In sal­vage ef­fort, Sel­l­as cher­ry picks some pos­i­tive mid-stage can­cer vac­cine da­ta

Eight months af­ter Sel­l­as $SLS re­verse merged its way on­to Nas­daq through what was left of Gale­na fol­low­ing the piv­otal im­plo­sion of Neu­Vax, the mi­cro­cap biotech has cher­ry picked its way through some Phase IIb da­ta to high­light ev­i­dence of the can­cer vac­cine’s pos­si­ble po­ten­tial.

An­ge­los Ster­giou

Through a spokesper­son, Sel­l­as’ CEO An­ge­los Ster­giou re­fused to tell me what the p val­ue of the pri­ma­ry end­point in its study was, pre­fer­ring to high­light a clin­i­cal ben­e­fit for Neu­Vax in pro­long­ing dis­ease-free sur­vival when com­bined with Her­ceptin in treat­ing a group of breast can­cer pa­tients with triple-neg­a­tive breast can­cer. 

The biotech’s bad­ly bat­tered stock bounced 160% high­er on their re­lease.

Sel­l­as grabbed Gale­na af­ter the biotech’s shares were evis­cer­at­ed in June, 2016, drop­ping 78% af­ter the com­pa­ny an­nounced that it had stopped a Phase III study of its lead can­cer vac­cine af­ter the mon­i­tor­ing com­mit­tee flagged it for fail­ing to help breast can­cer vic­tims. Neu­Vax is part of a wave of can­cer vac­cines that flopped bad­ly in key stud­ies.

Ster­giou said in a state­ment that the biotech planned to ad­vance the can­cer vac­cine through a “part­ner­ship or oth­er strate­gic col­lab­o­ra­tion,” and he of­fered this quote about the re­sults via email:

It’s im­por­tant to keep in mind that this is an ex­plorato­ry tri­al in­tend­ed to find the right pop­u­la­tion to pur­sue in a de­fin­i­tive tri­al.  As such, we aren’t as sen­si­tive to al­pha spend which could cur­tail a de­fin­i­tive tri­al.  We do be­lieve that the curves will con­tin­ue to sep­a­rate as we be­lieve that the boost­er-main­tained im­muno­log­ic mem­o­ry helps pro­tect these pa­tients from late re­cur­rences. What is im­por­tant to note, and al­so stat­ed by the Da­ta Safe­ty Mon­i­tor­ing Board, is that we iden­ti­fied the TNBC pop­u­la­tion and, as per DSMB, it is not nec­es­sary to con­tin­ue the study due to the TNBC da­ta and to con­tin­ue fol­low­ing pa­tients for safe­ty but al­low­ing pa­tients to con­tin­ue their treat­ment.

The old Gale­na had been in and out of trou­ble ahead of the Sel­l­as takeover. Aside from the Neu­Vax set­back in 2016, the DoJ al­so stepped in to in­ves­ti­gate its pro­mo­tion­al prac­tices for the opi­oid Ab­stral. Back in 2011 the com­pa­ny changed its name from RXi to Gale­na, split­ting op­er­a­tions.

As for Sel­l­as, it once struck a high-pro­file li­cens­ing deal with Fo­s­un in 2013, but the deal col­lapsed with both sides ac­cus­ing the oth­er of fail­ing to make good. Fo­s­un said Sel­l­as nev­er de­liv­ered the cash it promised. Lat­er Sel­l­as moved from Zurich to New York to get in­to can­cer drug de­vel­op­ment.

Sel­l­as has a mar­ket cap of about $20 mil­lion. Its shares have steadi­ly lost val­ue over the years, at one point re­quir­ing a 1 for 20 re­verse split to get out of pen­ny stock ter­ri­to­ry.

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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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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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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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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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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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.