Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III tri­al of its chikun­gun­ya vac­cine, the Vi­en­na-based biotech has closed out €40 mil­lion ($44 mil­lion) to foot the clin­i­cal and man­u­fac­tur­ing bills.

Erich Tauber

Its heavy­weight part­ners at Mer­ck — which signed a pact around a mys­te­ri­ous “block­buster in­di­ca­tion” last month — jumped in­to the Se­ries D, led by new in­vestors Far­al­lon Cap­i­tal and Hadean Ven­tures. Ad­ju­vant Cap­i­tal al­so joined, as did cur­rent in­vestors Glob­al Health In­vest­ment Fund, aws Gru­en­der­fonds, Omnes Cap­i­tal, Ven­tech and Welling­ton Part­ners Life Sci­ences.

Themis had planned to go pub­lic on Eu­ronext Am­s­ter­dam a year ago but end­ed up post­pon­ing the IPO due to mar­ket con­di­tions, lead­ing to the even­tu­al de­ci­sion to raise a pri­vate round, CEO Erich Tauber said.

With da­ta on the chikun­gun­ya vac­cine, MV-CHIK, ex­pect­ed in the sec­ond half of next year, Themis is in talks with reg­u­la­tors around the world about po­ten­tial ap­proval and any fol­low-up safe­ty stud­ies. The FDA’s pri­or­i­ty re­view vouch­er is a strong in­cen­tive for tar­get­ing US ap­proval first, Tauber said. Themis’ team of 30 — clus­tered in Vi­en­na with small of­fices in Boston and Zurich — might al­so seek help tack­ling what an­a­lysts have called a $500 mil­lion to $800 mil­lion com­mer­cial op­por­tu­ni­ty, but de­ci­sions about part­ner­ships are yet to be made, he added.

Themis is al­so al­lo­cat­ing parts of the new fund­ing to test in Phase I whether its measles virus vac­cine vec­tor tech­nol­o­gy — first li­censed from the In­sti­tut Pas­teur — can treat col­orec­tal can­cer.

Its ther­a­py comes in two parts: First pa­tients re­ceive the virus, which it­self has can­cer killing abil­i­ties, but al­so comes with a gene en­cod­ing for an en­zyme. That en­zyme cat­alyzes the con­ver­sion of an in­ac­tive pro­drug that pa­tients sub­se­quent­ly take, turn­ing it in­to a lo­cal chemother­a­py.

Max Planck in­ves­ti­ga­tor Ul­rich Lauer came up with the ap­proach and Themis gained ac­cess late last year.

They will like­ly com­bine this one-two punch ap­proach with check­point in­hibitors in clin­i­cal stud­ies, Tauber said.

Oth­er ap­pli­ca­tions of the measles virus vac­cine tech­nol­o­gy in­clude a slate of in­fec­tious dis­ease pro­grams rang­ing from Zi­ka and Las­sa fever to res­pi­ra­to­ry syn­cy­tial virus (RSV), cy­tomegalovirus (CMV), norovirus and Mid­dle East Res­pi­ra­to­ry Syn­drome (MERS). But those are fund­ed via pub­lic part­ner­ships or grants.

It’s un­clear whether Mer­ck is on­board for the more tra­di­tion­al vac­cine pro­grams or the im­muno-on­col­o­gy prospects.

“It’s a vote of con­fi­dence for us, and we’re al­so hap­py that we can use anti­gens from Mer­ck and test them in our sys­tem” is as far as Tauber was will­ing to go.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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