Maureen Hillenmeyer, Hexagon Bio CEO

Us­ing AI to se­quence fun­gi genomes for can­cer treat­ments, Hexa­gon Bio nets $47M in Se­ries A

A Stan­ford spin­out ex­plor­ing how fun­gi can be se­quenced to dis­cov­er new med­i­cines in on­col­o­gy and in­fec­tious dis­eases now has sig­nif­i­cant­ly more cash to do so.

Ear­ly Tues­day morn­ing, Hexa­gon Bio an­nounced the clos­ing of their Se­ries A fi­nanc­ing, pulling in $47 mil­lion from a group of in­vestors led by The Col­umn Group. The round, which al­so saw par­tic­i­pa­tion from 8VC and Two Sig­ma Ven­tures, will go to­ward cre­at­ing a pro­pri­etary ge­nomics data­base as well as build­ing out a drug dis­cov­ery team to de­vel­op the new com­pounds. Hexa­gon brought on Tod Smeal as its new CSO af­ter he served in the same po­si­tion at Lil­ly Re­search Labs.

“This is go­ing to take us in­to this next phase from com­pa­ny build­ing,” CEO Mau­reen Hil­len­mey­er told End­points News. “We’ve built this great plat­form, but now we’re at a stage where we’re re­al­ly fo­cused on tak­ing mol­e­cules to­wards the clin­ic.”

The tech that Hexa­gon has de­vel­oped aims to op­ti­mize the search for mi­crobes with­in fun­gi that can serve as foun­da­tions for can­cer treat­ments, Hil­len­mey­er said. His­tor­i­cal­ly, such search­es have been “brute force” meth­ods re­quir­ing painstak­ing ef­forts to se­quence.

But Hexa­gon wants to pair da­ta min­ing with drug dis­cov­ery in or­der to find such mi­crobes, al­so known as sec­ondary metabo­lites. Fun­gi pro­duce sec­ondary metabo­lites as self-de­fense mech­a­nisms, pro­tect­ing them­selves from dis­ease. Hil­len­mey­er’s goal is to ap­ply an AI al­go­rithm to se­quence and sift through mas­sive amounts of genome da­ta to try to de­ter­mine what oth­er fun­gi nat­u­ral­ly cul­ti­vate metabo­lites use­ful in even­tu­al can­cer ther­a­pies.

Smeal com­pared the task to check­ing out am­a­teur base­ball play­ers to draft for a cham­pi­onship team. The play­ers, or the metabo­lites, are all out there wait­ing to be dis­cov­ered, while the scouts and front of­fices — Hexa­gon’s plat­form and drug dis­cov­ery team, in this in­stance — try to de­ter­mine which have the most po­ten­tial.

“What’s ex­cit­ing about it is that, in the past, there’s al­ready been a lot of suc­cess in de­vel­op­ing drugs based on nat­ur­al prod­ucts but it was re­al­ly a non-sys­tem­at­ic ap­proach,” Smeal said. “Mau­reen’s team is in the process of go­ing through and sam­pling a huge di­ver­si­ty of the pos­si­ble agents that are out there. So it’s sort of a new fron­tier, but it’s be­ing done in a sys­tem­at­ic and ef­fi­cient way.”

Tod Smeal

Metabo­lites from fun­gi have been pro­duced be­fore, most no­tably peni­cillin in ad­di­tion to cho­les­terol-re­duc­ing statins. But while a rev­o­lu­tion­ary an­tibi­ot­ic, peni­cillin was dis­cov­ered by ac­ci­dent in the 1920s, and it took years for re­searchers to ful­ly se­quence the genomes used in statin-based med­i­cines.

That’s where Hexa­gon hopes the da­ta min­ing will pro­vide a huge boon, by cut­ting down the bulk search process it­self and get­ting pro­grams in­to the clin­ic at a faster clip.

“There’s about 5 mil­lion fun­gal genomes on the earth, of which on­ly about 5,000 have been se­quenced,” Hil­len­mey­er said. “Each of those genomes con­tains a huge amount of da­ta that we have to sift through to find what we call the nee­dle in the haystack: drugs that are use­ful for peo­ple.”

As of now, Hexa­gon says it’s too ear­ly to de­ter­mine what any treat­ment might end up look­ing like. Whether the com­pa­ny de­vel­ops an IV-based drug or a once-a-day pill, those de­ci­sions are still up in the air and will de­pend on what tar­gets the com­pa­ny ul­ti­mate­ly goes af­ter.

But one thing’s for cer­tain: Hexa­gon, be­liev­ing in its tech, is not go­ing to be picky.

“We’re fo­cused on on­col­o­gy, but ini­tial­ly we’re go­ing to be work­ing in any in­fec­tives and on­col­o­gy,” Smeal said. “We’re go­ing to be very op­por­tunis­tic, so de­pend­ing on what comes out of the plat­form, if there’s op­por­tu­ni­ties in oth­er ther­a­peu­tic ar­eas, we will prob­a­bly ex­plore them as well.”

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.

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.

#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.

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.

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.

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.

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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