In two-way race with No­var­tis, Mer­ck scores first reg­u­la­to­ry ap­proval for tar­get­ed lung can­cer drug

In the two-man race to de­vel­op a new in­hibitor for an ag­gres­sive form of lung can­cer, Mer­ck KGaA has won the first reg­u­la­to­ry ap­proval.

Japan be­came the first coun­try to ap­prove the phar­ma gi­ant’s MET in­hibitor tepo­tinib, the first tar­get­ed pill for the 3 to 4% of non-small lung can­cer pa­tients with a MET mu­ta­tion. In a Phase II study pub­lished last year in Clin­i­cal On­col­o­gy, just over half of the 89 pa­tients re­spond­ed to the treat­ment. The re­sponse last­ed for a me­di­an of 9.8 months.

Mer­ck pre­sent­ed that da­ta at AS­CO a year ago — the same day No­var­tis pre­sent­ed da­ta on their MET in­hibitor cap­ma­tinib, which showed a 68% over­all re­sponse in first-line pa­tients and 41% in sec­ond-line pa­tients. At the time, Mer­ck’s da­ta showed 59% in first-line pa­tients and 45% in sec­ond-line pa­tients. Du­ra­tion of re­sponse was sim­i­lar, al­though Mer­ck’s drug looked to be more tol­er­a­ble.

The Japan­ese de­ci­sion clears tepo­tinib as both a first and lat­er-line ther­a­py and means it will be the first of the two drugs to reach pa­tients. No­var­tis, though, has the lead on US ap­proval. Last month, the Swiss drug­mak­er filed for FDA ap­proval and won pri­or­i­ty re­view. They didn’t an­nounce a PDU­FA date, but bar­ring any pan­dem­ic-re­lat­ed dis­rup­tions or oth­er de­lays, the award should cut four months off the usu­al process and bring a de­ci­sion in Au­gust.

Mer­ck shouldn’t be far be­hind. They, like No­var­tis, won break­through sta­tus for the drug — of­ten a pre­cur­sor to pri­or­i­ty re­view — and are thought to be near­ing an FDA sub­mis­sion.

The spe­cif­ic mu­ta­tion both drugs tar­get is known as a MET ex­on 14 skip­ping mu­ta­tion. That ex­on codes for an E3 lig­ase bind­ing site, the area the body’s pro­tein degra­da­tion sys­tem latch­es on­to to dis­pose of the pro­tein. Its ab­sence has sev­er­al down­stream ef­fects, in­clud­ing an ac­cu­mu­la­tion of MET, that help give rise to can­cer.

No­var­tis CEO Vas Narasimhan in­clud­ed the com­pa­ny’s MET in­hibitor as one of sev­en po­ten­tial block­busters the com­pa­ny was hop­ing to bring on to the mar­ket in 2020. It was orig­i­nal­ly de­vel­oped by In­cyte.

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Aaron Royston, venBio

In­vest­ing in the time of coro­n­avirus: the good, the bad and the hope­ful, as biotech VC firms close funds worth $3B

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

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Lil­ly Asia Ven­tures co-leads $100M+ round for Chi­nese biotech and its late-stage lu­pus drug

Can a Chinese biotech deliver the first new lupus drug in decades? A high-profile group of VCs are betting on it.

Lilly Asia Ventures and Lake Bleu Capital are the co-headliners for RemeGen’s latest raise, which brought in more than $100 million. Hudson Bay Capital and Vivo Capital — which, like LAV, also invested in a pre-IPO round for Legend Biotech unveiled today — chimed in, as did Janchor Partners and OrbiMed.

GSK's asth­ma bi­o­log­ic Nu­cala is one step clos­er to ap­proval in key chron­ic rhi­nos­i­nusi­tis pop­u­la­tion

Months after GSK’s Nucala cleared in a pivotal rare blood disorder study, the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps.

The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps.

Servi­er bags an an­ti­body spe­cial­ist in its lat­est on­col­o­gy M&A deal with plans to add the plat­form tech

Whatever Servier learned about Symphogen during their 2-year development alliance must have significantly whetted their appetite for an acquisition.

Paris-based Servier announced Friday that it has struck a deal to buy out the antibody expert. The acquisition comes 2 years after Servier acquired Shire’s cancer business for $2.4 billion. They’ve been working with Symphogen on a slate of programs, including some favs – PD-1, LAG3 and TIM3 — where they are looking to differentiate themselves from the more prominent drugs in these niches.

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Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

→ Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is joining the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and has led global vaccine R&D since 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research.  IAVI is led by Mark Feinberg, the former CSO of Merck Vaccines.