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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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