Are­na bounces back. Stock soars on ozan­i­mod ri­val's PhII suc­cess

Its di­et pill was a com­mer­cial flop that al­most sent Are­na to the grave. Now — with its sec­ond pipeline drug re­port­ing pos­i­tive mid-stage da­ta — Are­na is mak­ing a come­back.

Af­ter a rocky few years that in­clud­ed mas­sive lay­offs, com­pa­ny­wide re­struc­tur­ing, and an oblit­er­at­ed stock, Are­na now has a fresh pipeline with two drugs that have pro­duced sol­id Phase II da­ta. The San Diego com­pa­ny’s stock $AR­NA, once in the gut­ter, has more than dou­bled since this time last year.

Amit Mun­shi

The stock price flew up 25% overnight fol­low­ing news late Mon­day that its ul­cer­a­tive col­i­tis drug etrasi­mod proved promis­ing in a Phase II study. The once-dai­ly oral drug is a S1P re­cep­tor mod­u­la­tor that works much like the block­buster hope­ful ozan­i­mod. That drug was the sub­ject of Cel­gene’s $7.2 bil­lion buy­out of an­oth­er San Diego com­pa­ny, Re­cep­tos, and has been tout­ed as $1 bil­lion-plus per year as­set. Its fu­ture, how­ev­er, is un­clear af­ter the FDA kicked back Cel­gene’s mar­ket­ing ap­pli­ca­tion just last month.

In a lengthy con­ver­sa­tion last year, Are­na’s CEO Amit Mun­shi told me its drug etrasi­mod was like ozano­mid… but bet­ter. “We be­lieve it’s safer and po­ten­tial­ly more ef­fi­ca­cious (than ozan­i­mod),” Mun­shi said.

In the re­cent Phase II study, Are­na re­port­ed pa­tients on the 2-mg dose of the drug had sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments over the place­bo in all pri­ma­ry, sec­ondary, and clin­i­cal re­mis­sion end­points.

Some in­vestors, how­ev­er, wor­ry the FDA’s re­cent re­ac­tion to ozan­i­mod might sig­nal safe­ty is­sues and a po­ten­tial class ef­fect that would cast a shad­ow on etrasi­mod. Biotech an­a­lysts at Leerink, though, see no rea­son to jump to that con­clu­sion.

We don’t think this is the case, or else they would have re­port­ed it by now, giv­en its ma­te­ri­al­i­ty. Man­age­ment has pre­vi­ous­ly spo­ken of S1P re­cep­tors 2 and 3 con­tribut­ing to car­diac, pul­monary, and pos­si­ble tu­mor-re­lat­ed risks. As a re­sult, ac­tiv­i­ty of S1P re­cep­tor mod­u­la­tors will man­i­fest un­want­ed car­diac AEs un­less the com­pound has se­lec­tiv­i­ty. Etrasi­mod has been de­signed to se­lec­tive­ly tar­get re­cep­tors 1, 4, and 5 for clin­i­cal ef­fi­ca­cy while avoid­ing 2 and 3. Sup­port­ing this claim, Are­na did not see any sub­stan­tial heart rate ef­fects in their Phase I study, which is re­flect­ed in the lack of dose titra­tion in the cur­rent Phase II study. Thus, al­though some in­vestors in­ter­pret the re­cent refuse-to-file let­ter for Ozan­i­mod to be due to safe­ty and a po­ten­tial class ef­fect, we con­tin­ue to think etrasi­mod could be dif­fer­en­ti­at­ed.

Pre­ston Klassen

Are­na is mov­ing the drug for­ward, not­ing that it would pur­sue new im­mune-re­lat­ed ap­pli­ca­tions for etrasi­mod, da­ta per­mit­ting. That means Are­na’s pipeline, once a one-trick pony with the com­mer­cial flop Belviq on cen­ter stage, is be­com­ing more ro­bust. In ad­di­tion to etrasi­mod, Are­na has a pul­monary ar­te­r­i­al hy­per­ten­sion drug, ra­linepag, which put up pos­i­tive Phase II da­ta last Ju­ly. The biotech plans to take that pro­gram in­to Phase III tri­als. The com­pa­ny al­so has a mid-stage cannabi­noid 2 re­cep­tor pain drug, APD3771, for pain as­so­ci­at­ed with Crohn’s dis­ease.

“We be­lieve these da­ta sup­port pro­ceed­ing to a Phase II pro­gram in ul­cer­a­tive col­i­tis and con­tin­u­ing ef­forts to un­der­stand the broad po­ten­tial util­i­ty of etrasi­mod in oth­er im­mune and in­flam­ma­to­ry dis­eases with sig­nif­i­cant un­met needs,” said Pre­ston Klassen, Are­na’s ex­ec­u­tive vice pres­i­dent of R&D and chief med­ical of­fi­cer. “Along with the pos­i­tive Phase II re­sults for ra­linepag re­port­ed last year, this im­por­tant mile­stone for the com­pa­ny fur­ther am­pli­fies our con­vic­tion in Are­na’s in­ter­nal­ly dis­cov­ered and de­vel­oped com­pounds and their po­ten­tial to be best-in-class.”

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.

#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.

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: 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.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

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.