Ebo­la! Zi­ka! ATM! In­ovio CEO Kim called out for gam­ing pan­dem­ic pan­ic

 

CN­BC’s Melis­sa Lee and Meg Tir­rell with In­ovio CEO Joseph Kim.

“You seem to be John­ny-on-the-spot when it comes to in­fec­tious dis­eases. When­ev­er some­thing pops up it seems In­ovio comes back in­to the news” and says its work­ing on a vac­cine.

That com­ment from CN­BC’s Melis­sa Lee set the stage for an un­usu­al­ly blunt in­ter­view with In­ovio ($INO) CEO Joseph Kim, with her col­league Meg Tir­rell jump­ing in with a se­ries of tough ques­tions.

The two CN­BC re­porters were all busi­ness in the in­ter­view, high­light­ing In­ovio’s habit of scram­bling on­to every pan­dem­ic wag­on that gets rolling and is­su­ing a string of bull­ish pro­jec­tions about lead­ing the race for a new vac­cine—all while rais­ing more cash from in­vestors.

Now that Zi­ka has come along, spurring scary head­lines around the plan­et, the com­pa­ny has a pipeline with 14 projects, but noth­ing has been ap­proved in the 37 years since the biotech was found­ed.

The ques­tions may have been tough, but the an­swers were all soft and fuzzy.

Spread too thin?

Kim: “I think our pipeline is very full and very pro­duc­tive.”

That yet-to-be-start­ed Phase III piv­otal study for cer­vi­cal dys­pla­sia. The Phase II was wrapped two years ago. Why the de­lay?

Kim: The FDA meet­ing was just a cou­ple of months ago, and be­sides, “it takes a long time to take new, dis­rup­tive tech­nolo­gies for these im­por­tant dis­eases for­ward.”

Our CN­BC Ebo­la in­ter­view oc­curred in No­vem­ber, 2014. Do you have the fund­ing and fo­cus nec­es­sary to com­plete the work?

Kim: There are 200 ded­i­cat­ed sci­en­tists and vac­cine de­vel­op­ers.

“We have a fab­u­lous tech make this prod­uct and ad­vance them.”

And lest any­one for­get: “The med­ical prod­uct de­vel­op­ment is a long and ar­du­ous road.”

In the mean­time, In­ovio con­tin­ues to match fundrais­ing with its pan­dem­ic PR. The biotech end­ed last week by fil­ing a $50 mil­lion ATM. It start­ed this week by an­nounc­ing that it was ready to roll on a Phase I study for its Zi­ka vac­cine, af­ter tout­ing pre­clin­i­cal da­ta.

With Zi­ka spread­ing fast, In­ovio wants you to know it’s rac­ing as fast as it can.

“We plan to dose our first sub­jects in the next weeks and ex­pect to re­port phase I in­ter­im re­sults lat­er this year,” not­ed the com­pa­ny’s PR.

And if Zi­ka doesn’t pan out, there’s an­oth­er pan­dem­ic ly­ing around the next cor­ner.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

UP­DAT­ED: In a land­mark first glimpse of hu­man da­ta from Ver­tex, CRISPR/Cas9 gene ther­a­py sig­nals ear­ly ben­e­fit

Preliminary data on two patients with blood disorders that have been administered with Vertex and partner CRISPR Therapeutics’ gene-editing therapy suggest the technology is safe and effective, marking the first instance of the benefit of the use of CRISPR/Cas9 technology in humans suffering from disease.

Patients in these phase I/II studies give up peripheral blood from which hematopoietic stem and progenitor cells are isolated. The cells are tinkered with using CRISPR/Cas9 technology, and the edited cells — CTX001 — are infused back into the patient via a stem cell transplant. The objective of CTX001 is to fix the errant hemoglobin gene in patents with two blood disorders: beta-thalassemia and sickle cell disease, by unleashing the production of fetal hemoglobin.

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UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Stephen Hahn (via Senate HELP Committee)

Stephen Hahn gets through Sen­ate’s soft­ball job in­ter­view — but most­ly plays dodge­ball on the is­sues fac­ing the FDA

Anyone looking for fresh insights on what kind of FDA commissioner Stephen Hahn will be got precious few clues during Wednesday’s Senate hearing on the nomination.

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Op­di­vo/Yer­voy com­bo for melanoma fails in key pa­tient pop­u­la­tion

Bristol-Myers Squibb’s efforts to expand their checkpoint inhibitor combination have run into another recalcitrant cancer.

The NJ-based pharma announced that a combination of Yervoy and Opdivo didn’t beat out Opdivo alone in patients with resected high-risk melanoma who had very low levels of PD-L1. The drug combo couldn’t improve recurrence-free survival in these post-surgery patients.

Ver­tex's stel­lar quar­ter car­ries on with French re­im­burse­ment deal

Vertex’s golden quarter just got brighter. About a month after the US drugmaker finally clinched a deal with UK authorities to cover its slate of cystic fibrosis (CF) drugs following years of protracted negotiations, the company on Wednesday secured a deal with France for its CF therapy, Orkambi.

After the UK, France has one of the largest CF populations outside the United States. Achieving French reimbursement unlocks an ~7000-patient CF population, around ~2500-3000 of which will likely be eligible to receive (and be reimbursed for) Orkambi, Stifel’s Paul Matteis wrote in a note.

Nello Mainolfi, Kymera via Youtube

Kymera hands the helm to No­var­tis vet — and found­ing CSO — Nel­lo Main­olfi

Kymera Therapeutics is turning to a co-founder to run the company.
The protein degradation specialist with a deep-pocket syndicate behind them has opted to give the helm officially to Nello Mainolfi. The new CEO is a veteran of the Novartis Institutes for Biomedical Research. He joined Atlas Venture in their entrepreneur-in-residence program and helped launch Kymera as the CSO three years ago with Atlas’ Bruce Booth.
The boast at Kymera is that they’re angling to create a new class of protein degraders, a popular field where there’s been a variety of startups. One of its chief advocates is NIBR head Jay Bradner, who launched C4 just ahead of joining Novartis, where he’s also been doing new work in the field.