DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Re­searchers call out Gilead for di­ver­si­ty of remde­sivir tri­als in NE­JM; Mex­i­co in vac­cine dose, tri­al talks

Racial and eth­nic mi­nor­i­ty groups suf­fer high­er rates of Covid-19 in­fec­tion, hos­pi­tal­iza­tion and death than white or non-His­pan­ic Amer­i­cans.

Yet when remde­sivir was test­ed in an NI­AID-fund­ed Adap­tive Covid-19 Treat­ment Tri­al, Black pa­tients ac­count­ed for 20% of par­tic­i­pants. And they ac­count­ed for just 11% of those as­signed to take the drug in a Gilead-fund­ed study, ac­cord­ing to the New Eng­land Jour­nal of Med­i­cine.

In a Per­spec­tive piece, NE­JM re­searchers called for in­creased di­ver­si­ty in Covid-re­lat­ed clin­i­cal tri­als.

“To pro­vide the nec­es­sary da­ta for gen­er­al­iz­ing ef­fi­ca­cy and safe­ty out­comes across racial groups, Covid-19 clin­i­cal tri­als must pri­or­i­tize in­clu­sion of pa­tient pop­u­la­tions that re­flect the de­mo­graph­ics of the on­go­ing pan­dem­ic, es­pe­cial­ly in the Unit­ed States, and fund­ing for sci­en­tists from un­der­rep­re­sent­ed eth­nic groups must be in­creased,” the piece states.

Black Amer­i­cans are in­fect­ed with Covid-19 at a rate 2.6 times high­er than white or non-His­pan­ic Amer­i­cans, ac­cord­ing to the CDC. And they are dy­ing at a rate 2.1 times high­er.

Na­tive Amer­i­can and Lat­inx Amer­i­can groups are both in­fect­ed at a rate of 2.8 times high­er than white Amer­i­cans. But they rep­re­sent­ed 23% and 0.7% of par­tic­i­pants re­spec­tive­ly in the ACTT-1 tri­al.

The CDC lists dis­crim­i­na­tion, ac­cess to health­care and in­sur­ance, hous­ing con­di­tions, and ed­u­ca­tion­al and in­come gaps as fac­tors that put racial mi­nori­ties at high­er risk for Covid-19 in­fec­tion. Those in mi­nor­i­ty groups are al­so more like­ly to hold es­sen­tial jobs, ac­cord­ing to the CDC.

As for the lack of di­ver­si­ty in clin­i­cal tri­als, the NE­JM sus­pects that med­ical dis­trust, cost, lan­guage bar­ri­ers, health lit­er­a­cy and im­plic­it bias are among the key con­tribut­ing fac­tors.

“It is alarm­ing that long-stand­ing racial health dis­par­i­ties have been ex­tend­ed to Covid-19 clin­i­cal tri­als when racial and eth­nic mi­nor­i­ty groups have so much to gain from this re­search, in­clud­ing the op­por­tu­ni­ty to re­ceive life­sav­ing treat­ment,” the ar­ti­cle states.  — Nicole De­Feud­is 

Mex­i­co to con­duct late-stage Covid-19 test­ing for three drug mak­ers

Mex­i­co struck deals to con­duct late-stage tri­als of Covid-19 vac­cines de­vel­oped by John­son & John­son, CanSi­no Bi­o­log­ics and Wal­vax Biotech­nol­o­gy, in the hopes of se­cur­ing dos­es when it comes time for pro­duc­tion.

Marce­lo Ebrard

“This is what wor­ries Pres­i­dent (An­drés Manuel) López Obrador, that we have it on time,” For­eign Min­is­ter Marce­lo Ebrard said, per a Reuters re­port.

The coun­try has the world’s third-high­est Covid-19 death toll, at near­ly 54,000 deaths.

Late-stage tri­als are set to be­gin be­tween Sep­tem­ber and Jan­u­ary, and CanSi­no and Wal­vax are eye­ing pro­duc­tion in Mex­i­co for dis­tri­b­u­tion through­out Latin Amer­i­ca, ac­cord­ing to Reuters.

John­son & John­son is ex­pect­ed to en­ter its Ad26 SARS-CoV-2 vac­cine in Phase III tri­als this Sep­tem­ber. Ini­tial­ly, it was set to be­gin clin­i­cal tri­als that month, but the com­pa­ny ac­cel­er­at­ed de­vel­op­ment and be­gan hu­man test­ing in Ju­ly. If ap­proved, John­son & John­son plans to make over 1 bil­lion dos­es next year.

CanSi­no be­came the first vac­cine ap­proved for lim­it­ed hu­man use in Ju­ly, when Chi­na al­lowed its mil­i­tary to take in­jec­tions. The com­pa­ny plans to en­ter Phase III test­ing soon.

And Wal­vax has part­nered with the Peo­ple’s Lib­er­a­tion Army (PLA) Acad­e­my of Mil­i­tary Sci­ences in Chi­na to de­vel­op an mR­NA can­di­date, which in­duced an­ti­bod­ies and a T cell re­sponse in mice and crab-eat­ing macaques. — Nicole De­Feud­is 

Rus­sia says Covid-19 vac­cine dos­es com­ing in next two weeks

In the next two weeks, Rus­sia ex­pects to in­ject med­ical pro­fes­sion­als with a Covid-19 vac­cine that has not com­plet­ed clin­i­cal tri­als.

The coun­try reg­is­tered the Gama­leya Re­search In­sti­tute’s Covid-19 can­di­date while it is still in Phase III tri­als, and Pres­i­dent Vladimir Putin said his daugh­ter has al­ready tak­en it. He an­nounced it as the “first vac­cine against the nov­el coro­n­avirus in­fec­tion in the world,” ac­cord­ing to RIA Novosti, a state-con­trolled news agency.

The first batch of dos­es is ex­pect­ed to be ready in two weeks, and will be ad­min­is­tered on a vol­un­tary ba­sis, pri­mar­i­ly to doc­tors.

Ear­li­er this month, the As­so­ci­a­tion of Clin­ic Tri­als Or­ga­ni­za­tions wrote in a let­ter to Russ­ian Health Min­is­ter Mikhail Murashko: “This is a Pan­do­ra’s Box and we don’t know what will hap­pen to peo­ple in­ject­ed with an un­proven vac­cine.”

Ac­cord­ing to RIA Novosti, Putin said his daugh­ter’s tem­per­a­ture “rose slight­ly” af­ter the sec­ond dose, but as­sured that she is feel­ing well and has high an­ti­body titers.  — Nicole De­Feud­is 

Ko­dak board mem­ber’s gift comes un­der scruti­ny

East­man Ko­dak’s $765 mil­lion gov­ern­ment loan to boost phar­ma­ceu­ti­cal man­u­fac­tur­ing ca­pac­i­ties was put on hold just last week, and now re­ports of a well-timed char­i­ta­ble do­na­tion have come to light.

Ko­dak board mem­ber George Kar­funkel and his wife Re­nee Kar­funkel re­port­ed in a se­cu­ri­ties fil­ing a do­na­tion val­ued at $116.3 mil­lion to a Jew­ish syn­a­gogue in Brook­lyn, NY, ac­cord­ing to the Wall Street Jour­nal. Per the fil­ing, the do­na­tion took place on Ju­ly 29, the day that Ko­dak’s stock hit its high­est peak since 2014.

The syn­a­gogue, Con­gre­ga­tion Chem­das Yis­roel, was in­cor­po­rat­ed in Delaware in 2018 and George Kar­funkel is list­ed as its pres­i­dent. It re­ceived tax-ex­empt sta­tus from the IRS last Sep­tem­ber as a pub­lic char­i­ty.

Kar­funkel’s do­na­tion came in the form of 3 mil­lion Ko­dak shares. Us­ing the av­er­age of Ju­ly 29’s high and low Ko­dak stock price at $38.75, which is how the IRS val­ues stock gifts, the do­na­tion amount­ed to the sin­gle largest gift record­ed to a re­li­gious group, the Jour­nal wrote cit­ing a list from Chron­i­cle of Phil­an­thropy.

Ko­dak held a call with in­vestors Tues­day af­ter­noon to dis­cuss sec­ond quar­ter earn­ings, but in an un­usu­al move did not hold a for­mal Q&A ses­sion af­ter­ward. Ex­ecs were tight-lipped about the loan, with CEO Jim Con­ti­nen­za men­tion­ing it briefly to em­pha­size that the Ju­ly loan an­nounce­ment was “on­ly a let­ter of in­ter­est.”

Since the news hit that Ko­dak was slat­ed to re­ceive that loan, mul­ti­ple in­ves­ti­ga­tions have been launched re­gard­ing the tim­ing of the an­nounce­ment and how it may have ben­e­fit­ted Ko­dak’s top of­fi­cers. The SEC and House De­moc­rats are both prob­ing the deal, with the lat­ter ques­tion­ing why the gov­ern­ment would choose Ko­dak af­ter it was “on the brink of fail­ure” as re­cent­ly as 2012.

The US In­ter­na­tion­al De­vel­op­ment Fi­nance Cor­po­ra­tion of­fi­cial­ly put the loan on hold on Au­gust 7, just be­fore mar­kets closed for the week­end. Ko­dak’s stock tanked about 40% over the week­end fol­low­ing the DFC’s an­nounce­ment.

Ac­cord­ing to the Jour­nal, Ko­dak said it would co­op­er­ate with any in­ves­ti­ga­tions, and no oth­er com­pa­ny ex­ec­u­tives have re­port­ed sell­ing shares since the price shot up. — Max Gel­man

Red­Hill Bio­phar­ma ex­pands test­ing of po­ten­tial Covid-19 treat­ment

Red­Hill Bio­phar­ma’s opa­ganib — one of hun­dreds of po­ten­tial can­di­dates to treat Covid-19 — was ap­proved for a Phase II/III tri­al in Mex­i­co.

The Is­rael-based bio­phar­ma al­ready has the green light to test opa­ganib in the UK and Rus­sia, and is un­der re­view for tri­als in Italy and Brazil. En­roll­ment is halfway through for a Phase II tri­al in the US in pa­tients with se­vere COVID-19 pneu­mo­nia who are hos­pi­tal­ized and re­quire sup­ple­men­tal oxy­gen.

Ear­ly re­sults show that the first Covid-19 pa­tients treat­ed with opa­ganib were all dis­charged from hos­pi­tal care with­out need­ing me­chan­i­cal ven­ti­la­tion, while 33% of those in the con­trol group re­quired ven­ti­la­tion. The me­di­an time to wean­ing from a high-flow nasal can­nu­la was 10 days in the opa­ganib group, ver­sus 15 days in the con­trol group

Red­Hill snagged the drug, a sphin­go­sine ki­nase-2 (SK2) se­lec­tive in­hibitor, from Apogee Biotech­nol­o­gy in 2015. It has com­plet­ed pre­clin­i­cal stud­ies in on­col­o­gy, in­flam­ma­tion, GI and ra­dio­pro­tec­tion, and a Phase I tri­al in can­cer pa­tients with ad­vanced sol­id tu­mors. It has or­phan drug des­ig­na­tion in the US to treat cholan­gio­car­ci­no­ma, and is al­so be­ing test­ed for the treat­ment of prostate can­cer. — Nicole De­Feud­is

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

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.