IDO-de­rived can­cer vac­cine scores in com­bo tri­al with Keytru­da; Vir teams up with WuXi on coro­n­avirus an­ti­bod­ies

→ Copen­hagen-based IO Biotech said that its can­cer vac­cine has passed the high bar set for its in­ter­im fu­til­i­ty analy­sis in Phase II, show­ing “a sub­stan­tial­ly high­er” over­all re­sponse rate among non-small cell lung can­cer pa­tients when com­bined to Keytru­da than the PD-1 alone —which ac­cord­ing to the com­pa­ny in­duced his­tor­i­cal ORR of 39%.

In­ves­ti­ga­tors will car­ry on eval­u­at­ing IO-102 plus Keytru­da, with fi­nal da­ta ex­pect­ed by the end of the year. The can­di­date is an IDO-de­rived pep­tide se­quence de­signed to stir up T cell ac­tion against IDO — the en­zyme tar­get for an ill-fat­ed class of small mol­e­cule drugs. “In that sense you have flags on the sur­face of im­mune sup­pres­sive cells and [tu­mor cells] that our T cells can rec­og­nize and there­by ac­tu­al­ly get rid of those IDO pos­i­tive cells, hence a com­plete­ly dif­fer­ent MOA than IDO SMI,” CEO Mai-Britt Zoc­ca told End­points News.

IO Biotech is fund­ing the study while part­ner Mer­ck gets to share the re­sults. A cock­tail of IO102 and IO103 — which di­rects T cells against PD-L1 — is be­ing test­ed in com­bi­na­tion with Op­di­vo for melanoma pa­tients.

→ A month af­ter join­ing the hunt for an­ti­bod­ies that could treat Covid-19, Vir Biotech­nol­o­gy is en­list­ing WuXi Bi­o­log­ics to do the cell-line de­vel­op­ment, process and for­mu­la­tion de­vel­op­ment as well as ini­tial man­u­fac­tur­ing. The San Fran­cis­co-based start­up said it’s iden­ti­fied a num­ber of mon­o­clon­al an­ti­bod­ies that bind to SARS-CoV-2, iso­lat­ed from in­di­vid­u­als who had sur­vived SARS. A deal with WuXi — which gives the pow­er­ful CRO rights to com­mer­cial­ize in Chi­na — po­si­tions them for quick ad­vance­ment, CEO George Scan­gos said.

As­traZeneca has di­vest­ed an­oth­er gas­troin­testi­nal drug, col­lect­ing $52.5 mil­lion up­front from Red­Hill Bio­phar­ma for par­tial rights to Movan­tik. The drug, which was orig­i­nal­ly de­vel­oped by Nek­tar Ther­a­peu­tics to treat opi­oid-in­duced con­sti­pa­tion, gen­er­at­ed US sales of $96 mil­lion last year (Dai­ichi Sankyo shares some of the prof­its). As­traZeneca will con­tin­ue to sup­ply the drug for a while.

→ Parisian biotech Sci­pio bio­science, which helps re­search and clin­i­cal labs with sin­gle-cell se­quenc­ing, has se­cured €6 mil­lion in Se­ries A fund­ing. The mon­ey will fu­el the fi­nal de­vel­op­ment of its sin­gle-cell RNA-se­quenc­ing kit, as well as mar­ket­ing and busi­ness de­vel­op­ment ef­forts to pre­pare for com­mer­cial launch in 2022.

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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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.

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'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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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.