World Health Organization Director-General Tedros Adhanom Ghebreyesus attends a press conference following an emergency committee meeting over Ebola epidemic in Democratic Republic of Congo at the WHO headquarters in Geneva on October 18, 2019. (via Getty Images)

As Con­go Ebo­la out­break fes­ters, FDA ap­proves first vac­cine to com­bat dead­ly virus

As an Ebo­la out­break rages on in the De­mo­c­ra­t­ic Re­pub­lic of Con­go — the FDA has ap­proved the first vac­cine to pro­tect against the dead­ly he­m­or­rhag­ic virus, months ear­li­er than ex­pect­ed. Man­u­fac­tured by Mer­ck the de­vel­op­ment of the vac­cine, chris­tened Erve­bo, be­gan dur­ing the West African out­break that oc­curred be­tween 2014 and 2016, which killed more than 11,000.

The ap­proval for the ge­net­i­cal­ly en­gi­neered at­ten­u­at­ed live vac­cine comes about five weeks af­ter its Eu­ro­pean en­dorse­ment. Mer­ck ex­pects to launch the vac­cine in the third quar­ter of 2020.

“We have not yet es­tab­lished a price for ERVE­BO. Mer­ck has com­mit­ted to mak­ing the vac­cine avail­able to Gavi (the Vac­cine Al­liance)-el­i­gi­ble coun­tries at the low­est pos­si­ble ac­cess price,” a com­pa­ny spokesper­son told End­points News.

Erve­bo has been test­ed in rough­ly 16,000 in­di­vid­u­als aged 18 and above in tri­als con­duct­ed in Africa, Eu­rope, and the Unit­ed States, and da­ta show the vac­cine is ef­fec­tive against the Zaire Ebo­la virus that cir­cu­lat­ed in West Africa in 2014-2016, as well as the cur­rent out­break in DRC.

In the Guinea tri­al, 3,537 con­tacts, and con­tacts of con­tacts, of in­di­vid­u­als with lab­o­ra­to­ry-con­firmed Ebo­la virus dis­ease re­ceived ei­ther “im­me­di­ate” or 21-day “de­layed” vac­ci­na­tion with Erve­bo. Some 2,108 in­di­vid­u­als were in the “im­me­di­ate” vac­ci­na­tion arm and 1,429 were in the “de­layed” vac­ci­na­tion group, and the re­sults show that Erve­bo was found to be 100% ef­fec­tive in pre­vent­ing Ebo­la cas­es with symp­tom on­set greater than 10 days af­ter vac­ci­na­tion. No Ebo­la cas­es with symp­tom on­set greater than 10 days af­ter vac­ci­na­tion were ob­served in the im­me­di­ate clus­ter group, com­pared with 10 such Ebo­la cas­es in the 21-day de­layed clus­ter group.

An­ti­body re­spons­es to Erve­bo were as­sessed in 477 in­di­vid­u­als in Liberia, rough­ly 500 in Sier­ra Leone and about 900 in­di­vid­u­als in Cana­daSpain, and the Unit­ed States — across ge­og­ra­phy, the an­ti­body re­spons­es were sim­i­lar.

Ebo­la is thought to have in­fil­trat­ed the hu­man pop­u­la­tion through close con­tact with the blood, se­cre­tions, or­gans or oth­er bod­i­ly flu­ids of in­fect­ed an­i­mals such as fruit bats, chim­panzees, go­ril­las, mon­keys, for­est an­te­lope or por­cu­pines. Even­tu­al­ly, it spread be­tween hu­mans through di­rect con­tact, via the blood or bod­i­ly flu­ids of an in­fect­ed per­son.

The cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of Con­go has shown case fa­tal­i­ty rates of more than 65%, the WHO has es­ti­mat­ed. Al­though there has been a re­cent spike in in­fec­tions, the cur­rent in­fec­tion rates are well be­low the 120 cas­es a week re­port­ed dur­ing the peak of the out­break in late April. On Thurs­day, the WHO said it had record­ed the first Ebo­la re­lapse in the cur­rent epi­dem­ic.

Ear­li­er this year the WHO de­clared the out­break — which so far has in­fect­ed more than 3,350 peo­ple — a pub­lic health emer­gency of in­ter­na­tion­al con­cern. As of De­cem­ber 17, over a quar­ter of all con­firmed Ebo­la cas­es in the DRC have been in chil­dren aged less than 18 years. A Mer­ck spokesper­son said the com­pa­ny has stud­ies un­der­way test­ing Erve­bo (same for­mu­la­tion, same dose) in chil­dren.

The vac­cine was ini­tial­ly en­gi­neered by sci­en­tists from the Pub­lic Health Agency of Cana­da’s Na­tion­al Mi­cro­bi­ol­o­gy Lab­o­ra­to­ry and sub­se­quent­ly li­censed to a unit of NewLink Ge­net­ics Corp. In 2014, as the virus wreaked hav­oc in West Africa, Mer­ck ac­quired the tech­nol­o­gy from NewLink (Bat­tered by a se­ries of set­backs, Newlink in Oc­to­ber be­came the ve­hi­cle for a re­verse merg­er).

In re­sponse to re­quests from the WHO, since May 2018, the large US drug­mak­er has do­nat­ed 275,000 dos­es of the vac­cine to com­bat the out­break in the DRC. With the FDA ap­proval, Mer­ck has al­so qual­i­fied for a trop­i­cal dis­ease pri­or­i­ty re­view vouch­er (PRV) — these vouch­ers, used to has­ten drug re­views, have been sold in the past for mil­lions, rang­ing from $95 mil­lion to even $350 mil­lion.

The rel­a­tive­ly few Ebo­la cas­es in the Unit­ed States have been due to in­ter­na­tion­al trav­el­ers or health care work­ers who have con­tract­ed the virus af­ter treat­ing Ebo­la pa­tients.

“While the risk of Ebo­la virus dis­ease in the U.S. re­mains low, the U.S. gov­ern­ment re­mains deeply com­mit­ted to fight­ing dev­as­tat­ing Ebo­la out­breaks in Africa, in­clud­ing the cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of the Con­go,” said An­na Abram, FDA Deputy Com­mis­sion­er for Pol­i­cy, Leg­is­la­tion, and In­ter­na­tion­al Af­fairs, in a state­ment.

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.

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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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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