Cyrus Harmon

Can ful­ly shut­ting down the es­tro­gen re­cep­tor make a dif­fer­ence in breast can­cer? Ole­ma scores $54M to find out in the clin­ic

From ta­mox­ifen to aro­matase in­hibitors to ful­ves­trant, there’s been no lack of en­docrine treat­ments tar­get­ed at es­tro­gen re­cep­tor-pos­i­tive breast can­cer. But Ole­ma On­col­o­gy be­lieves there’s room for more.

The San Fran­cis­co-based biotech has con­vinced in­vestors to pour in $54 mil­lion to prove it.

“We saw the need for a drug that could more ful­ly shut down the es­tro­gen re­cep­tor,” Cyrus Har­mon told End­points News. “We call it a com­plete es­tro­gen an­tag­o­nist to dis­tin­guish from oth­er com­pounds.”

Af­ter it­er­at­ing through mul­ti­ple gen­er­a­tions of can­di­dates for more than a decade — fund­ed by the founders them­selves, an­gel in­vestors and a now-de­funct phar­ma col­lab­o­ra­tion — Ole­ma closed its first ven­ture round in 2018 from BVF Part­ners.

BVF re­turned to co-lead the Se­ries B along­side Lo­gos Cap­i­tal and Janus Hen­der­son In­vestors, while new in­vestors Cor­morant As­set Man­age­ment, RA Cap­i­tal Man­age­ment, Welling­ton Man­age­ment Com­pa­ny, Sur­vey­or Cap­i­tal, Ven­rock Health­care Cap­i­tal Part­ners, and Fore­site Cap­i­tal joined.

“We were at­tract­ed to Ole­ma by its ex­cel­lent sci­ence, ro­bust pre­clin­i­cal da­ta, ex­pe­ri­enced man­age­ment team, and po­ten­tial to make a sig­nif­i­cant im­pact on what re­mains a large un­met need among pa­tients with breast and oth­er hor­mone-pos­i­tive can­cers,” Gor­jan Hrus­tanovic, prin­ci­pal at BVF Part­ners, said.

The new cash will bankroll the pro­gram Phase I/II for OP-1250, eval­u­at­ing the oral pill as a sin­gle agent for pa­tients with ER+, HER2- who have seen their can­cer come back de­spite treat­ment.

If the drug does what Ole­ma wants it to do in the first-in-hu­man test­ing, the next step will be to study it as a po­ten­tial “back­bone ther­a­py” in com­bi­na­tions with oth­ers.

“There’ve been a num­ber of tar­get­ed ther­a­pies for breast can­cer that have been de­vel­oped in the last decade or so, such as the CDK4/6 in­hibitors and PI3 ki­nase al­pha in­hibitors,” Har­mon said.

Where­as en­docrine ther­a­py was “orig­i­nal­ly al­ways used just by it­self,” it ap­pears to pair well with these new class­es of drugs.

That would re­quire more mon­ey and like­ly a larg­er team than the cur­rent 12 to run big­ger stud­ies — per­haps even an IPO that Har­mon says is too ear­ly to dis­cuss. But first, they need to get in­to the clin­ic.

“One step at a time,” he said.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.