitz.

Moderna put out a press release Wednesday afternoon pointing to two recently unveiled studies that, the biotech asserts, solidify the need for Covid-19 boosters, leaping into the ongoing debate for the shots. The release comes merely hours after briefing documents for the Pfizer/BioNTech adcomm went public, with Moderna putting forth an argument for why its vaccines are better suited to combat the Delta variant than Pfizer and BioNTech’s jab.

Covid-19 man­u­fac­tur­ing roundup: Kenya will add man­u­fac­tur­ing plant, up vac­ci­na­tion sites; South Ko­rea left wait­ing on Rus­sia vac­cine ex­ports

A fill-and-finish manufacturing site is popping up in Kenya to help assure Covid-19 vaccine supply, the ministry of health announced Wednesday.

The site will help third-party drugmakers put vaccines into vials. As a result, Kenya’s vaccination sites will more than triple — to 3,000 from 800 — leading to the doubling of vaccines in arms by December, Bloomberg reported.

Africa has been focused on self-sustainability on the Covid-19 vaccination front. In early September, BioNTech announced it is considering putting vaccine manufacturing sites in Rwanda and Senegal to help beef up the continent’s supply.