Clarus spear­heads a big, $150M raise so Galera can flip the PhI­II card on its new drug to treat ra­di­a­tion ef­fects

Any­one look­ing for sol­id ev­i­dence of the kind of im­pact the new, flush fund­ing en­vi­ron­ment — along with a more ac­com­mo­dat­ing FDA — is hav­ing on biotech need look no fur­ther than Galera Ther­a­peu­tics this morn­ing.

Mel Sorensen

Armed with pos­i­tive Phase IIb da­ta for a new can­cer-re­lat­ed ther­a­py, the small, 18-per­son crew at Galera has pieced to­geth­er a whop­ping $150 mil­lion raise; $70 mil­lion in an am­bi­tious Se­ries C with an $80 mil­lion roy­al­ty deal com­ing from one of its biggest back­ers. And CEO Mel Sorensen says that com­bo gives the com­pa­ny all the mon­ey it needs to get through a piv­otal study in the next cou­ple of years that could put them on the thresh­old of a mar­ket­ing de­ci­sion from the FDA.

“This fund­ing al­lows us to get all the way through the process,” Sorensen tells me, “to turn over the Phase III card.”

The “beach­head” in­di­ca­tion for Malvern, PA-based Galera is se­vere oral mu­cosi­tis, a com­mon side ef­fect in pa­tients with head and neck can­cer. Their drug, GC4419, tar­gets the tox­ic ef­fect of ra­di­a­tion ther­a­py as su­per­ox­ide swift­ly builds up in pa­tients, af­flict­ing the sen­si­tive tis­sue in their mouths.

The FDA has helped con­sid­er­ably, giv­ing Galera a break­through drug des­ig­na­tion and get­ting the CEO’s thumbs up for help­ing with the tri­al de­sign and keep­ing things on a rel­a­tive­ly tight sched­ule. Sorensen ex­pects to get the piv­otal Phase III un­der­way in the up­com­ing quar­ter, and he adds that it will like­ly take ap­prox­i­mate­ly 18 to 24 months to com­plete once they are un­der­way.

Em­mett Cun­ning­ham

At one point not long ago, the idea of a small biotech com­pa­ny tack­ling Phase III with­out at least a ma­jor part­ner would have ter­ri­fied most in­vestors. But times have changed, and the lev­el of cash flow­ing through the in­dus­try in the last 2 years has reached an un­prece­dent­ed depth. In Galera’s case, that means push­ing through Phase III while al­so lay­ing the foun­da­tion for a com­mer­cial­iza­tion ef­fort that could re­quire 50 peo­ple. Along the way, Galera will al­so study new in­di­ca­tions for their drug to see how they can build the fran­chise. 

Pre­sum­ably, an IPO has been on the ta­ble, es­pe­cial­ly as the cur­rent wave of biotechs go­ing pub­lic is dom­i­nat­ed by pre­clin­i­cal com­pa­nies with­out any­thing like a Phase IIb da­ta set. Sorensen, though, sim­ply says the com­pa­ny is keep­ing all op­tions on the ta­ble, pre­fer­ring to fo­cus now on the big step ahead.

In this case, Clarus not on­ly led the round, the firm al­so sup­plied the roy­al­ty cash through an­oth­er spe­cial­ized fund it runs. 

Clarus is jump­ing in along­side oth­er new in­vestors: Adage Cap­i­tal Man­age­ment, HBM Health­care In­vest­ments, Nan Fung Life Sci­ences, RA Cap­i­tal, Rock Springs Cap­i­tal and Tekla Cap­i­tal Man­age­ment LLC. Ex­ist­ing in­vestors Cor­re­la­tion Ven­tures, Galera An­gels, New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, No­vo Ven­tures and Sofinno­va Ven­tures al­so par­tic­i­pat­ed. And Clarus’ man­ag­ing di­rec­tor Em­mett Cun­ning­ham is jump­ing on the board.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

The drug, known as ofatumumab or Arzerra, has performed consistently well across late-stage trials in patients with the most common form of MS, including in head-to-head studies against Sanofi’s old blockbuster Aubagio. But, if the drug is approved, Novartis will find itself in a crosstown game of catch-up; since a 2017 approval, Roche’s Ocrevus has become the second best-selling MS drug on the market, nearly eclipsing Biogen’s Tecfidera last quarter with over a $1 billion in sales.

Coro­n­avirus out­break threat­ens short­age of 150 drugs — re­port

American patients who suffer from conditions other than Covid-19 could feel the impact of the coronavirus due to shortage of drugs — as 150 prescription drugs are now reportedly on a list of at-risk therapies. The list spans “antibiotics, generics and some branded drugs without alternatives,” Axios reported citing sources familiar with the list. The FDA declined to comment.

Although factories in China are gradually reopening, restrictions in travel and disruptions at transit hubs are still slowing down production. An Indian company that relies on active pharmaceutical ingredients (API) from China told Bloomberg last week that it’s seeing prices of commonly used drugs jump by 40% to 70%.

Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

Tim Mayleben (file photo)

Es­pe­ri­on's goldilocks cho­les­terol fight­er wins FDA ap­proval — will its 'tra­di­tion­al' pric­ing ap­proach spur adop­tion?

It’s more effective than decades-old statins but not as good as the injectable PCSK9 — the goldilocks treatment for cholesterol-lowering, bempedoic acid, has secured FDA approval.

Its maker, Esperion Therapeutics, is betting that their pricing strategy — a planned list price of between $10 to $11 a day — will help it skirt the pushback the PCSK9 cholesterol fighters, Repatha and Praluent, got from payers for their high sticker prices.

The sky-high expectations for the pair of PCSK9 drugs that were first approved in 2015 quickly simmered — and despite a 60% price cut, coupled with data showing the therapies also significantly cut cardiovascular risk, sales have not really perked up.

Esperion is convinced that by virtue of being a cheaper oral therapy, bempedoic acid will hit that sweet spot in terms of adoption.

“We’re kind of like the old comfortable shoe,” Esperion’s chief commercial officer Mark Glickman remarked in an interview with Endpoints News ahead of the decision date. “It’s an oral product, once-daily and nontitratable — these are things that just resonate so true with patients and physicians and I think we’ve kind of forgotten about that.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.

Deborah Dunsire

The fourth CGRP mi­graine drug is here. Time for Lund­beck to prove it's worth $2B

They may be late, but Lundbeck is now officially in the game for preventing migraine with CGRP drugs.

The FDA has OK’d eptinezumab, the prize in Lundbeck’s $2 billion acquisition of Alder. Like rival offerings from Amgen/Novartis, Eli Lilly and Teva, the antibody blocks the calcitonin gene-related peptide, which is believed to dilate blood vessels in the brain and cause pain.

It will now be sold as Vyepti. The company has yet to announce a price. Amgen and Novartis had set the wholesale acquisition cost of their pioneering Aimovig at $6,900 for a year’s supply before raising it slightly this year; Lilly and Teva had followed suit with Emgality and Ajovy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Tal Zaks (Moderna via YouTube)

For two decades, a new vac­cine tech­nol­o­gy has been slow­ly ap­proach­ing prime time. Now, can it stop a pan­dem­ic?

Two months before the outbreak, Moderna CMO Tal Zaks traveled from Cambridge, MA to Washington DC to meet with Anthony Fauci and the leaders of the National Institutes of Health.

For two years, Moderna had worked closely with NIH researchers to build a new kind of vaccine for MERS, one of the deadliest new viruses to emerge in the 21st century. The program was one test for a new technology designed to be faster, cheaper and more precise than the ways vaccines had been made for over a century. They had gathered evidence the technology could work in principle, and Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases and a longtime advocate for better epidemic preparedness, wanted to see if it, along with a couple of other approaches, could work in a worst-case scenario: A pandemic.

“[We were] trying to find a test case for how to demonstrate if our technology could rapidly prepare,” Zaks told Endpoints News.

Zaks and Fauci, of course, wouldn’t have to wait to develop a new test. By year’s end, an outbreak in China would short circuit the need for one and throw them into 24/7 work on a real-world emergency. They also weren’t the only ones with new technology who saw a chance to help in a crisis.

An ocean away, Lidia Oostvogels was still on vacation and relaxing at her mother’s house in Belgium when her Facebook started changing. It was days after Christmas and on most people’s feeds, the news that China had reported a novel virus to the World Health Organization blurred into the stream of holiday sweaters and fir trees. But on Oostvogels’s feed, full of vaccine researchers and virus experts, speculation boiled: There was a virus in China, something contained to the country, but “exotic,” “weird,” and maybe having to do with animals. Maybe a coronavirus.

Lidia Oostvogels

“I was immediately thinking like, ‘Hey, this is something that if needed, we can play a role,'” Oostvogels told Endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Drug ap­provals: FDA pub­lish­es dataset of CDER ap­provals since 1985

To provide researchers with more accurate and accessible data about historic drug approvals, the FDA on Friday released a dataset containing information about all new drugs and biologics approved by the Center for Drug Evaluation and Research (CDER) dating back to 1985.

“FDA created the compilation to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug,” the FDA writes, adding that the compilation should accurately reflect “the state of each application at the time of initial regulatory approval.”