Af­ter pa­tient deaths, failed part­ner­ships and a stock scan­dal, Han­mi fi­nal­ly gives up on con­tro­ver­sial ol­mu­tinib. What did we learn?

The ol­mu­tinib de­vel­op­ment pro­gram is fi­nal­ly dead.

South Ko­rea’s Han­mi has de­ter­mined that the drug —  once part­nered with Boehringer In­gel­heim and Zai Lab — is no longer com­mer­cial­ly vi­able. The drug was seen as more or less equiv­a­lent to As­traZeneca’s Tagris­so, ac­cord­ing to Han­mi. So they’ve opt­ed to punt the late-stage tri­al and shelve it once and for all.

“We will thor­ough­ly re­view the plan, putting pa­tients’ safe­ty first and fore­most,” Ko­rea’s health min­istry said in a state­ment, ac­cord­ing to Ko­rea Bio­med­ical Re­view. “We will al­so do our ut­most to make sure that pa­tients who are tak­ing the med­ica­tion will not face any dif­fi­cul­ty in their treat­ment.”

This is like­ly the fi­nal chap­ter for a drug that has re­peat­ed­ly stirred con­tro­ver­sy in Ko­rea. 

The tale goes back to Ju­ly, 2015, when a pa­tient in one of its ol­mu­tinib stud­ies died from Stevens-John­son dis­ease. Ac­cord­ing to sub­se­quent me­dia re­ports out of Ko­rea — not an easy place to ob­tain in­fo on cas­es like this — Han­mi was cit­ed for not re­port­ing the death un­til 14 months lat­er. Ac­cord­ing to Han­mi, they on­ly found out about it in Sep­tem­ber, 2016 — four months af­ter it was ap­proved in South Ko­rea. 

The con­tro­ver­sy was stirred by re­ports of heavy in­sid­er trad­ing on Han­mi shares just be­fore the news hit, and the op­po­si­tion par­ty lev­eled a va­ri­ety of ac­cu­sa­tions against Han­mi, ac­cus­ing the com­pa­ny of hid­ing ad­verse events — which re­port­ed­ly al­so claimed an­oth­er life — so that it could get the drug ap­proved first un­der an ac­cel­er­at­ed ac­tion pro­gram.

Boehringer In­gel­heim, which had signed a $730 mil­lion deal to part­ner on the drug, ex­it­ed just ahead of the in­ci­dent, with­out breath­ing a word of any safe­ty is­sues in its ini­tial state­ment. At the time, the com­pa­ny said the de­ci­sion was spurred by a “re-eval­u­a­tion of all avail­able clin­i­cal da­ta on ol­mu­tinib and re­cent treat­ment ad­vances made in the treat­ment of EGFR mu­ta­tion-pos­i­tive lung can­cer.” Boehringer lat­er told me that they knew of “two cas­es of tox­ic epi­der­mal necrol­y­sis, one of them fa­tal, and one case of Stevens-John­son-Syn­drome (non-fa­tal).” Com­pa­ny me­dia reps told me that they had done every­thing re­quired in alert­ing the prop­er reg­u­la­to­ry of­fi­cials.

Zai Lab did a deal for rights in Chi­na, but bowed out at the be­gin­ning of this month.

The sto­ry rais­es some un­com­fort­able ques­tions for the bio­phar­ma in­dus­try. De­vel­op­ers have re­peat­ed­ly hid­den deaths and oth­er se­ri­ous ad­verse events in their clin­i­cal tri­als from the pub­lic, sat­is­fied that they’ve met the let­ter of the law in alert­ing share­hold­ers, reg­u­la­tors and the tri­al sites where they work. As the de­vel­op­ment ef­fort goes glob­al, with a surge of hun­dreds of stud­ies in Asia, the lines around pub­lic ad­verse event re­port­ing gen­er­al­ly al­low pri­vate com­pa­nies to re­main mum — even though the in­for­ma­tion could be rel­e­vant to oth­er re­searchers, pa­tients and com­pa­nies study­ing sim­i­lar drugs. Han­mi, and more point­ed­ly a big de­vel­op­er like the pri­vate Boehringer, of­fers a case book ex­am­ple of how that can blow up. 

But there’s no sign that any of this is chang­ing, as re­cent ex­am­ples at Sol­id Bio and Unum il­lus­trate.

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

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.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

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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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.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

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.

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.