Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

De­spite the FDA putting a par­tial clin­i­cal hold on its lead pro­gram on­ly a few weeks ago, Boston-based Pieris Phar­ma­ceu­ti­cals is plow­ing for­ward with a new col­lab­o­ra­tion.

Pieris will work with Eli Lil­ly to fur­ther ad­vance stud­ies on PRS-343, a 4-1BB/HER2 bis­pe­cif­ic for HER2-pos­i­tive tu­mors, in com­bi­na­tion with the lat­ter’s ra­mu­cirum­ab and pa­cli­tax­el for the sec­ond-line treat­ment of pa­tients with HER2-pos­i­tive gas­tric can­cer in a sin­gle-arm, Phase II study.

At the time of the hold, reg­u­la­tors de­ter­mined that the biotech could con­tin­ue dos­ing pa­tients al­ready in the stud­ies, but couldn’t add pa­tients un­til af­ter it con­duct­ed “an ad­di­tion­al in-use and com­pat­i­bil­i­ty study of PRS-343 with var­i­ous in­fu­sion ma­te­ri­als un­der spe­cif­ic con­di­tions to con­firm suit­abil­i­ty of PRS-343 for ad­min­is­tra­tion in clin­i­cal set­tings.”

The FDA did not cite any ad­verse ef­fects and the Phase II is still on track for lat­er this year should the hold be lift­ed.

Un­der the terms of the new agree­ment, Eli Lil­ly will sup­ply the ad­di­tion­al com­pounds and col­lab­o­rate on da­ta while Pieris pre­pares to ini­ti­ate Phase II. — Max Gel­man

Op­di­vo + Yer­voy > Chemo

A com­bi­na­tion of Op­di­vo and Yer­voy has proven more ef­fec­tive than chemother­a­py as a first-line treat­ment for a form of mesothe­lioma in a Phase III study of 600 pa­tients. In the study, one of nu­mer­ous, Bris­tol My­ers Squibb is run­ning to test whether the two forms of check­point in­hibitors can be com­ple­men­tary, 40.8% of pa­tients with un­re­sectable ma­lig­nant pleur­al mesothe­lioma who re­ceived the im­munother­a­py cock­tail sur­vived for two years, com­pared with 27% of pa­tients on the chemother­a­py arm.

Just over 30% of pa­tients in both arms of the tri­al ex­pe­ri­enced grade 3 or grade 4 ad­verse events, but pa­tients were twice as like­ly to drop out as a re­sult in the com­bi­na­tion arm: 15%, com­pared with 7.4%.

Re­sults were pre­sent­ed Sat­ur­day at the In­ter­na­tion­al As­so­ci­a­tion for the Study of Lung Can­cer Vir­tu­al Pres­i­den­tial Sym­po­sium. — Ja­son Mast

Xcov­ery’s ALK in­hibitor out-runs Xalko­ri

In a Phase III tri­al an­nounced Fri­day, pa­tients giv­en Hong Kong-based Xcov­ery’s lead ALK in­hibitor re­spond­ed for twice as long as pa­tients giv­en Pfiz­er’s Xalko­ri. ALK-pos­i­tive non-small cell lung can­cer pa­tients giv­en Xcov­ery’s en­sar­tinib had a pro­gres­sion-free sur­vival time of 25.8 months, com­pared to 12.7 months for the pa­tients on Xalko­ri. The re­sponse rate was al­so high­er for en­sar­tinib, 75% com­pared to 67%.

The re­sults are a pos­i­tive sign for Xcov­ery but they are not nec­es­sar­i­ly sur­pris­ing: Xalko­ri was the first ALK-in­hibitor ap­proved in 2011, but since then, oth­er in­hibitors have come out and proven far more durable. Late last year, Take­da’s Alun­brig showed a sim­i­lar rate of pro­gres­sion-free sur­vival.  — Ja­son Mast

Vi­va Biotech buys up 80% of Langhua Phar­ma­ceu­ti­cal for $367M+

Just a week and a half af­ter sign­ing a deal with Mass­a­chu­setts-based Har­bour Bio­Med to help in­cu­bate new star­tups, Vi­va Biotech has con­tin­ued its march with a new ac­qui­si­tion.

The Chi­nese com­pa­ny — a half-in­cu­ba­tor, half-drug dis­cov­ery busi­ness — an­nounced the pur­chase of 80% of Langhua Phar­ma­ceu­ti­cal for about $367 mil­lion. With the ac­qui­si­tion, Vi­va ex­pects to ex­pand its R&D ca­pa­bil­i­ties and be­gin of­fer­ing CD­MO ser­vices.

“We have steady con­fi­dence to­wards the busi­ness prospects and po­ten­tial fu­ture growth of Langhua Phar­ma­ceu­ti­cal,” Vi­va Biotech CEO Chen (Ch­eney) Mao said in a state­ment.

Vi­va of­fers both “eq­ui­ty for ser­vice” and “cash for ser­vice” mod­els to US and Chi­nese bio­phar­mas look­ing for out­sourc­ing ser­vices. — Max Gel­man

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.

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.

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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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.

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.

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.

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.