FDA or­ders a par­tial hold on Epizyme’s lead can­cer drug tazeme­to­stat fol­low­ing T-cell lym­phoma case

Robert Baze­more, CEO Epizyme

Epizyme $EPZM is in some hot wa­ter this evening af­ter the biotech re­vealed a par­tial clin­i­cal hold on its cru­cial pro­gram for tazeme­to­stat.

The Cam­bridge, MA-based biotech was forced to slam the brakes on any en­roll­ment for its clin­i­cal tri­als of the drug for now as in­ves­ti­ga­tors sort out a pe­di­atric case of sec­ondary T-cell lym­phoma.

In­vestors didn’t like it. The biotech’s shares tanked 18% in af­ter-mar­ket trad­ing.

Says Epizyme:

Dos­es ex­plored in this study are high­er than those in the com­pa­ny’s Phase 2 adult stud­ies, an ap­proach not un­com­mon to drug de­vel­op­ment in ag­gres­sive, dif­fi­cult-to-treat pe­di­atric can­cers. At the time of the safe­ty re­port, the pa­tient had been on study for ap­prox­i­mate­ly 15 months and had achieved a con­firmed par­tial re­sponse. This pa­tient has now dis­con­tin­ued tazeme­to­stat and is be­ing treat­ed for T-cell lym­phoma. 

The EZH2 in­hibitor is be­ing stud­ied as a monother­a­py in on­go­ing Phase I and II pro­grams in mol­e­c­u­lar­ly de­fined sol­id tu­mors, in­clud­ing ep­ithe­lioid sar­co­ma and oth­er INI1-neg­a­tive tu­mors; both fol­lic­u­lar lym­phoma and dif­fuse large B-cell lym­phoma forms of NHL; mesothe­lioma; and com­bi­na­tion stud­ies in DL­B­CL and non-small cell lung can­cer.

Last sum­mer at AS­CO, as the biotech was look­ing to blaze an ac­cel­er­at­ed path­way to an ap­proval, in­ves­ti­ga­tors dis­ap­point­ed an­a­lysts with their lat­est set of re­spons­es in a Phase II for ep­ithe­lioid sar­co­ma.

“Pa­tient safe­ty is of the ut­most im­por­tance to Epizyme. We are work­ing ex­pe­di­tious­ly with clin­i­cal tri­al in­ves­ti­ga­tors and reg­u­la­to­ry au­thor­i­ties to ini­ti­ate the ap­pro­pri­ate steps to re­sume en­roll­ment,” said Robert Baze­more, pres­i­dent and chief ex­ec­u­tive of­fi­cer of Epizyme. “Epizyme, along with our glob­al in­ves­ti­ga­tor com­mu­ni­ty, has been very en­cour­aged by the clin­i­cal re­spons­es and tol­er­a­bil­i­ty of tazeme­to­stat ob­served in pe­di­atric and adult pa­tients with hema­to­log­i­cal ma­lig­nan­cies and sol­id tu­mors en­rolled in our tri­als. We re­main en­cour­aged by the po­ten­tial of tazeme­to­stat to ad­dress the un­met needs of many pa­tients liv­ing with can­cer.”

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

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.

#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.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.