Unum racks up yet an­oth­er FDA hold as it twists its way through a re­struc­tur­ing, look­ing for a fresh start with a pre­clin­i­cal drug

Chuck Wil­son Unum

The drum­beat of bad news at Unum Ther­a­peu­tics just won’t stop.

In a fil­ing with the SEC to­day, the trou­bled biotech re­port­ed that its ex­per­i­men­tal ther­a­py AC­TR707 — used in com­bi­na­tion with rit­ux­imab in pa­tients with CD20+ B cell non-Hodgkin lym­phoma — may have been re­spon­si­ble for a pos­si­ble new ma­lig­nan­cy. The FDA slapped a par­tial hold on the study March 4 while the agency and the biotech ex­plore what hap­pened to trig­ger the Grade 3 SAE.

Unum’s stock, which had al­ready sunk deep in­to pen­ny stock ter­rain, dropped 5% Mon­day evening af­ter an 8% drop over the day, leav­ing the stock at 46 cents. The com­pa­ny is helmed by Chuck Wil­son and chaired by At­las’ Bruce Booth. And they’ve had to deal with one set­back af­ter the next since fil­ing to go pub­lic 2 years ago.

The hold came ex­act­ly 2 days af­ter the biotech re­port­ed that it was re­struc­tur­ing the com­pa­ny, lay­ing off 60% of the staff, and re­fo­cus­ing ef­forts away from the trou­ble­some AC­TR707 in fa­vor of a pre­clin­i­cal sol­id tu­mor ef­fort in the pipeline. At the same time, CSO Seth Et­ten­berg re­signed af­ter 5 years with Unum.

Seth Et­ten­berg Unum

Last sum­mer the biotech re­port­ed that its then pre­mier drug — AC­TR087 — was linked to se­ri­ous ad­verse events that in­clud­ed grade 3 neu­ro­tox­i­c­i­ty and cy­tomegalovirus in­fec­tion as well as grade 4 res­pi­ra­to­ry dis­tress, trig­ger­ing a hold. That came af­ter the IPO, when Unum wait­ed un­til it filed the S-1 to re­port that their drug was linked to two deaths — with 2 cas­es of AC­TR087-re­lat­ed se­vere CRS while one pa­tient died from AC­TR087-re­lat­ed neu­ro­tox­i­c­i­ty.

That al­so trig­gered a hold which was lift­ed just ahead of the IPO.

Unum plans to file an IND ap­pli­ca­tion for BOXR1030 in late 2020 as it works to get back in­to the clin­ic. It has a long way to go, though, in restor­ing faith among in­vestors.

So­cial im­age: Chuck Wil­son, Unum Ther­a­peu­tics

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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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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'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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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.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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