Rich Heyman, Metacrine chairman (ARCH)

Metacrine, a Rich Hey­man biotech tar­get­ing NASH and oth­er liv­er dis­eases, rais­es $85M from IPO

A Rich Hey­man-backed start­up fo­cus­ing on NASH treat­ments, as well as oth­er liv­er, GI and meta­bol­ic dis­eases, is set to start trad­ing Wednes­day and join the al­ready-loaded class of 2020 biotech IPOs.

Metacrine has raised $85 mil­lion for its pub­lic of­fer­ing af­ter priced shares at $13 apiece, the mid­point of its ex­pect­ed range. Sell­ing 6.5 mil­lion shares, Metacrine makes good for a mar­ket val­ue of rough­ly $364 mil­lion.

Four dozen biotechs had al­ready hit Nas­daq through late Au­gust, sur­pass­ing the to­tal from all of 2019. Com­bined, the com­pa­nies have raised more than $11 bil­lion in a ban­ner year for the in­dus­try.

The com­pa­ny cur­rent­ly has two pro­grams in the clin­ic aim­ing to treat NASH, an in­di­ca­tion that has been tough to crack in re­cent years. Metacrine’s lead can­di­dates, MET409 and MET642, are once-dai­ly pills that func­tion as far­ne­soid X re­cep­tor ag­o­nists.

MET409 com­plet­ed a 58-pa­tient Phase Ib tri­al re­cent­ly ex­am­in­ing two dif­fer­ent dosage lev­els, with re­sults post­ed last month show­ing im­prove­ments in NASH bio­mark­ers af­ter 12 weeks of treat­ment. Metacrine said that the pill low­ered liv­er fat con­tent, with av­er­age rel­a­tive re­duc­tions of 55% in the 80 mg co­hort and 38% in the 50 mg co­hort, com­pared with 6% in place­bo. The com­pa­ny was al­so en­cour­aged by num­bers in­di­cat­ing MET409 achieved a 30% or greater rel­a­tive liv­er fat re­duc­tion in 13 of 14 of pa­tients in the 80 mg co­hort and 12 of 16 in the 50 mg co­hort, com­pared with just 2 of 18 who took the place­bo.

Those re­sults helped earn the pro­gram a fast track des­ig­na­tion from the FDA last month. Per the S-1, funds from the IPO raise will go to­ward a Phase IIa tri­al in NASH in com­bi­na­tion with an an­tidi­a­bet­ic agent, like­ly be­gin­ning in the first half of next year. MET642 is al­so ex­pect­ed to be­gin a Phase IIa monother­a­py tri­al in NASH with the mon­ey, and a sep­a­rate Phase IIa study will al­so be fi­nanced by the raise, eval­u­at­ing one of the can­di­dates in UC.

De­pend­ing on which pro­gram shows high­er ef­fi­ca­cy, the rest of the mon­ey will fund a Phase IIb monother­a­py tri­al of ei­ther MET409 or MET642 in NASH, as well as pre­clin­i­cal re­search in oth­er ar­eas.

Hey­man, a se­r­i­al en­tre­pre­neur who co-found­ed Metacrine in 2014, is most promi­nent­ly known for found­ing the biotechs Aragon and Ser­agon. Those com­pa­nies sold for more than $1 bil­lion apiece in the span of 12 months back in 2013 and 2014. J&J bought Aragon, and while Roche and Genen­tech pur­chased Ser­agon, the duo qui­et­ly scrapped that biotech’s lead pro­gram from Phase II stud­ies in 2017. Hey­man re­cent­ly joined the board of PMV Phar­ma af­ter it closed a $70 mil­lion Se­ries D raise last month.

NASH has seen lit­tle suc­cess ever since JP Mor­gan 2019, when sev­er­al com­pa­nies ap­peared po­si­tioned for break­outs in a mar­ket ripe for po­ten­tial block­busters. Gilead, Gen­Fit and oth­er small­er biotechs have since seen many ma­jor tri­al fail­ures, and Al­bireo kicked their own NASH pro­gram to the curb just last month de­spite hit­ting their pri­ma­ry end­point.

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.

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.

Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

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.

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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